The Biden administration is requesting a delay until at least 2026 for the release of COVID-19 vaccine safety data that has been withheld from the government’s usual adverse events reporting system.
This week, the Departments of Justice and Health and Human Services petitioned U.S. District Judge Reggie Walton to grant an 18-month stay, preventing the release of the FDA’s data to Just the News under the Freedom of Information Act (FOIA).
The federal agencies argued that “exceptional circumstances” justify the delay, citing the FDA’s heavy workload managing approximately 5.7 million pages of COVID-19 vaccine records in response to numerous public information requests related to the pandemic.
Just the News, represented by the America First Legal public interest law firm, is opposing the delay. A status conference is scheduled for Thursday before Judge Walton. Gene Hamilton, general counsel and vice president of America First Legal, criticized the government's request as a tactic to withhold crucial safety data from patients considering additional vaccine boosters.
Hamilton pointed out that during the pandemic, the FDA had sufficient resources to post Internet memes, suggesting that they could allocate personnel or contractors to expedite the release of the vaccine safety data, which is vital for patients and doctors making informed health decisions.
Just the News and America First Legal sued the Biden administration in February, asking the U.S. District Court in Washington, D.C., to compel the Department of Health and Human Services to comply with two FOIA requests directed at the FDA and the Centers for Disease Control and Prevention (CDC). These requests sought data on COVID-19 reactions kept in a nonpublic system linked to the Vaccine Adverse Event Reporting System (VAERS).
VAERS serves as the national repository for all reports of vaccine-related adverse events, including severe reactions and deaths. The lawsuit references statements from government officials, news articles, and private-sector scientists collaborating with the government on VAERS data. These sources indicated that there is a private database associated with VAERS containing crucial safety information on COVID-19 vaccines that is not publicly accessible.
Just the News submitted FOIA requests for this back-end data to both the FDA and CDC back in January. The FDA acknowledged the request but did not provide any data. In February, the CDC declined to release the information, claiming it fell under the FDA’s jurisdiction and subsequently closed the request.
Senator Ron Johnson (R-Wis.), who has conducted hearings on public concerns and mistrust regarding COVID-19 vaccines, previously expressed fears that drug companies and regulatory agencies are withholding negative information due to their investment in mRNA vaccine technology and the profits from COVID-19 vaccines.
While drugmakers, the FDA, and CDC acknowledge evidence of adverse events, they maintain that these effects are rare and should not deter Americans from vaccination. In February, the CDC recommended an additional vaccine booster in 2024 for Americans over the age of 65.
