FDA ramps up effort to persuade public that coronavirus vaccine decisions will be based on science, not politics

WASHINGTON — Federal health officials, worried about shaky confidence in a possible coronavirus vaccine, this week launched a public campaign to try to reassure Americans that regulators won't clear any vaccine that isn't vetted for safety and effectiveness. But President Donald Trump immediately demonstrated the difficulty of divorcing the issue from politics by asserting Thursday that a vaccine might be available "right around" Nov. 3, or Election Day.

Top Food and Drug Administration officials, in published articles and interviews, said they would approve a vaccine only after rigorous review and would consult an outside advisory committee — something that lawmakers and nongovernment scientists have been clamoring for. Agency officials insisted decisions will be based "solely on good science and data." They got backup from Anthony Fauci, the nation's leading infectious-disease expert, who told Reuters the FDA won't be swayed by political considerations. He has said a vaccine might be ready by early next year.

But Trump, who has a history of leaning on, and sometimes abusing, government scientists, told Geraldo Rivera on Thursday: "I'm rushing it. I am. I'm pushing everybody." He said he was focused on saving lives, not on winning the election.

As officials race to stop the pandemic, they are increasingly worried that public skepticism could spur a substantial number of people to reject a vaccine, undermining the nation's ability to return to some semblance of normal life. To try to counter those concerns, lawmakers and health experts are demanding the FDA adhere to stringent standards and be as open as possible in considering any vaccine.

But the FDA's efforts to convince the public the agency will make sound, data-driven decisions have been complicated by the White House's politicization of health and science issues, from the wearing of face masks and school reopenings to its advocacy of unproven treatments such as hydroxychloroquine. The FDA has itself played a role; it was roundly criticized for initially authorizing the anti-malarial drug that was touted by Trump for COVID-19. It subsequently reversed the decision.

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Bioethicists said that while the FDA's effort to strengthen public faith in a vaccine is an important first step, the administration's top scientists and regulators need to go further.

“You can’t have too many voices checking this decision — either to go or not go — given the crucial role that vaccines are going to play, given the political stakes and given the rising distrust of vaccination,” said Arthur Caplan, director of the division of medical ethics at the NYU Grossman School of Medicine. “It’s people worrying they’re going too fast, saying, ‘I don’t trust Trump, I don’t trust this whole process.’ There’s a huge number of people that are just not going to accept whatever FDA says as adequate.”

Caplan called for an independent commission made up not only of scientists, but also of groups of people most in need of a vaccine, as well as "trusted moral leaders."

"The administration has shown itself time and time again to push its political agenda and steamroll the science," he said.

Steven Joffe, a bioethicist at the University of Pennsylvania, said that what is important now is what the FDA does, not what it says.

"Specifically, I think transparency about the data and about the process for decision-making are going to be critical for public and professional/scientific confidence in the vaccine," he said.

Fears about vaccine uptake are flaring as the administration and manufacturers move at unprecedented speed to try to produce a coronavirus vaccine, with a few potential candidates already in late-stage trials. The accelerated timetable has buoyed hopes a vaccine might soon rescue the nation from crisis but also stoked fears that officials, if pressured by the White House, might cut corners to get a product out. Top health officials recognize that a vaccine will be all but useless if there is not broad public trust and support for whatever the FDA approves, according to one current and one former senior administration official.

Rep. Raja Krishnamoorthi, D-Ill., on Thursday introduced legislation requiring the FDA to solicit advice for every potential vaccine from the agency's Vaccines and Related Biological Products Advisory Committee, which is made up of outside experts. He stressed the need for the FDA to be as transparent as possible.

"At a time when there is already hesitancy and outright opposition to getting vaccines in the population, any effort that cuts corners or reduces information or public trust would be disastrous, because then we couldn't achieve herd immunity and resume normal lives," Krishnamoorthi, chairman of the House Oversight subcommittee on economic and consumer policy, said in an interview.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, which reviews vaccines, said in an interview that the agency plans to consult its advisory committee to promote "an open vetting of a vaccine." He said he wasn't sure every coronavirus vaccine in the future would need to considered by the committee, but said, "For the first ones that come along, it makes sense."

The agency has scheduled a meeting of its advisory committee for Oct. 22, Marks said.

In an article published Friday in JAMA,FDA Commissioner Stephen Hahn, Marks and Anand Shah, FDA's deputy commissioner for medical and scientific affairs, pledged "unequivocally" to review vaccines "according to the established legal and regulatory standards for medical products." In an opinion article in The Washington Post on Wednesday, Hahn said, "I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data." He also said he has been repeatedly asked whether there has been any inappropriate pressure on the FDA, but he didn't answer that question in the article. In June, in testimony to a House committee, he said he hadn't felt political pressure to make any specific decision.

The administration already is wrestling with who should get any vaccine first, how to distribute it and when to promote it to the public.

During a briefing for reporters last week, a senior administration official acknowledged the administration is trying to walk "a very fine line" on when it should promote coronavirus vaccines. "We don't know in whom these vaccines are going to work and who they're not," said the official, who spoke on the condition of anonymity, according to ground rules set by the Department of Health and Human Services.

"It's theoretically possible we could have 10 million doses in the middle of October, the end of October, it may not be till the end of December. It may be in early January," the official said.

"So the fine line we're walking is getting the American people very excited about the potential of vaccines and then missing on expectations, versus, you know, having a bunch of vaccines in the warehouse and not as many folks wanting to get it," the official said.

To address that, he said the federal government’s strategy for communications and promotion of vaccines is going to be “very intense, multichannel, highly targeted,” based on data from the clinical trials.