The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously on Thursday for a monovalent COVID-19 shot that includes coverage of the virus’ JN.1 lineage, the same recommendation it made last year.
But looming over Thursday’s discussions—Leerink analysts in a note called it “the elephant in the room—was the FDA’s recently announced risk-based approval framework for COVID-19 vaccines. Tuesday, Center for Biologics Evaluation and Research director Vinay Prasad, alongside his boss, FDA Commissioner Marty Makary, penned an editorial in the New England Journal of Medicine detailing this new strategy, which would shift the agency’s focus to seniors aged 65 and up and high-risk individuals 6 months through 64 years. This is in contrast to the universal vaccine recommendations the agency currently has for anyone six months or older.
According to Leerink, while many outside experts raised questions about this new framework and its potential impacts on the strain recommendations, the “FDA declined to discuss specifics in this meeting.” It also remains unclear when this new risk-based philosophy will translate into changes in the FDA’s requirements for approval applications.
On Thursday, while the recommendation to update the vaccines was unanimous, the VRBPAC was notably split on strain selection. Some of the experts urged vaccine developers to target a newer JN.1 subtype, called LP.8.1, according to reporting from the Associated Press. Others, meanwhile, took a more conservative stance, insisting that there is no need yet to update strains because last year’s vaccines appear to offer protection against LP.8.1.
The Leerink analysts said this “flexibility on specific sub-strain” could present a unique advantage to Novavax and commercialization partner Sanofi, whose COVID-19 vaccine is protein-based, not mRNA-based like Moderna’s and Pfizer/BioNTech’s shots which dominate the U.S. market. “Updating formulation is slower for their protein-based vaccine than the mRNA vaccines,” the analysts wrote, “and a flexible recommendation allows them to sell their current vaccine and update to the newer sub-strain as practical.”
These new COVID-19 vaccine recommendations come as the Trump administration pushes back on current coronavirus immunization guidelines. On Thursday, speaking during a Senate budget hearing, Makary claimed that “America doesn’t want COVID boosters.” Earlier this week, it was revealed that the FDA had requested that Pfizer/BioNTech and Moderna update the labels of their mRNA vaccines to reflect their risks of myocarditis and pericarditis.
Meanwhile, Health and Human Services Secretary Robert F. Kennedy Jr. said last month that he was considering pulling coronavirus shots from the CDC’s vaccination guidelines for children, while the CDC’s Advisory Committee on Immunization Practice is also considering narrowing its COVID-19 vaccination guidelines.
