COVID-19 Vaccine(Janssen)

The number of child deaths allegedly caused by Covid-19 vaccines likely will be lower than the 10 initially mentioned in an internal email from FDA vaccines and biologics head Vinay Prasad, two agency sources familiar with the investigation told Endpoints News . One of the people, both of whom spoke on condition of anonymity, said the number of deaths will likely be eight or nine once the investigation is finalized. The person also said that Prasad’s investigation, as detailed in the email to CBER staff last week, hasn’t definitively confirmed that the deaths were caused by the vaccines. Prasad claimed in the email that an agency review team looked at 96 deaths that occurred from 2021 to 2024, and “concludes that no fewer than 10 are related.” Prasad said that “if anything, this represents conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity. The real number is higher.” That does not, however, appear to be the consensus view, according to one of the people. They called Prasad’s analysis “a huge exaggeration.” Some of the deaths were rated as “‘possibly related,’ which is very far” from a causal relationship, the person said. The FDA has yet to make an official announcement about its investigation. But the apparent disagreement inside the agency is the latest sign that Prasad may not have the evidence he wants to shift how the agency regulates vaccines. The FDA told Endpoints on Wednesday that it will publish a report on the investigation by the end of the month. An agency spokesperson on Thursday reiterated that timeline when asked for comment. In a New England Journal of Medicine editorial Wednesday , 12 former FDA commissioners criticized the claim Prasad made regarding his investigation, saying he “offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation.” The editorial was a response to Prasad’s internal email and his stated plans to revisit vaccine standards. In past cases of significant safety issues, the FDA has investigated and quickly made public its findings when there was an urgent need to inform the public and medical professionals. For example, in 2021, there were a number of cases of blood clots in people who received Johnson & Johnson’s Covid-19 vaccine — including some deaths. The FDA and CDC announced the risk in April and called for a pause in the use of the shots, then convened an emergency meeting within a day to review the data in public. They then quickly updated the usage recommendations for the shot. Tracy Beth Høeg, who took over as director of the FDA’s office of drugs on Wednesday, led the review of the Covid vaccine deaths, according to Prasad’s email. In his email, Prasad acknowledged that FDA vaccine staff disagreed with the assessment that the reported deaths were caused by vaccines. But he also blamed staff for leaking to the media, calling attempts to undercut the conclusions “unethical, illegal, and, as this case illustrates, factually incorrect.” The cases were pulled from the FDA’s VAERS system, which collects voluntary reports of side effects.