Top US Vaccine Official Warns: Shocking Memo Reveals Alarming Truth—Are You at Risk?

In a controversial memo circulated to staff on Friday, the head of the U.S. Food and Drug Administration's (FDA) vaccine division announced plans to overhaul vaccine regulations, following claims that at least 10 children died from Covid vaccinations. However, the memo, written by Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), lacked supporting evidence and provided scant details about the proposed changes.

Experts are expressing growing concern over these developments, particularly the lack of input from external advisers and the absence of publicly available data. Dan Jernigan, a former director at the National Center for Emerging and Zoonotic Infectious Diseases, warned, “The ultimate outcome will be fewer vaccines and more vaccine-preventable illness.”

The reported deaths, involving children aged seven to 16 from 2021 to 2024, were noted in the Vaccine Adverse Event Reporting System (VAERS), a crowdsourced database that allows anyone to submit claims regarding vaccine-related adverse events. Prasad's memo raised alarm by stating, “For the first time, the US FDA will acknowledge that Covid vaccines have killed American children,” questioning whether the vaccines saved more children than they harmed.

Critics, including Paul Offit, an infectious diseases physician at Children’s Hospital of Philadelphia, underscored the need for evidence to back such serious claims. “When you make that kind of sensational claim, I think it’s incumbent upon you to provide evidence that supports that claim. He didn’t supply any evidence,” Offit stated.

The memo's implications are particularly concerning given the historical safety and efficacy of Covid vaccines, which have been administered to millions globally. Jernigan noted that it is highly unusual for a top vaccines regulator to disseminate information via email without prior consultation with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) or publishing data in a formal presentation.

While the memo highlighted myocarditis, a rare form of heart inflammation that has been associated with vaccinations, it failed to connect the dots regarding the cause of the reported child deaths. Offit pointed out that if myocarditis were responsible, autopsies would typically reveal specific heart damage. It’s crucial to establish whether any health issues stemmed from the vaccine or from Covid infections themselves.

Furthermore, the memo claimed that the actual number of vaccine-related child deaths could be higher than reported, yet Prasad provided no evidence for this assertion. The FDA did not respond to inquiries regarding the basis for these claims or the details of the impending regulatory changes.

Since the rollout of Covid vaccines, public health officials have emphasized the importance of monitoring adverse events. The CDC, for instance, implemented a new reporting system called V-safe, which encourages vaccinated individuals to report any side effects. This has led to a significant increase in reports submitted to VAERS, although many of these reports are not verified cases of vaccine-related harm.

Prasad's memo also touched on the regulation of multiple vaccines given simultaneously, a practice that has been safely used in the U.S. healthcare system for years. He suggested that the FDA’s approach would change, yet did not provide specific details or evidence to support the need for such changes. Dorit Reiss, a professor of law at UC Hastings College of Law, noted that altering existing guidelines without evidence of harm could complicate future vaccine approvals.

Additionally, the memo addressed the measles, mumps, and rubella (MMR) vaccines, stating that they provide societal benefits when administered to a sufficient number of people. However, it remains unclear how these benefits would be affected if vaccine uptake declines due to new regulatory hurdles.

Moving forward, Prasad indicated that the FDA would require randomized trials demonstrating clinical outcomes, such as illness reduction, rather than solely immune response for most new vaccine approvals. This shift is likely to complicate the annual flu vaccine framework and could jeopardize the availability of essential vaccines. Offit remarked that conducting new trials each year for flu vaccines would be impractical and delay their availability.

The potential reduction of vaccine access comes at a time when the nation is still grappling with vaccine-preventable illnesses, particularly following one of the worst influenza seasons on record. “Making the shots less accessible in the U.S. would lead to preventable deaths,” Reiss cautioned, highlighting the pressing need for flu vaccines in the upcoming seasons.

As the situation unfolds, experts stress that diminishing public confidence in vaccines poses a significant threat to public health. “Children are getting hospitalized and children are still dying from this virus,” Offit emphasized, indicating that the stakes are incredibly high.

Ultimately, the lack of transparency surrounding these claims and regulatory changes is causing confusion among both the public and healthcare professionals. “It’s getting harder for them to know which recommendations to follow and who they can trust,” Jernigan concluded, underscoring the critical need for clear communication and evidence-based guidance in the evolving landscape of vaccine regulation.