FDA Links COVID Vaccines to 10 Child Deaths, Policy Changes Announced

The U.S. Food and Drug Administration (FDA) has issued a memo indicating that COVID-19 vaccines may be linked to the deaths of at least 10 children due to heart inflammation. This revelation comes as the agency’s chief medical and scientific officer, Vinay Prasad, communicated these findings to FDA staff. The memo has stirred significant controversy and prompted a shift in U.S. health policy regarding vaccine access.

In a significant policy change, Health Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines will now be limited to individuals aged 65 and older, along with those having underlying medical conditions. Kennedy’s stance marks a departure from the previous administration’s vigorous endorsement of vaccines as crucial to public health during the pandemic.

The memo from Prasad, which has not yet been published in a peer-reviewed journal, indicates that the agency’s findings are based on an initial analysis of 96 deaths recorded between 2021 and 2024. Prasad stated, “These deaths are related to vaccination. This is a profound revelation.” He emphasized the difficulty in reconciling the reported deaths of children aged 7 to 16 with the benefits of COVID-19 vaccinations.

Critics have raised concerns regarding the implications of the memo. Dorit Reiss, a professor of law at UC Law San Francisco, criticized Prasad for suggesting regulatory changes based on findings from an unpublished investigation conducted by unspecified individuals. Reiss pointed out that Prasad’s background is not in vaccine science, which raises further questions about the validity of the conclusions drawn.

The memo did not disclose specific details regarding the health conditions of the affected children or the vaccine manufacturers involved. This lack of transparency has led to skepticism among public health experts, particularly considering that the Centers for Disease Control and Prevention (CDC) reported that 1,071 individuals aged between 5 and 18 died from COVID-19 between January 4, 2020, and June 24, 2023.

Prasad’s memo argued that comparing the number of child deaths from COVID-19 to those potentially linked to vaccinations is flawed. He stated, “We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported.”

Despite the controversy surrounding the memo, FDA Commissioner Marty Makary affirmed in a television interview that the COVID-19 vaccine has been highly effective for older populations. “The COVID shot was amazing for people at risk and for older people, especially when it was a good match for the circulating virus,” he noted.

The FDA’s new stance represents a significant shift in vaccine policy and has raised questions about the future of COVID-19 vaccination efforts in the U.S. As health officials continue to evaluate the implications of the FDA’s findings, public health advocates are urging for a thorough investigation and transparent communication regarding vaccine safety and efficacy.