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udicial Watch announced today it received 57 pages of heavily redacted records from the U.S. Department of Health and Human Services (HHS) that show, just two days prior to FDA approval of the Pfizer-BioNTech COVID-19 vaccine, a discussion between U.S. and UK health regulators regarding the COVID shot and “anaphylaxis,” with the regulators emphasizing their “mutual confidentiality agreement.”
Judicial Watch obtained the records through a Freedom of Information Act (FOIA) lawsuit against HHS (Judicial Watch v. U.S. Department of Health and Human Services (No. 1:22-cv-00660)) after the Food and Drug Administration (FDA), which is an agency of HHS, failed to respond to an August 30, 2021, FOIA request for:
All emails sent to and from members of the Vaccines and Related Biological Products Advisory Committee regarding adverse events, deaths and/or injuries caused by investigatory vaccines for the prevention or treatment of SARS-CoV-2 and/or COVID-19 currently produced by Pfizer/BioNTech, Moderna and/or Johnson & Johnson.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is the U.S. Government’s central advisory body, along with Advisory Committee on Immunization Practices (ACIP), advising whether to approve COVID vaccines.
A lengthy, heavily redacted December 2020 email exchange shows U.S. and UK health officials placing a heavy emphasis on their “mutual confidentiality agreement” in a discussion regarding “anaphylactoid reactions” to the COVID vaccine.
The exchange is initiated by Jonathan Mogford, policy director of the UK’s Medicines and Healthcare Products Regulatory Agency and is sent to Acting FDA Commissioner Janet Woodcock as well as Peter Marks, director of the Center for Biologics Evaluation and Research (CBER). The subject line and body of the email are fully redacted under FOIA Exemption B3 (relating to statutory prohibitions).
