FDA to present review of 25 child deaths after Covid vaccination
Agency insiders leaked details of an FDA review linking 25 paediatric deaths to Covid vaccination, sparking controversy ahead of a key CDC panel meeting in the coming week.
The U.S. Food and Drug Administration (FDA) is preparing to present evidence that 25 children died after receiving Covid-19 shots.
The findings are expected to be presented this week at a meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP) on September 18-19.
According to The New York Times and The Washington Post, both citing insiders likely from within the FDA and CDC, the analysis was compiled by Dr Tracy Beth Høeg, a senior adviser in the FDA’s vaccine division.
The reported deaths originated in the Vaccine Adverse Event Reporting System (VAERS), the government’s database for suspected vaccine harms. Unlike the raw entries often left unexamined, FDA officials say they’ve investigated the cases.
They contacted families, reviewed autopsy results and gathered medical records. It appears that, for the first time since the vaccine rollout, U.S. regulators have attempted a systematic, case-by-case review of paediatric deaths.
Hints of this surfaced on 4 September, when FDA Commissioner Dr Marty Makary appeared on CNN. “We’ve been looking into the VAERS database self-reports, [and] there have been children that have died from the Covid vaccine,” he said.
Makary promised a report “in the coming weeks,” describing “an intense investigation” involving families and doctors. “We think the public deserves to have that information,” he added.
His comments marked a sharp departure from the official line, which for years had insisted that no child deaths were linked to the Covid vaccines.