Unprecedented Alarm: Concern over memo from top US vaccine official

The top official in charge of vaccines in the United States issued a controversial memo on Friday, suggesting a major overhaul of vaccine regulations. The memo, which was lengthy and filled with contentious statements, claimed that at least ten children had died as a result of receiving the COVID-19 vaccine. However, no evidence was provided to support this claim, and details about the new regulatory approach were sparse. Experts have expressed concern over these proposed changes, fearing that vaccines like the flu shot could soon be unavailable, potentially undermining public confidence in vaccination programs.

Dan Jernigan, the former director of the National Center for Emerging and Zoonotic Infectious Diseases, warned that the consequence of such sweeping changes would likely result in fewer vaccines available to the public and a rise in vaccine-preventable illnesses. He stressed, "The ultimate outcome will be fewer vaccines and more vaccine-preventable illness."

The memo referred to reports in the Vaccine Adverse Event Reporting System (VAERS), a database that allows individuals to report adverse events following vaccinations. These reports, covering a period from 2021 to 2024, allegedly involve ten children, aged seven to sixteen, who died after receiving the COVID vaccine. However, the memo provided no information on the specifics of these deaths, such as the underlying health conditions, or how the deaths were connected to vaccination, particularly given that earlier investigations found no causal link. The FDA's top vaccine official, Vinay Prasad, stated that this was the first acknowledgment by the U.S. Food and Drug Administration (FDA) that COVID vaccines might have caused children's deaths. Prasad also raised concerns about whether the COVID vaccine had ultimately resulted in more fatalities than lives saved among children.

Paul Offit, an infectious disease specialist from the Childrens Hospital of Philadelphia, responded to the memo by emphasizing that any serious claim like this should be backed by evidence. "When you make that kind of sensational claim, its important to provide evidence to support it," Offit stated. "He didnt supply any evidence." Offit and other experts have reiterated that COVID vaccines have been administered to millions globally and have proven to be safe and effective.

Jernigan, who spent over three decades at the CDC, expressed astonishment at the memo's contents, calling it an unprecedented move for the FDA. He noted that it was unusual for the head of vaccine regulation to communicate such information via a staff-wide email without consulting advisory committees or making the data publicly available through formal presentations or studies. The memo also referenced myocarditis, a rare side effect that has been associated with COVID vaccines, but it did not offer any evidence linking it to the reported deaths. Myocarditis, while a known risk with COVID infection itself, is far less common after vaccination. If myocarditis had been a factor in any of these deaths, an autopsy would likely have confirmed this, said Offit.

The memo also mentioned changes to the way the FDA approaches vaccine approvals, including the potential requirement for randomized trials to show clinical outcomes, such as a reduction in illness, rather than relying solely on immune response data. However, experts like Offit caution that this could pose significant challenges, particularly for annual vaccines like the flu shot, which are essential to public health. The revised rules could make it difficult to update vaccines in time for flu seasons, with potential consequences for those at risk of severe illness.

Prasad also discussed the concept of "concomitant vaccines," referring to the practice of giving multiple vaccines in a single visit, which has been a common practice for years without evidence of harm. The memo suggested that the FDA might change its approach to these combinations, but experts argue that such changes should only be made based on evidence of potential harm.

The memo's tone and content have raised alarms, with experts expressing concerns about the potential impact on vaccine availability, public trust, and the broader public health system. "The stakes are high," Offit warned, stressing that undermining confidence in vaccines could lead to more preventable deaths and a resurgence of vaccine-preventable diseases. Jernigan further noted that the confusion generated by such statements could make it harder for both the public and healthcare professionals to trust health agencies and follow their guidelines effectively.

Author: Olivia Parker