The latest batch of documents released as part of a Freedom of Information Act (FOIA) lawsuit against the U.S. Food and Drug Administration (FDA) reveals that the FDA knew its safety monitoring system was inadequate for assessing the risk of heart problems associated with Pfizer’s COVID-19 vaccine when it approved the vaccine. The documents, released more than 800 days after the vaccine’s approval, also disclose manufacturing problems in Pfizer batches and acknowledge the phenomenon of vaccine-associated enhanced disease (VAED) in breakthrough COVID-19 cases.
The FDA’s safety monitoring system, the CBER Sentinel Program, was deemed “not sufficient” to assess the risks of myocarditis and pericarditis associated with Pfizer’s vaccine. The documents highlight that the program lacked the power to identify outcomes in patients aged 12-30 and was insufficient for follow-up on recovery status and long-term effects. Despite this, the FDA concluded that the benefits of the vaccine outweighed the risks.
The documents also reveal higher rates of cardiac disorders in trial participants who received the Pfizer vaccine compared to the placebo group. Nine participants who received the vaccine experienced cardiac-related deaths, including cardiac arrest and cardiovascular disease. Despite the higher number of cardiac events in vaccine recipients, the FDA deemed the deaths “unlikely to be related to vaccination.”
Additionally, manufacturing issues and quality oversight inadequacies in Pfizer batches were identified, with several batches deviating from product quality standards but still being released to the public.
The documents also mention vaccine-associated enhanced disease (VAED), a condition observed in individuals exposed to the wild-type pathogen after receiving a vaccine for the same pathogen. The FDA acknowledged reported deaths in fully vaccinated patients and stated that severe manifestations and death from COVID-19 increase the possibility of developing VAED.
The release of these documents comes after a FOIA lawsuit filed by the Public Health and Medical Professionals for Transparency (PHMPT), which aimed to force the disclosure of documents relied upon by the FDA in licensing Pfizer’s COVID-19 vaccine. The lawsuit highlighted the FDA’s delay in releasing the data, as the agency initially sought 75 years to release an estimated 451,000 documents.
Attorney Aaron Siri, who filed the lawsuit, criticized the federal government for shielding Pfizer from liability, providing billions of dollars, and mandating vaccination while delaying the release of safety and efficacy data until 2076. The documents were finally made public, allowing independent scientists and researchers to scrutinize the information used by the FDA in approving Pfizer’s COVID-19 vaccine.