Aaron Siri On Fierce Pharma
A federal judge has ordered the FDA to drastically accelerate the release of data on the Pfizer/BioNTech COVID-19 vaccine that was used to grant it emergency use authorization. Rather than taking up to 75 years as originally proposed by the FDA, the information must now be made public within around 8 months.
On Thursday, U.S. District Judge Mark Pittman ruled that the FDA must produce all remaining data on the vaccine at a rate of 55,000 pages per month. This is over 100 times faster than the FDA’s proposed rate of only 500 pages per month. Additionally, the FDA must hand over more than 12,000 pages by January 31st.
The ruling came in response to a Freedom of Information Act (FOIA) request by the group Public Health and Medical Professionals for Transparency. They sought expedited release of the approximately 450,000 pages of vaccine data submitted by Pfizer. The FDA will have to submit joint status reports with the plaintiffs every 90 days on the FOIA request’s progress.
