The US Food and Drug Administration is looking into whether or not deaths “across multiple age groups” have been associated to Covid-19 vaccines, a spokesperson stated Tuesday, weeks after a senior company official claimed — with out providing proof – that Covid-19 vaccinations resulted within the deaths of 10 youngsters.
Andrew Nixon, a spokesperson for the US Department of Health and Human Services, stated the FDA is conducting “a thorough investigation” however declined to supply particulars on what knowledge sources are getting used and what potential modifications, if any, are being thought of to Covid vaccine approval or advertising and marketing.
Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of its Center for Biologics Evaluation and Research, claimed in a memo late final month that “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”
Prasad didn’t present particulars concerning the 10 deaths or how the FDA got here to that conclusion however pointed to “an initial analysis” that examined 96 deaths and linked 10 to the Covid-19 vaccination. He also claimed that Covid “was never highly lethal for children” and that the results of it “are comparable” to respiratory viruses for which there aren’t annual vaccines.
More than 700 million doses of Covid-19 vaccines have been administered within the US since they turned accessible in late 2020, based on the World Health Organization. The shots have been extensively examined and frequently monitored for security, and serious side effects akin to anaphylaxis or myocarditis have been usually uncommon.
FDA laws require well being care suppliers to report deaths after vaccination to the Vaccine Adverse Event Reporting System (VAERS), even when it’s not clear that vaccination was the reason for demise. Members of most of the people can also submit occasions to the database, which federal businesses use to generate additional examine on vaccine security.
Prasad stated that because of the FDA evaluation, the company will undertake a brand new approval course of for vaccines that would require extra proof of their security and worth earlier than they are often marketed. Among the modifications can be stricter necessities for authorization of vaccines used for pregnant ladies and trials for pneumonia vaccines that might want to show the shots scale back illness, as an alternative of displaying that the vaccine produces sufficient antibodies to battle the sickness.
The company will also “revise the annual flu vaccine framework,” Prasad stated, and “will re-appraise safety and be honest in vaccine labels.”
HHS Secretary Robert F. Kennedy Jr. has repeatedly raised doubts concerning the effectiveness of vaccines and beforehand based the anti-vaccine group Children’s Health Defense.
As secretary, Kennedy has slashed funding for mRNA vaccine improvement, replaced the members of the vaccine advisory committee at the US Centers for Disease Control and Prevention, and directed the CDC to vary its web site to include false claims that hyperlink autism and vaccines.
NCS’s Kaanita Iyer, Adam Cancryn and Amanda Sealy contributed to this report.