The Food and Drug Administration on Wednesday approved a new round of COVID-19 vaccines, but only for Americans considered at higher risk of severe illness. The change marks a sharp departure from recent U.S. policy that recommended the shots broadly for nearly all age groups.
Under the new guidance, adults 65 and older are eligible, as well as younger people with underlying health conditions such as cancer, diabetes, obesity, chronic kidney disease, or heart problems. Immunocompromised patients are also included.
Health and Human Services Secretary Robert F. Kennedy Jr. said the shots remain available for anyone who seeks them after consulting a doctor. But with the FDA’s authorization limited to high-risk groups, it is unclear how easily healthy adults and children will be able to obtain the vaccines, or whether insurance companies will continue to cover them.
Pfizer, Moderna, and Novavax all received FDA clearance for their updated shots under the narrowed framework. Pfizer’s vaccine is authorized for adults 65 and older and for those ages 5 to 64 with at least one high-risk condition. Moderna’s vaccine is cleared for the same older group, and for patients ages 6 months through 64 who are considered high risk. Novavax’s shot is available for high-risk patients ages 12 and older. The companies expect doses to reach pharmacies and clinics within days.
The decision also ends emergency use authorizations that previously allowed Pfizer’s shot to be given to children as young as six months. Pediatricians expressed concern about the shift. The American Academy of Pediatrics said restricting access could leave infants and toddlers vulnerable heading into respiratory virus season. The American College of Obstetricians and Gynecologists also continued to recommend vaccination for pregnant women.
The limited approval reflects broader changes in federal vaccine policy under Kennedy, who has reshaped the government’s advisory panels and rolled back prior recommendations.
Source: CNBC