FDA Advisory Committee votes unanimously for Comirnaty booster dose for emergency use in people 65 and older and certain high risk populations.- Pfizer + BioNTech SE

The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA. VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy.

At this time, VRBPAC did not vote in favor of approval of a booster dose for the full population for which Pfizer and BioNTech submitted their supplemental Biologics License Application, which was individuals 16 and older. The same data have recently been submitted to the European Medicines Agency (EMA) and will be filed with other regulatory authorities in the coming weeks. The companies remain vigilant and continue to generate relevant Comirnaty booster dose data for evaluation for future licensure in further groups as well as to address emerging variants of concern.

Real-world surveillance data also were presented to the VRBPAC by the Israel Ministry of Health, providing further support for the public health impact of boosters. The data presented from Israel included an analysis published this week in The New England Journal of Medicine. The analysis comprised approximately 1.1 million individuals ages 60 years and older who were eligible for a booster dose of the vaccine between July 30 through August 31, 2021. No new safety signals were observed, and reported adverse events were lower than those observed after dose two. The analysis showed that a booster dose restored very high levels of protection against COVID-19 infections and severe disease in this period when Delta was the dominant strain. Individuals who received the booster dose were less likely by a factor of 11.3 (95% CI: 10.4, 12.3) to develop a confirmed infection and less likely by a factor of 19.5 (95% CI: 12.9, 29.5) to develop severe illness compared to those who were previously fully vaccinated but did not receive a booster dose. The additional protection after receiving a booster translated to vaccine effectiveness comparable to levels seen early in the country’s vaccine rollout (an estimated 95%), when the Alpha variant was predominant..

The FDA is expected to make its decision in the coming days. This decision could allow Comirnaty to be the first COVID-19 vaccine with a booster authorized in the U.S.