The top vaccine chief at the Food and Drug Administration sent out a memo saying the FDA will seek a stricter review and approval protocol for vaccine trials.
In the memo on Friday, Dr. Vinay Prasad claimed a new review of records linked 10 children’s deaths to the Covid vaccine.
“These deaths are related to vaccination (likely/probable/possible attribution made by staff,” Prasad wrote.
No information about how the conclusions were reached was shared in the memo, nor were they made public or published in a peer-reviewed journal.
The memo was first reported by a PBS Newshour correspondent and later obtained and posted online by the Washington Post.
FDA Commissioner Marty Makary, in an interview with Fox News over the weekend, said the agency would make information available on the deaths related to the coronavirus shot that he said the Biden administration didn’t.
When talking about the recommended booster shots, Makary said, “It makes a mockery of science if we’re just going to rubber-stamp things with no data.”
Makary did add, however, that the COVID-19 vaccine worked well for older recipients. “The COVID shot was amazing for people at risk and for older people, especially when it was a good match for the circulating virus,” Makary said.
ABC News has reached out to the FDA and the Department of Health and Human Services for a comment.
A young child receives a Moderna Covid-19 6 months to 5 years vaccination at Temple Beth Shalom in Needham, Massachusetts on June 21, 2022. The temple was one of the first sites in the state to offer vaccinations to anyone in the public.. US health authorities on Saturday cleared the Pfizer and Moderna Covid-19 vaccines for children aged five and younger, in a move President Joe Biden greeted as a “monumental step” in the fight against the virus.
Joseph Prezioso/AFP via Getty Images
Many public health experts questioned the findings, taking to social media and speaking with ABC News.
Dorit Reiss, a professor of law at UC Law San Francisco who has studied the FDA approval process, criticized Prasad for suggesting changes to the approval for respiratory vaccines based on the conclusion of an unpublished investigation.
“Dr. Prasad is not suggesting a deliberative process to assess next steps, as was FDA’s usual practice,” Reiss wrote in a post on X. “It is more problematic given that Dr. Prasad’s expertise is not in vaccines, but it would be problematic even if he were a vaccine expert.”
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security and a spokesperson for the Infectious Disease Society of America, said in a statement to ABC News, “The FDA’s memo on vaccines is bereft of any actual medical data that could justify their conclusion linking deaths with Covid vaccines.”
“To make such a claim, one would need to know basic things such as the age of the patients, the type of vaccines they received, their underlying conditions, what type of analysis was done to establish a causal link, etc,” Adalja added.
“The statement will only serve to increase anti-vaccine sentiment and further politicize an issue that should not be politicized,” Adalja said.
