A federal judge has ordered the U.S. Food and Drug Administration to release more information supporting the authorization of a COVID-19 vaccine after failing to persuade the court to end a public records lawsuit.
in judgment, On Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, ruled against a group of scientists who wanted to know the licensing information the FDA relied on to approve Pfizer and BioNTech's coronavirus vaccine. The authorities were ordered to submit a “permit” file. .
Pittman, who was appointed by then-President Donald Trump in 2019, said, “Now that the COVID-19 pandemic is long gone, it is important to give the American people the information the government relied on to approve the Pfizer vaccine.'' There is no good reason to hide it.”
The lawsuit, filed in late 2021, says it could take decades for the FDA to process and release records to the group that filed the lawsuit, Public Health and Medical Professionals for Transparency. What he said attracted attention.
The FDA declined to comment.
Aaron Siri, an attorney representing public health and medical professional groups that advocate transparency, welcomed Pittman's order.
“The FDA clearly lacks confidence in the review it conducted to authorize Pfizer's COVID-19 vaccine, as it is doing everything it can to prevent independent scientists from conducting an independent review.” said Siri.
He said authorities “hid from courts and plaintiffs one million pages of clinical trial documents related to coronavirus vaccine trials.”
The FDA has the authority to grant “emergency use authorization” for vaccines and some other medical products.
“The medical and scientific community and the public have a vested interest in reviewing the data and information underlying the FDA's approval of the Pfizer vaccine,” the complaint said.
The agency countered that its “emergency use authorization” file was not subject to the scientists group's records request.
The FDA said in its filing that it produced more than 1 million pages of records in the lawsuit.
The filing also said it spent more than $3.5 million to launch an “unprecedented and extraordinary operation” to comply with Mr. Pittman's directives to expedite the search and distribution of responsive records.
The Transparency Public Health and Medical Professionals Association, whose members include professors and scientists from Yale University, Harvard University, the University of California, Los Angeles, and Brown University, has thousands of records posted on its website. There is.
The case is Public Health and Medical Professions for Transparency v. U.S. Food and Drug Administration, U.S. District Court for the Northern District of Texas, No. 4:21-cv-01058-P.
