web analytics
a

Facebook

Twitter

Copyright 2015 Libero Themes.
All Rights Reserved.

8:30 - 6:00

Our Office Hours Mon. - Fri.

703-406-7616

Call For Free 15/M Consultation

Facebook

Twitter

Search
Menu
Westlake Legal Group > Posts tagged "Food and Drug Administration"

When Will You Be Able to Get a Coronavirus Vaccine?

Westlake Legal Group 17VIRUS-VAXTIMELINE1-facebookJumbo When Will You Be Able to Get a Coronavirus Vaccine? Vaccination and Immunization United States Politics and Government Trump, Donald J Shortages Redfield, Robert R Pfizer Inc Novavax Inc Moderna Inc Johnson&Johnson Food and Drug Administration Coronavirus (2019-nCoV) Clinical Trials Centers for Disease Control and Prevention AstraZeneca PLC Advisory Committee on Immunization Practices

Americans are desperate to know when a coronavirus vaccine will be available to finally curb the pandemic that has already taken nearly 200,000 lives in the United States, and allow schools and the broader economy to reopen.

Scientists and vaccine makers have long said that a handful of vaccines could be available by the end of the year, if everything goes according to plan. But in recent weeks, President Trump has insisted that a vaccine will be ready before the presidential election on Nov. 3, raising fears that one could be rushed against the advice of scientists and regulators.

Testing and producing a vaccine is a complex process with a lot of uncertainties. But the best guess for now, experts say, is this: If every aspect of the vaccines’ development and distribution goes exactly as planned — and history has shown that rarely happens — certain people in high-risk groups could get vaccinated this year. Most other Americans, however, will quite likely have to wait until well into next year.

At a news conference on Wednesday evening, Mr. Trump doubled down on that unrealistic timeline, saying that a vaccine could be ready by mid-October and that it would then be made available “immediately” to the general public.

“We’re not looking to say, ‘Gee, in six months, we’re going to start giving it to the general public,’” he said. “No, we want to go immediately.”

In doing so, he contradicted his own director of the Centers for Disease Control and Prevention, Dr. Robert R. Redfield, who had testified to senators earlier in the day that a vaccine would most likely not be available until the middle of next year. Mr. Trump’s statements also contrasted with comments made Wednesday morning by officials with Operation Warp Speed, the federal effort to accelerate a vaccine, who said that supplies would be limited in the first months that a vaccine is available.

It was not the first time the president had pushed an accelerated timeline. Just the night before, at a town-hall meeting hosted by ABC News, he said one could be available in three to four weeks.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-09-17T18:32:51.005Z

Dr. Redfield’s timeline is consistent with the best guess estimates from other vaccine experts, who say that the general public won’t have access to the vaccine until February at the very earliest, and possibly more like July or August.

Of the three companies with vaccines in late-stage clinical trials in the United States, just one — Pfizer — has said that it could have initial results by the end of October. The other two companies, Moderna and AstraZeneca, have been more vague, saying only that they hope for results before the end of the year. If a coronavirus vaccine were to show results this year, it would shatter the previous record of four years for the development of a new vaccine.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the Food and Drug Administration’s vaccine advisory panel, was skeptical that Pfizer could be so sure of its timeline. “I think it’s irresponsible — they don’t know,” he said. “I think the more responsible answer is, ‘Hopefully, we’ll know something by the beginning of next year.’ That would seem to me to be the most likely scenario.”

Moderna’s top executives said in interviews this week that they could have initial results by November. But a trial blueprint the company released on Thursday indicated an even longer timeline, suggesting that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Later analyses, projected for March and May, are more likely to provide an answer, the company said in its blueprint. (A company spokesman said the November estimate is an updated assessment of what was in the blueprint.)

AstraZeneca’s timeline is also in question after it halted global trials this month because of a participant who had developed severe neurological symptoms after receiving the experimental vaccine. The company has not released details about the medical condition of the person, nor has it said whether the reaction was because of the vaccine. The trials have since resumed in the United Kingdom and in Brazil, but not in the United States, where it has been paused since Sept. 6.

While clinical trials are underway, independent panels of experts periodically check in on the data. If the vaccine shows signs that it is extremely effective, the board could decide it would be unethical to continue the trial and keep giving some participants a placebo. This outside panel could also ask a company to stop a trial if it was not preventing Covid-19 cases, or if there were serious safety concerns.

Whether the vaccine is effective is determined by comparing how many people in each group — the vaccine group and the placebo group — develop the disease. If many more people in the placebo group get infected, that means the vaccine works. As a result, the trials’ speed is determined by how fast the virus is spreading in the communities where trials are underway. Organizers try to guess where infections are on the rise and set up trials there, but in a fast-moving pandemic, that’s not always easy.

Trial pauses for safety reasons — like the one recently announced by AstraZeneca — could also slow down the timeline, even if the safety problems are ultimately found to be unrelated to the vaccine.

Once the results are available, the Food and Drug Administration will review the data and either issue an emergency authorization — most likely for specific, high-risk groups of people like health care workers — or a broader approval for commercial licensure. Either way, the agency has said that it will consult with an advisory board of experts before making a decision.

Companies have been in contact with F.D.A. officials all along the way, and many experts predict that the agency will be able to approve an emergency authorization within days, if the results are clear enough.

The best-guess range from scientists, investors and federal health officials is the first half of next year.

Even if one of the front-runners gets an answer about its vaccine this year, too few vaccines will have been produced to distribute them widely to the public. The head of Operation Warp Speed, Dr. Moncef Slaoui, told NPR that he estimated about 20 to 30 million doses of a vaccine would be ready by the end of the year, far short of the 100 million doses that Mr. Trump said Wednesday. (The front-runner vaccines all require two doses, given several weeks apart, further complicating the process.)

Dr. Slaoui also recently said that Americans would most likely not be widely vaccinated until the middle of 2021, and that the chance of having a vaccine by October or November was “extremely unlikely.”

The first few months of a vaccine’s availability will limit access to high-risk groups like older people or health care workers and police officers.

Peter Lurie, president of the Center for Science in the Public Interest and a former F.D.A. official, said he thought it was not unreasonable to expect that the first batches for high priority groups could be ready by February — “if everything lines up. And the lesson of drug development is that everything hardly ever all lines up.”

Earlier this month, the C.D.C. told public health agencies that two million doses of a vaccine might be available by the end of October, with 10 to 20 million doses possibly available by November, and 20 to 30 million by the end of December.

In a briefing for reporters Wednesday, officials with Operation Warp Speed described the first few months of a vaccine’s availability as a “constrained” phase when it would be available only to high-priority groups.

Those groups alone include millions of people. At a recent meeting of the Advisory Committee on Immunization Practices of the C.D.C., an agency official presented a slide showing that in the United States, there are as many as 20 million health care workers, up to 80 million essential workers and about 53 million people older than 65. Each of those people would need two doses of the vaccine for it to be effective.

For everyone else, the timing depends on the speed of manufacturing and distribution, and a willingness by the public to actually get vaccinated.

In the best-case scenario, additional vaccines could become available to the public early next year. Johnson & Johnson has said it expected to begin late-stage trials of its vaccine this month, and another company, Novavax, could begin its trial soon.

Stéphane Bancel, the chief executive of Moderna, said in an interview Wednesday that he expected a global shortage of vaccines well into next year. “In the first half of next year, at least maybe until Labor Day next year, I anticipate that the world is going to be massively supply-constrained, meaning not enough vaccine to vaccinate everybody,” Mr. Bancel said.

And that’s assuming that everyone wants to take a vaccine. Recent polls have shown that is not necessarily the case, especially if the vaccine is seen to have been rushed to market for political reasons.

Carl Zimmer contributed reporting.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

Westlake Legal Group vaccine-makers-keep-safety-details-quiet-alarming-scientists Vaccine Makers Keep Safety Details Quiet, Alarming Scientists Vaccination and Immunization Trump, Donald J Research Pfizer Inc Oxford University Offit, Paul A Moderna Inc Krumholz, Harlan M Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Clinical Trials AstraZeneca PLC

The morning after the world learned that a closely watched clinical trial of a coronavirus vaccine had been halted last week over safety concerns, the company’s chief executive disclosed that a person given the vaccine had experienced serious neurological symptoms.

But the remarks weren’t public. Instead, the chief executive, Pascal Soriot of AstraZeneca, spoke at a closed meeting organized by J.P. Morgan, the investment bank.

AstraZeneca said on Saturday that an outside panel had cleared its trial in Britain to begin again, but the company still has not given any details about the patient’s medical condition, nor has it released a transcript of Mr. Soriot’s remarks to investors, which were reported by the news outlet STAT and later confirmed by an analyst for J.P. Morgan.

Another front-runner in the vaccine race, Pfizer, made a similarly terse announcement on Saturday: The company is proposing to expand its clinical trial to include thousands more participants, but it gave few other details about its plan, including how it would determine the effectiveness of the vaccine in its larger study.

It’s standard for drug companies to withhold details of clinical trials until after they are completed, tenaciously guarding their intellectual property and competitive edge. But these are extraordinary times, and now there is a growing outcry among independent scientists and public health experts who are pushing the companies to be far more open with the public in the midst of a pandemic that has already killed more than 193,000 people in the United States.

These experts say American taxpayers are entitled to know more since the federal government has committed billions of dollars to vaccine research and to buying the vaccines once they’re approved. And greater transparency could also help bolster faltering public confidence in vaccines at a time when a growing number of Americans fear President Trump will pressure federal regulators to approve a vaccine before it is proved safe and effective.

“Trust is in short supply,” said Dr. Harlan Krumholz, a cardiologist and health care researcher at Yale University in New Haven, Conn., who has spent years prodding companies and academic researchers to share more trial data with outside scientists. “And the more that they can share, the better off we are.”

Last week, nine pharmaceutical companies, including AstraZeneca and Pfizer, pledged to “stand with science” and rigorously vet any vaccine for the coronavirus — an unusual pact among competitors. But the researchers said that missing from the joint statement was a promise to share more critical details about their research with the public and the scientific community.

None of the three companies with coronavirus vaccines in advanced clinical trials in the United States have made public the protocols and statistical analysis plans for those trials — the detailed road maps that could help the independent scientists better understand how the trials were designed, and hold the companies accountable if they were to deviate from their plans. In some cases, crucial details about how the trials have been set up — such as at what points an independent board can review early study results, or under what conditions a trial could be stopped early — have not been made public.

“We’ve never had such an important clinical trial — or series of clinical trials — in recent history,” said Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, Calif., and a longtime expert on clinical trials. “Everything should be transparent.”

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-09-12T12:04:20.515Z

Public confidence in the drug companies’ findings and federal regulators’ rigor will be critical in persuading Americans to get vaccinated. A growing number of people are skeptical. A poll by the Kaiser Family Foundation this past week found that nearly two-thirds of Americans — 62 percent — are worried that the Food and Drug Administration will rush to approve a coronavirus vaccine without making sure it is safe and effective, under political pressure from Mr. Trump.

ImageWestlake Legal Group merlin_176725947_318c5cec-7124-475f-9a77-989b2356036c-articleLarge Vaccine Makers Keep Safety Details Quiet, Alarming Scientists Vaccination and Immunization Trump, Donald J Research Pfizer Inc Oxford University Offit, Paul A Moderna Inc Krumholz, Harlan M Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Clinical Trials AstraZeneca PLC
Credit…Hans Pennink/Associated Press

Pharmaceutical companies are counting on their vaccine research to help them rebuild reputations that have been tarnished by soaring drug prices and the industry’s role in fueling the opioid epidemic.

In an effort to restore public trust, senior regulators at the F.D.A. took the highly unusual step of promising in a USA Today op-ed piece on Thursday to uphold the scientific integrity of the process of evaluating treatments and vaccines, and to maintain the agency’s independence.

Representatives for the three companies with vaccine candidates in large, advanced trials in the United States — Moderna, Pfizer and AstraZeneca — said they had released many details about the trials.

Pfizer said in a statement that the novelty of the virus and the fast-moving nature of the coronavirus crisis had meant that the protocol had to be flexible “to enable us to enhance the evaluation of the potential vaccine’s safety and efficacy.” The company said it would publish the full protocol from the trial as part of its submission to a medical journal “that will include results, enrollment criteria and final number of participants enrolled.”

