The US Food and Drug Administration has added extra time to a daylong meeting Thursday of its vaccine advisers, who are gathering to discuss a potential coronavirus vaccine.
The meeting will now include at least an hour and a half for public input, according to an agenda posted online. The agency has been working to boost faith in the regulatory process after President Donald Trump pushed for a vaccine by Election Day, feeding fears that the federal government was cutting corners to rush a vaccine to market for political reasons.
The meeting of the Vaccines and Related Biological Products Advisory Committee will also stream live on YouTube – an unusual social media performance for an typically obscure gathering of experts on immunology, molecular biology, infectious diseases and biostatistics.
While vaccines can be controversial – thanks to an increasingly loud, if still small, vaccine skeptic movement – this particular group of vaccines is coming under enormous scrutiny.
One or more of these vaccines are the best hope for rescuing humanity from the nearly year-long pandemic that’s infected more than 40 million people globally and killed more than 1.1 million of them. In the US, the count is 8.2 million cases and 220,000 deaths.
Four vaccines have started Phase 3 trials in the United States: those by Moderna, Pfizer with its partner BioNtech, AstraZeneca and Johnson & Johnson.
Dr. Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, which approves vaccines, says the agency is making the process as open and public as possible in the hope of boosting confidence.
“The materials will be discussed in an open session of the advisory committee meeting for Covid-19 vaccines and will be posted on FDA’s website and available to the public like they would be for any advisory committee meeting. And we’ll intend to stream video of the meetings so that they can be viewed by members of the public who wish to do so,” Marks said on the FDA’s podcast this week.
“It’s hoped that this will increase public confidence in vaccines through transparency into the decision-making process that we use for the authorization or approval of a vaccine.”
The committee is not discussing approval or authorization of any of the vaccines in trials now. None of the companies has the data to even ask for that consideration.
Instead, they’ll be treated to a day of presentations about what’s known about the virus, what the federal government has done to help develop vaccines, how the US Centers for Disease Control and Prevention will help monitor the safety of any vaccines after they are authorized or approved, how vaccines will be distributed, efforts to boost the public’s confidence in vaccines, manufacturing considerations and what kind of data to expect on patient reactions to the vaccines.
“We will be engaged in a general discussion about what we are looking for in these vaccines regarding safety and efficacy endpoints,” Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia and a member of the committee, told CNN.
The companies almost certainly will seek emergency use authorization, or an EUA, rather than full licensure, said Marks.
“And this pathway was put in place after the terrorist attacks of 9/11 to ensure that potentially life-saving medical products could be available to people in medical need before they’ve fully been studied to the same level as approved products,” he added.
Full licensing approval of a vaccine usually takes months or even years.
Marks said the FDA will be flexible, but will be tougher in its assessment than it would be for an EUA for a drug.
In a move broadly seen as a declaration of independence from political influence, the FDA earlier this month posted guidelines for companies working on vaccines, saying they will have to include at least two months of follow-up after volunteers get their second doses of the vaccine.
“I’m definitely feeling better that the decision on vaccines won’t be influenced by the White House,” Offit said.
The extra two month safety period would mean no company could seek an EUA before mid-November because the vaccines furthest along in clinical trials – those made by Pfizer and Moderna – both require waiting either 21 or 28 days between doses.
Pfizer chairman and CEO Albert Bourla has said his company expects to apply for an EUA around the third week of November. Moderna CEO Stéphane Bancel has said his company will not have enough data to file for an EUA until November 25. The trials of AstraZeneca’s and Johnson & Johnson’s vaccines are on hold for safety reviews.
Nonetheless, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said current efforts are “on a really good track.”
“A couple of the vaccines are very close to getting some sort of information,” Fauci said during a call with the nation’s governors earlier this month, according to audio of the call obtained by CNN.
“We’re getting to the point where we’re almost being able to look at the first look at the data, which is a predetermined thing done by the data and safety monitoring board,” he said. That’s the independent group that peeks at the data independently of the federal government, the groups testing the vaccines and the companies developing them.
The NIAID is helping sponsor some of the coronavirus vaccine trials and as its director, Fauci will be among the first people to see the data from Moderna, Johnson & Johnson and AstraZeneca, but not from Pfizer, which is not using the federal government network to test its vaccine.
The FDA’s advisory committee has also been padded out with extra experts who are temporary voting members.
The committee includes Kathryn Holmes, an emeritus professor at the University of Colorado School of Medicine, whose expertise on coronaviruses goes back decades. Dr. Michael Nelson, the president of the American Board of Allergy and Immunology and a staff physician at Walter Reed National Military Medical Center, is also on the committee.
The committee’s acting chair, Dr. Arnold Monto of the University of Michigan’s School of Public Health, is one of the world’s top experts on how influenza spreads and on how vaccination can limit that spread.
Dr. James Hildreth, the president and chief executive officer of Meharry Medical College, a historically Black college, received special dispensation to sit on the committee because his school is taking part in vaccine trials and he has personally volunteered to take part.
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“Considering the disproportionate burden of disease in communities of color, it is incumbent upon the FDA to convene a committee that includes experts on health issues of concern to minority populations. To this end, Dr. Hildreth is uniquely qualified to serve on the committee, both as an accomplished scientist/researcher with extensive experience in virology, immunology, pharmacology, and internal medicine, and also as an expert in health disparities,” the FDA says in its meeting materials.
