COVID-19 vaccine: Experts warn of waning public confidence

Regulatory NewsRegulatory News | 22 September 2020 |  By 

Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine.
Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposition between vaccine makers’ pledge to not seek US Food and Drug Administration (FDA) approval without Phase 3 data and the increasingly frequent and specific pledges made by President Trump that a vaccine will be available before the Nov. 3 general election. (RELATED: Drugmakers, FDA try to build public confidence in COVID vaccine decisions, Regulatory Focus 8 Sept. 2020.)
Experts have repeatedly averred that a science-based vaccine approval would be very unlikely before November, noted Avorn and Kesselheim.
However, the day before nine major vaccine makers announced their united pledge, “the president stated, ‘We’ll have the vaccine soon, maybe before a special date. You know what date I’m talking about,’ ” they wrote. “The more Trump suggests the possibility of an ‘October surprise’ approval, the more concerned the public becomes about the soundness of the vaccine development and evaluation process.”
While FDA guidance sets a relatively high bar for approval of a COVID-19 vaccine – a 50% or greater reduction in disease severity or incidence – it also allows for authorization of a vaccine via an emergency use authorization (EUA) as an interim step once there is safety and efficacy data. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold, Regulatory Focus 30 June 2020).
Approval of a vaccine or therapeutic normally would be up to the FDA commissioner, who need not heed staff or advisory committee recommendations, the authors noted, adding “the criteria for an EUA are even less rigorous: the commissioner must simply believe, in a public health emergency, that a product’s ‘known and potential benefit…outweigh [its] known and potential risks.’”
They also noted that the federal government could push for approval or authorization of a vaccine even without the sponsor’s request. An unprecedented level of political influence on FDA during the public health emergency could lead to an EUA based on seemingly promising antibody data, regardless of sponsor request, they said, pointing to the Health and Human Service department’s recent revocation of FDA’s premarket review of laboratory-developed tests as a precedent.
Indeed, Health and Human Services Secretary Alex Azar exerted his authority to approve all regulations issued by agencies under his purview, including FDA, in a memorandum issued the same day as the authors’ perspective piece, according to original reporting by the New York Times.
“With that background, It is not unthinkable that a similar level of intrusion could be attempted for a vaccine. Could the president even threaten to use the Defense Production Act (DPA) to compel a company to produce a vaccine for which the manufacturer had not requested approval or for which approval was not granted? Such an action would be extreme and unlikely, but even if there is no follow-through, a presidential threat to use the DPA for this purpose might still be politically useful to Trump,” Avorn and Kesselheim wrote.
They concluded that “the dueling statements of vaccine makers and the president have set the stage for critical decisions in the next 2 months…. The federal response will help determine not just the fate of the first Covid-19 vaccines, but also what remains of the public’s eroding trust in one of the most important aspects of U.S. science policy.”
The authors reported no relevant conflicts of interest.
NEJM (Open Access)


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy