Posted by Michael Wonder on 26 Aug 2021
Pfizer and BioNTech initiate rolling submission of supplemental biologics license application to U.S. FDA for booster dose of Comirnaty in individuals 16 and older
25 August 2021 - New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralising antibody titres and demonstrated a favourable safety and tolerability profile.
Pfizer and BioNTech today announced the initiation of a supplemental biologics license application to the U.S. FDA for the approval of a booster (third) dose of Comirnaty (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.
