FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations

On June 25, 2025, FDA added class safety warnings for myocarditis and pericarditis to mRNA COVID-19 vaccines, noting an incidence of about 27 cases per million in males aged 12-241.

In September 2025, FDA Commissioner Marty Makary announced an intense investigation into reports of COVID-19 vaccine-related deaths in healthy children, based on VAERS submissions, with no confirmed evidence of major safety risks beyond rare heart inflammation2.

An internal FDA memo from Vinay Prasad suggested COVID shots 'probably contributed' to at least 10 child deaths from heart inflammation among 96 cases reviewed from 2021-20243.

Makary is in a power struggle with HHS Secretary RFK Jr. over vaccine safety studies; RFK Jr. pushes for quick studies, while Makary prioritizes a new side-effect examination system4.

Recent FDA approvals for 2025-26 COVID vaccines limit use to high-risk groups like those 65+ or with conditions, revoking EUA for young children in some cases5.

FDA chief addressed reports of potential black-box warnings for myocarditis/pericarditis linked to COVID vaccines6.