17 September 2021 - Committee reviewed clinical data showing a booster dose of Comirnaty elicits high neutralisation titres against SARS-CoV-2 and all currently tested variants.
Pfizer and BioNTech announced today that the U.S. FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend the FDA grant Emergency Use Authorisation for a booster dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19.
The committee recommended that the additional dose be administered at least six months after the two-dose series.