On Saturday, Pfizer said it would ask the F.D.A. for permission to expand its trial to 44,000 participants, from its initial target of 30,000. But the announcement raised new questions about how the company would be able to know the results by its goal of the end of October, with so many new participants. A Pfizer spokeswoman, Amy Rose, said, “We are not going to speak to timing or specifics of any interim analyses.”

AstraZeneca did not initially report that a participant’s illness had halted its clinical trials around the world. The studies were paused last Sunday, but not reported until the news was broken by STAT on Tuesday. The company still has not disclosed the patient’s illness that led to the pause, even though it has discussed the medical condition of another participant who developed multiple sclerosis in July, which led to another brief halt of the trial. That illness was determined to be unrelated to the vaccine.

The company said that Mr. Soriot’s appearance at the J.P. Morgan meeting was part of a long-planned event, and that he largely discussed the company’s business outlook, with a few questions about the trial. The New York Times has reported that the patient developed symptoms consistent with transverse myelitis, or inflammation of the spinal cord.

A spokeswoman for AstraZeneca, Michele Meixell, said that while trial sponsors were required to notify the doctors operating clinical trial sites if an “unexplained event” occurred, “it is not common practice for those pauses to be communicated beyond the clinical community involved in a trial — including the media — in order to protect the privacy of individual participants and maintain the integrity of the trial.”

There is precedent for greater transparency. The large Recovery trial being run by the University of Oxford in Britain — which helped determine that the steroid dexamethasone reduces deaths in patients with Covid-19 — has published its trial protocol and statistical analysis plans.

While the broad outlines of the vaccine trial designs have been made available — including on a federal clinical trial registry — crucial details remain a mystery.

For example, Pfizer’s chief executive has said the company could apply to the F.D.A. for emergency authorization of its vaccine as early as October. But the company has not said how many times — and at what point in the trial — it will allow an independent review board to examine its study data to evaluate whether the evidence of safety and efficacy is strong enough that it can stop the trial early and apply for an emergency approval from federal regulators.

And none of the companies have published the criteria they will use to determine when these outside boards would advise stopping the trial, which could happen if the vaccine showed overwhelming efficacy, if it showed that it did not protect against Covid-19 or if it was linked to serious safety issues.

Credit…Jeenah Moon/Getty Images

These so-called interim analyses are the subject of intense interest, because they are the only way that late stage trials could be halted early.

Company executives have provided some trial details when they have spoken on discussion panels or at investor conferences, or in news releases. But researchers looking for clues have had to comb through transcripts, videos and articles posted online, rather than to examine documents that the companies provided.

The lack of transparency is unacceptable, several researchers said, given that the federal government has billion-dollar deals with each of the companies.

“Look, we paid for it,” said Saad B. Omer, the director of the Yale Institute for Global Health. “So it’s reasonable to ask for it.”

A federal clinical trial registry details the number of trial participants, who should be included and excluded from the study, and the main outcomes. But it only skims the surface, Dr. Krumholz said. “The protocols are much more detailed.”

Peter Doshi, who is on the faculty at University of Maryland School of Pharmacy in Baltimore and an editor with The BMJ, a medical journal, said he recently requested the protocols from Pfizer, Moderna and AstraZeneca. None of the companies shared them, he said.

“I imagine most of the public would like to believe scientists are all sharing their data, that this process is open to scrutiny among the scientific community,” said Dr. Doshi, who has helped pressure drug makers to share trial records with researchers. “Just not true.”

Dr. Doshi said the protocols could help researchers answer important questions about the studies, and possibly to critique them. For example, can the trials determine whether the vaccine can prevent Covid-19 and complications in high-risk groups like older adults? When the researchers test for the coronavirus, how do they account for false results?

Other independent scientists said they were eager to examine the trials’ statistical analysis plans, which would guide them in analyzing the results.

“Frankly, I would love to know what they’re planning to do, and how they’re planning to do it,” said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University in Morgantown.

By making these documents public, outside experts said they would be able to hold the companies accountable if they changed the way they analyzed the results.

“There’s no downside” to sharing the documents, said Dr. Paul A. Offit, a professor at the University of Pennsylvania in Philadelphia who serves on the F.D.A. advisory committee that will review coronavirus vaccines. “People are skittish about these vaccines. I think it helps to be transparent.”

Dr. Omer said he was in favor of the companies releasing the protocols and analysis plans, but he said he also worried that, in the wrong hands, the technical documents could be misinterpreted.

“You cannot kid around with this kind of stuff,” he said. In the long run, however, he said it was to the companies’ advantage to allow qualified researchers to evaluate the plans.

If independent researchers agreed the trials were set up properly — and Dr. Omer said he expected that would be the case — that could help enhance their credibility. They can say: “Hold your horses. No need to jump up and down.”

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Backed by Federal Funds, New Virus Tests Are Hitting the Market

Westlake Legal Group backed-by-federal-funds-new-virus-tests-are-hitting-the-market Backed by Federal Funds, New Virus Tests Are Hitting the Market United States Politics and Government Trump, Donald J Tests (Medical) Regulation and Deregulation of Industry Quidel Corporation national institutes of health Health and Human Services Department Giroir, Brett P Food and Drug Administration Fluidigm Coronavirus (2019-nCoV) Centers for Disease Control and Prevention Budgets and Budgeting Abbott Laboratories

WASHINGTON — The coronavirus pandemic remained a distant threat to many Americans on Jan. 24 when Douglas C. Bryant, the president and chief executive officer of Quidel Corporation, got a call from an official at the Food and Drug Administration.

If the government helped, the official asked, would Quidel make tests to detect coronavirus infections?

Mr. Bryant decided to go for it, even though some experts at the time were predicting the United States would quickly tame any outbreak.

The gamble has paid off. Quidel, a San Diego-based maker of diagnostic tests, developed a swab-based coronavirus test that produced results from an analyzer in 15 minutes. It sold 1.2 million of them for less than $20 apiece to the federal government for use at nursing homes. A grant from the National Institutes of Health is enabling Quidel to expand its production by about 140 million tests a year, company officials said.

With the pandemic still raging as fall approaches, the government’s efforts to support development and deployment of a variety of testing methods are a rare if belated bright spot amid widespread failures to contain the virus.

In the latest round of government backing, the N.I.H. said on Wednesday that it was providing nine more companies with $123.3 million from a $2.5 billion pot of money allocated last spring by the stimulus bill to support testing. That will bring the total amount disbursed so far by the N.I.H. to $372 million across 16 companies.

The goal is to support production of a broad spectrum of tests, making them more widely available and perhaps ultimately as easy to use as a home pregnancy test. Tests must show that they meet the Food and Drug Administration’s standards for safety and accuracy before they can be sold.

“It’s going to be a wonderful competition,” Dr. Francis S. Collins, the N.I.H. director, said in an interview on Tuesday evening.

Yet even as the government helps rush new tests to market, the administration continues to issue conflicting — and sometimes flatly contradictory — messages about how many and what types of tests are needed, when they should be administered and to whom.

President Trump has long derided testing, complaining that it drives up the number of confirmed cases. The lack of a clear national strategy has confused the public, deeply frustrated public health officials and befuddled pharmaceutical executives.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-09-02T21:05:34.070Z

But as testing options have multiplied, easing some of the shortages and laboratory bottlenecks that hampered the early response to the pandemic, universities, employers, state and local governments and other institutions have been increasingly filling in some of the vacuum left by the administration with their own testing plans.

A growing number of businesses — ranging from Soupergirl, a small company in Washington, D.C., with 30 employees that makes vegan soups, to Amazon, the world’s biggest retailer — are testing their workers.

The National Basketball Association allowed Yale University scientists access to its players for its research identifying the coronavirus in saliva samples. The Food and Drug Administration last month granted emergency use authorization for Yale’s testing method, which aimed to keep the cost to less than $10 per test. Anne Wyllie, an associate research scientist working on the project, said more than 200 laboratories had contacted Yale about it.

Among those interested is Indiana University, which is putting in place a testing program for its 120,000 students, faculty and staff. Arriving students were greeted last month with rapid-result, nasal swab tests before they could move into their dorms. Those who tested positive were either sent home or housed in an isolation dorm.

ImageWestlake Legal Group merlin_176487624_8a41ecf6-108c-41ec-be43-fe1a73b11fd4-articleLarge Backed by Federal Funds, New Virus Tests Are Hitting the Market United States Politics and Government Trump, Donald J Tests (Medical) Regulation and Deregulation of Industry Quidel Corporation national institutes of health Health and Human Services Department Giroir, Brett P Food and Drug Administration Fluidigm Coronavirus (2019-nCoV) Centers for Disease Control and Prevention Budgets and Budgeting Abbott Laboratories
Credit…Jeremy Hogan/Sipa, via Associated Press

Students living off campus submitted their own saliva samples, which were then shipped to laboratories. The university is continuing to test on a targeted basis, aiming for broader screening soon, using its own laboratories. The cost is $10 million and counting.

“We figured this out ourselves,” said Dr. Aaron E. Carroll, an associate dean at the university’s medical school, who helped devise the program. Federal guidelines were of little use, he said.

Trump administration officials like Adm. Brett P. Giroir, the testing czar and an assistant secretary of health, say they want states and localities to create their own testing plans that fit their specific needs rather than to be forced to follow federal dictates. But many experts complain that the lack of federal decision-making — including how many tests a day the United States should aim for — is an impediment in the nation’s battle against the virus, which so far has killed more than 184,000 people and infected more than six million.

“Let’s not just say we are ramping up and hope we get there. Let’s have a goal in mind,” said Dr. Mark McClellan, the director of the Duke-Margolis Center for Health Policy and the commissioner of the Food and Drug Administration under former President George W. Bush. “It’s not just a matter of getting the tests to market.”

In a recent interview, Dr. Bruce J. Tromberg, who directs the N.I.H.’s test development program, estimated that the United States needed to test about six million people a day, citing reports by experts at the Rockefeller Foundation and other organizations. Without federal assistance, he said, companies would at best produce only half that number by the end of the year.

The government’s purchases of hundreds of millions of tests for nursing homes and other hot spots has helped spur development and manufacturing. The N.I.H. is trying to encourage even more production, Dr. Tromberg said, with grants that have allowed companies to build laboratories and open new manufacturing lines.

Six million daily tests “is what we are on the trajectory for,” he said.

But in a briefing last month with reporters, Admiral Giroir appeared to contradict that. “I am really tired of hearing from people who are not involved in the system that we need millions of tests every day,” he said. “We are doing the appropriate amount of testing now.”

Then, in an interview on Friday, Admiral Giroir suggested that he had misspoken. “Since Day 1, we’ve been trying to increase the number of tests,” he said.

Credit…T.J. Kirkpatrick for The New York Times

Admiral Giroir has laid out broad principles for a national strategy: People with symptoms should be tested, and some level of surveillance — testing of large swaths of the population, regardless of symptoms — should be conducted to pinpoint outbreaks. Those can then be controlled by surges of tests, he has said.

But beyond that broad outline lies much uncertainty. To the dismay of many public health officials, for example, the Centers for Disease Control and Prevention has publicly wavered about whether people who have been in close contact with an infected person but who have no symptoms should be tested.

.css-1wxds7f{margin-bottom:10px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:0.875rem;line-height:1.25rem;color:#333 !important;}.css-2al2sh{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;margin-top:20px;margin-bottom:5px;font-weight:700;}@media (min-width:740px){.css-2al2sh{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}@media (min-width:740px){.css-2al2sh{margin-bottom:10px;}}.css-1yyoic1{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-1yyoic1{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-zkk2wn{margin-bottom:20px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.875rem;line-height:1.5625rem;color:#333;}.css-1dvfdxo{margin:10px auto 0px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.5625rem;color:#121212;}@media (min-width:740px){.css-1dvfdxo{font-size:1.25rem;line-height:1.875rem;}}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-19mumt8{background-color:white;margin:30px 0;padding:0 20px;max-width:510px;}@media (min-width:740px){.css-19mumt8{margin:40px auto;}}.css-19mumt8:focus{outline:1px solid #e2e2e2;}.css-19mumt8 a{color:#326891;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ccd9e3;}.css-19mumt8 a:visited{color:#333;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ddd;}.css-19mumt8 a:hover{border-bottom:none;}.css-19mumt8[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-19mumt8[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-19mumt8[data-truncated] .css-5gimkt:after{content:’See more’;}.css-19mumt8[data-truncated] .css-6mllg9{opacity:1;}.css-a8d9oz{border-top:5px solid #121212;border-bottom:2px solid #121212;margin:0 auto;padding:5px 0 0;overflow:hidden;}

The government’s $2.5 billion pot of money to develop new tests is split between the N.I.H.’s program, called Rapid Acceleration of Diagnostics, or RADx, and an agency within the Department of Health and Human Services.

