- First results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative vaccine efficacy of 95.6% against disease during a period when Delta was the prevalent strain
- In trial with more than 10,000 participants 16 years of age and older, COVID-19 booster was found to have a favorable safety profile
- Companies plan to submit these data to FDA, EMA and other regulatory agencies to further support licensure in the U.S. and other countries
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older. In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.
These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat of this pandemic. We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world.