A senior vaccine official at the Food and Drug Administration has triggered a national debate after issuing an internal memo calling for a more rigorous approval process for Covid vaccine trials. The memo, written Friday by Dr. Vinay Prasad, claims that a recent internal review connected the deaths of ten children to the Covid vaccine.
In the document, Prasad wrote that agency staff categorized the deaths as “likely, probable, or possible” vaccine-related. However, the memo did not include any supporting data, explanation of the methodology, or details about how the conclusions were reached. None of the findings have been made public, nor have they appeared in any peer-reviewed study.
The memo first came to light through a PBS NewsHour correspondent and was later obtained and published online by the Washington Post. The disclosure immediately fueled questions about transparency and scientific backing.
FDA Commissioner Marty Makary, speaking to Fox News over the weekend, said the agency plans to release additional information about the alleged vaccine-related deaths—details he claims the previous administration did not disclose. Addressing the issue of updated booster recommendations, Makary emphasized the need for solid evidence, saying, “It makes a mockery of science if we’re just going to rubber-stamp things with no data.”
Even so, Makary clarified that Covid vaccines provided strong protection for older adults and high-risk groups, especially when tailored to the circulating strains.
ABC News has reached out to both the FDA and the Department of Health and Human Services for their response but has not yet received comments.
As the memo circulated, numerous public health experts voiced concern across social platforms and in discussions with ABC News. Dorit Reiss, a law professor at UC Law San Francisco who specializes in FDA regulatory procedures, criticized Prasad’s approach, pointing out that major decisions about respiratory vaccines typically undergo a structured, evidence-based review. Reiss also noted that Prasad’s background does not lie in vaccinology, heightening the concern.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, echoed these criticisms. He stated that the memo lacks essential medical details needed to support any claim of causality—including the children’s ages, vaccine types, health histories, and the analytical methods used.
Adalja warned that the memo, without clear evidence, risks inflaming anti-vaccine sentiment and further politicizing an issue that should remain rooted in data and science.
