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The U.S. Food and Drug Administration (FDA) is expanding its probe into COVID-19 vaccine-related deaths to adults, after initially confirming that the agency was investigating the deaths of 10 children who died after receiving the shot.
The “FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines,” a U.S. Department of Health and Human Services (HHS) spokesperson told The Defender today. HHS provided no further details.
Bloomberg is credited with first reporting on the expanded inquiry.
In September, the FDA initiated an “intense investigation” into the deaths of children who received the COVID-19 vaccine, drawing on reports from the Vaccine Adverse Event Reporting System (VAERS), a surveillance system jointly run by the FDA and the Centers for Disease Control and Prevention.
As of press time, the FDA had not issued a statement explaining why it is expanding its investigation into COVID-19 vaccine-related deaths.
As of Aug. 28, there were 38,773 reports of deaths filed in VAERS among all age groups, according to the OpenVAERS Project. More recent numbers are not publicly available.
However, the actual number of deaths is likely much higher, since VAERS has historically been shown to report less than 1% of all adverse events.
A 2022 audit by React19, an organization advocating on behalf of COVID-19 vaccine injury victims and their families, found that 1 in 3 COVID-19 vaccine adverse event reports in VAERS were not posted publicly or were deleted.
Leaked memo confirmed ‘at least’ 10 kids died from COVID vaccine
The FDA’s expanded inquiry into COVID-19 vaccine-related deaths comes roughly two weeks after an internal analysis outlined in a leaked memo to staff revealed that “at least” 10 children died from the COVID-19 vaccine.
In the memo, obtained by The Washington Post, the agency’s top vaccine regulator said the agency will make changes to how it approves all vaccines.
Dr. Vinay Prasad, who heads up the FDA Center for Biologics Evaluation and Research, said a recent review of 96 deaths among children ages 7 to 16 concluded that “no fewer than 10” were related to the shot. The deaths were reported to VAERS between 2021 and 2024.
According to the memo, the estimated 10 deaths is “certainly an underestimate due to underreporting, and inherent bias in attribution.”
Prasad implied that the deaths were linked to myocarditis, an inflammation of the heart muscle.
“This is a profound revelation,” Prasad wrote. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
CHD petitions FDA to revoke licenses for Pfizer, Moderna COVID vaccines
On Monday, Children’s Health Defense (CHD) filed a Citizen Petition with the FDA, asking the agency to revoke the licenses for the Pfizer and Moderna COVID-19 vaccines.
The petition alleges the agency granted the licenses without requiring the manufacturers to meet the legal standards that typically govern licensed vaccines.
An HHS spokesperson confirmed that the FDA is reviewing the petition and that the agency will respond directly to CHD. Meanwhile, CHD urged the public to comment on the petition.
The petition asks FDA Commissioner Martin A. Makary to determine that the two mRNA vaccines — Comirnaty and Spikevax — are misbranded and adulterated.
A Citizen Petition is a formal request to the agency to take regulatory action. Citizen Petitions, typically submitted by an organization, require extensive documentation of the issue and the legal basis for the claim.
The FDA is now obligated to review the petition and respond within 180 days, although the agency may extend that timeline.
CHD is urging the public, including healthcare workers, parents and military members, to submit comments on the petition, sharing their thoughts and experiences with the COVID-19 vaccines.
Attorney Ray Flores, outside counsel to CHD and one of the petition’s signatories, said the petition should “become the focal point for exposing COVID-19 vaccines.”
Related articles in The Defender- Leaked Memo: FDA Confirms ‘At Least’ 10 Child Deaths From COVID Vaccine, Promises Sweeping Reforms
- CHD Asks FDA to Revoke COVID Vaccine Licenses, Calls on Public to Submit ‘Hundreds of Thousands’ of Comments
- 1 in 10 Adults Seriously Injured by a COVID Vaccine, New Survey Says
- FDA to Report on 25 Child Deaths Linked to COVID Vaccine, Washington Post Reports
- FDA Conducting ‘Intense Investigation’ of Child Deaths Following COVID Shot
- Number of Children Who Died After COVID Shots Much Higher Than VAERS Reports Indicate, Analyst Says
