A former FDA commissioner and a vaccine co-inventor told a House panel on Wednesday that they are confident in the FDA’s review process for vaccines, but some remain concerned about pressure from the Trump administration to accelerate the normal timeline.
“Speed matters,” said Mark McClellan, MD, PhD, former FDA commissioner and the founding director of the Duke-Margolis Center for Health Policy, said at a hearing before a House Energy & Commerce Subcommittee on Wednesday.
While he praised the administration for creating Operation Warp Speed to accelerate the development of vaccines and therapeutics, he disagreed with recent statements from the White House suggesting that the FDA is “unnecessarily raising the bar” by developing additional written guidance around EUA of a vaccine.
“That is not the case,” he said.
“FDA has made clear in public statements as recently as [Tuesday] that its emergency authorization standards for vaccines are different and much higher than those for therapeutic products already on the market, like convalescent plasma, and are generally the same as for the safety and effectiveness of other vaccines,” McClellan said.
The agency is calling on manufacturers to produce large safety databases monitoring for side effects, for longer than a month or two after the time that most serious side effects might occur, he noted. The agency, through an EUA, will also require companies to collect substantial post-market data.
McClellan also said that proposed actions by governors to create “new and untested” vaccine review processes would “create uncertainty” and “diminish confidence in the FDA.”
Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and co-inventor of the rotavirus vaccine, said he understands the skepticism that many people are feeling around the development of a vaccine right now.
Pressure from the administration to approve drugs such as hydroxychloroquine and convalescent plasma through an EUA “without clear evidence of safety or efficacy” has created concern that “the same low standards” would apply to a vaccine, he said.
Offit said, however, that he is “optimistic,” that the same scenario will not be repeated with a vaccine because the presence of the DSMB that supervises these process will hold companies to the same standards for any vaccines, and because FDA Commissioner Stephen Hahn, MD, has said he would rely on the advice of the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC), which includes academics and researchers who are not affiliated with the government.
Offit is currently a member of that committee and has gotten to know FDA staff involved in vaccine licensure, he said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and … from people like Drs. Francis Collins and Tony Fauci who are trusted by the American public,” he said.
Those who are nervous about the release of a COVID-19 vaccine should “take comfort” in those in supervisory roles and the academic scientists who monitor the process and who are “looking out for the public’s best interest,” Offit said.
McClellan argued that despite recent political actions, the vaccine development and review process is much more complex than, for example, issuing CDC guidance.
“This is not an easy process to disrupt, just because somebody says something about it,” McClellan noted. “It does undermine confidence, though.”
Similarly, Ashish Jha, MD, MPH, dean of Brown University’s School of Public Health in Providence, Rhode Island, said he too could understand why people are concerned about the integrity of the vaccine development process, given the “unfortunate hyping” of convalescent plasma and the authorization of hydroxychloroquine.
Three actions can help counter the politicization of this process and the undermining of public trust, Jha said.
He called for letting “pre-specified standards” determine EUA approval of a vaccine; for more transparency about safety signals in vaccine clinical trials and how they’re being addressed; and for allowing FDA career scientists to speak directly to the public when an EUA is ultimately issued.
In addition to each of these steps there has to be a strong communication plan to engage community, public health, and religious leaders about the vaccine review process, he said.
Also, political leaders and appointees need to “knock it off” and in particular, stop talking about timelines, Jha said.
He later said that he didn’t think whole new independent bodies at the state level were needed to review the process, noting that there are already bodies of independent experts like the VRBPAC to advise on safety and efficacy.
“If they believe the process has had high integrity, I think that would be enormously helpful and would go along way to offering assurance with the American people,” Jha said.
As for acceptance of an eventual vaccine, companies need to ensure that various demographics, including people of color, are represented trials, in trials.
As Offit, who is 65, noted, “I’m not going to get any vaccine that hasn’t been tested in my age group.”
A “discussion draft” providing recommendations on the “equitable allocation” of a COVID-19 vaccine is available from the National Academies of Sciences, Engineering, and Medicine, and a final draft is expected to be released on Friday.