The U.S. Food and Drug Administration's outside advisers will not be vetting any biopharmaceutical company's marketing application for a COVID-19 vaccine at the agency's Oct. 22 public meeting. Instead, the experts will discuss the general terms of development and emergency authorization or licensure of those products, the FDA said Aug. 27.
With so much at stake — most notably the public's trust — it is important now more than ever the FDA not put a COVID-19 vaccine on the U.S. market unless there is overwhelming evidence of safety and efficacy backed up by a certified data and safety monitoring board, said Arthur Caplan, professor of bioethics at New York University School of Medicine.
But the FDA's Vaccines and Related Biological Products Advisory Committee is not expected to hear any such evidence Oct. 22 about specific products and will instead be "kicking around ideas in the abstract — and that's not the best," Caplan told S&P Global Market Intelligence.
The FDA's decision to convene its advisory committee without a specific application for the panel to vet means the advisers will not be able to provide an up-or-down recommendation based on evidence of safety and efficacy — or the lack thereof.
It also means the American public will not be able to weigh in on the evidence for specific products and judge for themselves whether there is reason to have confidence — or not.
"Advisory committee meetings are an important vehicle for the public to learn about the evidence supporting a product and potential concerns or questions about that evidence before FDA makes a decision," said Patti Zettler, associate professor of law at The Ohio State University. "For that reason, advisory committee meetings are always important."
The open meetings of the FDA's advisers are even more important right now to help ensure transparency around the agency's decision-making and to help foster public trust at a time when there are "incredibly troubling signs of unprecedented political interference," Zettler told S&P Global Market Intelligence.
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It is unclear what value a general advisory committee meeting would provide when the FDA has already issued guidelines for COVID-19 vaccine development, said Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania.
Those guidelines are already strong on emphasizing the importance of not approving a vaccine based only on immune response or granting an emergency use authorization, or EUA, until after several statutory requirements are met, Fernandez Lynch said.
The FDA stated in the guidelines that issuing an EUA for a COVID-19 vaccine before large randomized efficacy studies are completed "could reduce the ability to demonstrate effectiveness of the investigational vaccine in a clinical disease endpoint efficacy trial to support licensure."
FDA Commissioner Stephen Hahn and other top officials have publicly pledged to hold advisory committee meetings before granting an EUA or full licensure to any COVID-19 vaccines. But it is unclear if Hahn will deem the Oct. 22 general meeting sufficient before allowing a vaccine on the market. The FDA declined to say whether product-specific meetings will be held before an EUA or license is granted.
A general meeting is no substitute for a product-specific meeting, said Leigh Turner, associate professor at the University of Minnesota Center for Bioethics.
The FDA made the October date official in a Federal Register notice posted online Aug. 27, though Hahn had confirmed the date a day earlier in a tweet. Another top official had acknowledged Aug. 20 during a forum with reporters that the FDA had tentatively put the Oct. 22 date on the books, though it was unclear at that time the committee of experts would only be examining general information.
Caplan and other public health experts questioned the timing of the meeting, given it falls shortly before the Nov. 3 U.S. election. President Donald Trump has made no secret about the fact that he wants the FDA to approve a vaccine before the election, telling Geraldo Rivera on his radio show Aug. 6 that he was "pushing everybody" to get it done. "I'm rushing it. I am," Trump said.
But U.S. National Institutes of Health Director Francis Collins told reporters Aug. 13 it was highly unlikely that phase 3 trial results for any of the experimental COVID-19 vaccines would be in hand and analyzed by October for U.S. regulators to judge whether one of those products could be used in Americans, despite what some companies — most notably Pfizer Inc. — have said about having data ready by then to submit an application.
Given Trump had openly pressured the FDA to grant EUAs to convalescent plasma — which White House Chief of Staff Mark Meadows admitted to Aug. 23 — and hydroxychloroquine, which was later revoked, "it's a pretty clear signal [regulators] are trying to figure out how they can satisfy the administration's interest in having a vaccine before the election," Caplan said.
Hahn has some work to do to reestablish trust with the public and the FDA's independence after he misrepresented data about convalescent plasma Aug. 23 at the White House, said Rachel Sachs, associate professor of law at Washington University in St. Louis.
Hahn has yet to retract or correct his misleading remarks.
He explained in a series of tweets and during an appearance on "CBS This Morning" that he had confused absolute risk reduction with relative risk reduction — a perplexing error for the former cancer researcher to make.
"It will take more than a Twitter thread and morning show appearance for Commissioner Hahn to repair the damage caused by his actions," Sachs wrote in an Aug. 27 commentary in the public policy journal Health Affairs.
If the FDA moves forward with a regulatory decision on a vaccine before it holds an advisory committee meeting on a specific vaccine, "that would be disastrous" for public trust, Caplan said.
A lack of trust is a primary cause of vaccine hesitancy, a factor that will hinder uptake once a shot to prevent COVID-19 becomes available, said Efthimios Parasidis, professor of law and public health at The Ohio State University.
"Untoward consequences from a few rash decisions can impact a generation's trust in an agency that is instrumental to the health and welfare of society," Parasidis wrote in an Aug. 26 op-ed in Barron's. "That trust has already begun to erode and the FDA needs to do more than merely proclaim it will make better decisions next time. To roll back the damage, the FDA must first acknowledge the harm that's already been done."