Federal officials acknowledged for the first time that COVID-19 vaccines resulted in deaths among children.
The Food and Drug Administration has concluded that at least 10 deaths of children were related to COVID-19 vaccination.
It’s the first time federal officials have determined that COVID-19 vaccines played a role in the deaths of minors.
“This is a profound revelation,” Dr. Vinay Prasad said in an internal memorandum sent on Nov. 28 and obtained by The Epoch Times.
Prasad, head of the FDA’s Center for Biologics Evaluation and Research, was one of the early opponents of keeping COVID-19 vaccines available for younger people. He has has supported COVID-19 vaccination for seniors and younger people with underlying conditions.
The FDA regulates vaccines and drugs, and the new finding means there will be changes moving forward, regulators said.
Here’s what to know.
Investigation Starts and Concludes
FDA official Dr. Tracy Beth Hoeg in the summer started looking into reports lodged with the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the FDA and the Centers for Disease Control and Prevention and accepts reports from health care practitioners, people who experience problems after vaccination, and contacts of those people.
The investigation was spurred by concerns that the previous administration misled the public about harms COVID-19 vaccines can cause, including myocarditis, or heart inflammation, Prasad indicated in the memo. Myocarditis symptoms include chest pain and irregular heartbeats and the condition can result in death.
Hoeg determined that some of the deaths among children following COVID-19 vaccination “were due to vaccine receipt,” Prasad wrote.
Prasad said he asked staff members with the agency’s Office of Biostatistics and Pharmacovigilance to perform an independent analysis of the deaths. The office concluded that at least 10 of the deaths were related to vaccination.
“If anything, this represents conservative coding,” Prasad wrote. “The real number is higher.”
Millions of children received a COVID-19 vaccine during the pandemic. They were first authorized for some teenagers in 2020, and later made available to children as young as 6 months of age.
Prasad said that causality is easy to assess in a randomized trial, but with case reports such as those in VAERS, causality is assessed on a scale ranging from certain to unlikely. In the scale, deaths ruled as “certainly,” “likely,” and “probably” linked to vaccination “are broadly considered as related to the product.”
VAERS reports can include documents such as autopsies, medical testing, and death certificates, which are written by medical examiners and include causes of death. The FDA has not released details of the assessed deaths, such as the ages of the children who died and how vaccines are believed to have played a role. Similar investigations in other countries have featured ruling out other possible causes.
