Judge Gives FDA Eight Months Instead of 55 Years to Release Pfizer Vaccine Data

Last November, I reported that in response to a Freedom of Information Act request, the Food & Drug Administration (FDA) asked a federal court to grant the agency until 2076, 55 years, to process and release all the data on the Pfizer COVID-19 vaccine.

The judge has given them eight months instead.

A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.That’s roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine.The court “concludes that this FOIA request is of paramount public importance,” wrote U.S. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019.

The rate of the documentation release will be substantially faster than the 500 pages per month initially requested by the FDA.

Pittman’s ruling requires the FDA to start producing documents at an expedited pace — more than 12,000 pages before Jan. 31. That timeline is also in line with the agency’s proposal. But deviating sharply from the FDA’s desired timeline, the judge 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.”Public Health and Medical Professionals for Transparency said the data should be made public quickly because the FDA took just under four months to review the data before granting full approval for the Pfizer-BioNTech COVID-19 vaccine.“Pfizer began its rolling submission on May 7, 2021, and the vaccine was licensed on August 23, 2021, a total of 108 days from initial submission to licensure,” it wrote in a December filing.Pittman cited a quote from the late Sen. John McCain, the Arizona Republican and 2008 GOP presidential nominee, that excessive secrecy from a government agency “feeds conspiracy theories and reduces the public’s confidence in the government.”

It may be a bit too late to prevent the reduction in the public’s confidence in government, however. Per Newsweek:

Less than a third of Republicans say they trust the U.S. government, a dramatic double-digit decline compared with a year ago, new polling shows….The survey results, published Thursday, show that while 48 percent of Republicans said they had “some” trust in the U.S. government in January 2021, that number has now plummeted to just 28 percent. That marks a decline of 20 points over the past year.Meanwhile, trust in federal elections among Republicans has dipped as well. A year ago, 43 percent of GOP voters had “some” trust in the U.S. electoral system. Now, that amount has dipped by 8 percentage points to just 35 percent—or slightly more than a third.

Newsweek blames President Donald Trump. Yet any explanation that does not take into account the numerous flip-flops and confusing recommendations from government “experts” related to coronavirus response is missing a critical element in its assessment.

Tags: FDA, Wuhan Coronavirus

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