Judicial Watch Sues for FDA Records about Pfizer/BioNTech Vaccine


We filed a Freedom of Information Act (FOIA) suit against the Department of Health and Human Services (HHS) for FDA emails and records about the Pfizer/BioNTech for COVID-19 vaccine (Judicial Watch v. U.S. Department of Health and Human Services (No. 1:22-cv-00733))

We sued after HHS failed to reply to our August 24, 2021, FOIA request for:

Any and all records submitted by Pfizer and/or BioNTech for the SARS-CoV-2 vaccine known as Comirnaty, which received approval from the FDA on August 23, 2021.

All emails related to the vaccine that became known as Comirnaty sent to and from the following FDA officials: Acting FDA Commissioner Janet Woodcock; Deputy Commissioner Andi Lipstein Fristedt; Deputy Commissioner James Sigg; Chief of Staff Julia C. Tierney, J.D.; Associate Commissioner Judith A. McMeekin, Pharm.D.; Associate Commissioner Lauren Roth, J.D.; and Acting Assistant Commissioner Michael Felberbaum.

All internal FDA studies, analyses, memoranda and reports related to the drug known as Comirnaty.

According to Pfizer’s website: “Comirnaty [COVID-19 Vaccine, mRNA] is FDA-approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under EUA to provide a two-dose primary series in individuals 12 through 15 years. Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide a two-dose primary series in individuals 12 years of age and older and to provide a two-dose primary series to individuals 5 through 11 years of age.”

In violation of FOIA law the FDA is covering up complete details on its approval of the controversial Pfizer COVID vaccine. The public deserves to know everything possible – as soon as possible – about a vaccine that is currently impacting tens of millions of people.

In January, a federal judge in Texas ordered the FDA to make the data it relied on to license Pfizer’s COVID-19 vaccine available to the public. The judge imposed a schedule that should result in the release of all information by September 2020. The court concluded, “that this FOIA request is of paramount public importance.”

The judge denied the FDA’s attempt to have 75 years to complete the FOIA request made by a group of doctors and scientists who asked for information about the vaccine. The FDA claimed it could only manage to release 500 pages of records per month of its 450,000 pages that are responsive to the Texas case.

We recently filed a lawsuit against HHS for records about its subagency Biomedical Advanced Research and Development Authority (BARDA) research into COVID-19 boosters, and for communications related to adverse eventscaused by COVID-19 vaccines.

In January through a FOIA lawsuit we uncovered records from the CDC that show Director Rochelle Walensky’s request for details about the death of a teenager who died days after receiving a coronavirus vaccination.


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