Updates on FDA panel meeting on the Pfizer/BioNTech Covid-19 vaccine - STAT

A panel of outside experts is meeting Thursday to consider whether the Food and Drug Administration ought to give an emergency use authorization to the Covid-19 vaccine being developed by Pfizer and BioNTech, a vaccine that appeared to be highly efficacious in a Phase 3 clinical trial.

Earlier this week, the United Kingdom started using the vaccine, which is currently known by the working name BNT162b2. On Wednesday, Canada’s drug regulator announced it had approved emergency use of the vaccine.

The U.S. begins its process with Thursday’s meeting of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. If the panel recommends the issuance of an EUA, and if the FDA follows the advice, the rollout of Covid-19 vaccine will begin within a few days in the United States.

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It’s widely assumed VRBPAC will vote to recommend the vaccine and the FDA will issue the EUA; in a report to the panel published online on Tuesday, the FDA’s scientists endorsed the vaccine’s safety and efficacy.

But that doesn’t mean questions won’t be asked and concerns won’t be raised during the day-long meeting. (Draft agenda found here.)  VRBPAC members come to a meeting ready to kick tires hard on behalf of the American public.

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Our live coverage of the meeting is below. We’ll be posting updates and analysis throughout the day, in reverse chronological order.

NEJM editorial: Vaccine is a ‘triumph’

9:30 a.m.: As today’s FDA panel gets underway, one of the invited experts — and a voting member of the panel — has already expressed his opinion that the Pfizer/BioNTech Covid vaccine is a “triumph.”

Eric Rubin, an immunologist at the Harvard T.H. Chan School of Public Health, co-authored a laudatory editorial about the vaccine, published this morning in the New England Journal of Medicine. While highlighting minor issues with the clinical trial design, the vaccine results are “impressive enough to hold up in any conceivable analysis,” Rubin wrote.

He adds:

“This is a triumph. Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year. The sequence of the virus that led to the development of the specific antiviral RNA sequence required to design the vaccine didn’t become known until it had been determined and widely disseminated by the Chinese Center for Disease Control and Prevention in January 2020. There is a lot of credit to go around: to the scientists who shared data and who developed the underlying methods and implemented them to create a vaccine, to the clinical trialists who performed high-quality work in the setting of a health emergency, to the thousands of participants who volunteered to take part in the trial, and to the governments that helped create performance standards and a market for the vaccine. And all this stands as a template for the many other Covid-19 vaccines currently in development, some of which have already completed their phase 3 trials.”

The Phase 3 trial results from Pfizer/BioNTech were also published in NEJM this morning.

— Adam Feuerstein

Here we go!

9 a.m.: The meeting has just been called to order. It is streaming here, if you are interested in checking in.

The virtual audience for this meeting is expected to be large, and global. The world is watching how U.S. agencies are evaluating the effectiveness and safety of Covid-19 vaccines and how it’s thinking about prioritizing vaccine allocation.

How do we know? Well, nearly 32,000 computers in more than 66 countries and most parts of the United States were streaming the Dec. 1 meeting of the Advisory Committee on Immunization Practices, an expert panel that helps the Centers for Disease Control and Prevention assess vaccines and prioritize their use. It is not common that an ACIP meeting would garner that much attention.

During that meeting, ACIP members voted to recommend health care workers and residents of nursing homes get first access to Covid vaccines when supplies are limited.

The VRBPAC audience will likely be larger. The FDA is considered the gold standard for regulatory agencies. It is the only one that requires companies applying to bring a drug or vaccine to market to supply its raw data, which the agency’s scientists recalculate to ensure that the claims being made by the drug or vaccine sponsor are supported by the evidence.

Pro tip: If you’re wondering how long after today’s meeting it will take for FDA to decide on Pfizer’s emergency use authorization application, this afternoon’s discussion will be critical. Norman Baylor, a former director of FDA’s office of vaccines research and review, said Wednesday that if it seems like the committee members agree with the positive tone of the FDA’s review of the vaccine and vote unanimously to recommend an EUA be granted, things could move very rapidly.

