The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously in favor of granting Emergency Use Authorization (EUA) for a booster dose of Comirnaty (COVID-19 vaccine, mRNA) for individuals 65 years and older and those at high risk of severe COVID-19. The panel, however, was not in favor (16 no, 2 yes) of a booster dose for all individuals 16 years of age and older based on the totality of evidence presented at the meeting.
The committee reviewed data from several studies, including a phase 3 trial (ClinicalTrials.gov Identifier: NCT04955626) that evaluated the efficacy, safety and tolerability of a booster dose of Comirnaty in 306 participants 18 to 55 years of age who were previously vaccinated with a 2-dose primary regimen. Results showed that the booster elicited high neutralization titers against SARS-CoV-2.
Additionally, real-world surveillance data presented by the Israel Ministry of Health, showed that among individuals 60 years and older who received a booster dose, the rates of COVID-19 and severe disease were substantially lower.
“The data we submitted to the FDA, EMA and other regulatory authorities underline that a booster induces a strong immune response against all tested variants of concern and may contribute to address a public health need,” said Özlem Türeci, MD, Co-founder and Chief Medical Officer of BioNTech.
However, the panel felt that current evidence did not sufficiently support approval of a booster in all individuals 16 years of age and older. Under the current EUA, Comirnaty may be provided to individuals 12 years of age and older who have been determined to be immunocompromised. A decision on whether to authorize the booster for additional populations is expected within the coming days.
Although not bound by the committee’s recommendations, the FDA does take them into consideration when making decisions on approval.
FDA advisory committee votes unanimously in favor of Comirnaty booster for emergency use in people 65 and older and certain high-risk populations. News release. September 17, 2021. https://www.pfizer.com/news/press-release/press-release-detail/fda-advisory-committee-votes-unanimously-favor-comirnatyr.