The U.S. Food and Drug Administration (FDA) has been sued for withholding the results of key COVID-19 vaccine safety analyses.
The suit is seeking the raw results from the FDA’s analyses of reports to the Vaccine Adverse Event Reporting System (VAERS).
The system, which the FDA runs with the U.S. Centers for Disease Control and Prevention (CDC), accepts reports of post-vaccination adverse events.
As part of its vaccine safety monitoring, the FDA pledged to run an analysis called Empirical Bayesian (EB) data mining on the reports to see if any safety signals were triggered. These signals give agencies an idea of which problems may be caused by vaccines. Agencies are supposed to research signals to verify them or rule them unrelated to vaccination.
“A report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed,” the CDC states on its website.
The FDA denied CHD’s request for the results of the data mining, claiming that the records are “intra-agency memoranda consisting of opinions, recommendations, and policy discussions within the deliberative process of FDA, from which factual information is not reasonably segregable.”
The FDA also claimed that the sought-after information “contains a discussion of legal and policy matters and fall within the attorney work product and attorney-client privileges as enunciated by the Supreme Court.”
In a set of operating procedures, the federal government said that the FDA would carry out EB data mining and that the CDC would conduct a separate type of analysis using a method called Proportional reporting ratio, or another way to analyze the VAERS data.
Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said at the time that the agency’s refusal to provide the analyses wasn’t acceptable.
“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak said.
The FDA and CDC publicly acknowledge only a small number of adverse events as being definitely caused by or potentially caused by the messenger RNA vaccines, including myocarditis, or heart inflammation.
The CDC claimed that the results of its analyses “were generally consistent with EB data mining.”
CHD says that the refusal by the FDA to release the EB mining results violates the Freedom of Information Act, which enables people and organizations to request information from federal agencies.
While exemptions exist, the FDA improperly withheld the requested data, the new lawsuit charges. It notes that the FDA didn’t provide any evidence to support its claims that it couldn’t release the records.
While the CHD appealed to the government for a fresh look at the request, the FDA said it wouldn’t have a response to the appeal until “around” the summer of 2023.
The Freedom of Information Act requires an agency to make requested records “promptly available” to a requester and imposes other time restrictions, which haven’t been adhered to, the suit says.
CHD is asking the court to find the FDA’s failures to meet the time requirements unlawful and to order the FDA to produce all nonexempt records within 20 days. It’s also asking the court to award attorneys’ fees and other litigation costs.
The FDA didn’t respond to a request for comment.
“It is long overdue for the FDA to release the data on the Empirical Bayesian data mining that it promised even before the COVID shot rollout” Mary Holland, president and general counsel of CHD, said in a statement. “It is reprehensible for this agency, established to protect the American people, to conceal critical data. I trust that the courts will command the FDA to do its job.”
