Federal regulators have approved a COVID-19 vaccine made by Moderna for some children aged 6 months through 11 years, according to an approval letter made public on July 10.
The Food and Drug Administration approved Spikevax, the vaccine, for children at least 6 months of age who are pegged as being at heightened risk for COVID-19, the FDA’s top vaccine official, Dr. Vinay Prasad, told Moderna in the missive.
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions,” Moderna CEO Stéphane Bancel said in a statement. “Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization. We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”
The FDA referred a request for comment to its parent agency, the Department of Health and Human Services. A spokesperson for the department told The Epoch Times in an email that “the FDA’s Center for Biologics Evaluation and Research granted this approval following a targeted review of the vaccine’s data, focused specifically on protecting children at highest risk.”
The spokesperson said the move “reflects a careful evaluation of the scientific evidence and aligns with the FDA’s regulatory standards for vaccine approvals.”
The approval for the vaccine also covers other individuals through 64 years of age who have at least one risk factor that federal officials say places them at higher risk of severe COVID-19 outcomes, as well as all people aged at least 65.
The updated vaccine could target L.P.8.1., based on guidance from the FDA. Moderna says it expects to have the updated vaccine ready to distribute in the fall.
The FDA in 2024 granted emergency authorization for Spikevax for all children aged 6 months through 11 years. The FDA had also approved Spikevax for individuals aged at least 12 years.
Those moves came despite no clinical data being available for the vaccines.
FDA officials at the time said that animal data and information from previous versions of the shots were sufficient.
Approval has a higher bar of evidence of safety and efficacy than emergency authorization.
The new approval was based on three clinical trials, according to Prasad, including one that found the vaccine triggered antibodies and that placebo recipients were more likely to test positive for COVID-19. Results for the other two trials are not yet publicly available, with one still listed as ongoing.
Americans have largely stopped receiving COVID-19 vaccines. Just 13 percent of children and 23 percent of adults had received one of the currently available vaccines as of April 26, according to the latest statistics available from the CDC.
Some took issue with the approval.
“The FDA’s approval is a disappointing shift from the vaccine’s prior emergency use authorization (EUA) for pediatric populations,” the Independent Medical Alliance, a health care nonprofit, said in a statement. “While Moderna claims the vaccine protects vulnerable children, the risks of serious side effects far outweigh any potential.”
Others said it was welcome, including Dr. Peter Lurie, president and executive director of the Center for Science in the Public Interest, who said in a statement that “it is good to see that this vaccine has been approved.”
Prasad and Dr. Marty Makary, the FDA’s new commissioner, announced in May that the agency would no longer clear COVID-19 vaccines for people younger than 65 who lack a risk factor, such as obesity, that officials say places them at higher risk for severe COVID-19 outcomes.
The officials also said they would keep clearing shots for some 100 million to 200 million Americans who are either elderly or have a risk factor, based on data showing vaccines trigger antibodies.
The CDC later in May stopped recommending COVID-19 vaccines for healthy children and pregnant women, although it said children could receive a shot after consulting with parents and their doctors.
The FDA on May 31 approved a different Moderna COVID-19 vaccine, called mNEXSPIKE, for adults aged at least 65 and people aged 12 to 64 who have at least one of the risk factors.
Moderna is also working on a combination vaccine against COVID-19 and influenza. The company said in June that results from a study of an updated flu vaccine were favorable and that it planned to ask the FDA for clearance for the combination shot.