Pfizer, BioNTech Initiate Rolling Submission of Application to FDA for Covid Booster

 

• New Phase 3 data show booster (third) dose of COMIRNATY induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile
• SARS-CoV-2 neutralizing titers against the wild-type strain one month after booster dose were 3.3 times the titers one month after the second dose
• Pfizer and BioNTech intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world in coming weeks

https://www.businesswire.com/news/home/20210825005638/en/Pfizer-and-BioNTech-Initiate-Rolling-Submission-of-Supplemental-Biologics-License-Application-to-U.S.-FDA-for-Booster-Dose-of-COMIRNATY%C2%AE-in-Individuals-16-and-Older