FDA Can Withhold Key COVID Vaccine Safety Records for Now: Judge

This article originally appeared on The Epoch Times and was republished with permission.

Guest post by Zachary Stieber

The U.S. Food and Drug Administration (FDA) is being allowed to withhold COVID-19 vaccine safety data for at least six months, under a recent order from a federal judge.

Lawyers representing the FDA said that the agency is overburdened by court orders forcing it to produce a certain amount of records pertaining to the authorization of the Pfizer and Moderna COVID-19 vaccines.

The FDA’s Center for Biologics Evaluation and Research is “dealing with an unprecedented workload” and “specific and unprecedented hardships,” the lawyers said in a motion for a stay. They asked for an 18-month pause in processing a Freedom of Information Act request that seeks the results of COVID-19 vaccine safety data mining.

U.S. District Judge Reggie Walton sided with the government.

“Unfortunately I would have to conclude that because of the extraordinary orders that have been issued by the courts down in Texas … requiring just an exorbitant amount of document production within a relatively short period of time, considering the number of documents involved and all of the other litigation I know that agencies have, I would have to conclude that extraordinary circumstances have been established,” Judge Walton said in a Nov. 20 hearing in Washington, according to a transcript reviewed by The Epoch Times.

Judge Walton eliminated pending deadlines in the case.

The ruling means the FDA can continue withholding materials on its analyses of reports to the Vaccine Adverse Event Reporting System, which have spiked since the introduction of COVID-19 vaccines. The nonprofit Informed Consent Action Network sued after the FDA declined to provide any of the materials. The agency also refused to provide them to The Epoch Times.

Companion analyses that were obtained by The Epoch Times showed U.S. authorities detected hundreds of safety signals for the COVID-19 vaccines, many of which authorities have never provided evidence of examining further. Authorities said the analyses the FDA ran were “more robust.”

FOIA

The Freedom of Information Act (FOIA) requires agencies to respond to FOIA requests in certain timeframes but agencies can skirt the requirements if they show that “exceptional circumstances” exist and they are conducting “due diligence.”

Two suits brought against the FDA for not adhering to timelines in FOIA requests for documents relating to the agency’s authorizations of the COVID-19 vaccines yielded rulings in favor of plaintiffs. The court in those cases ordered the FDA to produce a certain amount of documents responsive to the requests on a monthly basis.

Those orders required the agency to produce at least 90,000 pages per month starting in July, though the FDA has since finished production in one of the cases.

Those orders, coupled with an increase in FOIA requests and lawsuits in recent years, meet the criteria of exceptional circumstances, government lawyers said. They said most FDA FOIA workers are tied up with the orders.

Lawyers representing the plaintiff countered that the FDA did not slow down COVID-19 vaccine authorization due to a lack of resources and that it should apply the same focus to processing FOIA requests. They also said the FDA had not met the criteria of exceptional circumstances, noting that FOIA requests have been on the rise since before the COVID-19 pandemic.

Read the full story at The Epoch Times.