New Delhi: Dr Vinay Prasad, the US Food and Drug Administration’s chief medical and scientific officer, announced a change in the vaccine approval process last week, claiming that Covid-19 vaccines have been linked to child deaths. Prasad is also the director of the agency’s Centre for Biologics Evaluation and Research.
In two public letters, former US health officials have since criticised the proposed changes, warning that they put public health at risk.
“We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,” read one of the letters, authored by 12 former commissioners of the Food and Drug Administration (FDA).
Dr Peter Marks, who resigned earlier this year as the FDA’s vaccine chief following a disagreement with Health and Human Services Secretary Robert F Kennedy Jr, described the proposal as part of Kennedy’s “anti-vaccine playbook”.
What FDA said on vaccines
Prasad claims that “no fewer than 10” of 96 child deaths reported in the Vaccine Adverse Event Reporting System (VAERS) from 2021 and 2024 were from Covid-19 vaccinations. He alleges that the number could be higher and accuses the agency of ignoring the glaring safety concerns for years—a claim refuted by former US health officials.
The FDA memo comes days before the CDC (Centers for Disease Control and Prevention) vaccine advisory committee meeting to discuss the childhood vaccine schedule and the hepatitis B shot, which is set to take place next week.
The memo used a “highly ideological language”, said CNN in its report. The FDA memo called the current Covid-19 vaccine requirements “coercive”, claiming that past agency decisions may have harmed rather than saved children. In the memo, Prasad even suggested that staff members who disagree with the agency should resign.
Prasad went on to criticise the Biden administration and Rochelle Walensky, former director of the CDC, as “dishonest and manipulative”.
Earlier this year, the health leadership spearheaded by Kennedy limited the eligibility to get a Covid-19 vaccine, prioritising those aged 65 and older and individuals with underlying medical conditions for vaccination.
Kennedy has often downplayed the benefits of vaccines and has described the mRNA vaccines as particularly dangerous, calling the mRNA Covid-19 vaccine “the deadliest vaccine ever made”.
In an interview with Fox News, FDA Commissioner Marty Makary said that the agency will not “rubber-stamp new products that don’t work”, adding that doing so makes a “mockery of science”.
Also read: 91% of Indians report feeling safer because of street dogs, says new survey
What are health officials saying?
In their letter, published Wednesday in the New England Journal of Medicine, the former FDA commissioners warned that the changes proposed by Prasad would “upend core policies governing vaccine development and updates”.
The former officials highlighted that the data from VAERS does not contain enough medical information to prove a causal link between the proposed vaccines and child deaths, adding that government scientists had already reviewed these reports and found no such link.
“The proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity,” the letter read.
(Edited by Prasanna Bachchhav)