A federal judge on Thursday ordered the U.S. Food and Drug Administration to produce, at a rate of 55,000 pages per month, the documents it relied on to license the Pfizer-BioNTech COVID-19 vaccine.The rate of 55,000 pages a month would mean the FDA has just over eight months to fully produce all of Pfizer’s pre-licensure safety data. That is much faster than the 500 pages-per-month rate the FDA proposed in December 2021. That rate would have effectively given the agency roughly 75 years to fully produce the data, Aaron Siri, a lawyer working on the case, previously observed.
