FDA approves updated Covid-19 vaccines for limited groups as US cases continue to rise
The U.S. Food and Drug Administration approved updated COVID-19 vaccines but for a more limited group: adults age 65 and older and younger people who are at higher risk from COVID-19.
"FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors," US Health and Human Services Secretary Robert F. Kennedy Jr. said in a .
Kennedy said in this post that he had promised "to keep vaccines available to people who want them, especially the vulnerable," but the move may limit access to COVID-19 shots for people who were routinely able to get them in the past.
It may be significantly more difficult for infants and young children to be vaccinated, although they are especially vulnerable to COVID-19. Last respiratory virus season, there were 48 COVID-19 hospitalizations for every 100,000 children under 5 – nearly seven times the rate for older children and more than twice the rate for adults under 50.
Emergency use authorizations for COVID-19 vaccines are rescinded, Kennedy said on Wednesday, which means Pfizer's COVID is no longer available for children younger than 5. Moderna's vaccine is approved for children as young as 6 months, but only if they have an underlying condition that puts them at higher risk. The FDA had already approved , but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.
"Our health care system is now solidly anti-children and anti-science. The data are clear: young children–especially infants–remain highly vulnerable to severe illness and hospitalization from COVID-19. By restricting access to safe, evidence-based vaccines, federal leaders are choosing ideology over science," Fatima Khan, co-founder of the nonprofit grassroots group Protect Their Future, which advocates for vaccine access for kids, told CNN. "Denying children a critical tool to prevent avoidable tragedies will be a lasting stain on every policymaker who allowed it to happen."
In May, Kennedy that the U.S. Centers for Disease Control and Prevention would no longer recommend COVID-19 vaccines for healthy children or pregnant women. The CDC's immunization schedule was updated to reflect that children would be able to get the vaccines after consulting with a health care provider — what's known as "shared decision-making." For pregnant women, there is no recommendation.
Last week, the broke from the CDC to recommend COVID-19 shots for infants and young children. The also reaffirmed support for COVID-19 vaccination during pregnancy,
FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of FDA's Center for Biologics Evaluation and Research, also in May there's not enough evidence that healthy children and adults get clinically meaningful benefit from regular COVID-19 shots, and they want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups.
COVID-19 levels have been on the rise for months in the U.S., with transmission increasing in most states, . Surveillance data from WastewaterSCAN suggests that virus levels are about half of what they were during the peak of last summer's surge, but they match the peak from the summer of 2023 – and epidemiologist Caitlin Rivers noted in her that there are no signs of slowing yet, so activity will likely continue to increase in the weeks ahead. There were about 1.7 Covid hospitalizations for every 100,000 people during the first week of August, CDC shows, with the highest rates among seniors and children under 5.
This is a breaking news story and will be updated.