One of the new tests, made by the Maryland-based company Maxim Biomedical, is what Dr. Tromberg calls a “dipstick” antigen test that relies on a nasal swab and can deliver results in 15 minutes without any additional instruments. The test has yet to receive an F.D.A. greenlight, Dr. Tromberg said, but “we’re excited.”

So far, the new tests fall short of what some experts argue is most needed: a method that is cheap and simple enough to be widely used at home, twice a week or more, regardless of symptoms. Dr. Collins said the technology for such tests, which might resemble a pregnancy test, is close at hand, but regulatory obstacles remain. No test has been authorized that can be bought over the counter and conducted entirely at home.

Some of the most attention-grabbing developments have taken place without federal grants, although the government remains a large purchaser. Abbott, a major health care company, last month won emergency approval from the Food and Drug Administration for an antigen test that is the size of a credit card, costs about $5, delivers results in 15 minutes and is intended to be given in health care settings to patients who are within a week of the onset of symptoms.

Unlike standard lab-based tests, antigen tests hunt for coronavirus proteins and can run from start to finish in settings such as a doctor’s office, urgent care clinic or pharmacy. So far, the Food and Drug Administration has granted emergency approval to about 180 lab-based tests, but fewer than 10 that can be done outside the lab.

Abbott has said it will produce 50 million tests a month by October. The federal government has agreed to buy 150 million of them, at a cost of $750 million, and will ship them to assisted living centers, nursing homes and other locations.

Credit…Charlie Riedel/Associated Press

Together with such advances, federal officials say the government’s effort is helping to create a kind of testing smorgasbord for consumers.

One recipient of a grant from the N.I.H., a company called Fluidigm, is developing a test that collects saliva samples to be processed in laboratories. Fluidigm’s test received emergency authorization from the Food and Drug Administration last week; with the government’s funding, the company plans to expand its manufacturing capacity to more than one million tests a day by the end of March.

A Massachusetts-based firm called Ginkgo Bioworks is pioneering the use of genome sequencing to detect the coronavirus. Ginkgo used the more than $40 million it received from the N.I.H. to help construct a new laboratory that will run about 250,000 coronavirus tests a day, according to Barry Canton, a co-founder of the company. Customers will be able to purchase the test for about $25, ship their samples to Ginkgo and receive results within about 48 hours.

Some experts question whether the government’s umbrella is wide enough. Ten of the 16 N.I.H. grant recipients require test samples to be processed in a lab. Five others, while simpler and faster, still rely on expensive or cumbersome machines to yield results, making them poor candidates for widespread use.

What the N.I.H. is doing, said Dr. Syra Madad, an infectious disease epidemiologist in New York, “is a subset of what we’re looking for.”

Sharon LaFraniere reported from Washington and Katherine J. Wu from Boston. Kitty Bennett contributed research.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be.

Some of the nation’s leading public health experts are raising a new concern in the endless debate over coronavirus testing in the United States: The standard tests are diagnosing huge numbers of people who may be carrying relatively insignificant amounts of the virus.

Most of these people are not likely to be contagious, and identifying them may contribute to bottlenecks that prevent those who are contagious from being found in time. But researchers say the solution is not to test less, or to skip testing people without symptoms, as recently suggested by the Centers for Disease Control and Prevention.

Instead, new data underscore the need for more widespread use of rapid tests, even if they are less sensitive.

“The decision not to test asymptomatic people is just really backward,” said Dr. Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health, referring to the C.D.C. recommendation.

“In fact, we should be ramping up testing of all different people,” he said, “but we have to do it through whole different mechanisms.”

In what may be a step in this direction, the Trump administration announced on Thursday that it would purchase 150 million rapid tests.

The most widely used diagnostic test for the new coronavirus, called a PCR test, provides a simple yes-no answer to the question of whether a patient is infected.

But similar PCR tests for other viruses do offer some sense of how contagious an infected patient may be: The results may include a rough estimate of the amount of virus in the patient’s body.

“We’ve been using one type of data for everything, and that is just plus or minus — that’s all,” Dr. Mina said. “We’re using that for clinical diagnostics, for public health, for policy decision-making.”

But yes-no isn’t good enough, he added. It’s the amount of virus that should dictate the infected patient’s next steps. “It’s really irresponsible, I think, to forgo the recognition that this is a quantitative issue,” Dr. Mina said.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-08-29T18:44:25.833Z

The PCR test amplifies genetic matter from the virus in cycles; the fewer cycles required, the greater the amount of virus, or viral load, in the sample. The greater the viral load, the more likely the patient is to be contagious.

This number of amplification cycles needed to find the virus, called the cycle threshold, is never included in the results sent to doctors and coronavirus patients, although it could tell them how infectious the patients are.

In three sets of testing data that include cycle thresholds, compiled by officials in Massachusetts, New York and Nevada, up to 90 percent of people testing positive carried barely any virus, a review by The Times found.

On Thursday, the United States recorded 45,604 new coronavirus cases, according to a database maintained by The Times. If the rates of contagiousness in Massachusetts and New York were to apply nationwide, then perhaps only 4,500 of those people may actually need to isolate and submit to contact tracing.

One solution would be to adjust the cycle threshold used to decide that a patient is infected. Most tests set the limit at 40, a few at 37. This means that you are positive for the coronavirus if the test process required up to 40 cycles, or 37, to detect the virus.

Tests with thresholds so high may detect not just live virus but also genetic fragments, leftovers from infection that pose no particular risk — akin to finding a hair in a room long after a person has left, Dr. Mina said.

Any test with a cycle threshold above 35 is too sensitive, agreed Juliet Morrison, a virologist at the University of California, Riverside. “I’m shocked that people would think that 40 could represent a positive,” she said.

A more reasonable cutoff would be 30 to 35, she added. Dr. Mina said he would set the figure at 30, or even less. Those changes would mean the amount of genetic material in a patient’s sample would have to be 100-fold to 1,000-fold that of the current standard for the test to return a positive result.

ImageWestlake Legal Group merlin_171395976_32309997-11ea-4f14-95c6-0c79da5c12fd-articleLarge Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be. your-feed-healthcare Tests (Medical) Quarantines Medicine and Health Laboratories and Scientific Equipment Food and Drug Administration Coronavirus (2019-nCoV) Contact Tracing (Public Health) Centers for Disease Control and Prevention Abbott Laboratories
Credit…Erin Schaff/The New York Times

The Food and Drug Administration said in an emailed statement that it does not specify the cycle threshold ranges used to determine who is positive, and that “commercial manufacturers and laboratories set their own.”

The Centers for Disease Control and Prevention said it is examining the use of cycle threshold measures “for policy decisions.” The agency said it would need to collaborate with the F.D.A. and with device manufacturers to ensure the measures “can be used properly and with assurance that we know what they mean.”

The C.D.C.’s own calculations suggest that it is extremely difficult to detect any live virus in a sample above a threshold of 33 cycles. Officials at some state labs said the C.D.C. had not asked them to note threshold values or to share them with contact-tracing organizations.

For example, North Carolina’s state lab uses the Thermo Fisher coronavirus test, which automatically classifies results based on a cutoff of 37 cycles. A spokeswoman for the lab said testers did not have access to the precise numbers.

This amounts to an enormous missed opportunity to learn more about the disease, some experts said.

“It’s just kind of mind-blowing to me that people are not recording the C.T. values from all these tests — that they’re just returning a positive or a negative,” said Angela Rasmussen, a virologist at Columbia University in New York.

“It would be useful information to know if somebody’s positive, whether they have a high viral load or a low viral load,” she added.

.css-1wxds7f{margin-bottom:10px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:0.875rem;line-height:1.25rem;color:#333 !important;}.css-2al2sh{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;margin-top:20px;margin-bottom:5px;font-weight:700;}@media (min-width:740px){.css-2al2sh{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}@media (min-width:740px){.css-2al2sh{margin-bottom:10px;}}.css-1yyoic1{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-1yyoic1{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-zkk2wn{margin-bottom:20px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.875rem;line-height:1.5625rem;color:#333;}.css-1dvfdxo{margin:10px auto 0px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.5625rem;color:#121212;}@media (min-width:740px){.css-1dvfdxo{font-size:1.25rem;line-height:1.875rem;}}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-19mumt8{background-color:white;margin:30px 0;padding:0 20px;max-width:510px;}@media (min-width:740px){.css-19mumt8{margin:40px auto;}}.css-19mumt8:focus{outline:1px solid #e2e2e2;}.css-19mumt8 a{color:#326891;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ccd9e3;}.css-19mumt8 a:visited{color:#333;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ddd;}.css-19mumt8 a:hover{border-bottom:none;}.css-19mumt8[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-19mumt8[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-19mumt8[data-truncated] .css-5gimkt:after{content:’See more’;}.css-19mumt8[data-truncated] .css-6mllg9{opacity:1;}.css-a8d9oz{border-top:5px solid #121212;border-bottom:2px solid #121212;margin:0 auto;padding:5px 0 0;overflow:hidden;}

Officials at the Wadsworth Center, New York’s state lab, have access to C.T. values from tests they have processed, and analyzed their numbers at The Times’s request. In July, the lab identified 794 positive tests, based on a threshold of 40 cycles.

With a cutoff of 35, about half of those tests would no longer qualify as positive. About 70 percent would no longer be judged positive if the cycles were limited to 30.

In Massachusetts, from 85 to 90 percent of people who tested positive in July with a cycle threshold of 40 would have been deemed negative if the threshold were 30 cycles, Dr. Mina said. “I would say that none of those people should be contact-traced, not one,” he said.

Other experts informed of these numbers were stunned.

“I’m really shocked that it could be that high — the proportion of people with high C.T. value results,” said Dr. Ashish Jha, director of the Harvard Global Health Institute. “Boy, does it really change the way we need to be thinking about testing.”

Dr. Jha said he had thought of the PCR test as a problem because it cannot scale to the volume, frequency or speed of tests needed. “But what I am realizing is that a really substantial part of the problem is that we’re not even testing the people who we need to be testing,” he said.

The number of people with positive results who aren’t infectious is particularly concerning, said Scott Becker, executive director of the Association of Public Health Laboratories. “That worries me a lot, just because it’s so high,” he said, adding that the organization intended to meet with Dr. Mina to discuss the issue.

The F.D.A. noted that people may have a low viral load when they are newly infected. A test with less sensitivity would miss these infections.

But that problem is easily solved, Dr. Mina said: “Test them again, six hours later or 15 hours later or whatever,” he said. A rapid test would find these patients quickly, even if it were less sensitive, because their viral loads would quickly rise.

PCR tests still have a role, he and other experts said. For example, their sensitivity is an asset when identifying newly infected people to enroll in clinical trials of drugs.

But with 20 percent or more of people testing positive for the virus in some parts of the country, Dr. Mina and other researchers are questioning the use of PCR tests as a frontline diagnostic tool.

People infected with the virus are most infectious from a day or two before symptoms appear till about five days after. But at the current testing rates, “you’re not going to be doing it frequently enough to have any chance of really capturing somebody in that window,” Dr. Mina added.

Highly sensitive PCR tests seemed like the best option for tracking the coronavirus at the start of the pandemic. But for the outbreaks raging now, he said, what’s needed are coronavirus tests that are fast, cheap and abundant enough to frequently test everyone who needs it — even if the tests are less sensitive.

“It might not catch every last one of the transmitting people, but it sure will catch the most transmissible people, including the superspreaders,” Dr. Mina said. “That alone would drive epidemics practically to zero.”

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Emily Miller and Another P.R. Expert Ousted At F.D.A. After Blood Plasma Fiasco

Westlake Legal Group 28VIRUS-FDA1-facebookJumbo Emily Miller and Another P.R. Expert Ousted At F.D.A. After Blood Plasma Fiasco Vaccination and Immunization Trump, Donald J Pines, Wayne L Miller, Emily J Health and Human Services Department Hahn, Stephen M (1960- ) Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) convalescent plasma Blood Azar, Alex M II Appointments and Executive Changes APCO Worldwide

The head of the Food and Drug Administration ousted its top spokeswoman from her position on Friday in an urgent bid to restore the tarnished credibility of the agency after he made erroneous claims that overstated the benefits of plasma treatments for Covid-19 at a news conference with President Trump.

