As Robert F. Kennedy Jr.’s revamped Centers for Disease Control and Prevention (CDC) vaccine advisory panel gears up to meet next week, U.S. health officials are reportedly planning to connect the deaths of 25 children to the use of COVID shots.
That link has allegedly been drawn using information submitted to the U.S.’ Vaccine Adverse Event Reporting System (VAERS), The Washington Post reports, citing four anonymous sources close to the matter.
The VAERS can be used by anyone to submit reports of side effects or negative experiences after receiving a vaccine, although the Department of Health and Human Services (HHS) stresses on its own website that the events in the database do not imply a “cause-and-effect relationship” between vaccines and adverse reactions.
Millions of vaccines are given to children less than a year old in the U.S. each year, the HHS’ website explains. Infants at that age “are at greatest risk for certain medical adverse events, including high fevers, seizures, and sudden infant death syndrome (SIDS),” and some may experience those medical events shortly after vaccination “by coincidence.”
“These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination,” the HHS website states.
The ages of the children included in the planned report are not clear.
The FDA and the CDC routinely parse through the VAERS and other safety monitoring data in the U.S., “and those reviews are being shared publicly through the established ACIP process,” an HHS spokesperson said when reached for comment.
“Until that is shared publicly, any [of] this should be considered pure speculation,” the spokesperson caveated.
The WaPo’s report comes a little less than a week before the next scheduled meeting of the FDA’s Advisory Committee on Immunization Practices (ACIP), which is slated to run from Sept. 18 to Sept. 19.
The committee, which makes vaccine recommendations to the CDC, is expected to weigh in on shots for COVID-19, hepatitis B, measles, mumps and rubella and respiratory syncytial virus, according to meeting notes (PDF) added to the U.S. Federal Register. The items on the agenda are subject to change “as priorities dictate,” according to the filing.
Back in June, HHS Secretary RFK Jr. removed all 17 sitting members of ACIP and swiftly slotted in his own appointees, many of whom hold controversial views on vaccine policy. Reports of seven new potential nominees earlier this month raised further concerns about growing anti-vaccine sentiment on the influential panel.
The presentation on pediatric deaths is not final, one of the WaPo’s sources said. The newspaper noted that it could not immediately confirm the methodology behind the purported vaccine safety analysis.
Shares in COVID-19 vaccine makers fell between 3% and 8% Friday afternoon after the release of the WaPo report.
Moderna stressed in an emailed statement that the safety of its mRNA COVID shot is “rigorously monitored” by the company, the FDA and regulators around the globe.
“Multiple, overlapping safety monitoring systems are in place that work to detect and evaluate any new or evolving safety considerations,” the spokesperson said, adding that those systems “have not identified any new or undisclosed safety concerns in children or in pregnant women.”
“Peer-reviewed, high-quality research from Moderna and independent investigators around the world continues to demonstrate a favorable risk–benefit profile for Spikevax,” the spokesperson continued.
Moderna’s COVID-19 vaccine is currently approved in the U.S. for use in kids as young as 6 months old following an updated approval issued this summer. At the same time, the FDA revoked the emergency use authorization for Pfizer and BioNTech’s mRNA shot, Comirnaty, in kids between the ages of 6 months and 4 years. Comirnaty is now approved for children ages 5 and older.
Under the new FDA nods granted this summer, both Moderna and Pfizer’s vaccines are approved broadly in people over the age of 65, but those seeking the shot who fall under that age must also have at least one underlying health condition that puts them at higher risk for COVID complications to be eligible.
Pfizer did not immediately respond to Fierce Pharma’s request for comment on the reported safety presentation slated for next week’s ACIP meeting.
The purported safety presentation tracks with comments made by the FDA’s Marty Makary, M.D., during a recent interview. Makary’s FDA is conducting an “intense investigation” into the potential link between COVID vaccines and the deaths of children, the Trump-appointed commissioner told CNN’s Jake Tapper last week.
Industry experts raised concerns about the potential for RFK Jr. and other Trump-appointed health officials to spread vaccine skepticism through the U.S. federal health apparatus almost immediately after RFK Jr.’s nomination to lead the HHS became public.
Now, some eight months into the new administration’s tenure, many of those fears have been affirmed.
Following the unceremonious departure of Peter Marks, M.D., Ph.D., from the FDA’s Center for Biologics Evaluation and Research in late March, the former vaccine official said in an interview with The Associated Press he’d been ousted after refusing to grant RFK Jr. unfettered access to the VAERS. Marks expressed concern in the interview that RFK Jr.’s team would “write over it or erase the whole database” if given free rein over the vaccine injury reporting system.
More recently, prominent vaccine expert Paul Offit, M.D., was blocked from participating on the FDA’s Vaccines and Related Biological Products Advisory Committee.