FDA to revise vaccine approval process following allegations of deaths linked to Covid-19 vaccination
A senior Food and Drug Administration official disclosed plans to change the agency’s vaccine approval process, citing allegations that Covid-19 vaccination resulted in the deaths of 10 children, reports BritPanorama.
In an internal memo, Dr. Vinay Prasad, the FDA’s chief medical and scientific officer, alleged that “healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”
Prasad referred to “an initial analysis” indicating that out of 96 examined deaths, 10 were linked to the vaccine. He argued that Covid-19 “was never highly lethal for children,” suggesting its effects were comparable to other respiratory viruses that do not have annual vaccines.
“I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product,” he stated. “The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm.”
As a result of the FDA’s analysis, the agency plans to implement a new approval process requiring greater evidence of safety and efficacy before vaccines can be marketed. Stricter authorization requirements will be enforced for vaccines used during pregnancy, and pneumonia vaccine trials will need to demonstrate a reduction in disease, rather than simply producing sufficient antibodies.
Additionally, Prasad mentioned that the agency intends to “revise the annual flu vaccine framework” and “re-appraise safety and be honest in vaccine labels.”
Although specifics of the changes remain unclear, the new process could involve larger studies that may considerably extend timelines for vaccine approval.
Prasad expressed openness to discussions about the proposed changes but indicated that such conversations should take place internally within the FDA. He encouraged dissenting staff to submit their resignation letters if they disagreed with “core principles and operating principles.”
CNN has reached out to the FDA and the Department of Health and Human Services for comment.
The memo aligns with long-standing concerns raised by HHS Secretary Robert F. Kennedy Jr., who has been vocal regarding his skepticism about vaccine effectiveness and previously founded the anti-vaccine group Children’s Health Defense.
As HHS secretary, Kennedy has cut funding for mRNA vaccine development and dismissed members from the vaccine advisory committee at the CDC, while directing updates to the CDC website to include unsupported claims linking autism and vaccines.
The CDC’s Advisory Committee on Immunization Practices, appointed by Kennedy, is scheduled to meet next week to deliberate on the childhood vaccine schedule, including the timing of the hepatitis B vaccine.
Currently, the first dose of the hepatitis B vaccine has been recommended for infants shortly after birth for over 30 years, effectively reducing the incidence of this potentially fatal disease. Despite the absence of new safety or effectiveness data, the new advisory panel is contemplating whether to postpone the initial doses by months or even years.
As developments unfold, the implications of these potential changes on public health and vaccine strategies remain to be seen.
