FDA AdCom votes for Comirnaty booster jab, but only for older and at-risk people

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted unanimously to recommend the FDA grants Emergency Use Authorization (EUA) for a booster dose of Comirnaty (COVID-19 Vaccine, mRNA; BNT162b2) in individuals 65 years of age and older and individuals at high risk of severe COVID-19.

The vaccine was discovered by Germany’s BioNTech (Nasdaq: BNTX) and was further developed and is marketed under a licensing deal with US Pharma giant Pfizer (NYSE: PFE), which posted $7.8 billion from sales of Comirnaty in the second quarter of this year and the company expects full-year sales to hit $33.5 billion. Forecasts compiled by life sciences consultancy Airfinity predict sales next year of Comirnaty will reach $56 billion.

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.