The U.S. Food and Drug Administration (FDA) on Wednesday approved updated Covid-19 vaccines, but the authorization is limited to specific populations: adults 65 and older and younger individuals with underlying health conditions that put them at higher risk for severe illness.
“These vaccines are now authorized for those at higher risk,” HHS Secretary Robert F. Kennedy Jr. said in a post on X, noting that Moderna (6+ months), Pfizer (5+ years), and Novavax (12+ years) vaccines are available for patients after consulting with their healthcare providers. The updated formulations target more recent coronavirus strains, but the narrower approval means access will be restricted for many who were previously eligible.
Infants and young children face particularly limited options. Last respiratory virus season, Covid-19 hospitalization rates for children under 5 were 48 per 100,000 — nearly seven times the rate for older children and more than double that of adults under 50. With emergency use authorizations rescinded, Pfizer’s Comirnaty vaccine is no longer available for children under 5. Moderna’s Spikevax can be given to children as young as 6 months, but only if they have a high-risk condition. Novavax, the U.S.’s only protein-based, non-mRNA vaccine, remains limited to adults 65+ and children 12+ with risk factors.
Critics argue the new guidance severely restricts access for vulnerable populations. Fatima Khan, co-founder of the nonprofit Protect Their Future, told CNN, “Our health care system is now solidly anti-children and anti-science…By restricting access to safe, evidence-based vaccines, federal leaders are choosing ideology over science.”
FDA officials, including Commissioner Dr. Marty Makary and Dr. Vinay Prasad, have said more research is needed to determine the benefits of routine Covid-19 vaccination in healthy children and adults. They called for additional placebo-controlled trials, especially in adults aged 50–64, before expanding recommendations. An FDA spokesperson emphasized that the vaccines remain available for those who choose them in consultation with their healthcare provider.
Health experts note that many underlying conditions — including lung, heart, and kidney diseases, obesity, cancer, HIV, and pregnancy — increase risk from Covid-19. While vaccines may be accessible “off-label” to healthy younger people, Dr. Tina Tan, president of the Infectious Diseases Society of America, warned that the decision “completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access.”
The policy has already drawn concern from pediatric and obstetric organizations. Dr. Susan Kressly, president of the American Academy of Pediatrics, said the FDA action “prevents parents from accessing vaccines for their children, adding confusion and stress as families try to make the best health decisions.” Last week, the American Academy of Pediatrics broke from the CDC to recommend Covid-19 vaccination for infants and young children, and the American College of Obstetricians and Gynecologists reaffirmed support for vaccination during pregnancy.
Covid-19 levels continue to rise across the U.S., with transmission increasing in most states, according to CDC data. Wastewater surveillance indicates virus levels are about half of last summer’s peak but match the summer 2023 peak. Epidemiologist Caitlin Rivers noted there are no signs of slowing, suggesting activity will likely continue to increase. Hospitalizations remain highest among seniors and children under 5, with 1.7 hospitalizations per 100,000 people reported during the first week of August.
Pump Radar
Stock Alerts