FDA approves updated COVID vaccines with restrictions
The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines for the upcoming fall/winter season for some Americans.
The Pfizer-BioNTech vaccine was approved for use in adults aged 65 and older and for those between ages 5 and 64 with at least one underlying condition that puts them at high risk for severe COVID.
In a press release, the companies said their 2025-2026 COVID-19 vaccine will target a sublineage known as LP.8.1, an offshoot of the JN.1 subvariant, in line with FDA guidance to more closely match circulating strains.
"These vaccines are available for all patients who choose them after consulting with their doctors," Health and Human Services Secretary Robert F. Kennedy Jr. wrote in a post on X. "The American people demanded science, safety, and common sense. This framework delivers all three."
Americans who are 6 months and older and at high risk can receive the Moderna vaccine; those 12 years and older can get the Novavax vaccine, according to Kennedy.
Healthy children under age 18 will be able to receive a COVID-19 vaccine after consulting with a health care provider.
The American Academy of Pediatrics (AAP) leading pediatrician group in the nation says that the FDA’s decision today on COVID vaccines, which may limit the availability of the shots for kids and young adults, is “deeply troubling”.
Typically, after vaccines are approved by the FDA , the next step is a meeting among the members of the Centers for Disease Control and Prevention's vaccine advisory panel. The panel then makes recommendations on the vaccine's use to the CDC, which are signed off by the agency's director.
In June, Kennedy removed all 17 members of the CDC's vaccine advisory committee and replaced them with his own hand-selected members, many of whom have previously expressed vaccine skeptic views.
The change in approvals could leave some Americans facing out-of-pocket costs when receiving the COVID-19 vaccine. Insurers often rely on the CDC's vaccine panel's recommendations to determine what they will and won't cover.
If certain vaccines aren't recommended by the ACIP, it may lead to parents or guardians facing out-of-pocket costs if their children receive the shot. It could also mean the shots aren't covered by the Vaccines for Children (VFC) program, a federally funded program that provides no-cost vaccines to eligible children.
A COVID-19 vaccine could cost more than $140 in the private sector, according to the CDC vaccine price list.
The FDA approval comes after Kennedy announced in late May that the CDC would no longer recommend COVID-19 vaccines for healthy children and healthy pregnant women. Previously, the COVID vaccine was recommended for all Americans aged 6 months and older.
The CDC later updated the guidance to a "shared clinical decision making" model -- leaving the decision to vaccinate between patients or parents and a doctor.
In response, the AAP issued its annual immunization schedule recommending children ages 6 months to 23 months should receive a COVID-19 vaccine. The AAP also recommended those ages 2 to 18 receive a COVID vaccine if they are at high risk of severe COVID, live in a long-term care facility or congregate setting, if they have never been vaccinated against COVID or if they live with someone at high risk for severe COVID.
Additionally, the American College of Obstetricians and Gynecologists, the leading medical group representing OB-GYNs nationwide, said last week that patients should receive an updated COVID vaccine at any point during pregnancy, when planning to become pregnant, in the postpartum period or when lactating.
