US District Judge Orders Immediate Release of Pfizer Vaccine Licensing Documents

U.S. District Judge Mark Pittman ordered the FDA to produce more than 12,000 pages on or before Jan. 31. Pittman then ordered the agency to “produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.”

Mimi Nguyen Ly REPORTER

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Judge Gives FDA Just Over 8 Months to Produce Pfizer’s Safety Data

The decision rejects the FDA’s request to release the data over what would be 75 yearsByMimi Nguyen LyJanuary 6, 2022Updated: January 7, 2022biggersmallerPrint

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 thePfizer-BioNTechCOVID-19 vaccine.

The rate of 55,000 pages a month would mean theFDAhas 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 FDAproposed 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.

U.S. District Judge Mark Pittman orderedthe FDA to produce more than 12,000 pages…

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