FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

Abbott wins U.S. emergency use authorization for new COVID-19 antibody test

(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.

The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.

Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.

The FDA’s emergency use authorization allows the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases with no adequate or approved alternatives.

IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201012:nPn8KFxtXa.

Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.

However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Shares of Abbott were up 0.5% at $110.21 in early trading.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)

Source Article

Abbott Wins U.S. Emergency Use Authorization for New COVID-19 Antibody Test | Top News

(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.

The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.

Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.

The FDA’s emergency use authorization allows the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases with no adequate or approved alternatives.

IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201012:nPn8KFxtXa.

Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.

However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Shares of Abbott were up 0.5% at $110.21 in early trading.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)

Copyright 2020 Thomson Reuters.

Source Article

Regeneron asks FDA for emergency authorization of its Covid-19 antibody therapy that was given to Trump last week

Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus.



a woman preparing food in a kitchen: New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.


© Regeneron
New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.

The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night.

“Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the statement said. “At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.

Regeneron’s experimental antibody treatment is still in large-scale clinical trials, but has been available for compassionate use, something the FDA has to approve on an individual basis, like it did for the President.

The antibody therapy is a combination of two monoclonal antibodies that is designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19, according to the company’s statement.

A cocktail antibody therapy uses two or more lab-engineered antibodies. Regeneron’s cocktail includes a monoclonal antibody that targets the spike protein the virus uses to drill into healthy cells, and another antibody that targets a different part of the novel coronavirus. With two, the hope is to trap and shut down viral replication.

“When you weigh the potential benefit versus the risks, the downsides are very low here because we have not seen any safety concerns,” Regeneron CEO Dr. Leonard Schleifer told CNN in an interview after Trump received an 8 gram dose of the treatment.

Early data from the company’s antibody trials released recently showed it worked fairly safely with few side effects.

“This class of drugs is an extremely safe class,” Schleifer said.

Dr. Richard Besser, a former acting director of the US Centers for Disease Control and Prevention who now heads the Robert Wood Johnson Foundation, said it makes sense that a treatment that gives a patient antibodies would help the immune system, but he said peer review will find any holes or pitfalls.

“I would withhold judgment on this until we see the data,” Besser said. “You know these early results that keep coming out from companies in press releases strike me as being … much more about the stock price than they are about science.”

But Dr. Thomas Frieden, also a former CDC director, disagreed with Besser.

Although Regeneron’s antibody therapy is unproven, it is “a promising treatment,” Frieden told CNN.

“There’s a report that only fewer than 300 patients have received it,” he said. “It seems to be most effective early in the disease, especially before patients make antibodies of their own.”

“We don’t know if it’ll be helpful,

U.S. FDA Safety Guidelines Likely to Push COVID-19 Vaccine Authorization Past Election | Top News

By Michael Erman and Manas Mishra

(Reuters) – The U.S. Food and Drug Administration told coronavirus vaccine developers on Tuesday it wants at least two months of safety data before authorizing emergency use, a requirement that would likely push any U.S. vaccine availability past the Nov. 3 presidential election.

A senior administration official confirmed the White House had approved the plan, which undercuts President Donald Trump’s hopes of getting a vaccine before voters go to polls.

Trump voiced his displeasure in a Twitter post late on Tuesday: “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”

The FDA released the guidance laying out more stringent recommendations for drugmakers hoping to apply for an emergency use authorization (EUA) for their experimental vaccines.

The New York Times reported on Monday that the guidelines had been blocked by the White House. The senior administration official said there he had been no holdup of the guidance, which underwent normal regulatory review.

The move is the latest effort by U.S. officials to play down politics around the vaccine and assure public safety.

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Dr. Peter Marks, director of the FDA division responsible for approving vaccines, said in a statement.

The White House could still force authorization of a vaccine without that additional safety data. Doing so would put it in open disagreement with the FDA and its career scientists, and add to the perception that politics was playing a role in pushing out a vaccine.

If the agency follows its own guidelines, it is unlikely to authorize a vaccine before sometime in late November. It wants two months of data from half of a trial’s volunteers.

Pfizer Inc and partner BioNTech <22UAy.F> are expected to be the first to announce results from a late-stage U.S. clinical trial.

About half the volunteers in the 44,000-subject Phase III trial had received the second dose of the two-shot vaccine by late September.

Pfizer had previously said it expected to release efficacy data as early as this month and provide FDA with safety data, including the median of two months’ safety data after the second dose, on a rolling basis.

The head of the U.S. government’s Operation Warp Speed vaccine development program said on Tuesday efficacy data on one or two vaccines will be available within the next month or two, and that there should be enough supply to immunize 30 million people during November and December.

Moderna Inc

appears likely to be the second company after Pfizer that will have U.S. trial data available for an EUA review.

Pfizer Chief Executive Albert Bourla tweeted on Tuesday that the company had not discussed the FDA’s standards with the White House, saying that could compromise the agency’s independence.

FDA wants 2 months of safety data for Covid-19 vaccines in trials before considering authorization

The US Food and Drug Administration made clear Tuesday it will want to see two months of follow-up data after volunteers get their second vaccine doses for clinical trials testing potential coronavirus vaccines.



Vaccine Trials


© Emory University
Vaccine Trials

That would make it difficult, if not impossible, for any vaccine maker to apply for emergency use authorization by Election Day, as President Trump has suggested, or by the end of October, as the CEO of Pfizer has hinted.

The process will also make it “pretty darn hard for mischief,” National Institutes of Health Director Dr. Francis Collins said Tuesday.

The agency posted new guidance for manufacturers that says they need to provide at least two months of follow-up safety data after vaccinating volunteers before even asking the FDA to consider giving emergency use authorization (EUA) for a vaccine.

It made similar suggestions in documents for an October 22 meeting that has long been scheduled for vaccine advisers to meet and discuss requirements for either emergency use authorization or a full biologics license application for any potential coronavirus vaccine.

“Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect,” the FDA said in the guidance.

The two months number should come as no surprise. The FDA has been telling companies for some time, says Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, the FDA division that approves vaccines.

“We’ve made it clear that we want to see a median of about two months of follow up for any of the vaccines that come in, and while it would be nice to have much more, we have to balance the safety we get upfront with the need to try to save lives with a vaccine that’s helping to prevent a virus that’s killing 1,000 or more people a day in the United States,” Marks said in a YouTube interview with the Journal of the American Medical Association posted Monday.

The two vaccines that are furthest along in clinical trials — those made by Moderna and Pfizer — each require two doses. Moderna’s is being given to volunteers in two doses 28 days apart; Pfizer’s is being delivered in two doses 21 days apart.

The researchers testing the vaccines are then waiting to see how may people eventually become infected with the virus, and whether fewer people who get the real vaccine become infected versus those injected with placebo.

The FDA also wants to wait to ensure that people do not report side effects after that second shot.

“Safety is what keeps me up at night,” Marks said in the JAMA interview. “Because the way we’re going