If however, VRBPAC members — who have been pouring over the Pfizer data in preparation for the meeting — raise a bunch of red flags, there could be delays, said Baylor, who is now president and CEO of Biologics Consulting.

— Helen Branswell

The FDA’s questions — and the placebo problem

8:45 a.m.: The FDA has posted the questions that the panel will be charged with discussing. The big one, the voting question, is no surprise:

“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?”

It would be a big surprise if the panel doesn’t vote positively, although I’d expect discussion about the meaning of each “yes.”

In addition to the voting question, there are two discussion questions:

1. “Please discuss any gaps in plans described today and in the briefing documents for further evaluation of vaccine safety and effectiveness in populations who receive the Pfizer-BioNTech Vaccine under an EUA.” 

2. “Pfizer has proposed a plan for continuation of blinded, placebo-controlled follow-up in ongoing trials if the vaccine were made available under EUA. Please discuss Pfizer’s plan, including how loss of blinded, placebo-controlled follow-up in ongoing trials should be addressed.”

I want to focus a bit on the second. This is going to be a big issue for all of the vaccine studies. Volunteers in these clinical trials generally expect that even if they were randomly assigned to get the placebo, they’ll be switched to the vaccine once it is effective.  Experts, in particular the ones on the VRBPAC panel, generally want to hold off the moment when placebo patients get the vaccine for as long as possible. Once it comes, the ability to compare the vaccine to a placebo to determine efficacy and side effects is lost.

But there’s another problem, which is that once a vaccine is available, patients may try to get it outside the trial, which is even worse from the perspective of getting good data than switching them over. A month ago STAT obtained a Pfizer memo saying that the company’s plan was to switch patients over as soon as they were eligible to receive the vaccine. There will be a lot more discussion of that plan all day, with time specifically allotted to this issue at 10:50.

— Matthew Herper

VRBPAC’s agenda

6 a.m.: Good day, folks. In honor of what promises to be an historic day, a crowd of us here at STAT— Matt, Adam, Damian and I — will be monitoring and live-blogging on the day’s discussions.

For starters, let’s introduce you to the committee members. The FDA has a very strict conflict of interest policy for VRBPAC members. Anyone involved in any of the Covid-19 clinical trials — even a member who works at a university that is a trial site — is “conflicted out,” which means that temporary replacements who are equally stringently vetted are named in their place.

The early part of the meeting, which begins at 9 a.m. EST, is about setting the table for the discussion that will follow. It includes discussion of what is happening in the U.S. outbreak right now, the plans for monitoring for adverse events potentially triggered by vaccination, as well as a presentation on distribution.

At or about 10:50 a.m. EST (VRBPAC discussions can run long) there will be an important discussion about what steps can be taken to ensure that issuing EUAs for some vaccines don’t interfere with the efforts to run placebo-controlled trials on others that are behind them in the pipeline. This is a thorny but critical issue.

After an early lunch, Pfizer will make a presentation on the vaccine. Then the FDA will make a presentation, which will lay out for committee members what issues the agency wants their advice on and what questions it wants them to answer by holding votes.

Then, starting at 3:10 p.m. EST (or thereabouts), the committee members will begin their deliberations. That’s crunch time.

— Helen Branswell

The context

The Covid-19 pandemic is raging around the world but most especially in the United States, which has the highest number of cases and deaths of any country on the planet. More than 15.3 million Americans have been diagnosed with Covid-19 and more than 288,000 have died.

The country has invested billions of dollars into fast-tracking development and production of Covid vaccines through a military-led project called Operation Warp Speed. While vaccines have been developed at an exceptional pace, there’s been a steady decline in the estimates of how quickly Americans will be vaccinated. Operation Warp Speed currently estimates it will have enough vaccine for 20 million people by the end of December — though vaccines in warehouses and vaccines in arms are two different things.

The administration now estimates that every American who wants to be vaccinated will be able to access vaccine by the end of the second quarter of 2021. Thursday’s hearing starts that process.

— Helen Branswell

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