The FDA has released the final batch of documents related to the approval of Pfizer’s Comirnaty COVID-19 vaccine, more than 800 days after the vaccine was approved. The release comes as a result of a Freedom of Information Act (FOIA) lawsuit. The documents reveal that the FDA acknowledged its safety monitoring system was “not sufficient” to assess the risks of heart conditions associated with the vaccine, specifically myocarditis and pericarditis.
The documents also highlight manufacturing issues in Pfizer batches released to the public and disclose the FDA’s awareness of vaccine-associated enhanced disease (VAED) in individuals who experienced breakthrough COVID-19 after vaccination. VAED refers to a modified presentation of a clinical infection in those exposed to the wild-type pathogen after receiving a vaccine for the same pathogen.
Despite claims of an intensive vaccine safety monitoring effort, the FDA memo states that its CBER Sentinel Program was not adequate to assess the risks associated with Pfizer’s COVID-19 vaccine, particularly in individuals aged 12-30. Cardiac disorders were reported more frequently in trial participants who received the vaccine compared to the placebo group, and some participants experienced cardiac-related deaths.
The release of the documents was the result of a FOIA lawsuit filed by the Public Health and Medical Professionals for Transparency, a nonprofit group. The FDA’s delay in releasing the data raised concerns about transparency and accountability, with critics arguing that the federal government shielded Pfizer from liability and prevented the timely release of safety and efficacy data until 2076. The FDA took 108 days from Pfizer producing records to approve the vaccine, despite the lengthy delay in releasing the associated documents.