The Food and Drug Administration should hold hearings and publish data before it approves a COVID-19 vaccine to boost public confidence, experts in infectious diseases and vaccination advise.
“It is incumbent on us as scientists to convey to the American public what we’re finding and seeing very, very clearly and loudly,” said Jay Bhattacharya, a Stanford School of Medicine health economist and professor of medicine, at a House Oversight Subcommittee on Economic and Consumer Policy hearing Tuesday.
The fallout from disinformation falsely linking the measles, mumps, and rubella vaccine to autism, seeding the anti-vaccine movement, is a cautionary tale, he said.
“There, the early publication of essentially misleading information was incredibly damaging. So I think in the future and for the vaccine that comes out of this process . . . making the data transparent and available so everybody can see what the safety concerns are, if there are any, is absolutely critical,” Bhattacharya said.
Trust in an eventual COVID-19 vaccine will be fragile, public experts worry, because of these anti-vaccine conspiracy theories; the project’s unprecedented speed; FDA’s reversal on authorization for antimalarial drug hydroxychloroquine to be used against COVID-19; historical harms to Black Americans; and deep disapproval of President Donald Trump’s response to the pandemic.
Lawmakers fear there will be immense pressure on FDA Commissioner Stephen Hahn to announce a victory on a vaccine before the November elections from a president who has sometimes shown a willingness to override his own scientific experts.
“Commissioner Hahn has yet to respond to my request for a briefing on the topic. His refusal to respond is glaring and makes me wonder if there’s something to hide here,” Subcommittee Chairman Raja Krishnamoorthi, D-Ill., said in a statement to CQ Roll Call.
Some U.S. vaccine candidates will soon begin to be tested in phase 3 trials, the final phase in which investigators determine if vaccines are safe and effective.
At least 70 percent to 85 percent of the population must have immunity through prior infection or a vaccine to approach herd immunity, according to the Trump administration’s top scientists.
It’s still unclear whether FDA will make a vaccine available through the approval process, which requires drugmakers to prove a vaccine is safe and effective, or through the emergency use authorization, or EUA, process, which only requires drugmakers to prove the vaccine’s benefits outweigh its risks. Emergency use authorizations are only issued during a crisis.
Push to highlight FDA vaccine panel
Krishnamoorthi is pressuring the agency to consider the expertise of the Vaccine and Related Biological Products Advisory Committee, which advises the FDA commissioner.
That committee is an independent body made up of academic researchers and public health experts with a range of expertise, plus a representative from consumer groups and the pharmaceutical industry.
Krishnamoorthi acknowledged the committee may seem “obscure.”
But he said the committee provides a pathway for citizens to participate in FDA vaccine approval. Meetings are open to the public and anyone can submit testimony. Meetings are streamed on the FDA website.
“It sounds like one of the biggest positive aspects of VRBPAC is that it has public deliberations so that there’s widescale understanding of what’s going on. Would you agree with that sentiment?” Krishnamoorthi said at the hearing.
“I completely agree. I think it’s not only so the public can understand. It's a two-way street. It's also so members of the public can make their concerns heard,” said Ruth Karron, director of the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health. Karron is also a former VRBPAC chair and an investigator on a vaccine candidate by Moderna.
Others on the committee’s panel of experts agreed.
“If an EUA were to be considered, VRBPAC could absolutely and should be part of those conversations as well,” said Jason Schwartz, a health policy professor at the Yale School of Public Health. “There’s a place for them no matter which path the FDA considers in the months ahead.”
The FDA has not yet committed to this step.
Democrats on the other side of the Capitol building also are pushing for more work by the FDA to ensure confidence in an eventual vaccine.
Senate Minority Leader Charles E. Schumer and Sen. Patty Murray, D-Wash., the Senate Health, Education, Labor and Pensions Committee ranking member, released a memo Monday pushing for a public VRBPAC meeting and for clinical trial data to be published during trial stages and upon authorization or approval of a vaccine.
Public participation will also be needed as drug companies recruit volunteers for massive phase 3 clinical trials, which experts say require at least 30,000 participants. Recruiting enough volunteers from communities of color has historically been a challenge.
“There is real fear based on history if you look at Henrietta Lacks or the Tuskegee experiments,” Rep. Ayanna S. Pressley, D-Mass., said. Lacks' cultured cells were used without her permission by Johns Hopkins researchers.
FDA published public guidance on how it will evaluate vaccine candidates on June 30. The agency specified it would only approve vaccines with 50 percent efficacy over a placebo.
But concerns remain. The FDA granted an emergency use authorization for hospitals to receive hydroxychloroquine and chloroquine donated to the Strategic National Stockpile, but revoked it because of the risks of heart attack. Former Biomedical Advanced Research and Development Authority Rick Bright alleged in a whistleblower complaint that he authored the EUA because of pressure from Trump administration appointees.
If a vaccine was granted emergency authorization and later discovered to have severe side effects and the authorization was revoked, in the way the emergency use authorization for hydroxychloroquine was granted and then revoked, experts worry it could not only reduce COVID-19 vaccination rates but damage vaccination rates for generations.
“The emergence of a serious safety concern related to a COVID-19 vaccine, or even the perception by the public that corners were cut or political pressure was applied in a rush to approve it, would be greatly damaging not only to COVID-19 vaccination efforts, but also to public confidence in all recommended vaccines,” Schwartz said.