New York, NY, and Mainz, Germany – September 5, 2024

Pfizer Inc. and BioNTech SE today announced positive results from the Phase 3 clinical trial of their respiratory syncytial virus (RSV) vaccine candidate.

“We’re encouraged by these results, which demonstrate the potential of our RSV vaccine candidate,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer.

Key Findings:

– Vaccine efficacy of 85.7% against severe RSV-mediated lower respiratory tract disease.

– Statistically significant reduction in hospitalizations due to RSV.

– Favorable safety profile.

Trial Design:

– Randomized, double-blind, placebo-controlled trial.

– Enrolled approximately 5,000 participants aged 60 and older.

Next Steps:

– Submission of Biologics License Application (BLA) to the U.S. FDA.

– Regulatory filings with other global health authorities.

About Pfizer and BioNTech:

Pfizer and BioNTech are collaborating to develop and commercialize the RSV vaccine candidate.

Media Contact:

Pfizer Media Relations

(212) 733-1226

media@pfizer.com

BioNTech Media Relations

+49 (0) 6131 9084 1274

media@biontech.de