Pfizer-BioNTech Statement to ACIP Meeting 19th September 2025

Pfizer-BioNTech Statement to ACIP Meeting 19th September 2025

On behalf of our teams at Pfizer and BioNTech, thank you for the presentations today and the opportunity to address the committee.

COVID-19 has transitioned from a pandemic to an endemic disease. Even so, COVID-19 disease still hospitalizes hundreds of thousands of Americans and is responsible for the death of thousands every year.(1)

Pfizer and BioNTech remain deeply committed to making safe and effective vaccines that help protect lives in the U.S. and around the world. The Pfizer-BioNTech COVID-19 vaccine has been reviewed by multiple regulatory authorities, including the FDA, and has met all safety and quality control guidelines.

Pfizer's safety systems work in concert with U.S. government safety monitoring; we report information gathered to the appropriate governmental channels and carry out specific scientific studies under the approval of FDA. In addition to routinely reviewing all published scientific literature for safety concerns, we are conducting many studies that use real-world data from millions of people to continue to assess the safety of our COVID-19 vaccines. At Pfizer we carefully review every adverse event reported to us and ensure they are reported to VAERS. VAERS is an early warning system, however, it cannot assess causation (2,3). As such, FDA and CDC use multiple additional safety systems to understand causation-- these were enhanced during the pandemic-- to include COVID-19 Pregnancy Registries, and V-Safe real-time user reporting (4,5,6). Each of these monitoring tools and surveillance systems have their own strengths and weaknesses, but together, they build a safety monitoring "net" that enables identification and investigation of even rare safety signals. Since the COVID-19 vaccine was approved in 2020, assessments conducted along with regulatory bodies across the world, show that the benefits of COVID-19 mRNA vaccines continue to outweigh the risks.

It's important to consider any potential risk in the context of the demonstrated benefits of vaccination. In the past year alone, COVID-19 vaccines prevented somewhere between 68,000 to 100,000 hospitalizations, averted 13,000 to 18,000 intensive care unit stays, and saved five to almost seven thousand lives in the U.S.(7,8)

In summary, Pfizer and BioNTech remain steadfast in our dedication to vaccine safety, quality and effectiveness through constant safety monitoring and ongoing research. With 5 billion doses distributed to date globally and continued approval by regulatory agencies in 83 countries, our vaccines are among the most extensively monitored products licensed in the world-helping prevent hospitalizations and saving lives.

References

1. MacNeil A. CDC. Current Epidemiology of COVID-19. ACIP presentation, June 25, 2025. https://www.cdc.gov/acip/downloads/slides-2025-06-25-26/02-MacNeil-COVID-508.pdf. Accessed: September 15, 2025
2. Vaccine Adverse Even Reporting System. VAERS - About Us. Accessed: September 15, 2025
3. Anita M. Loughlin, et. al. Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), Vaccine, Volume 30, Issue 50, 2012, Pages 7253-7259, ISSN 0264-410X, https://doi.org/10.1016/j.vaccine.2012.09.074.
4. Meyer S. CDC. Update on CDC's COVID-19 Vaccine Safety Monitoring. Update on CDC's COVID-19 Vaccine Safety Monitoring. Accessed: September 15, 2025
5. Myers TR, et. al. The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response. Vaccine. 2023;41(7):1310-1318. doi: 10.1016/j.vaccine.2022.12.031.
6. Vaccine Safety Systems. COVID-19 Vaccine Pregnancy Registry. COVID-19 Vaccine Pregnancy Registry | Vaccine Safety Systems | CDC. Accessed: September 15, 2025.
7. 2025-2026 COVID-19 Vaccine Formula: Pfizer-BioNTech Supportive Data. Vaccine and Related Biological Products Advisory Committee. May 22,2025 Vaccines and Related Biological Products Advisory Committee May 22, 2025 Meeting Announcement - 05/22/2025 | FDA. Accessed: September 15, 2025.
8. Ryan E. Wiegand, et. al. Estimating COVID-19 associated hospitalizations, ICU admissions, and in-hospital deaths averted in the United States by 2023-2024 COVID-19 vaccination: A conditional probability, causal inference, and multiplier-based approach, Vaccine, Volume 49, 2025, doi: https://doi.org/10.1016/j.vaccine.2025.126808.

• Covid-19