The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination trends.
After awarding a narrow approval for an updated version of Novavax’s COVID-19 vaccine, the FDA appears to be applying those restrictions to COVID-19 vaccines more broadly, according to new approval standards revealed by the agency on Tuesday.
In an editorial published Tuesday in the New England Journal of Medicine, FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) director Vinay Prasad outlined a risk-based strategy for the approval of new COVID-19 vaccines focused on adults over 65 and high-risk individuals six months to 64 years old.
The CDC’s list of underlying medical conditions conveying a higher risk of COVID-19 includes cancer, cardiovascular disease, obesity and mental health conditions such as depression. For these people, “the FDA anticipates that it will be able to make favorable benefit–risk findings” on the basis of immunogenicity, or evidence that a vaccine can generate antibody titers, according to Prasad and Makary.
During an FDA Town Hall Tuesday afternoon devoted to the new framework, both FDA leaders emphasized the intention of restoring the public’s faith in the agency’s oversight of these vaccines. “We have launched down this multi-year campaign of booster after booster after booster and distrust of the American public, and we do not have gold standard science to support this for average-risk, low-risk Americans,” Prasad said. “We must develop randomized evidence.”
Industry analysts were unshaken by the development. In a note to investors Tuesday afternoon, Guggenheim said the new regulatory framework “largely formalizes current market trends,” leading them to believe that “this policy change will have a limited impact on Pfizer’s vaccine business.”
Truist Securities similarly wrote that the shift “carries no burden for [the] key COVID vaccine target market,” which they said is largely made up of these high-risk populations.
As for healthy, younger adults, the FDA leaders recommended placebo-controlled studies before a biologics license application can be granted. The primary endpoint for these trials—which will prioritize individuals between 50 and 64 years, a population where Prasad said uncertainty exists regarding the value of COVID-19 vaccination,—will be clinical endpoints.
In their editorial, Makary and Prasad write that 100 million to 200 million Americans will have access to vaccines based on this framework. This is a strategy that will better align the U.S. with other high-income nations, they said.
It is also largely in line with the approval granted to Novavax’s Nuvaxovid, which was authorized Friday for all seniors aged 65 years and older, and adults 12 through 64 years with “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.”
The proposal comes as the FDA’s sister agency, the CDC, considers a shift toward risk-based recommendations for COVID vaccination. Last month, the CDC’s Advisory Committee on Immunization Practices (ACIP) seemed largely in favor of such a change, which it will vote on in June.
In a note to investors Tuesday afternoon, Jefferies analysts wrote that given the ACIP’s position, the new approval policy was “generally expected” and that Moderna’s stock was up Tuesday afternoon in response to the new framework. “[E]ssentially it doesn’t change anything among those who are 65+ years or older or those who are 6mos-64 years old who are high risk for covid”—currently the strongest market for COVID vaccines, they wrote.
Truist in its note struck a similar note. “We view this as a favorable outcome, as the US COVID-19 vaccine market is now primarily driven by the 65+ population, which has represented the majority of vaccinations in recent years,” the analysts wrote.
Meanwhile, Georgia-based vaccine developer GeoVax sought to capitalize on the new framework. In a statement issued Tuesday morning in anticipation of the FDA’s announcement, CEO David Dodd wrote that the recommendation “underscores the urgent need for next-generation immunization strategies—precisely the role that GeoVax’s multi-antigen COVID-19 vaccine, GEO-CM04S1, is designed to fulfill.”
Toward the end of the Town Hall, Prasad touched on a consistent theme for the administration: the “public distrust” he and Makary said has been directed toward the FDA during the past five years. “We are getting close to a crisis of public trust in vaccines, and in order to get over that, I think we have an obligation at FDA to generate data in populations where there is genuine, genuine equipoise,” he said.
Makary and Prasad spoke out specifically against COVID-19 boosters “in perpetuity.” Prasad—who has often been labeled a “contrarian” by various media sources—pushed back against the title, saying, “no one to my knowledge has ever surveyed the attitudes among all scientists on this question.”
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet Thursday to discuss the regulatory proposal and make recommendations on the selection of the 2025-2026 formula for COVID-19 vaccines in the U.S.