The decision came just a day after the F.D.A.’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations consultant who had advised the F.D.A. commissioner, Dr. Stephen M. Hahn, to correct his misleading claims that 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”

The removals come at a moment when the agency, which will be making critical decisions about whether to approve coronavirus vaccines and treatments, is struggling to salvage its reputation as a neutral scientific arbiter.

The ousted spokeswoman, Emily Miller, had little experience in health care. She had spent years working in Washington for Republicans, including the former Texas Congressman Tom DeLay and Senator Ted Cruz of Texas, and as a journalist for One America News, the conservative cable network. She was in her agency post for just 11 days.

Credit… 

“This is a low moment for the F.D.A. in at least a generation,” Daniel Carpenter, a professor at Harvard University who studies the agency, said of Dr. Hahn’s failure to control the public message about the plasma authorization. “This was a major self-inflicted wound.”

The most recent controversy over plasma follows a series of missteps by the F.D.A. that have fueled concerns that the agency is losing the public’s trust as the nation faces a presidential election in November and a pandemic that has taken more than 180,000 American lives.

Also this week, the nation’s premier public health agency, the Centers for Disease Control and Prevention, was accused of bowing to political pressure after it revised its testing guidelines to say people without symptoms of the virus didn’t need to get tested.

Dr. Hahn has already been criticized for a series of worrisome actions, including authorizing the emergency use of two malaria drugs Mr. Trump had favored — a decision that was later revoked — and for having allowed the sale of shoddy antibody tests early in the U.S. outbreak.

“The agency needs to work very hard to regain the trust of the American people — there have been too many unforced errors,” said Dr. David A. Kessler, who was F.D.A. commissioner under Presidents George Bush and Clinton, and is advising Joseph R. Biden Jr.’s presidential campaign. “It needs to focus on what it does best, which is to put the data in front of the medical and scientific community and the American public, and stick with the data.”

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-08-28T22:33:01.825Z

Dr. Hahn notified senior leadership at the F.D.A. on Friday that Ms. Miller would no longer be the official spokeswoman for the agency, and that he would be appointing someone to replace her in an interim capacity. Ms. Miller could not be reached for comment.

Credit…

The consultant who was removed by the health and human services department, Wayne L. Pines, said he wasn’t told why his contract was severed.

“I did recommend that he correct the record,” he said. “If a federal official doesn’t say something right, and chooses to clarify and say that the criticism is justified, that’s refreshing.”

The Department of Health and Human Services denied that Mr. Pines’s contract was terminated because of his involvement in the plasma messaging.

It was “100 percent coincidence,” said Brian Harrison, the department’s chief of staff. “H.H.S. has been reviewing and canceling similar contracts, so I had it sent to our lawyers, who recommended termination. This was routine,” he said.

Nevertheless, the decision by Dr. Hahn to clarify his remarks and to grant a series of media interviews appears to have rankled H.H.S. officials, who saw it as ill-timed, given that the Republican convention was underway. Trump administration officials are often reluctant to publicly admit error out of concern that doing so provides political ammunition to their critics.

Mr. Pines is president of the large health care practice at APCO Worldwide, a public relations and lobbying firm that represents health companies that do business before the F.D.A. He said he did this work on his own, outside of his APCO practice. He would not say how much he was paid, but noted that as a friend to Dr. Hahn, he is willing to continue advising him for free.

Meredith McGehee, executive director of Issue One, which promotes bipartisan political reform, was critical of the contract, noting the potential for conflicts of interest in Mr. Pines’s work for the F.D.A., and his company’s health care client base.

“This notion that, ‘Oh, I’m doing it in my private capacity, on the one hand, and I’m representing health care interests, on the other,’ it doesn’t pass the smell test,” said Ms. McGehee.

The F.D.A. did not respond to requests for comment on Friday about Mr. Pines’s contract or whether it was vetted for conflicts of interest.

.css-1wxds7f{margin-bottom:10px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:0.875rem;line-height:1.25rem;color:#333 !important;}.css-2al2sh{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;margin-top:20px;margin-bottom:5px;font-weight:700;}@media (min-width:740px){.css-2al2sh{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}@media (min-width:740px){.css-2al2sh{margin-bottom:10px;}}.css-1yyoic1{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-1yyoic1{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-zkk2wn{margin-bottom:20px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.875rem;line-height:1.5625rem;color:#333;}.css-1dvfdxo{margin:10px auto 0px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.5625rem;color:#121212;}@media (min-width:740px){.css-1dvfdxo{font-size:1.25rem;line-height:1.875rem;}}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-19mumt8{background-color:white;margin:30px 0;padding:0 20px;max-width:510px;}@media (min-width:740px){.css-19mumt8{margin:40px auto;}}.css-19mumt8:focus{outline:1px solid #e2e2e2;}.css-19mumt8 a{color:#326891;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ccd9e3;}.css-19mumt8 a:visited{color:#333;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ddd;}.css-19mumt8 a:hover{border-bottom:none;}.css-19mumt8[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-19mumt8[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-19mumt8[data-truncated] .css-5gimkt:after{content:’See more’;}.css-19mumt8[data-truncated] .css-6mllg9{opacity:1;}.css-a8d9oz{border-top:5px solid #121212;border-bottom:2px solid #121212;margin:0 auto;padding:5px 0 0;overflow:hidden;}

Ms. Miller was hired on Aug. 17 after a career in both politics and journalism. In 2004, while working for the Department of State, she made headlines after she apparently cut off an interview for a taped segment between Tim Russert, the host of NBC’s “Meet the Press,” and her boss, the then Secretary of State Colin L. Powell, who could be heard apologizing to Mr. Russert and saying “Emily, get out of the way.” In 2015, reporters cast doubt on whether Ms. Miller had been a victim of a home invasion, a story that she had repeatedly included in public remarks and in a book, “Emily Gets Her Gun: But Obama Wants to Take Yours.”

The decision to hire Ms. Miller as the agency’s top spokeswoman was seen as puzzling by outside observers, given that she had little experience in health care. On May 30, Ms. Miller tweeted, “Remember coronavirus?”

The F.D.A. had been considering allowing the use of convalescent plasma as a treatment for Covid-19 on an emergency basis, but last week The New York Times reported that the decision had been delayed after top health officials Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened and expressed concern that the available evidence on the effectiveness of the treatment was too weak. F.D.A. officials argued that although the data was preliminary and needed continued analysis as more patients are treated, plasma still met the agency’s standard for emergency use authorization.

On Saturday morning, Mr. Trump tweeted that the “deep state” at the F.D.A. was slowing drug development. Late that night, the White House press secretary tweeted that the president would have a news conference the next day “concerning a major therapeutic breakthrough.”

The announcement should have been a rare win for the F.D.A., which for months had fended off criticism of its track record on the pandemic, and questions about the independence of Dr. Hahn, who was previously pressured by Mr. Trump to authorize malaria drugs that turned out to be ineffective for Covid-19 and carried risks of harmful side effects. But last weekend, finally, the agency could reveal some legitimate good news: convalescent plasma, the antibody-rich plasma donated by Covid-19 survivors, showed promise for a subset of patients when given early.

The announcement, made at the White House on Sunday, has instead spurred a week of recriminations, anger and mistrust between the F.D.A. and H.H.S. The officials’ statements Sunday cast nuanced and preliminary data as “a very historic breakthrough,” as Mr. Trump put it. The exaggerated statements drew criticism from scientists and at least three former agency commissioners.

Within the F.D.A. and H.H.S., officials have offered conflicting accounts for how a single misleading statistic — that plasma led to a 35 percent reduction in deaths — appeared in the remarks of Mr. Trump, Dr. Hahn and Alex. M. Azar II, the health and human services secretary. It was also unclear why Dr. Hahn, a longtime cancer doctor, and Mr. Azar, a former pharmaceutical executive, did not themselves catch the overstated statistic. No randomized trials have found a survival benefit for convalescent plasma. The 35 percent number referred to a tiny subset of patients, and was a relative comparison between two groups, not an absolute reduction in deaths.

At a speech at the convention on Thursday evening, the president again overstated what’s known about the benefits of plasma, promising it “will save thousands and thousands of lives.”

Missteps by the F.D.A., a federal agency that has long prided itself on its scientific independence, have heightened concerns that the American public may not be willing to take a vaccine approved by the agency, particularly if the decision is seen as having been made under pressure from Mr. Trump.

“It’s very important for the leadership of the agency, especially the commissioner, to be accurate about the information he’s providing and to do it in a way that really sticks to the facts,” said Dr. Mark McClellan, who was F.D.A. commissioner under President George W. Bush.

“There’s almost not enough adjectives to describe how appalling this is,” said Emily K. Brunson, a medical anthropologist at Texas State University. Opinion polls have shown that many Americans are already wary of taking a vaccine for the virus.

If approval of a vaccine is viewed as politically motivated, she said, “it has the potential to really make this a disastrous situation.”

Sharon LaFraniere and Maggie Haberman contributed reporting.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

F.D.A. Allows Expanded Use of Plasma to Treat Coronavirus Patients

Westlake Legal Group f-d-a-allows-expanded-use-of-plasma-to-treat-coronavirus-patients F.D.A. Allows Expanded Use of Plasma to Treat Coronavirus Patients United States Politics and Government Trump, Donald J Marks, Peter Hahn, Stephen M (1960- ) Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Clinical Trials Blood

The Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients, allowing President Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention.

Mr. Trump cited the approval, which had been held up by concerns among top government scientists about the data behind it, as welcome news in fighting a disease that has led to 176,000 deaths in the United States and left the nation lagging far behind most others in the effectiveness of its response.

At a news briefing, he described the treatment as “a powerful therapy” made possible “by marshaling the full power of the federal government.”

The decision will broaden use of a treatment that has already been administered to more than 70,000 patients. But the F.D.A. cited benefits for only some patients. And, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations. Mr. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.

Mr. Trump has portrayed his demands to cut red tape and speed approval of treatments and vaccines as a necessary response to a public health emergency.

But Sunday’s announcement came a day after he repeated his unfounded claim that the F.D.A. was deliberately holding up decision-making until after the election, this time citing a “deep state.” That accusation exacerbated concerns among some government scientists, outside experts and Democrats that the president’s political needs could undermine the integrity of the regulatory process, hurt public confidence in safety and introduce a different kind of public health risk.

While no randomized trials of the sort researchers consider most robust have shown benefit from convalescent plasma yet, the F.D.A. said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of Covid-19 illness in some hospitalized patients,” in particular those who receive it early.

Patients less than 80 years old who received plasma with a high level of virus-fighting antibodies within three days of diagnosis, and who were not on a respirator, were about 35 percent more likely to be alive a month later compared with those who received plasma with a low level of the antibodies, according to Dr. Peter Marks, the director of F.D.A.’s center for biologics, evaluation and research.

Mr. Trump stripped away the agency’s nuanced language during his appearance before reporters at the White House, saying that convalescent plasma has been “proven to reduce mortality by 35 percent.”

The F.D.A., which is responsible for approving new medicines, delayed the authorization for about a week after top health officials, including Dr. Francis S. Collins, the director of the National Institutes of Health, and Dr. Anthony S. Fauci, the top infectious disease specialist, questioned whether the data was sufficient.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-08-22T19:39:07.771Z

Mr. Trump complained in a tweet on Saturday, claiming without any evidence that officials were “hoping to delay the answer until after November 3rd” — Election Day — and urging the F.D.A. to “focus on speed, and saving lives!”

Mark Meadows, the White House chief of staff, also accused government regulators over the weekend of slow-walking the approval, calling it “a fumble.” Mr. Meadows said Mr. Trump was not trying to “cut corners,” but had “a real frustration with some of the bureaucrats who think they can just do this the way they normally do it.”

At his news conference, Mr. Trump struck a more positive note, saying the agency had “really stepped up,” especially “over the last few days.”

Democrats and some health experts said the president’s criticism of federal regulators undermined public confidence and threatened the credibility of the agency charged with determining whether drugs and medicines are safe and effective.

Nancy Pelosi, the House speaker, called Mr. Trump’s Saturday tweet “very dangerous.”

