Effectiveness of COVID-19 Vaccines Under Operation Warp Speed

On September 2, 2025, President Donald J. Trump issued a public request for data from drug companies demonstrating the safety and effectiveness of the COVID-19 vaccines authorized for use under Operation Warp Speed (OWS) in 2020 (Pfizer-BioNTech and Moderna). Operation Warp Speed was a transformative public-private partnership created under the first Trump administration to facilitate the development and distribution of COVID-19 vaccines and therapeutics in the global pandemic. The current call for additional data sharing and transparency about the effectiveness and safety of the vaccines that resulted is welcome and supports an effective and trustworthy health science enterprise.

Evidence of Vaccine Effectiveness

In addition to the results of the large, randomized controlled trials shared by drug companies to earn emergency use authorization from the U.S. Food and Drug Administration in December 2020 [1], subsequent clinical trials and their meta-analyses demonstrate that the Pfizer-BioNTech and Moderna vaccines were highly effective in preventing deaths and hospitalizations [2-9].

Meta-analyses are significant because they analyze findings across multiple studies involving numerous populations, countries, and health systems, rather than relying on a single, isolated result. Rigorous, peer reviewed meta-analyses produce more reliable conclusions than any single study, making them one of the strongest forms of convergent scientific evidence.

According to a 2024 meta-analysis that assessed 50 studies across four continents between 2020 and 2022, the Pfizer-BioNTech and Moderna vaccines were 84 to 86 percent effective in preventing hospitalization among adults. While their effectiveness declined over time and with new COVID variants, it remained strong for prevention of hospitalization and severe disease, at 50 to 80 percent, depending on the season and the population [3]. This is comparable to, or better than, the effectiveness of influenza vaccines over a similar time period [10].

Operation Warp Speed as a Successful Public-Private Partnership

Operation Warp Speed was a bold and groundbreaking effort to propel lifesaving innovation during an unprecedented global pandemic. The Pfizer-BioNTech and Moderna vaccines authorized and distributed under the program saved millions of lives [11-12] and averted hundreds of billions of dollars in direct medical costs [13-15]. OWS conclusively demonstrated how the federal government can play an effective role in de-risking vital biomedical innovation and should serve as a model for public-private partnership, especially during public health emergencies.

