Judicial Watch has released 58 pages of FDA records revealing that Pfizer conducted a study in 2021 with 23 participants to assess reactions to its COVID vaccine booster before seeking FDA approval. This information was obtained through a Freedom of Information Act (FOIA) request after the Department of Health and Human Services failed to respond to an earlier FOIA request.
The records include a July study titled “Phase 1 Booster Safety and Immunogenicity Data up to 1 Month Post-Dose 3 of BNT162b2 30 µg in Study C4591001.” This study provided preliminary safety and immunogenicity data for a group that received two vaccine shots and a booster shot seven to nine months later.
The study showed that a booster dose increases the breadth of neutralizing response against SARS-CoV-2 variants. The data suggested that a third dose could prolong protection and increase the breadth of protection.
The participants in the study included 11 people aged 18 to 55 and 12 people aged 65 to 85. The study assessed their symptoms up to one month after the booster shot and evaluated the booster’s immunogenicity.
The records also reveal the involvement of Biomedical Advanced Research and Development Authority (BARDA) in the development of the COVID-19 vaccine and the partnership between BioNTech, a German pharmaceutical company, and Pfizer in developing the original vaccine.
After the study, the FDA approved a single booster dose of the Pfizer-BioNTech vaccine for specific groups, including those over 65 and individuals at high risk of severe COVID-19.
Judicial Watch has been actively using FOIA requests to uncover information related to COVID-19 issues, including the origins of the virus and vaccine safety.
These revelations raise questions about the approval process for COVID vaccine boosters and highlight concerns over transparency and decision-making in public health policy.