The Food and Drug Administration is preparing to unveil data at a key vaccine advisory meeting next week that it says links Covid-19 shots to child deaths, a move likely to spark intense scrutiny and debate among public health experts.
The presentation is expected during the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) session on Thursday and Friday, where members will review and make recommendations on several vaccines, including updated Covid shots for the fall.
Just last week, FDA Commissioner, Marty Makary, told foreign media outlets that the agency was examining reports of deaths among otherwise healthy children following vaccination.
According to three sources familiar with the plan, the FDA’s analysis is based on reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a publicly accessible database jointly maintained by the FDA and CDC. VAERS accepts submissions from doctors, patients, and caregivers about potential adverse events following vaccination.
However, two of the sources cautioned that the FDA is drawing on a system that is widely misinterpreted. Experts stress that VAERS reports are unverified and cannot by themselves establish a causal link between a vaccine and an adverse outcome.
Vaccine policy specialists underscored the limitation.
The Department of Health and Human Services also noted that FDA and CDC staff routinely analyze VAERS along with other safety monitoring systems, and make their findings available through ACIP’s public process.
While the reports are unverified, federal health agencies treat VAERS as an early-warning tool to flag possible safety concerns that may warrant further investigation.
Officials say next week’s meeting will provide a fuller opportunity to discuss how the data fits into broader safety monitoring of Covid-19 vaccines.
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