A senior leader at the U.S. Food and Drug Administration stated on Friday that the agency intends to revise its vaccine approval procedures, citing an internal assessment that associated ten child deaths with Covid-19 vaccination. The statement appeared in an internal memo obtained by CNN and written by Dr. Vinay Prasad, the FDAs chief medical and scientific officer and head of the Center for Biologics Evaluation and Research.
In the memo, Prasad asserted that healthy young children, who faced a very low risk of fatality, were pressuredthrough school and workplace mandates linked to the Biden administrationto receive a vaccine that carried the potential for severe outcomes. He referred to an initial analysis of 96 death reports, which he said connected ten cases to the Covid-19 vaccine. The memo did not explain the methodology behind that determination.
Prasad wrote that Covid-19 was never highly lethal for children and suggested its impact was similar to other respiratory viruses that do not require yearly immunization. He emphasized that while vaccines have saved countless lives, they must be administered appropriately: A medication given to the right person at the right moment can be life-saving, but the same product can be harmful if used improperly.
According to Prasad, the agency will implement a new vaccine review framework requiring stronger evidence of both safety and efficacy before products can reach the market. Planned adjustments include stricter standards for vaccines intended for pregnant individuals, as well as updated requirements for pneumonia vaccine trials that must demonstrate actual disease reduction rather than solely antibody response.
Prasad added that the FDA will also update the annual influenza vaccine process and reassess safety and ensure transparency in vaccine labeling. He acknowledged that these changes could necessitate larger, lengthier clinical studies, potentially slowing the approval timeline.
While inviting internal dialogue about the reforms, Prasad noted that those who fundamentally disagree with the outlined principles should consider resigning. CNN has requested comment from both the FDA and the Department of Health and Human Services (HHS), which oversees the agency.
The memo aligns with views frequently expressed by HHS Secretary Robert F. Kennedy Jr., who has long questioned vaccine effectiveness and once founded the group Childrens Health Defense. Since taking office, Kennedy has reduced funding for mRNA vaccine research, removed all members of the CDCs vaccine advisory committee, and instructed the CDC to adjust its website to include claims linking autism to vaccines.
The CDCs newly restructured Advisory Committee on Immunization Practices, selected by Kennedy, is scheduled to meet next week to review the childhood vaccination schedule and reconsider the timing of the hepatitis B vaccine, according to a draft agenda.
For over three decades, U.S. health authorities have advised administering the first hepatitis B shot shortly after birtha policy credited with nearly eliminating the life-threatening infection among American children. Despite no new evidence regarding the vaccines safety or effectiveness, the new advisory group is exploring whether to delay the first dose by several months or longer.