Biologics

FDA Covid-19 Pediatric Review Raises New Scrutiny

FDA is facing renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the release of documents by Senator Ron Johnson (R-WI) that he says show federal health officials failed to fully disclose vaccine safety concerns.

The controversy centers on a 12/2025 FDA analysis that was publicly released last week by Johnson, chairman of the Senate Permanent Subcommittee on Investigations, as part of his ongoing inquiry into the federal government’s handling of Covid-19 vaccine safety data.

According to Johnson’s office, the internal FDA review examined 96 pediatric deaths reported to the Vaccine Adverse Event Reporting System, or VAERS, following Covid-19 vaccination. It stated that no deaths were classified as “certainly” caused by vaccination, while seven cases were deemed “possibly” related and two “probably” related. These determinations do not reconcile with claims former CBER director Vinay Prasad was making that ten children had died due to the vaccine (see story). At the time, leading vaccine experts sharply criticized the FDA memo and its claims.

Johnson said the document raises concerns that the Biden administration failed to provide transparency about vaccine-related adverse events. In a 5/12 letter to HHS secretary Robert F. Kennedy Jr., Johnson called for accelerated production of additional records related to pediatric deaths following Covid-19 vaccination. “The public deserves complete transparency about the safety of the Covid-19 vaccines,” Johnson wrote.

FDA has not publicly announced any new regulatory action tied to the memo. Current labeling for mRNA Covid-19 vaccines already includes warnings about myocarditis and pericarditis risks, particularly in younger males.

The issue has also intensified broader political disputes over vaccine oversight within the Trump administration’s health agencies. Some lawmakers have separately accused FDA leadership of interfering with the publication of vaccine safety studies that found no new safety signals associated with Covid-19 vaccines (see earlier story).

VAERS, the database referenced in the FDA review, is a passive reporting system jointly managed by the FDA and CDC that allows healthcare providers, manufacturers and members of the public to submit reports of adverse events following vaccination. Federal health agencies have long cautioned that reports to VAERS alone do not establish that a vaccine caused a reported event.

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FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome