FDA Sued Over Hiding Records From Moderna COVID-19 Vaccine Approval

A Freedom of Information Act lawsuit has been filed against the FDA over hiding records from the approval of a Moderna COVID-19 vaccine named Spikevax by Defending the Republic.

FDA Sued Over Hiding Records From Moderna COVID-19 Vaccine Approval 1

A Texas-based non-profit called Defending the Republic filed a Freedom of Information Act lawsuit against the FDA for refusing to turn over records related to the clearance of Moderna’s COVID-19 vaccines.

The group requested records linked to the Food and Drug Administration’s (FDA) internal review process of Moderna’s COVID-19 vaccine, marketed as “Spikevax,” through a Freedom of Information Act (FOIA) request.

Because the factors that influenced the FDA’s decision to approve the vaccine may have influenced Americans’ decisions on whether or not to get vaccinated against COVID-19, Defending the Republic requested that pertinent records be processed quickly.

“Please provide all data and information submitted by Moderna relating to the FDA review and approval of Spikevax. This includes, but is not limited to, all safety and effectiveness data and information; all data and information in the biological product file; and all ingredients,” outlined the initial FOIA request.

The FDA denied the request for expedited processing on February 9th, less than a week after the initial FOIA was filed, forcing Defending the Republic to file an appeal.

“The FDA declined the appeal, leaving Defending the Republic with no choice but to file this action seeking a court order requiring the FDA produce the requested records on an expedited schedule— just as those who obtained a court order for the expedited production of records relating to the FDA approved Pfizer-BioNTech vaccine,” according to the complaint.

Defending the Republic was particularly interested in learning more about the approval process for Moderna’s COVID-19 vaccine, as evidence has showed that the vaccine’s risks were not fully conveyed to individuals who received it, and data on its efficacy is still unknown. As explained by Defending the Republic:

Despite the FDA’s promises, a closer inspection of the Spikevax approval reveal there may be glaring issues in the approval process. The Spikevax package insert concedes “[a]vailable data on SPIKEVAX administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

And while the FDA publicly pronounced that the “data demonstrated that Spikevax was 93% effective in preventing COVID-19,” the Spikevax fact sheet for recipients and caregivers provides important context omitted by the public officials: “The [Spikevax] duration of protection against COVID19 is currently unknown.

Read the lawsuit below:

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