–Victor J. Dzau, MD, President, National Academy of Medicine

References

1. Patel, R., M. Kaki, V. S. Potluri, P. Kahar, and D. Khanna. 2022. A comprehensive review of SARS-CoV-2 vaccines: Pfizer, Moderna & Johnson & Johnson. Human Vaccines & Immunotherapeutics 8(1):2002083. DOI: 10.1080/21645515.2021.2002083.
2. Beladiya, J., A. Kumar, Y. Vasava, K. Parmar, D. Patel, S. Patel, S. Dholakia, D. Sheth, S. H. S. Boddu, and C. Patel. 2023. Safety and Efficacy of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Controlled and Randomized Clinical Trials. Reviews in Medical Virology. https://doi.org/10.1002/rmv.2507.
3. Kang-Fai Wong, B., and N. A. Mabbott. 2024. Systematic Review and Meta-Analysis of COVID-19 mRNA Vaccine Effectiveness Against Hospitalizations in Adults. Immunotherapy Advances 4(1):ltae011. https://doi.org/10.1093/immadv/ltae011.
4. Piechotta, V., W. Siemens, I. Thielemann, M. Toews, J. Koch, S. Vygen-Bonnet, K. Kothari, K. Grummich, C. Braun, P. Kapp, V. Labonté, O. Wichmann, J. J. Meerpohl, and T. Harder. 2023. Safety and Effectiveness of Vaccines Against COVID-19 in Children Aged 5-11 Years: A Systematic Review and Meta-Analysis. Lancet Child & Adolescent Health 7(6):379-391. DOI: 10.1016/S2352-4642(23)00078-0.
5. Rahmati, M., D. K. Yon, S. W. Lee, L. Butler, A. Koyanagi, L. Jacob, J. I. Shin, and L. Smith. 2023. Effects of COVID-19 Vaccination During Pregnancy on SARS-CoV-2 Infection and Maternal and Neonatal Outcomes: A Systematic Review and Meta-Analysis. Reviews in Medical Virology 33(3):e2434. DOI: 10.1002/rmv.2434.
6. Soheili, M., S. Khateri, F. Moradpour, P. Mohammadzedeh, M. Zareie, S. Madhavi Mortazavi, S. Manifar, H. Gilzad Kohan, and Y. Moradi.The Efficacy and Effectiveness of COVID-19 Vaccines Around the World: A Mini-Review and Meta-Analysis. Annals of Clinical Microbiology and Antimicrobials 22(42). https://doi.org/10.1186/s12941-023-00594-y.
7. Watanabe, A, R. Kani, M. Iwagami, H. Takagi, J. Yasuhara, and T. Kuno. 2023. Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years: A Systematic Review and Meta-analysis. JAMA Pediatrics 177(4):384-394. DOI: 10.1001/jamapediatrics.2022.6243.
8. Xu, K, Z. Wang, M. Qin, Y. Gao, N. Luo, W. Xie, Y. Zou, J. Wang, and X. Ma. 2023. A Systematic Review and Meta-Analysis of the Effectiveness and Safety of COVID-19 Vaccination in Older Adults. Frontiers in Immunology 14:1113156. DOI: 10.3389/fimmu.2023.1113156.
9. Zheng, C., W. Shao, X. Chen, B. Zhang, G. Wang, and W. Zhang. Real-World Effectiveness of COVID-19 Vaccines: A Literature Review and Meta-Analysis. 2022. International Journal of Infectious Diseases 114:252-260. DOI: 10.1016/j.ijid.2021.11.009.
10. Centers for Disease Control and Prevention. 2025. CDC Seasonal Flu Vaccine Effectiveness Studies. https://www.cdc.gov/flu-vaccines-work/php/effectiveness-studies/index.html (accessed September 4, 2025).
11. Ioannidis, J. P. A., A. M. Pezzullo, A. Cristiano, and S. Boccia. 2025. Global Estimates of Lives and Life-Years Saved by COVID-19 Vaccination During 2020-2024. JAMA Health Forum 6(7):e252223. DOI:10.1001/jamahealthforum.2025.2223.
12. Watson, O. J., G. Barnsley, J. Toor, A. Hogan, P. Winskill, and A. C. Ghani. 2022. Global Impact of the First Year of COVID-19 Vaccination: A Mathematical Modelling Study. Lancet 22(9):1293-1302. https://doi.org/10.1016/S1473-3099(22)00320-6.
13. Bartsch, S. M., P. T. Wedlock, K. J. O’Shea, S. N. Cox, U. Strych, J. B. Nuzzo, M. C. Ferguson, M. E. Bottazzi, S. S. Siegmund, P. J. Hotez, and B. Y. Lee. 2021. Lives and Costs Saved by Expanding and Expediting Coronavirus Disease 2019 Vaccination. Journal of Infectious Diseases 224(6):938-948. DOI: 10.1093/infdis/jiab233.
14. Sah, P., T. N. Vilches, A. Pandey, E. C. Schneider, S. M. Moghadas, and A. P. Galvani. 2022. Estimating the Impact of Vaccination on Reducing COVID-19 Burden in the United States: December 2020 to March 2022. Journal of Global Health 12:03062.
15. Turner, S., E. C. Kranzler, S. Trigger, A. Kearsley, J. N. Luchman, C. J. Williams, B. Denison, H. Dahlen, J. C. Kim, M. Bennett, T. Nighbor, T. Beleche, L. Hoffman, and J. Peck. 2024. Benefit–Cost Analysis of the HHS COVID-19 Campaign: April 2021–March 2022. American Journal of Preventive Medicine 67(2):258-264. https://www.ajpmonline.org/article/S0749-3797(24)00110-7/fulltext#%20.