FDA should revamp its COVID-19 vaccine advisory committee meetings: Editor’s Commentary
FDA should break the mold when its advisory committee meets to discuss J&J's COVID-19 vaccine.
FDA should break the mold when its advisory committee meets to discuss Johnson & Johnson's COVID-19 vaccine, says BioCentury’s Washington Editor Steve Usdin.
One of the lessons from the COVID-19 experience is that influencing beliefs and actions is crucial for prevailing over a pandemic. Public health policies and medical countermeasures can only be implemented effectively if millions of people understand and agree with them.
FDA has failed to seize the opportunities provided by advisory committee meetings to shape public opinion. It should rethink the meetings, starting with the Feb. 26 Vaccines and Related Biological Products Advisory Committee (VRBPAC) about the COVID-19 vaccine candidate from Johnson & Johnson (NYSE:JNJ). News and social media accounts of the meeting will animate discussions that determine whether the vaccine is embraced or if it becomes a source of confusion and division.
To promote the confidence and clarity that are prerequisites of effective public health measures, FDA should break the mold it used for December meetings at which the VRBPAC discussed the two now-authorized COVID-19 mRNA vaccines from Moderna Inc. (NASDAQ:MRNA) and partners Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX).
The agency treated those meetings as vehicles for applying a veneer of peer review, a thumb’s up to decisions it had already made, rather than seeking expert advice, providing a forum for committee members to express their views, or synthesizing complex data in ways that the public can digest.
“Transparency focuses debates on a shared set of facts.”
The VRBPAC meetings were valuable, however, because they provided a context for FDA to release the underlying data supporting its regulatory decisions, along with summaries of reviews conducted by agency staff and the sponsors’ interpretations.
That level of transparency sets the FDA process apart from regulatory agencies in most of the rest of the world, and transparency focuses debates on a shared set of facts.
Facts are necessary but not sufficient, especially when government leaders have actively undermined confidence in experts and convinced tens of millions of people that truth is a matter of personal preference.
The politicization of COVID-19 decision-making during the Trump administration amplified the importance of FDA’s independent review. The erosion in confidence in FDA amplified the voices of pundits and journalists who have little or no knowledge of drug development and regulation to appoint themselves as instant experts, tweeting half-baked hot takes that amplify anxiety.
Observers who are unfamiliar with the process believe that advisory committees conduct deep reviews of the raw data, and that the vote tally at the end of meetings, like the score in a sporting competition, is the most important outcome.
At their best, advisory committee meetings are venues for pressure-testing FDA’s and the sponsor’s interpretations of data. They are also opportunities for the agency to lift the curtain on the complexity of its reviews, to air any disputes among its staff, and to provide information that will smooth the path for continued medical progress.
The debate that occurs in these meetings, and especially the explanations of the reasons behind the votes of committee members with different areas of expertise, are more important than the vote tallies.
There are many topics FDA could explore at the Feb. 26 VRBPAC meeting. Because the data about the J&J’s vaccine are difficult to interpret, FDA should focus the meeting’s attention and expertise to answer questions that millions of people will be asking over dinner tables and in late-night expeditions to the far corners of the internet:
What does the lower overall efficacy level reported for the vaccine from J&J, compared with that of the mRNA vaccines, mean for individuals and for populations?
Does it make sense to reserve use of the J&J vaccine to specific groups, and if so, who will make that determination?
Is there a strategy for adding a second dose to the regimen and if so, should it be the same or a different vaccine?
What is known about protection against SARS-CoV-2 variants; what is the strategy to learn more and to act on that knowledge?
If FDA and VRBPAC fail to define how the J&J vaccine fits into the war against COVID-19, individuals with far less expertise, including those advancing agendas at odds with public health, will step up to fill the gap.
Signed commentaries do not necessarily reflect the views of BioCentury.