4 takeaways from FDA’s Covid-19 vaccine meeting
While there is no specific vaccine on the table yet, the committee is hearing from federal agencies and vaccine makers about their efforts to prove a shot is both safe and effective.
An expert panel advising the Food and Drug Administration on coronavirus vaccines wants more details on who is volunteering for trials and how research will continue if a shot is authorized for emergency use.
The Vaccines and Related Biological Products Advisory Committee — a panel of infectious disease experts, doctors and federal scientists — convened Thursday for the first in what is likely to be a string of meetings on Covid-19 shots.
While there is no specific vaccine on the table yet, the committee is hearing from federal agencies and vaccine makers about their efforts to prove a shot is both safe and effective. Although the FDA does not have to heed its committees’ advice, it generally does — and the vaccine panel has taken on an outsized importance against the backdrop of increasingly politicized coronavirus rhetoric.
Here are some takeaways from the daylong, presentation-packed meeting.
Trials need to keep going after a shot is authorized for emergency use.
In the runup to the vaccine meeting, at least one company — Pfizer — questioned whether clinical trials should continue unaltered if a shot gets emergency authorization from the FDA. Pfizer wants to be able to dose willing placebo patients with the shot if it is cleared for emergency use.
But federal officials argue that could stall all ongoing coronavirus vaccine trials — making it harder to find concrete answers to justify full approval. FDA has already told vaccine manufacturers that they must follow at least half of their patients for two months before filing for that authority, a bar lower than approval.
Committee members and federal officials dove into the issue at the meeting Thursday.
“Once a decision is made to unblind an ongoing placebo controlled trial, that decision cannot be walked back. That controlled follow is lost forever,” said Doran Fink, a deputy director of vaccine reviews at FDA, referring to unveiling which people got a working shot in a trial — effectively ending the experiment.
Following trial participants after a vaccine authorization is critical, said CDC’s Stephanie Schrag, an epidemiologist who studies respiratory diseases. If the FDA allows emergency use of a vaccine before a trial is over, experts may not know how long or how well the shot protects people. Plus, real-world factors — things like getting people in for their booster shot — could impact how effective a shot is outside of controlled trials.
Experts are still concerned about a lack of diversity in clinical trials.
“We know that individuals from underserved minorities are hit harder by this pandemic. We know that we need specific information in these groups,” said Hilary Marston, a medical officer at the National Institute of Allergy and Infectious Diseases.
Marston said that the vaccine trials in which the NIH is participating include requirements about enrolling patients with specific risk factors, such as heart problems, obesity and diabetes in a bid to ensure trial participants reflect the population. The government is also working to encourage racial and ethnic minorities that are historically skeptical of medical establishment, because of past abuse and mistreatment, to enroll in trials.
Recruiting very elderly people and young children may still be a barrier. Only Pfizer is enrolling children as young as 12 years old. There is still a gap in data for younger children and pregnant women.
FDA’s Steven Anderson, director of the Office of Biostatistics and Epidemiology, suggested that manufacturers may get some of the data they need by registering women of childbearing age for a study after a vaccine is approved. He also said regulators are working with pediatric hospitals for eventual research on younger volunteers.
Anti-vaccine sentiment could hamper the rollout of a vaccine.
NIAID’s Marston also raised sliding public confidence in vaccines and Covid-19 shots in particular, noting that the sentiment can be particularly strong in underserved communities.
A sobering presentation by the Reagan Udall Foundation laid out comments the nonprofit group received in a poll about Americans’ trust in the government, medical establishments and the health care industry. Deep-set mistrust was apparent in responses submitted by people of color, who said that African Americans are treated differently by doctors and that people of color feel like “guinea pigs” because of an unethical history of medical experimentation.
More broadly, nearly half of Americans believe that President Donald Trump is pressuring FDA to rush a shot, according to a recent POLITICO/Morning Consult poll. Most Americans want shots fully tested, even if it means delaying their access.
Past emergency use authorizations could haunt the government.
There is a public perception nowadays that an FDA emergency-use authorization is a low bar that does not necessarily signal a treatment is promising, said Paul Offit, a University of Pennsylvania vaccine expert on the advisory committee — blaming the agency’s recent decisions to greenlight hydroxychloroquine and convalescent plasma on thin evidence. FDA reversed its decision on hydroxychloroquine after it was clear it had no benefit; convalescent plasma is still in trials.
Those moves created a “language problem” leaving the general public to assume “that critical safety guidelines or efficacy guidelines are being curtailed, but that’s really not the story,” Offit said. He suggested that FDA use another term for authorized vaccines because of the higher standards, seemingly echoing an HHS approach that FDA resisted.
FDA officials also acknowledged a confidence issue and public skepticism about whether coronavirus vaccines will work or be safe.
“Discussing these in today’s public forum is critical to building trust and confidence in Covid-19 vaccines by the general public and the medical community,” FDA’s Marion Gruber, director of the Office of Vaccines Research & Review, said as she kicked off the meeting.