Marks: Why ‘Dramatic Departure’ from Vaccine Policy?

Former CBER director Peter Marks says the FDA announcement of a new “evidence-based approach to Covid-19 vaccination” is a “dramatic departure” not just from previous agency vaccine policies but also from the deliberate and measured way in which the agency previously made such policy, with open public discussion and issuance of guidance. Writing in a New England Journal of Medicine Perspective column, Marks says the FDA action “also diverges markedly from the past in its scope, since with it, FDA has taken on aspects of policymaking that have previously been in the domain of the Centers for Disease Control.”

He says the fact that the new policy is called an approach to vaccinations, rather than to the approval of vaccine products, reflects the new FDA focus.

“Although the current federal administration has repeatedly stated that it is committed to transparency and gold-standard science, the issuance of the new policy appears to achieve neither objective,” Marks writes.

In terms of transparency, he says, there was no discussion of the change in policy purview with either the Vaccine and Related Biological Products Advisory Committee or the CDC’s Advisory Committee on Immunization Practices. “If the administration had a rationale for revising the well-established respective roles of FDA and CDC in making policy,” Marks says, “it would have best served transparency by discussing their proposal in a public forum, perhaps even at the level of the National Vaccine Advisory Committee of the Department of Health and Human Services.”

He also notes the policy changes were not discussed in a public forum and did not benefit from the diverse viewpoints of multiple stakeholders.

Addressing the goal of gold-standard science, Marks reviews the current status of Covid-19 and what is known about adverse effects from the existing vaccines. “On the basis of objective review of the available evidence,” he writes, “it is difficult to understand the limitations that FDA has placed on the use of the vaccines in people younger than 65 years of age, and particularly the limitations for pregnant women.”

He says it would be reasonable at this point for the CDC Advisory Committee on Immunization Practices to ask questions such as: In a prolonged period during which variants from the same lineage have been circulating, do we still need to vaccinate all people six months of age and older against Covid-19? If not, he continues, how do we know which easily identifiable populations to focus on, so that the overall population will benefit most from the approach that’s deployed?

Another question to ask, he says, is based on the constantly evolving nature of SARS-CoV-2 and asks what emerging epidemiologic and clinical data might trigger a change in vaccination policy for the population owing to the spread of a more virulent variant.

“When answering such questions and developing the next policy for Covid-19 vaccinations,” Marks says, “FDA and CDC should take the opportunity to thoroughly examine all the scientific, clinical, and experiential data that have accrued since SARS-CoV-2 first came on the scene, in the context of everything that has been learned over the past century of vaccinology and clinical development.”

Marks concludes that FDA’s departure from established process “requires some explanation, particularly since the outcome of issuance of the new vaccination policy does not appear to be consistent with the objectives of transparency and scientific excellence that were concomitantly communicated. In the future, taking the time to ensure that all the available evidence can be reviewed publicly will be critical to achieving the needed clarity and confidence in vaccine policy across the entire public health ecosystem. Finally, FDA and CDC owe such careful consideration of the evidence to everyone in the U.S., since there is no place in public health for policies, practices, or organizations that do not constantly strive to objectively apply the best understanding of scientific truth for the benefit of human health.”