January 1, Judge: FDA Must Turn Over COVID Vaccine Safety Data in 8 Months — Not 75 Years

A federal judge ruled that the Food and Drug Administration must release its complete trove of documents it used to license its COVID-19 vaccine in about eight months — a dramatic decrease from the original 75-year deadline.

A group of doctors and scientists with the nonprofit Public Health and Medical Professionals for Transparency filed a Freedom of Information Act (FOIA) lawsuit against the FDA, seeking roughly 450,000 documents regarding the vaccine’s creation process. The FDA proposed producing 500 pages a month, but U.S. District Judge Mark Pittman ordered the agency to release more than 55,000 a month.

Under Pittman’s timeline, all of the Pfizer vaccine data should be publicly available by late September. Under the FDA’s original proposal, the documents wouldn’t be available in their entirety until 2097.

“Here, the Court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA,” Pittman wrote in his four-page ruling. “But, as expressed at the scheduling conference, there may not be a ‘more important issue at the Food and Drug Administration … than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not rush[ed] on behalf of the United States.”

The judge’s order requires the FDA to produce more than 12,000 pages before January 31. After that, the agency must “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.”

Pittman cited a quote from the late Sen. John McCain (R-AZ) that excessive secrecy from a government entity “feeds conspiracy theories and reduces the public’s confidence in the government.”

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Judge scraps 75-year FDA timeline to release Pfizer vaccine safety data, giving agency eight months