Pfizer, BioNTech File Initial Data to FDA on Vaccine Booster (1)

(Updates with further details from release on antibody response, companies’ plans.)

Pfizer and BioNTech have submitted Phase 1 data to the FDA to support evaluation of a Covid vaccine booster dose for future licensure.

• Booster dose elicited “significantly higher” neutralizing antibody titers against the initial virus, and the beta and delta variants, compared with levels observed after the two-dose primary series, companies say
• “Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19,” companies say
• Data will also ...