ImageWestlake Legal Group 23dc-fda3-articleLarge F.D.A. Allows Expanded Use of Plasma to Treat Coronavirus Patients United States Politics and Government Trump, Donald J Marks, Peter Hahn, Stephen M (1960- ) Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Clinical Trials Blood
Credit…Erin Schaff/The New York Times

White House officials have been urging speedy approval not just of Covid-19 treatments, but of vaccines. Their public statements that a safe and effective vaccine could be just around the corner have alarmed scientists who fear that White House pressure will result in premature approval timed to increase the president’s re-election chances.

In a July 30 meeting with Ms. Pelosi and Senator Chuck Schumer of New York, the Democratic minority leader, top administration officials suggested the administration might grant emergency approval for a vaccine before Phase 3 trials in the United States are complete, perhaps as early as September, according to two people briefed on the discussion. Such a move would be highly unusual and most likely prompt more concern about whether the administration was pressuring the F.D.A. to approve drugs for political purposes.

During the discussion in Ms. Pelosi’s conference room, the people briefed on it said, Mr. Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate for early approval. Their discussion was first reported by the Financial Times.

AstraZeneca is conducting Phase 3 trials in Britain, South Africa and Brazil, but only began its Phase 3 clinical trial in the United States a few days ago.

Senior administration officials disputed the account of the meeting, saying Mr. Meadows and Treasury Secretary Steven Mnuchin were either being misquoted or had been misunderstood on every major point.

Nonetheless, their remarks suggested to at least some participants that the administration was hoping that robust results from AstraZeneca’s overseas trials would lead to early emergency authorization, using the same authority the F.D.A. used to green-light the use of convalescent plasma. An aide to Ms. Pelosi said she warned officials at the meeting against taking short cuts.

.css-1wxds7f{margin-bottom:10px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:0.875rem;line-height:1.25rem;color:#333 !important;}.css-2al2sh{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;margin-top:20px;margin-bottom:5px;font-weight:700;}@media (min-width:740px){.css-2al2sh{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}@media (min-width:740px){.css-2al2sh{margin-bottom:10px;}}.css-1yyoic1{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-1yyoic1{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-zkk2wn{margin-bottom:20px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.875rem;line-height:1.5625rem;color:#333;}.css-1dvfdxo{margin:10px auto 0px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.5625rem;color:#121212;}@media (min-width:740px){.css-1dvfdxo{font-size:1.25rem;line-height:1.875rem;}}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-19mumt8{background-color:white;margin:30px 0;padding:0 20px;max-width:510px;}@media (min-width:740px){.css-19mumt8{margin:40px auto;}}.css-19mumt8:focus{outline:1px solid #e2e2e2;}.css-19mumt8 a{color:#326891;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ccd9e3;}.css-19mumt8 a:visited{color:#333;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ddd;}.css-19mumt8 a:hover{border-bottom:none;}.css-19mumt8[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-19mumt8[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-19mumt8[data-truncated] .css-5gimkt:after{content:’See more’;}.css-19mumt8[data-truncated] .css-6mllg9{opacity:1;}.css-a8d9oz{border-top:5px solid #121212;border-bottom:2px solid #121212;margin:0 auto;padding:5px 0 0;overflow:hidden;}

The F.D.A. typically requires clinical trials with American patients before approving vaccines for use in this country. Although there have been exceptions to that rule, experts said, approval of a coronavirus vaccine on the basis of overseas trials would present challenging issues for regulators, partly because of differences in demographics as well as in the size of the trials.

One senior administration official briefed on the meeting, who declined to speak about the discussion on the record, said neither Mr. Meadows nor Mr. Mnuchin suggested a vaccine could be approved as early as late September. The official said the administration would not approve a vaccine solely on the basis of foreign clinical trials.

Spokespeople for both Mr. Meadows and Mr. Mnuchin said neither man discussed AstraZeneca.

Credit…Paul Ellis/Agence France-Presse — Getty Images

On Sunday, Mr. Trump again raised hopes for a successful vaccine, saying, “You’ll be hearing about” that “very soon, very shortly.” Dr. Collins, the N.I.H. director, has said it “would be astounding” if a vaccine was ready for approval by October — and that even November or December is highly optimistic.

The decision by the White House to publicly increase the pressure on the F.D.A. injected a political element into what some scientists called a notable advance in expanding the use of convalescent plasma. Other experts sounded a note of caution, saying the evidence was still preliminary.

In a statement, the president of the Infectious Disease Society of America, Dr. Thomas M. File Jr., said that the data on the treatment shows “some positive signals,” but that “we lack the randomized controlled trial data we need to better understand its utility in Covid-19 treatment.”

In a phone call with reporters on Sunday, Dr. Stephen Hahn, the F.D.A.’s commissioner, said the agency would continue working with researchers studying the treatment and might update the authorization. He encouraged the continuation of randomized trials to prove the treatment’s effectiveness.

“This is not the end,” he said.

Dr. Hahn softened the president’s claim that the treatment reduces mortality by 35 percent, saying that will be true “if the data continue to pan out.” It was not immediately clear where the 35 percent figure came from; it did not appear to be included in technical documents released by the agency in support of the decision.

Dr. Marks told reporters that more than 70,000 patients had already received convalescent plasma under a special agency program. The decision to authorize the treatment so that even more doctors could use it was based on an analysis of months of data that suggested that when given early in the course of the disease, plasma “can improve outcomes and decrease mortality,” he said.

“We’re confident that convalescent plasma is safe to use in this setting,” he said, after reviewing results from the first 20,000 patients who received it.

Dr. Hahn said that the decision to authorize the treatment was made “solely on the basis of the science and the data and on nothing else.”

Reporting was contributed by Katie Rogers, Nicholas Fandos, Andrew Jacobs and Carl Zimmer.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Blood Plasma Treatment for Covid-19 Now on Hold at F.D.A.

Westlake Legal Group blood-plasma-treatment-for-covid-19-now-on-hold-at-f-d-a Blood Plasma Treatment for Covid-19 Now on Hold at F.D.A. your-feed-healthcare mayo clinic Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Clinical Trials blood donation

WASHINGTON — Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.

The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.

Donated by people who have survived the disease, antibody-rich plasma is considered safe. President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.

But clinical trials have not proved whether plasma can help people fighting the coronavirus.

Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.

The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and on animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has infused more than 66,000 people with Covid-19 thanks to financing from the federal government.

An F.D.A. spokeswoman declined to comment.

Plasma, the pale yellow liquid leftover after blood is stripped of its red and white cells, has been the subject of months of intense enthusiasm from scientists, celebrities and Mr. Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for coronavirus vaccines.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-08-19T13:28:43.151Z

Emergency authorizations, which do not require the same level of evidence as a full F.D.A. approval would, have been a fraught subject for the government during the pandemic. The agency gave one to the malaria drugs hydroxychloroquine and chloroquine only to rescind it months later after the drugs were found to be ineffective against the coronavirus, and potentially harmful. An emergency authorization for blood plasma would most likely ease the clerical burdens on hospitals in conducting infusions.

Senior health officials have privately expressed concern about the rapid growth of the Mayo program and the perceived rush to declare plasma effective without the affirmation of results from randomized trials, which scientists have long relied on as the gold standard of evidence. Skyrocketing enrollment in the program has prompted a debate among researchers about what kind of empirical certainty is needed in treating patients in a public health emergency.

An emergency approval now would “change the way people view trials,” said Dr. Mila B. Ortigoza, an infectious disease specialist at N.Y.U. Langone Health who started a trial with colleagues at Montefiore Medical Center.

“We want to make sure that when we say it works, we are confident, with indisputable evidence,” she said. “We’re dealing with patients’ lives here.”

Unlike the malaria drugs, plasma, which has been used since the 1890s to treat infectious diseases, has earned the attention of a highly credentialed community of microbiologists and immunologists eager to prove its usefulness. The Mayo Clinic has already published analysis on tens of thousands of patients in its expanded access program showing that plasma is safe.

The most recent batch of data from the program included more than 35,000 Covid-19 patients, many of them in intensive care and on ventilators, and suggested that plasma administered within three days of a diagnosis reduced mortality rates. When calculated a month after the infusions, the death rate of patients who received plasma within three days of diagnosis was lower (21.6 percent) than it was for those who received plasma later (26.7 percent).

But the study did not have a control group of patients given a placebo to compare with those given plasma, making it difficult for scientists to assess whether the treatment really worked. And given the limited supply of plasma, it is not clear how realistic treating patients within three days of diagnosis would be.

The program’s enrollment has surged to more than 30 times as high as initially expected, complicating the ability of scientists to recruit sick patients to randomized trials.

It “ballooned to a degree that, you know, is becoming unmanageable,” Dr. Lane said.

Statisticians at the F.D.A. are now examining the Mayo data to better understand what factors other than the treatment might have influenced patient responses, such as higher-quality care in the hospital, Dr. Lane said.

A research team from Houston Methodist hospitals also published preliminary results from a plasma trial last week. Their study of hospitalized Covid-19 patients in the American Journal of Pathology reported that a group of 136 patients who received the treatment were more likely to be alive four weeks later compared with 251 patients who did not receive it. That study found a statistically significant benefit only when patients were treated within three days of admission and when the plasma contained a high concentration of antibodies.

.css-1wxds7f{margin-bottom:10px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:0.875rem;line-height:1.25rem;color:#333 !important;}.css-2al2sh{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;margin-top:20px;margin-bottom:5px;font-weight:700;}@media (min-width:740px){.css-2al2sh{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}@media (min-width:740px){.css-2al2sh{margin-bottom:10px;}}.css-1yyoic1{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-1yyoic1{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-zkk2wn{margin-bottom:20px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.875rem;line-height:1.5625rem;color:#333;}.css-1dvfdxo{margin:10px auto 0px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.5625rem;color:#121212;}@media (min-width:740px){.css-1dvfdxo{font-size:1.25rem;line-height:1.875rem;}}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-19mumt8{background-color:white;margin:30px 0;padding:0 20px;max-width:510px;}@media (min-width:740px){.css-19mumt8{margin:40px auto;}}.css-19mumt8:focus{outline:1px solid #e2e2e2;}.css-19mumt8 a{color:#326891;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ccd9e3;}.css-19mumt8 a:visited{color:#333;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ddd;}.css-19mumt8 a:hover{border-bottom:none;}.css-19mumt8[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-19mumt8[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-19mumt8[data-truncated] .css-5gimkt:after{content:’See more’;}.css-19mumt8[data-truncated] .css-6mllg9{opacity:1;}.css-a8d9oz{border-top:5px solid #121212;border-bottom:2px solid #121212;margin:0 auto;padding:5px 0 0;overflow:hidden;}

The Houston study was not randomized, meaning that all of the patients enrolled received the treatment and none received a placebo. (The researchers later compared their outcomes to records from other Covid-19 patients who were not in the study but were matched to be similar to them.)

ImageWestlake Legal Group merlin_174329469_b5f5c73d-5e40-4498-b38e-94542d04f84f-articleLarge Blood Plasma Treatment for Covid-19 Now on Hold at F.D.A. your-feed-healthcare mayo clinic Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Clinical Trials blood donation
Credit…Erin Schaff/The New York Times

A surge in cases in Texas this summer quickly brought the hospital system to its enrollment cap, and doctors there have not been able to provide the experimental treatment since mid-July. If the F.D.A. gave an emergency authorization, doctors at the hospital could possibly begin administering it again, said Dr. Eric Salazar, the study’s principal investigator.

But an emergency authorization could have the unintended effect of making it harder for rigorous clinical trials to definitively show whether plasma works. Scientists have struggled to recruit patients for randomized trials, as many patients and their doctors — knowing they could get the treatment under the Mayo program — have been unwilling to risk receiving a placebo.

Last month, one such trial in the Netherlands was stopped when researchers realized that patients given plasma showed no difference in mortality, length of hospital stay or disease severity compared with those given a placebo. Most of the patients had already developed their own antibodies by the time they entered the study, the researchers noted.

At least 10 randomized trials in the United States have collectively enrolled only a few hundred people. They have also been stymied by the waning of the virus outbreak in many cities, complicating the ability of researchers to recruit sick people. Dr. Collins has encouraged a strategy of pooling the results from randomized trials, an idea that has met resistance from some researchers.

Dr. R. Scott Wright, who is helping oversee the Mayo Clinic’s plasma program, was an early proponent of conducting randomized trials. But he said in a recent interview that the mechanics of setting up large studies were complicated by early shortages of plasma, coordination via videoconference calls and the difficulty of predicting where the virus would spread next.

If the F.D.A. does grant the emergency authorization, it could make it even harder to get answers, said Dr. Ortigoza of N.Y.U.

