Summarised by Centrist
The FDA has released the final batch of documents related to Pfizer’s COVID-19 vaccine, more than 800 days after its approval. These documents, obtained through a Freedom of Information Act (FOIA) lawsuit, reveal the FDA was aware that its safety monitoring system was inadequate for assessing the risk of heart conditions associated with the vaccine.
They also show manufacturing issues in Pfizer’s vaccine batches and mention vaccine-associated enhanced disease (VAED) in those vaccinated with breakthrough COVID-19.
Despite concerns, the FDA concluded the vaccine’s benefits outweighed the risks.