The US Food and Drug Administration (FDA) is set to impose a stringent new protocol for Covid-19 vaccinations, following an internal report which concluded the shots contributed to the deaths of at least ten children.
This significant policy shift was revealed in a Friday memo from the agency's vaccine division director, Dr Vinay Prasad, which was obtained by major news outlets. The memo also indicated a comprehensive review of the guidance for annual flu shots.
A Profound Revelation on Vaccine Safety
In the communication to staff, Dr Prasad stated that a detailed analysis of deaths voluntarily reported to the VAERS system had led officials to determine that the ten children had died "after and because of" the coronavirus vaccine. He specified that their deaths were medically linked to myocarditis, an inflammation of the heart.
"This is a profound revelation," Dr Prasad wrote. "For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children." The memo did not disclose the identities of the children, whether they had underlying health conditions, or which vaccine manufacturers were involved.
Sweeping New Regulations and Internal Tensions
The FDA's new approach extends beyond Covid-19 vaccines. Dr Prasad's memo labelled the existing framework for annual flu vaccinations a "catastrophe of low-quality evidence" and announced the agency would re-examine this policy.
Further changes include a review of whether Americans should receive multiple vaccines simultaneously and the implementation of tightened restrictions for authorising new vaccines for pregnant women.
The memo concluded with a stark ultimatum to staff. While Dr Prasad expressed he remained "open to vigorous discussions and debate," he instructed that employees who disagreed with the foundation of these new policies should submit their resignations.
Context and Criticism from Health Experts
The memo was released less than a week before a scheduled meeting of the Centers for Disease Control and Prevention's (CDC) vaccine committee. The current Health and Human Services Secretary, Robert F. Kennedy Jr., a long-standing vaccine sceptic who oversees the FDA, had previously removed all 17 sitting members of that CDC panel in June, stating the move was meant to "restore public trust" in vaccines.
However, the new direction has been met with concern from some public health figures. Dr Jesse Goodman, who held Dr Prasad's role from 2003 to 2009, told the Washington Post that he believes current vaccine guidelines are already "quite strict" and that approvals are based on "strong scientific evidence."
Michael Osterholm, Director of the Center for Infectious Disease Research and Policy at the University of Minnesota, suggested the timing of the memo was deliberate and irresponsible. "This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events," he told the New York Times.