“We will keep going, because we’re in desperate need of a randomized placebo-controlled trial for convalescent plasma,” she said. “This is something our country and the world really needs right now.”

Noah Weiland and Sharon LaFraniere reported from Washington, and Sheri Fink from Houston. Katie Thomas contributed reporting from Chicago.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Stephen Hahn, F.D.A. Chief, Is Caught Between Scientists and the President

As the coronavirus surged across the Sunbelt, President Trump told a crowd gathered at the White House on July 4 that 99 percent of virus cases are “totally harmless.”

The next morning on CNN, the host Dana Bash asked Dr. Stephen Hahn, the commissioner of the Food and Drug Administration and one of the nation’s most powerful health officials: “Is the president wrong?”

Dr. Hahn, an oncologist and former hospital executive, certainly understood the deadly toll of the virus, and the danger posed by the president’s false statements. But he ducked the journalist’s question.

“I’m not going to get into who’s right and who’s wrong,” he said.

The exchange illustrates the predicament that Dr. Hahn and other doctors face working for a president who often disregards scientific evidence. But as head of the agency that will decide what treatments are approved for Covid-19 and whether a new vaccine is safe enough to be given to millions of Americans, Dr. Hahn may be pressured like no one else.

Unlike Dr. Anthony S. Fauci or Dr. Francis S. Collins, leaders at the National Institutes of Health who have decades of experience operating under Republican and Democratic administrations, Dr. Hahn was a Washington outsider.

Now seven months into his tenure, with the virus surging in parts of the country and schools debating whether to reopen, the push for a vaccine is intensifying. The government has committed more than $9 billion to vaccine makers to speed development, and last week Mr. Trump speculated that one could be ready by Election Day — a timeline that is unrealistic, according to scientists, and shows the strain Dr. Hahn may be under.

Many medical experts — including members of his own staff — worry about whether Dr. Hahn, despite his good intentions, has the fortitude and political savvy to protect the scientific integrity of the F.D.A. from the president. Critics point to a series of worrisome responses to the coronavirus epidemic under Dr. Hahn’s leadership, most notably the emergency authorization the agency gave to the president’s favorite drug, hydroxychloroquine, a decision it reversed three months later because the treatment did not work and harmed some people.

“When you’ve got a White House that is not interested in science, it’s important to have a strong counterweight,” said Dr. Peter Lurie, a former associate commissioner at the F.D.A. who now runs the Center for Science in the Public Interest.

Dr. Hahn, he said, “is not a powerful presence.”

In an interview, Dr. Hahn, 60, defended his record as F.D.A. chief. All of his decisions have been guided by the data, he said, and sometimes, rapidly evolving science has led to policy changes.

“I do not feel squeezed,” Dr. Hahn said. “I have been consistent in my message internally about using data and science to make decisions.”

ImageWestlake Legal Group merlin_169596186_35e1d9e9-462c-4f74-bcd4-1abc4a81c724-articleLarge Stephen Hahn, F.D.A. Chief, Is Caught Between Scientists and the President Vaccination and Immunization United States Politics and Government Tests (Medical) Health and Human Services Department Hahn, Stephen M (1960- ) Food and Drug Administration Drugs (Pharmaceuticals) Coronavirus (2019-nCoV)
Credit…T.J. Kirkpatrick for The New York Times

On the line as he spoke was Michael Caputo, a deputy to Dr. Hahn’s boss, Alex M. Azar II, the secretary of the Department of Health and Human Services. Since working for the consulting firm of the longtime Trump adviser Roger J. Stone Jr. in the 1980s, Mr. Caputo has been a cheerleader and even, once, a driver for the president.

Dr. Hahn is not allowed to speak to the press without Mr. Caputo or another official on the phone — a marked contrast to the practice under the last F.D.A. commissioner, Dr. Scott Gottlieb, a powerful force in Washington who came to the job with years of experience at the F.D.A. and political think tanks. He called reporters whenever he felt like it, which was often.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 40px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; /* padding-top: 1.25em; border-top: 1px solid #e2e2e2; */ } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-08-10T10:03:31.897Z

Dr. Hahn said he didn’t mind the restriction on his press calls.

“I’m going to tell you how I feel and the truth as I know it, regardless of who is listening on the line,” Dr. Hahn said.

But people close to the commissioner point out that if he is too honest, he could be out of a job.

“The president has shown if you disagree with him too much, he fires you,” said Dr. Hahn’s longtime friend and former colleague Kevin B. Mahoney, chief executive of the University of Pennsylvania Health System.

In late July, Mr. Mahoney noted, the president retweeted a viral video of fringe doctors praising hydroxychloroquine that social media platforms later removed for its misleading claims. One of those doctors had given sermons warning that women having sex with demonic spirits in their dreams can cause certain gynecological ailments.

“To say that any public health official can control what is going on right now is expecting too much for that person,” Mr. Mahoney said.

The job of F.D.A. commissioner is a lightning rod in the best of circumstances. Every White House and every Congress has its agendas, from Ronald Reagan’s broad mission to deregulate, to the Obama administration’s specific order not to ban flavored e-cigarettes.

But the F.D.A. has never been pushed as hard as it is being pushed now, when it must vet every new treatment and vaccine for a disease that has already killed more than 160,000 Americans, under a president who downplays the severity of the pandemic and recommends unproven treatments.

“Given when he started, this level of intrusion is all that Steve Hahn has really known, but it is not normal,” said Dr. Margaret Hamburg, who was F.D.A. commissioner for six years under President Barack Obama. “There’s no doubt that the president believes he can massage F.D.A. decisions.”

Before joining the Trump administration, Dr. Hahn had climbed the ranks of academic medicine, spending 18 years at the University of Pennsylvania followed by five years at the University of Texas MD Anderson Cancer Center, where his last role was chief medical executive. A wine aficionado who studies Italian (his rescue dog is named Baci), Dr. Hahn is known for being affable, perhaps to a fault.

It did not take long for Dr. Hahn to discover the intense scrutiny that came along with his new job.

In late January, when only a handful of coronavirus cases had been recorded in the United States, Dr. Hahn planned to reach out to the chief executives of private companies about developing diagnostic tests, according to four current and former senior administration officials who requested anonymity because they were not authorized to speak to the press. Dr. Gottlieb had made the suggestion to Dr. Hahn.

According to two of the officials, Dr. Hahn told them that he had been informed that the Health and Human Services department did not want him reaching out to the companies. Dr. Hahn declined to comment on any communication regarding the companies, but one of the officials said Dr. Hahn expressed disappointment over the situation.

In a statement, Mr. Azar denied giving any such order. “There is not a shred of truth to this. In fact, I encouraged F.D.A. to reach out to industry from the earliest days of the response,” he said. Asked whether someone else in the agency might have conveyed the message, Caitlin Oakley, a spokeswoman for Health and Human Services, said: “H.H.S. has 80,000 employees and I can’t speak for all of them.”

The F.D.A. soon discovered serious problems with the country’s first coronavirus tests issued by its sister agency, the Centers for Disease Control and Prevention. The F.D.A. discovered that there was contamination in two C.D.C. labs, leading to significant delays.

But it took about three more weeks after the F.D.A. confirmed these problems before it allowed state and commercial labs to more easily use their own validated tests. State labs had been stuck with the C.D.C.’s flawed version — losing critical time when hospitals across the country were desperate to isolate infected people.

“This was a catastrophic delay that was a major part of why we had to shut down,” said Dr. Ashish Jha, director of the Harvard Global Health Institute.

In an effort to respond to public demand for more coronavirus tests, the agency then changed course, permitting scores of companies to sell tests that detect coronavirus antibodies, which show whether someone has been exposed to the virus in the past.

Many of the tests failed and few companies bothered to alert the F.D.A., as required. The agency has taken some off the market, but many shoddy tests are still being sold.

While his administration’s testing missteps were fueling the early pandemic, Mr. Trump began a crusade for what were then chiefly known as malaria and lupus drugs, hydroxychloroquine and chloroquine.

.css-1wxds7f{margin-bottom:10px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:0.875rem;line-height:1.25rem;color:#333 !important;}.css-2al2sh{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;margin-top:20px;margin-bottom:5px;font-weight:700;}@media (min-width:740px){.css-2al2sh{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}@media (min-width:740px){.css-2al2sh{margin-bottom:10px;}}.css-1yyoic1{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-1yyoic1{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-zkk2wn{margin-bottom:20px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.875rem;line-height:1.5625rem;color:#333;}.css-1dvfdxo{margin:10px auto 0px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.5625rem;color:#121212;}@media (min-width:740px){.css-1dvfdxo{font-size:1.25rem;line-height:1.875rem;}}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-19mumt8{background-color:white;margin:30px 0;padding:0 20px;max-width:510px;}@media (min-width:740px){.css-19mumt8{margin:40px auto;}}.css-19mumt8:focus{outline:1px solid #e2e2e2;}.css-19mumt8 a{color:#326891;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ccd9e3;}.css-19mumt8 a:visited{color:#333;-webkit-text-decoration:none;text-decoration:none;border-bottom:2px solid #ddd;}.css-19mumt8 a:hover{border-bottom:none;}.css-19mumt8[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-19mumt8[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-19mumt8[data-truncated] .css-5gimkt:after{content:’See more’;}.css-19mumt8[data-truncated] .css-6mllg9{opacity:1;}.css-a8d9oz{border-top:5px solid #121212;border-bottom:2px solid #121212;margin:0 auto;padding:5px 0 0;overflow:hidden;}

At a March 19 news conference, Mr. Trump said that the drugs would be approved for Covid-19 as well, thanks to the quick work of the F.D.A. and Dr. Hahn, in particular. “I’d shake his hand, but I’m not supposed to do that,” Mr. Trump said. “But he’s been fantastic.”

It was startling news, given that scant data had shown that the drugs could treat the disease. Speaking immediately after the president, Dr. Hahn tried to hedge, saying that clinical trials were needed. But he also acknowledged Mr. Trump’s personal role in the matter, noting, “that’s a drug that the president has directed us to take a closer look at.”

Nine days later, the F.D.A. issued an emergency authorization for the drugs in patients hospitalized with Covid-19.

“The science they had wasn’t sufficient to make that decision,” said Dr. Luciana Borio, who worked as a top F.D.A. scientist during the Ebola and Zika outbreaks and was also director for medical and biodefense preparedness at the National Security Council under the Trump administration. “I don’t know how they say it’s not politics.”

In June, the agency revoked its emergency authorization after it found that more than 100 Covid-19 patients taking the drugs developed serious heart disorders, including 25 who had died.

Hydroxychloroquine wasn’t the agency’s only authorization lacking solid evidence, some scientists say. In April, the F.D.A. partnered with the Mayo Clinic to give Covid-19 patients across the country access to convalescent plasma, even though the jury is still out on whether it works. The agency also gave emergency authorization to several blood purification systems that critics say don’t help patients get better.

“F.D.A. is giving approvals right, left and center,” said Dr. Swapnil Hiremath, a nephrologist at the University of Ottawa and a critic of the blood filtration devices. “You need data.”

After a month of playing defense with an exasperated scientific community, Dr. Hahn found himself on CNN, again struggling to cover for Mr. Trump. This time, he was asked about the president’s disturbing suggestion that injecting disinfectant might be a good way to treat Covid-19.

“I think this is something a patient would want to talk to their physician about,” Dr. Hahn replied. Then he seemed to remember his medical training. “And no, I certainly wouldn’t recommend the internal ingestion of a disinfectant.”

Many of Dr. Hahn’s colleagues, as well as longtime observers of the F.D.A., say that Dr. Hahn is doing his best to uphold the mission of his agency under exceedingly difficult circumstances.

“I think some mistakes have been made. I think probably Dr. Hahn has learned from those mistakes,” said Diana DeGette, a Democratic congresswoman from Colorado who heads the oversight panel of the House Committee on Energy and Commerce, which has jurisdiction over the F.D.A. “My perception is he’s trying to accommodate real efforts to treat the virus.”

Credit…Al Drago for The New York Times

More than 30 experimental coronavirus vaccines are now in clinical trials, with several companies racing to have the first product in the U.S. ready by the end of the year. With the public highly skeptical of these new vaccines, the F.D.A.’s vetting process will be Dr. Hahn’s biggest test yet.

In June, the F.D.A. issued guidelines saying that, in order to be approved, a coronavirus vaccine must be at least 50 percent more effective than a placebo, on par with most flu vaccines.

