Washington, D.C. (Agencies): A U.S. District Judge has ordered the Food and Drug Administration (FDA) to release an additional million pages of documents from Pfizer’s COVID-19 vaccine trials. This decision comes after the FDA attempted to withhold these documents for over 75 years.
The ruling was made in response to a Freedom of Information Act lawsuit filed by Public Health and Medical Professionals for Transparency (PHMPT), a group of scientists and doctors seeking transparency in the vaccine approval process. The court’s decision significantly shortens the FDA’s timeline for document release, requiring the agency to produce 55,000 pages every 30 days until all documents are made public.
PHMPT has alleged that the FDA is withholding crucial clinical trial documents, and this ruling is seen as a victory for those advocating for greater transparency and independent review of the vaccine data. The FDA has stated that it has already produced over one million pages of documents and established unprecedented operations to meet the court’s expedited timelines. However, the agency has not commented on the ongoing litigation.
The released documents will include every scrap of paper submitted to the FDA for the entirety of the pandemic, but experts caution that this data may be taken out of context or cherry-picked by anti-vaccine advocates. Despite this, the court emphasized the paramount public importance of releasing the documents quickly and the necessity of expediting the process.
This ruling underscores the importance of transparency in the vaccine approval process and aims to ensure that the public has access to all relevant information regarding the Pfizer-BioNTech COVID-19 vaccine.