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# Senator Seeks FDA Records on Covid Vaccine Safety Review
- URL: https://www.fdaweb.com/senator-seeks-fda-records-on-covid-vaccine-safety-review/
- Published: 2026-06-18T12:00:00.000Z
- Updated: 2026-09-14T13:41:24.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161333

Sen. **Ron Johnson** (R-WI) has launched a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from HHS, FDA and CDC related to internal discussions about adding a warning for "myocarditis with fatal outcomes" to mRNA Covid-19 vaccine labeling.

In a [6/16 letter](https://www.ronjohnson.senate.gov/wp-content/uploads/2026/06/2026-06-16-RHJ-to-HHS-CDC-FDA3.pdf?ref=fdaweb.com) to HHS secretary Robert F. Kennedy Jr., CDC acting director Jay Bhattacharya and FDA acting commissioner Kyle Diamantas, Johnson cited records obtained through the Senate Permanent Subcommittee on Investigations that he said show FDA officials considered a safety labeling change in late 2025 after reviewing pediatric death cases potentially linked to Covid-19 vaccination.

The letter focuses on documents indicating that CBER initially identified 10 pediatric deaths as possibly or probably related to Covid-19 vaccination before later revising three cases to "un-assessable" or "unlikely," leaving seven cases that agency officials reportedly continued to view as possibly or probably vaccine-related ([see earlier story](https://www.fdaweb.com/fda-covid-19-pediatric-review-raises-new-scrutiny/)).

According to records cited by Johnson, an FDA Division of Pharmacovigilance official wrote in a 12/5/2025 email that the office's recommendation was to initiate a Safety Labeling Change process "to include myocarditis with fatal outcomes in labeling for mRNA Covid-19 vaccines" and planned to present that recommendation at a 12/11/2025 safety working group meeting. Johnson said it remains unclear whether the meeting occurred and whether FDA ultimately considered or rejected the proposed labeling change.

The lawmaker is requesting records explaining whether the 12/2025 meeting took place, whether FDA agreed to any labeling modifications, and, if not, why the recommendation was not adopted. He also requested communications between FDA and CDC regarding pediatric deaths potentially linked to mRNA Covid-19 vaccines.

Johnson's inquiry also targets CDC's reported award of $1.24 billion in contracts to Pfizer for adult and pediatric Covid-19 vaccines. He argued that the contracts raise questions about the agency's consideration of vaccine safety concerns and requested documents related to the procurement decisions and internal discussions regarding vaccine safety.

The letter builds on a series of investigations by the Permanent Subcommittee on Investigations examining FDA and CDC oversight of Covid-19 vaccine safety monitoring. Johnson cited a earlier committee report alleging that federal officials failed to address shortcomings in FDA's vaccine safety surveillance systems that may have obscured potential safety signals. He also referenced prior findings regarding agency handling of myocarditis risks associated with mRNA Covid-19 vaccines.