While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization (EUA).
Overall, the meeting will provide a foundation for when the FDA convenes the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in the future to evaluate individual vaccine candidates for which an EUA has been requested. But, perhaps more importantly, the FDA appears to be counting on this week’s adcom as a public relations (PR) effort to build confidence in the vaccines that will eventually be approved.
Despite repeated commitments from industry and FDA officials that vaccine approval decisions will be driven by science, the heated rhetoric surrounding the upcoming presidential election continues to erode public confidence in the process – thus, the need for public education about the vaccines.
Recognizing that need, the FDA pledged again this week that the process of vaccine development and its evaluation of the safety and effectiveness of the vaccines will continue to be as open and transparent as possible. “Why is this so important? Transparency in FDA’s processes can help people feel more confident in receiving COVID-19 vaccines, which is critical to their widespread use,” the agency said.
The PR aspects of Thursday’s meeting weren’t lost on analysts. Noting the meeting will include a presentation on vaccine confidence, Mizuho Securities USA LLC analysts Vamil Divan, Uy Ear and Sean Kim said that confidence will be “a critical part of successfully rolling out a COVID-19 vaccine and something that we believe should be boosted by an open, public discussion with external experts such as this one.”
The adcom agenda itself speaks to the foundation-building and PR role the meeting is expected to play. The 8.5-hour meeting, to be live-streamed via the FDA’s YouTube channel, will include a 90-minute public hearing session, as well as expert presentations on the following:
- the epidemiology, virology and clinical features of COVID-19;
- NIH activities in developing the vaccines;
- Biomedical Advanced Research and Development Authority activities in vaccine development;
- the CDC’s plans to monitor vaccine safety and to evaluate vaccines under EUA use and post-licensure;
- the FDA’s Center for Biologics Evaluation and Research (CBER) surveillance systems and postmarketing efforts;
- the operational aspects of distributing and tracking the vaccines;
- COVID-19 vaccine confidence;
- vaccine clinical considerations and chemistry, manufacturing and controls considerations under an EUA.
Unlike other adcoms, the FDA has been promoting this one for several weeks. For instance, it issued a consumer update Oct. 20 explaining the part adcoms play in providing FDA staff with independent expert advice. CBER Director Peter Marks echoed that message in a recent FDA Voices blog and in an interview on the agency’s Insight podcast.
Avoiding conflicts of interest
During the podcast, Marks said the standing vaccine committee – which is made up of experts from academia, medical specialties and other government agencies – “has been augmented for COVID-19 with leading experts in the field. Those are people familiar with coronaviruses such as COVID-19, and all of those have been vetted for conflict of interest … to be independent of the companies that are involved in the development of these vaccines.”
The number of companies pursuing or partnering on potential vaccines and the massive trials underway at teaching hospitals and medical centers across the country have made it challenging to find experts with no conflict. As it is, two of the seven temporary members added to the panel for Thursday’s meeting received waivers for conflicts of interest.
The waivers granted for James Hildreth, president and CEO of Meharry Medical College, and Jeannette Lee, a biostatistics professor at the University of Arkansas for Medical Sciences, noted “multiple recusals of invited participants” due to conflicts. Additionally, seven of the 18 regular VRBPAC members, including the chair, Hana El Sahly, a professor at the Baylor College of Medicine, will not be participating in the meeting.
Hildreth’s conflict is related to his position at Meharry, which is one of three historically Black medical schools in the U.S. As a trial site for a COVID-19 vaccine candidate supported by the NIH through Operation Warp Speed, the Nashville, Tenn.-based college will receive between $500,000 and $750,000, according to the FDA waiver.
Lee’s conflict stems from her holding of $25,000 to $50,000 worth of stock in Philip Morris International, which owns about one-third of a company involved in COVID-19 vaccine development. The waivers were granted in recognition of Hildreth’s and Lee’s expertise and unique qualifications.
And the first up…
Looking ahead, the first COVID-19 vaccine candidate likely to come before the adcom as it seeks an EUA will be Pfizer Inc.’s mRNA-based vaccine. Citing the FDA’s EUA requirement for companies to provide two months of safety data following the final dose of a vaccine, Pfizer CEO Albert Bourla said last week that, based on its current trial enrollment and dosing pace, the company expects to reach that milestone in the third week of November.
Given the commitments Pfizer, of New York, has “from governments in various developed countries to supply more than 450 million doses at a price that we believe is not less than the $19.50/dose that was agreed to with the U.S. government,” the Mizuho analysts said global sales of the vaccine, if approved, could exceed $8.5 billion between 2020 and 2021 before tapering off as the pandemic lessens.
“Although investors may not be willing to place much value on a bolus of sales such as that, it would still be meaningful even to a company of Pfizer's size and would provide Pfizer with additional options in terms of investing in their business, pursuing acquisition or licensing opportunities, or returning cash to shareholders,” analysts Divan, Ear and Kim said.
They added that the speed with which Pfizer has moved to develop its vaccine candidate suggests that it “may be able to meet its stated objectives of being a faster moving, more nimble biopharmaceutical company.”