FDA Examining Potential Vaccine Safety Signals: Official

The regulatory agency will take action if the signals are deemed sufficient, Dr. Vinay Prasad said.

Dr. Vinay Prasad, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, in an undated photograph. FDA via The Epoch Times

Food and Drug Administration (FDA) employees are examining multiple potential safety signals for vaccines, its top vaccine official said on June 10.

“I can’t say exactly what they are, but we’re exploring a number of potential safety signals for vaccine products very aggressively using large real-world data,” Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a video released by the agency.

Safety signals are data points that indicate possible problems related to vaccination. The specific vaccines and signals were not identified.

The analyses include observational research using electronic health records.

“When we find these safety signals—if and when we do—if they are sufficient to warrant regulatory action, it will be incredibly swift,” Prasad said.

He pointed out that the FDA and the Centers for Disease Control and Prevention (CDC) in May advised doctors to stop administering the only vaccine available for the chikungunya virus to older adults because of postmarketing reports of serious adverse events. That pause is giving the FDA time to investigate the reports, Prasad said later.

The CDC found hundreds of safety signals for COVID-19 vaccines in 2022 after analyzing data from the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC, according to files obtained by The Epoch Times. The agency said it investigated some of the signals, confirming a few, such as myocarditis, and ruling others out.

Officials said that for safety monitoring, they primarily relied on a different analysis that was completed by the FDA. Internal emails describing that analysis, released in January, showed the FDA identified safety signals for the vaccines in 2021.

Dr. Peter Marks, who was head of the Center for Biologics Evaluation and Research during the COVID-19 pandemic, and stepped down earlier this year over disagreements with Health Secretary Robert F. Kennedy Jr. on vaccines, told members of Congress in a 2024 hearing that vaccine safety “is closely and continuously monitored through multiple surveillance systems” and that the benefits of available vaccines “far outweigh any risks.”

Marks repeatedly urged people to get COVID-19 vaccines and other shots, while Prasad said earlier in June that the FDA’s role is to make products available to people, not to recommend them.

Improving Systems

Dr. Marty Makary, the FDA’s commissioner, said in the new video that the FDA is trying to improve its adverse event reporting systems, including reducing the amount of information one has to enter to log a report.

“These adverse event reporting databases are not very good,” he said. “They can give us a signal to look at with a more proper methodological study in big data. But we can make zero inferences about rates, and so we need to do better.”

Issues with the systems include that some of the reported events are not related to vaccination, Prasad said. Additionally, events related to vaccination are sometimes not reported, he said.

The Department of Health and Human Services, the parent agency of the FDA and CDC, has said that the existing vaccine safety systems are broken and that it is building new systems.

Makary said that using other sources, such as electronic health records, can help officials assess possible issues.

“We can start by say going back over the last year all FDA-approved products ... then you can understand how they’re working in the real world,” he said. “You can develop synthetic controls. You can ask whether or not a drug we approve on surrogate endpoints also is associated with increased overall survival, whatever question you want to ask, and so that is powerful.”

Makary and Prasad wrote in an article published on June 10 that “robust clinical data can provide better inferences about adverse events than those derived from existing clunky adverse reporting databases that rely on self-reported data.”

Doctor Weighs In

Dr. Joel Wallskog, co-chairman of React19, a nonprofit dedicated to offering support for people who experienced side effects after COVID-19 vaccination, told The Epoch Times via email that he was pleasantly surprised by the comments from the top FDA officials given that he sees VAERS as a system that is “fraught with weaknesses,” including a lack of clear mandatory reporting for health care providers and a lack of full processing of some reports.

React19, in a review of 126 reports made to VAERS, found that 34 percent were not publicly visible.

Some of those reports had been deleted, according to the nonprofit.

“We demanded the FDA in the past perform an independent audit of VAERS,” Wallskog said. “We never received a response to this request.”

Wallskog said that the “radical transparency” promised by Kennedy should include the release of data about COVID-19 vaccines.

“Vaccine hesitancy, and frankly health care hesitancy, will continue to grow without these honest discussions with the American public,” he said.