Judge orders the FDA to speed up the release of COVID vaccine data

A federal judge just ordered the Food and Drug Administration (FDA) to speed up the publicization of the data that it used to approve Pfizer’s coronavirus vaccine. 

Now, rather than 75 years from now, the data will likely all be released by the end of the year, assuming the FDA isn’t able to get this court ruling overturned.

Background info

The FDA was looking to release about 12,000 pages of the data that it used to approve Pfizer’s coronavirus vaccine by the end of January. Then, after that, the agency was looking to release a minimum of 500 pages a month. Considering that the agency has about 400,000 pages of data, under this scheme it would take about 75 years, until 2097, for all of the data to be released.

This, of course, raised serious concerns about transparency. And, it is what led to the Freedom of Information Act (FOIA) that the Public Health and Medical Professionals for Transparency filed against the FDA.

As Aaron Siri, one of the lawyers representing the Public Health and Medical Professionals for Transparency, put it, the release rate is “so slow that the documents will not be fully produced until almost all of the scientists, attorneys, and most of the Americans that received Pfizer’s product, will have died of old age.”

Siri also called it “dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”

The FDA’s excuse was that it had staffing issues.

Victory

This week, the Public Health and Medical Professionals for Transparency scored a victory as U.S. District Judge Mark Pittman ruled in their favor.

Now, the FDA has been ordered to up the release rate to 55,000 pages a month. This means that all of the data that the FDA used to approve Pfizer’s coronavirus vaccine could be released within the next eight months.

Pittman described the case as being “of paramount public importance.” At one point, he quoted President John F. Kennedy, that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”

Siri celebrated the victory as a “great win for transparency.” He said that it “removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program.”

The FDA and the U.S. Department of Justice (DOJ) have yet to respond to the decision. Many express doubt as to whether the FDA will comply with Pittman’s order.

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