With numerous COVID-19 vaccines in late-stage testing, the FDA may soon face critical decisions on whether the candidates are safe and effective enough for emergency use or widespread distribution. While the agency has come under political pressure during the pandemic, Commissioner Stephen Hahn, M.D., on Monday stressed its procedures are adequate to maintain independence for the forthcoming reviews.
Career experts at the Center for Biologics Evaluation and Research, an organization within the FDA, will have the authority to “make the assessment around safety, effectiveness, [and] quality manufacturing,” Hahn said during a virtual interview with the CEO of AdvaMed, the medtech industry’s trade group.
The FDA has “processes in place to make sure that the centers are protected from any outside pressure, and that they’re focused solely on looking at the science and the data,” he said, adding “I have absolute faith and confidence in those decisions.”
Hahn's reassurance comes right after COVID-19 vaccines came up during the recent presidential debate between President Donald Trump and Democratic nominee former Vice President Joe Biden. Trump has repeatedly said vaccines could be available in the coming weeks, while his administration's health officials have said they won't be widely available until next year. Biden said he doesn’t trust the president on the process and would listen to scientists.
After the debate, Pfizer CEO Albert Bourla wrote in an open letter that he was “disappointed” the vaccine progress was "discussed in political terms," warning politics could threaten uptake for a safe and effective vaccine. Pfizer could be the first to report phase 3 data, as the CEO has said he expects early results late this month. Aside from Pfizer, AstraZeneca, Moderna, Johnson & Johnson and Novavax have also reached late-stage testing.
At times during the pandemic, the FDA has run into controversy and faced criticisms that politics affected its decision-making.
Perhaps most notably, when the FDA issued an emergency use authorization for convalescent plasma, Hahn said the treatment was associated with a “35% improvement in survival.” Experts pointed out that the data were from a single-arm observational study, and that the survival figure was a comparison of benefit for patients who received plasma with a high dose of antibodies versus a low dose. That's not sufficient evidence to claim a survival benefit at all, experts said. Hahn later walked his claim back.
Before that, Trump accused the FDA of harboring “deep state” employees who are seeking to hurt the administration’s response to the pandemic. That statement—and Hahn’s lack of a response—bothered several lawmakers, who wrote (PDF) to the commissioner that it’s his “responsibility to lead and defend the agency.” In their letter, the lawmakers pointed out several instances of “science being politicized" during the Trump administration's COVID-19 response, including the hydroxychloroquine saga in the spring.
A recent Axios-Ipsos poll found that 57% of Americans have some degree of trust in the agency.