US FDA memo links 10 child deaths to COVID vaccines

WASHINGTON: An internal memo by the US Food and Drug Administration (FDA) has suggested that at least 10 children may have died as a result of COVID-19 vaccination, with myocarditis — an inflammation of the heart muscle — identified as a potential cause, The New York Times reported on Friday.

The Department of Health and Human Services, which oversees the FDA, has not yet commented on the development.

According to the report, the confidential document was authored by Vinay Prasad, the FDA’s Chief Medical and Scientific Officer, who described the findings as “a profound revelation”. The memo does not specify the ages or medical history of the children, nor does it name the vaccine manufacturers involved.

The disclosure emerges as U.S. Health Secretary Robert F. Kennedy Jr. pushes major changes to national vaccine policy. Access to COVID-19 vaccines has now been restricted to those aged 65 or above and individuals with chronic health conditions — a dramatic shift from earlier years when mass vaccination was promoted as a life-saving public health tool.

Kennedy, a long-time critic of vaccines prior to joining Donald Trump’s administration, has linked immunisation to autism and has advocated for a restructuring of the country’s vaccination framework.

Both the Trump administration during the pandemic and later President Joe Biden’s government had backed COVID-19 vaccines as critical to reducing mortality and controlling outbreaks.

The New York Times reported that Prasad intends to tighten regulatory oversight, including mandatory randomised studies across all demographic groups before further vaccine approvals. However, the memo’s findings have not yet been peer-reviewed or published in a scientific journal.

The U.S. Centers for Disease Control and Prevention (CDC) vaccine advisory committee is expected to meet next week to discuss the matter.

Prasad, who previously gained prominence for criticising vaccine and mask mandates during the pandemic, was reinstated as the FDA’s chief medical and scientific officer in September. He now advises senior officials on regulatory science and public health risks.