WASHINGTON, Sept 13 — United States health officials are planning to link Covid-19 vaccines to the deaths of 25 children as they consider limiting access to the shots, the Washington Post reported yesterday, citing four people familiar with the matter.
The findings appear to be based on information submitted to the federal Vaccine Adverse Event Reporting System, VAERS, that contains unverified reports of side effects or bad experiences with vaccines, the report added.
The US Food and Drug Administration (FDA) and the Centres for Disease Control and Prevention (CDC) staff routinely analyse VAERS and other safety monitoring data, the US Health and Human Services Department said in an email response.
Until the vaccine safety data is shared publicly, this should be considered “pure speculation”, the statement added.
Health officials plan to include the paediatric deaths claim in a presentation next week to an expert panel of advisers to the CDC that is considering new Covid-19 vaccine recommendations, the report added.
Reuters has not independently verified the report.
Shares of vaccine maker Moderna closed 7.4 per cent lower, Pfizer slipped 4 per cent, and US-listed shares of its German partner BioNTech slid 7.3 per cent. Novavax shares closed 3.6 per cent lower.
Regulators in more than 90 countries have not identified any new or undisclosed concerns in children or pregnant women for Moderna’s Covid-19 shot, the company said in an email response.
Pfizer said in a statement the vaccine it developed with BioNTech has been given to more than a billion people, including adults, adolescents and children, and has generated “robust data which demonstrate a favorable safety profile”.
Novavax told Reuters that clinical data and real-world evidence for its Covid-19 vaccine is available to the FDA, the CDC, “along with dozens of regulatory bodies around the world and scientific and medical experts in public health”.
In an interview on CNN last week, FDA commissioner Marty Makary said “there have been children who have died from the Covid vaccine”, citing the self-reported VAERS database.
“We’re doing a proper investigation,” he said in that interview, noting that the FDA plans to release a report in the coming weeks.
US Health Secretary Robert F. Kennedy Jr, a longtime vaccine critic, has significantly rolled back Covid-19 vaccine recommendations. The agency has dropped routine vaccination guidance for healthy children, teenagers and pregnant women, and while it cleared the vaccines for everyone over 65 years, it narrowed eligibility in the younger population to people with underlying medical conditions.
Moderna’s updated Spikevax shot is authorised for people six months and older with at least one underlying condition, while Pfizer and BioNTech’s updated version of Comirnaty was approved for individuals aged 5 through 64 years with at least one high-risk condition. The 2022 emergency use authorisation for the Covid-19 vaccine for children under age 5 had been rescinded.
The policy shift has sparked pushback from medical and public health organisations, including the American Academy of Pediatrics, which continues to recommend Covid-19 vaccination for children and pregnant women.
President Donald Trump has backed Kennedy despite congressional pressure, public health concerns and the political risks of changing vaccine policies nationwide.
Kennedy has also slashed funding for vaccine research and ousted the head of the CDC, which makes US vaccine recommendations, fired all 17 members of the vaccine expert panel and replaced them with hand-picked advisers.
The revamped advisory committee is scheduled to meet on September 18 and 19.
