The Food and Drug Administration’s top vaccine chief sent a memo saying the FDA will seek a stricter review and approval protocol for vaccine trials.
In Friday’s memo, Dr Vinay Prasad claimed that a new review of records linked the deaths of 10 children to the Covid vaccine.
“These deaths are related to vaccination (probable/possible attribution made by staff,” Prasad wrote).
The memo did not share information about how the conclusions were reached, nor were they made public or published in a peer-reviewed journal.
The note was first reported by a PBS Newshour correspondent and later obtained and published online by the Washington Post.
FDA Commissioner Marty Makary, in an interview with Fox News over the weekend, He said the agency would make available information on coronavirus vaccine-related deaths, which he said the Biden administration did not do.
Discussing recommended booster shots, Makary said: “It’s a mockery of science if we’re just going to approve things without data.”
Makary added, however, that the COVID-19 vaccine worked well in older recipients. “The COVID vaccine was amazing for people at risk and for older people, especially when it was compatible with the circulating virus,” Makary said.
ABC News has reached out to the FDA and the Department of Health and Human Services for comment.
A toddler receives the Moderna Covid-19 vaccine ages 6 months to 5 years at Temple Beth Shalom in Needham, Massachusetts, on June 21, 2022. The temple was one of the first sites in the state to offer vaccines to anyone in the public. US health authorities on Saturday approved the Pfizer and Moderna Covid-19 vaccines for children five years old and younger, in a move that President Joe Biden hailed as a “monumental step” in the fight against the virus.
Joseph Prezioso/AFP via Getty Images
Many public health experts disputed the findings, taking to social media and speaking to ABC News.
Dorit Reiss, a law professor at UC Law San Francisco who has studied the FDA approval process, criticized Prasad for suggesting changes to the approval of respiratory vaccines based on the conclusion of unpublished research.
“Dr. Prasad does not suggest a deliberative process to evaluate next steps, as was the FDA’s usual practice,” Reiss wrote in a post on X. “It’s more problematic given that Dr. Prasad’s expertise is not in vaccines, but it would be problematic even if he were a vaccine expert.”
doctor amesh Adalya, a senior researcher at the Johns Hopkins Center for Health Security and spokesperson for the Infectious Diseases Society of America said in a statement. to ABC News, “The FDA memo on vaccines lacks real medical data that could justify its conclusion linking deaths to Covid vaccines.”
“To make such a claim, one would need to know basic things like the age of the patients, the type of vaccines they received, their underlying conditions, what type of analysis was performed 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.
