FDA Guidance Won’t Recommend Another Booster for Most Individuals

In a news release published Tuesday, the FDA announced that most individuals who already received a bivalent booster vaccine would not be eligible for another dose. FDA officials said they intend to decide about future vaccinations in June after more information on fall strain composition becomes available.

The guidance also stated that most individuals who have not received a booster may receive a single dose of a bivalent vaccine. Additionally, individuals older than 65, the immunocompromised, and the unvaccinated are eligible to receive a bivalent booster dose.

Recommendations were based on the high prevalence of immunity across the US population generated by previous infection or vaccination and the FDAs mission to simplify future vaccine schedules for COVID-19.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines, and the agency believes that this approach will help encourage future vaccination,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Evidence is now available that most of the US population five years of age and older have antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines.”

The Pfizer–BioNTech partnership and Moderna vaccines were the only two bivalent boosters included in the announcement based on their safety and effectiveness profiles. Neither shot required a clinical trial, and both received emergency use authorization (EUA) based on their monovalent predecessor’s clinical trial data.

One competitor, Novavax, is also preparing to launch a protein-based booster shot that could be ready for distribution in the fall. The company is pursuing steep cost-cutting measures to stay afloat after its initial COVID-19 vaccine failed to reach the market on time and was initially plagued by vaccine injury-related issues.

As the FDA approved the new boosters for the elderly and immunocompromised, they also withdrew the EUAs for the original monovalent vaccines. These vaccines were designed to help generate immunity against older coronavirus strains, making them useless against new Omicron variants.

Currently, most Americans have not received a booster dose of Moderna or Pfizer–BioNTech, with about 50% of the fully vaccinated population having received an updated booster and 17% of the eligible US population being boosted.

The FDA plans to hold its Vaccines and Related Biological Products Advisory Committee meeting in June to prepare for the fall schedule of boosters. In their announcement, FDA officials compared the meeting to its process for deciding on annual influenza vaccines indicating that COVID-19 will be treated the same way going forward.