Worried that an ineffective or unsafe vaccine would fan fears about immunizations, a bipartisan trio of senators introduced legislation last week to improve oversight of the vaccine approval process, and nearly 400 health experts sent a letter urging Dr. Hahn to use the agency’s vaccine advisory group. On Friday, the commissioner and two of his deputies wrote in JAMA that “transparent discussion” by the advisory panel would be needed before any vaccine authorization or approval.

The president, for now, appears to be pleased with the commissioner.

Dr. Hahn was “really speeding up the process of therapeutics and vaccines,” Mr. Trump said at a recent news conference on drug pricing. “It’s very important, Stephen. Can you move it faster, please, OK? Thank you, great job.”

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Scientists Worry About Political Influence Over Coronavirus Vaccine Project

In April, with hospitals overwhelmed and much of the United States in lockdown, the Department of Health and Human Services produced a presentation for the White House arguing that rapid development of a coronavirus vaccine was the best hope to control the pandemic.

“DEADLINE: Enable broad access to the public by October 2020,” the first slide read, with the date in bold.

Given that it typically takes years to develop a vaccine, the timetable for the initiative, called Operation Warp Speed, was incredibly ambitious. With tens of thousands dying and tens of millions out of work, the crisis demanded an all-out public-private response, with the government supplying billions of dollars to pharmaceutical and biotechnology companies, providing logistical support and cutting through red tape.

It escaped no one that the proposed deadline also intersected nicely with President Trump’s need to curb the virus before the election in November.

The ensuing race for a vaccine — in the middle of a campaign in which the president’s handling of the pandemic is the key issue after he has spent his time in office undermining science and the expertise of the federal bureaucracy — is now testing the system set up to ensure safe and effective drugs to a degree never before seen.

Under constant pressure from a White House anxious for good news and a public desperate for a silver bullet to end the crisis, the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation, according to interviews with administration officials, federal scientists and outside experts.

Even in a less politically charged environment, there would be a fraught debate about how much to accelerate the process of trials and approval. The longer that vaccines are tested before being released, the likelier they are to be safe and effective.

But with 1,000 people dying each day in the United States, schools finding it difficult to reopen and the deep recession inflicting economic pain across the country, the desire to find a way to return to normal life is powerful and transcends partisan politics and borders. On Sunday, Russia announced that it planned to start a nationwide inoculation campaign in October with a vaccine that had yet to complete clinical trials, the latest evidence of the global potential for cutting corners.

Despite concerted efforts by the Trump administration and a bevy of pharmaceutical companies it is working with, the original October target has slipped, with the administration now pushing to have hundreds of millions of doses available by the end of the year or early 2021.

But experts inside and outside the government still say they fear the White House will push the Food and Drug Administration to overlook insufficient data and give at least limited emergency approval to a vaccine, perhaps for use by specific groups like front-line health care workers, before the vote on Nov. 3.

“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two or three vaccines, and say, ‘We’ve tested it on a few thousand people, it looks safe, and now we are going to roll it out,’” said Dr. Paul A. Offit of the University of Pennsylvania, who is a member of the Food and Drug Administration’s vaccine advisory committee.

“They are really worried about that,” he added. “And they should be.”

Mr. Trump relentlessly touts progress toward a vaccine, raising hopes of quick approval. Touring a North Carolina biotechnology lab last week, he vowed to “deliver a vaccine in record time.” In a tweet last month, he explicitly tied vaccines to his re-election hopes.

ImageWestlake Legal Group merlin_174998298_fafae08f-3300-4d48-b24e-863359750565-articleLarge Scientists Worry About Political Influence Over Coronavirus Vaccine Project Vaccination and Immunization United States Politics and Government Trump, Donald J Slaoui, Moncef M Regulation and Deregulation of Industry Public-Private Sector Cooperation Presidential Election of 2020 Polls and Public Opinion Moderna Inc Medicine and Health Kushner, Jared Health and Human Services Department Hahn, Stephen M (1960- ) Food and Drug Administration Fauci, Anthony S Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Conflicts of Interest Clinical Trials Birx, Deborah L Azar, Alex M II Appointments and Executive Changes
Credit…Hans Pennink/Associated Press

The president’s son-in-law and senior adviser, Jared Kushner, who is helping to steer the re-election campaign from the White House, is a regular participant in meetings of a board formed to oversee the vaccine effort.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #ffffff; color: #121212; box-sizing: border-box; margin: 30px auto; max-width: 510px; width: calc(100% – 80px); border-top: 5px solid #121212; border-bottom: 2px solid #121212; padding: 5px 0 10px 0; } @media only screen and (min-width: 600px) { #styln-briefing-block { margin: 40px auto; } } #styln-briefing-block a { color: #121212; } #styln-briefing-block ul { margin-left: 15px; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 1.125rem; line-height: 1.375rem; display: inline-block; margin-bottom: 5px; } @media only screen and (min-width: 600px) { #styln-briefing-block .briefing-block-header { font-size: 1.25rem; line-height: 1.5625rem; } } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-header a::after { content: ‘›’; position: relative; font-weight: 500; margin-left: 5px; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; } /* #styln-briefing-block .briefing-block-briefinglinks { padding-top: 1em; margin-top: 1.75em; border-top: 1px solid #E2E2E3; } */ #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: none; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 12px; display: block; } @media only screen and (min-width: 600px) { #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-08-01T01:26:45.732Z

While White House officials do not specifically mention the election during the board’s discussions, people familiar with the conversations say they ask regularly about October, a date that hangs over the effort. Trump campaign advisers privately call a pre-election vaccine “the holy grail.”

The Food and Drug Administration’s approval of a new vaccine is typically an exhaustive process, where agency employees meticulously go through data from clinical trials to review whether the vaccine is both safe and effective. The threshold for approving vaccines is typically higher than it is for therapeutic drugs because they will be used in millions of otherwise healthy people, meaning that even rare side effects could affect many more people than a drug that treats a specific illness.

An independent advisory panel of outside experts also weighs in, and while the agency has the power to make its own decision, it typically follows the advice of its outside panels. The Food and Drug Administration’s senior regulator has the power to approve or deny vaccines for emergency use, but that decision could be overridden by the agency’s top leaders, or by the secretary of health and human services.

White House officials said that Mr. Trump would not distort the vaccine review process to help his campaign. “The rapid research, development, trials and eventual distribution of a Covid-19 vaccine is emblematic of President Trump’s highest priority: the health and safety of the American people,” said Judd Deere, a White House spokesman. “It has nothing to do with politics.”

Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, told lawmakers on Friday that he remained “cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021.”

Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, has not ruled out emergency approval of a vaccine.

“We would consider using an emergency use authorization if we felt that the risks associated with the vaccine were much lower than the risks of not having a vaccine,” he told The Journal of the American Medical Association in an online interview.

He also said regulators would certify that any vaccine would meet the agency’s rigorous standards, adding, “My job as commissioner is to make sure to the fullest extent possible that any pressure that comes to the agency is not reflected downward” onto regulators and scientists studying the vaccines.

Operation Warp Speed got its start in April, the brainchild of Dr. Peter Marks, a pencil-thin, bespectacled physician who leads the regulatory unit at the Food and Drug Administration that approves vaccines and therapies.

A “Star Trek” fan, Dr. Marks named the initiative Warp Speed and pitched it in an April 10 phone call to Alex M. Azar II, the secretary of health and human services, who quickly embraced it. In a follow-up phone call a few days later, according to a person familiar with the discussions, several health officials said the October deadline was unrealistic; over the next few months, officials began publicly citing the end of the year or early 2021 as a target.

With his job on the line, Mr. Azar, the target of Mr. Trump’s wrath over the virus, was especially eager to prove his worth to the White House. He teamed up with Defense Secretary Mark T. Esper, whose department has long experience with vaccine development and distribution to protect troops. An expert in complex logistics, Gen. Gustave F. Perna, became the operation’s chief operating officer.

Mr. Kushner, Dr. Deborah L. Birx, the White House coronavirus coordinator, and others interviewed Dr. Moncef Slaoui, a pharmaceutical industry veteran, and orchestrated his appointment as chief scientific adviser despite concerns within the Food and Drug Administration about conflicts of interest because of his financial ties to two companies that are developing a vaccine. Rather than being bothered by the conflict, Mr. Kushner and others reasoned that it took someone with such industry experience to oversee the effort.

Credit…Doug Mills/The New York Times

Dr. Slaoui resigned from the board of Moderna, which has received nearly $1 billion in federal support to develop a vaccine. But as of May he still had nearly $10 million of stock in GlaxoSmithKline, a partner with the French drugmaker Sanofi, which last week signed a $2.1 billion agreement to produce 100 million doses. Dr. Slaoui, who is working on a $1 contract, cleared an ethics review by the Department of Health and Human Services and has said he is determined to avoid any conflict.

Shortly after Dr. Slaoui’s appointment, Dr. Marks resigned from the project he conceived and returned full-time to his post as a senior regulator at the Food and Drug Administration, where he will be the key decision maker on whether a vaccine merits approval.

The administration has conducted the vaccine hunt with a focus lacking in much of the rest of its pandemic response. Contracts have been executed at a brisk pace. Mobile trailers have been speedily delivered for experimental doses to be administered. When a company was short on needles, the Pentagon dispatched planes to deliver supplies within 48 hours.

The pharmaceutical companies are reporting the results of their trials at regular intervals, accelerating the review process. With the government paying much of the cost, the companies are beginning the process of manufacturing millions of doses of vaccine essentially on spec so that they can be distributed quickly if they secure approval.

The process has moved at a remarkable clip. Two vaccine candidates, one developed by Moderna in conjunction with Dr. Fauci’s institute and another by Pfizer, last week began Phase 3 trials, the final stage of clinical experimentation. Others are expected soon.

In Mr. Azar’s conference room at the Department of Health and Human Services headquarters, Mr. Kushner and Dr. Birx join meetings with Mr. Azar, Mr. Esper and others. Mr. Kushner repeatedly pushes the group to move faster and has deputized two close associates, Brad Smith and Adam Boehler, to press the case.

The team has sought to ensure that a variety of different types of potential vaccines are being pursued to increase the chances that at least one will work. Dr. Birx has been interested in what is known as a subunit protein vaccine, and at one point called executives at the biotechnology company Genentech and asked what they could do. (Warp Speed is now working with two companies pursuing that type of vaccine.)

Mark Meadows, the White House chief of staff, also talks with pharmaceutical executives. People briefed on the discussions say the White House has also pushed for progress by the fall on therapeutics — drugs to treat people who fall ill to the disease — including the possibility of an emergency use authorization for one or more of those drugs. Late last month, Mr. Trump called the chief executive of Regeneron Pharmaceuticals to check on the progress of a potential antibody treatment.

Credit…Samuel Corum for The New York Times

Career officials have assured Dr. Hahn that they would stand behind him to head off any vaccine decision not based on science. But Dr. Hahn already lost a measure of credibility with the scientific community for approving the emergency use of hydroxychloroquine and chloroquine, two anti-malaria drugs promoted by the president as treatments for the coronavirus over the objections of his public health advisers. The Food and Drug Administration later revoked the authorization, concluding the risks outweighed the benefits.

Scientists have argued that it would be unwise to cut corners on a vaccine that is to be injected into some 300 million Americans, adding that a failed effort would fuel public distrust of vaccines generally.

But a senior White House official, who discussed the matter on the condition of anonymity, said that it would also be unethical to withhold an effective vaccine for an extra three or four months while more people died just to check the boxes of a more routine trial process.

Michael R. Caputo, a spokesman for Mr. Azar, said October was not the goal.

“Everybody at H.H.S. hopes Operation Warp Speed will achieve 300 million doses of a safe and effective Covid vaccine for Americans by January 2021,” he said. “We know that’s optimistic. I have never heard mention of any other timeline, and certainly not from the secretary.”

Mr. Caputo rejected suggestions that a vaccine would be approved before it was ready. “Careless talk about career F.D.A. regulators somehow approving an unsafe and ineffective vaccine just for politics only undermines confidence in the public health system,” he said.

It is not clear that a vaccine approval shortly before the election would be an “October surprise” sufficient to alter the outcome of the vote. An announcement could give Americans hope that the end is in sight. But some Republican strategists said that it might not help Mr. Trump because his opponent, former Vice President Joseph R. Biden Jr., the presumptive Democratic nominee, would surely continue the vaccine process if elected.

