Posted by Michael Wonder on 27 Feb 2023
Pfizer and BioNTech submit supplemental biologics license application for US FDA approval of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine for ages 12 years and older as primary series or booster
24 February 2023 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the US FDA for approval of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for individuals 12 years of age and older.
On 26 January 2023, the US FDA’s Vaccines and Related Biological Products Advisory Committee voted to harmonise the composition of COVID-19 vaccines across booster and primary series doses.
