Defending the Republic, a Texas-based non-profit filed a Freedom of Information Act lawsuit against the Food and Drug Administration for refusing to turn over records related to the approval of Moderna’s COVID-19 vaccines.
The group filed a Freedom of Information Act (FOIA) request seeking the production of records relating to the Food and Drug Administration’s (FDA) internal review process of Moderna’s COVID-19 vaccine marketed as “Spikevax.” Given that the forces impacting the FDA’s decision to authorize the vaccine could have influenced Americans’ decision on whether or not to get vaccinated against COVID-19, Defending the Republic requested expedited processing of relevant records.
“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.
On February 9th, less than a week after the initial FOIA was filed, the FDA refused the request for expedited processing, prompting Defending the Republic to appeal the decision.
“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,” explains a complaint filed by Defending the Republic.
Defending the Republic was especially interested in better understanding the review process for Moderna’s COVID-19 vaccine, as data has shown its risk were not adequately explained to those receiving it and data surrounding its efficacy remains obscured. As Defending the Republic explains:
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.