“Does it turn everything around for him politically? I don’t know,” said Sarah Longwell, a conservative strategist and prominent Republican opponent of Mr. Trump who regularly conducts focus groups and has found that public attention is more focused on government relief checks and school reopenings.

“If the vaccine is an October surprise, there’s a lot of other things that are cutting against” it as a game-changer, she said.

The drug companies find themselves caught in the middle. While eager to bring products to market as quickly as possible, they face risks in moving too quickly in order to fit an election calendar, analysts said.

“They are acutely aware of the political dynamic here,” said Rob Smith, the director of Capital Alpha Partners, a research firm. A vaccine that flopped would jeopardize their broader business, he said, and it would not make sense “to take a huge reputational risk not just for your vaccine but for all the products across your portfolio to benefit the president politically.”

Dr. Fauci has expressed confidence that the system will hold.

“Historically, the F.D.A. has based their decisions on science,” he told a House committee last week. “They will do so this time also, I am certain.”

Kitty Bennett contributed research.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

U.S. Weighs Early Vaccine Access for Minorities and Others at Risk

Federal health officials are already trying to decide who will get the first doses of any effective coronavirus vaccines, which could be on the market this winter but could require many additional months to become widely available to Americans.

The Centers for Disease Control and Prevention and an advisory committee of outside health experts in April began working on a ranking system for what may be an extended rollout in the United States. According to a preliminary plan, any approved vaccines would be offered to vital medical and national security officials first, and then to other essential workers and those considered at high risk — the elderly instead of children, people with underlying conditions instead of the relatively healthy.

Agency officials and the advisers are also considering what has become a contentious option: putting Black and Latino people, who have disproportionately fallen victim to Covid-19, ahead of others in the population.

In private meetings and a recent public session, the issue has provoked calls for racial justice. But some medical experts are not convinced there is a scientific basis for such an option, foresee court challenges or worry that prioritizing minority groups would erode public trust in vaccines at a time when immunization is seen as crucial to ending the pandemic.

“Giving it to one race initially and not another race, I’m not sure how that would be perceived by the public, how that would affect how vaccines are viewed as a trusted public health measure,” said Claire Hannan, executive director of the Association of Immunization Managers, a group represented on the committee.

While there is a standard protocol for introducing vaccines — the C.D.C. typically makes recommendations and state and local public health departments decide whether to follow them — the White House has pressed the agency at times to revise or hold off on proposals it found objectionable. President Trump, who has been pushing to reopen schools, fill workplaces and hold large public events, has been acutely focused on the political consequences of public health guidance.

Since the beginning of the pandemic, almost every aspect of the administration’s response has involved scarce resources, high demand and claims that the privileged were receiving unfair advantage. The White House recently created Operation Warp Speed, a multiagency effort to accelerate vaccine development that has invested billions of federal dollars in a growing number of companies. At the public advisory committee hearing, held in mid-June, a Defense Department representative said the operation would address the distribution plans in coming weeks.

To speed distribution, the most promising vaccines will start being made even before they have cleared the final stages of clinical trials and been authorized for public use by the Food and Drug Administration.

But there will be a gap between the first doses coming off the manufacturing lines and a stockpile large enough to vaccinate the U.S. population. “I would say months,” Dr. José R. Romero, the chairman of the Advisory Committee on Immunization Practices, predicted.

ImageWestlake Legal Group merlin_174315897_9b51dd17-0bc9-4b57-b38e-48d645b7c864-articleLarge U.S. Weighs Early Vaccine Access for Minorities and Others at Risk Vaccination and Immunization United States Trump, Donald J Redfield, Robert R Race and Ethnicity Hispanic-Americans Food and Drug Administration Coronavirus (2019-nCoV) Centers for Disease Control and Prevention Black People Advisory Committee on Immunization Practices
Credit…Andrew Caballero-Reynolds/Agence France-Presse — Getty Images

The committee, which reports to the C.D.C. director, has long played a key role in determining how to implement new vaccines. The group includes 15 voting members selected by the health secretary who come from immunology, infectious disease and other medical specialties, 30 nonvoting representatives from across the health field, and eight federal officials focused on vaccines. Still, it operates largely out of sight.

#styln-briefing-block { font-family: nyt-franklin,helvetica,arial,sans-serif; background-color: #F3F3F3; padding: 20px; margin: 37px auto; border-radius: 5px; color: #121212; box-sizing: border-box; width: calc(100% – 40px); } #styln-briefing-block a { color: #121212; } #styln-briefing-block a.briefing-block-link { color: #121212; border-bottom: 1px solid #cccccc; font-size: 0.9375rem; line-height: 1.375rem; } #styln-briefing-block a.briefing-block-link:hover { border-bottom: none; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 7px; color: #333; font-size: 12px; margin-left: -13px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-bullet:not(:last-child) { margin-bottom: 0.75em; } #styln-briefing-block .briefing-block-header-section { margin-bottom: 16px; } #styln-briefing-block .briefing-block-header { font-weight: 700; font-size: 16px; line-height: 20px; display: inline-block; margin-right: 6px; } #styln-briefing-block .briefing-block-header a { text-decoration: none; color: #333; } #styln-briefing-block .briefing-block-footer { font-size: 14px; margin-top: 1.25em; } #styln-briefing-block .briefing-block-briefinglinks { padding-top: 1em; margin-top: 1.75em; border-top: 1px solid #E2E2E3; } #styln-briefing-block .briefing-block-briefinglinks a { font-weight: bold; margin-right: 6px; } #styln-briefing-block .briefing-block-footer a { border-bottom: 1px solid #ccc; } #styln-briefing-block .briefing-block-footer a:hover { border-bottom: 1px solid transparent; } #styln-briefing-block .briefing-block-header { border-bottom: none; } #styln-briefing-block .briefing-block-lb-items { display: grid; grid-template-columns: auto 1fr; grid-column-gap: 20px; grid-row-gap: 15px; line-height: 1.2; } #styln-briefing-block .briefing-block-update-time a { color: #999; font-size: 12px; } #styln-briefing-block .briefing-block-update-time.active a { color: #D0021B; } #styln-briefing-block .briefing-block-footer-meta { display: flex; justify-content: space-between; align-items: center; } #styln-briefing-block .briefing-block-ts { color: #D0021B; font-size: 11px; display: inline-block; } @media only screen and (min-width: 600px) { #styln-briefing-block { padding: 30px; width: calc(100% – 40px); max-width: 600px; } #styln-briefing-block a.briefing-block-link { font-size: 1.0625rem; line-height: 1.5rem; } #styln-briefing-block .briefing-block-bullet::before { content: ‘•’; margin-right: 10px; color: #333; font-size: 12px; margin-left: -15px; top: -2px; position: relative; } #styln-briefing-block .briefing-block-header { font-size: 17px; } #styln-briefing-block .briefing-block-update-time a { font-size: 13px; } } @media only screen and (min-width: 1024px) { #styln-briefing-block { width: 100%; } }

Updated 2020-07-09T10:04:11.935Z

“It’s a back-room kind of thing,” said Dr. Nancy Bennett, a health professor at the University of Rochester who led the advisory committee from 2015 to 2018.

Dr. Romero is among four committee members who have been deliberating on the plans since this spring alongside doctors at the C.D.C., representatives from the health field, ethicists and other outside consultants. In June, they briefed the full committee on their work, offering a glimpse of the questions being considered.

As they come up with a multitiered schedule for the first 1.2 million vaccine doses and then the next 110 million, they have focused on who should be considered essential workers, what underlying conditions should be taken into account and what kinds of living environments — nursing homes, homeless shelters — put people at high risk. Among the questions: What should be done about pregnant women? Should teachers go toward the front of the line? Should prisoners be in a top tier?

But for the broader committee, questions of whether to prioritize race and ethnicity sparked the most debate.

Black and Latino people have become infected with the virus at three times the rate of whites, and have died nearly twice as frequently. Many of them have jobs that keep them from working at home, rely on public transportation or live in cramped homes that increase their risk of exposure. They are more likely to suffer from underlying health problems, including diabetes and obesity, that raise the risk of hospitalization and death. Not only do the groups have less access to health services, they have a documented history of receiving unequal care.

The questions come amid a national uproar over the United States’ racist past, which stretches into its response to infectious disease — including the infamous Tuskegee syphilis study, when the government deliberately let hundreds of Black men go untreated even when there was a known cure for the disease.

Dr. Sharon Frey, a professor of infectious diseases at St. Louis University, pointed to health disparities among Black and Latino people at the recent meeting.

“I think it’s very important that the groups get into a high tier,” she said. “Maybe not an entire group, but certainly to address people who are living in the urban areas in these crowded conditions.”

Dr. Peter Szilagyi, a professor of pediatrics at the University of California, Los Angeles, said he was “really struggling with what to do about race and ethnicity.”

He wondered if a lot could be accomplished for minority groups by prioritizing people in general with underlying conditions and by trying to improve their access to health care.

Dr. Romero, the chairman, was doubtful. “This will not address the problem that exists now,” he said. “I think we need to deal with this issue at this time with the information that we have. And it is: They are groups that need to be moved to the forefront, in my opinion.”

Dayna Bowen Matthew, dean of the George Washington University Law School, who has focused on racial inequality in health care and is serving as a consultant on the prioritization issue, agreed.

“It’s racial inequality — inequality in housing, inequality in employment, inequality in access to health care — that produced the underlying diseases,” Dr. Matthew said in an interview. “That’s wrong. And it’s that inequality that requires us to prioritize by race and ethnicity.”

Harald Schmidt, an assistant professor of medical ethics and health policy at the University of Pennsylvania, is not a member of the committee, but has been suggesting other ways vaccine prioritization could work. He predicts that courts would strike down any guidelines explicitly based on race and ethnicity. Instead, he has proposed using an index that takes into account education, income, employment and housing quality to rank neighborhoods by socioeconomic disadvantage that he says could serve as a good proxy.

“It’s imperative that we pay attention to how Covid has impacted the health of minorities differently; otherwise it compounds the inequalities we’ve seen,” Dr. Schmidt said.

There may be substantial differences in how racial and ethnic groups view vaccines. A recent Pew survey found that a little over half of Black adults said they would definitely or probably get a coronavirus vaccine if one were available today, while 44 percent said they would not. Among Hispanic and white adults, 74 percent said they would get the vaccine, while around a quarter said they would not.

“Because of Tuskegee and structural racism within the health care system, you have to make a case much more strongly to the African-American population,” Dr. Schmidt said.

Whoever is prioritized for the first doses, it will not matter if the vaccines don’t work for those demographics. And that will not be determined unless the vaccine trials themselves include those groups. So far, several vaccine candidates have entered final Phase 3 trials.

At a Senate hearing last week, Dr. Robert R. Redfield, the C.D.C. director, and Dr. Francis Collins, head of the National Institutes for Health, emphasized the need for racial and other diversity within the trials.

“The last thing we want to be is trying to recommend who gets the vaccine and we don’t have any data on how the vaccine works in the population that we think really needs this vaccine,” Dr. Redfield said.

Credit…Pool photo by Saul Loeb

“This has got to be a really high priority,” Dr. Collins said. “This may make it more challenging to run a Phase 3 vaccine trial. When you’re trying to enroll a very diverse set of volunteers, it would be much easier just to line up a bunch of 20-somethings who happen be from the white population, but that is not the only answer. We need to really have this diversity.”

Dr. Collins said he and Dr. Redfield had pushed to bring the National Academy of Medicine, an independent nonprofit, into the advisory committee’s work because people were “uneasy about the government calling the shots here.”

Dr. Romero said that the advisory committee would start holding more frequent public meetings on prioritization later this summer, and that it would eventually involve representatives of the communities being considered in its deliberations.

“If we feel that minority populations are important, then certainly we would look at the perceptions of those target groups,” he said.

At the committee’s recent meeting, Col. Matthew Hepburn, the Defense Department’s vaccine coordinator in Operation Warp Speed, said the multiagency effort was preparing to focus on prioritization.

“From an Operation Warp Speed standpoint, in our first few weeks, we really focused on the earlier product development and making some of those important decisions to get to accelerate the product development pipeline,” said Colonel Hepburn, who is also a physician.

But now, he said, there were other questions to consider: “How would these vaccines be distributed based on their induction? Which populations benefit most from vaccinations? Those are critical issues that need to be addressed, and our intention is to address those in the coming weeks.”

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com