FDA approves updated Covid-19 vaccines for limited groups as US cases continue to rise

By Jamie Gumbrecht, Deidre McPhillips, Brenda Goodman, CNN

(CNN) — The US Food and Drug Administration approved updated Covid-19 vaccines Wednesday, but for a limited group: adults 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 post on X.

The vaccines have been updated to target coronavirus strains circulating more recently.

Kennedy said in this post that he had promised “to keep vaccines available to people who want them, especially the vulnerable,” but the narrower approval 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 get 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Emergency use authorizations for Covid-19 vaccines are rescinded, Kennedy said Wednesday, which means Pfizer’s Covid-19 vaccine, Comirnaty, is no longer authorized for children younger than 5. Moderna’s Spikevax 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 Novavax’s Covid-19 vaccine — the only protein-based, non-mRNA vaccine available in the US — 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.”

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, also said in May that 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.

A spokesperson for the FDA said in a statement that the decision “does not affect access to these vaccines. These vaccines remain available to those who choose them in consultation with their healthcare provider.”

Many health conditions increase risk with Covid-19, according to the CDC, including lung, heart and kidney conditions; obesity; cancer; HIV and pregnancy.

And vaccines may be accessible to healthy younger people “off-label,” Dr. Tina Tan, president of the Infectious Diseases Society of America, said in a statement. However, she said, the new FDA decision “completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans’ choice to be protected and increasing the risk of severe outcomes from COVID.”

The president of the American Academy of Pediatrics said Wednesday’s FDA actions could be a barrier to vaccination.

“Any parent who wants their child vaccinated should have access to this vaccine; today’s unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children,” Dr. Susan Kressly said in a statement. “Parents and pediatricians, together, make the best decisions to protect children’s long-term health.”

Approved vaccines are available after they’ve been recommended for use by the CDC. Kennedy previously announced that the agency 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, known as “shared decision-making.” For pregnant women, there is no recommendation.

Last week, the American Academy of Pediatrics broke from the CDC to recommend Covid-19 shots for infants and young children. The American College of Obstetricians and Gynecologists also reaffirmed support for Covid-19 vaccination during pregnancy,

Covid-19 levels have been on the rise for months in the US, with transmission increasing in most states, according to the CDC. 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 newsletter that there are no signs of slowing yet, so activity will probably 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 data shows, with the highest rates among seniors and children under 5.

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