The U.S. Food and Drug Administration (FDA) has approved updated COVID vaccines for this fall, but with new restrictions that are expected to limit access, especially for young children.
Secretary of Health and Human Services Robert F. Kennedy Jr. made the announcement via the social media platform X, saying “FDA has now issued marketing authorization for those at higher risk … . These vaccines are available for all patients who choose them after consulting with their doctors.”
The new 2025-2026 vaccines should be highly protective against recently dominant COVID variants, according to manufacturers.
The FDA Has Narrowed Its Vaccine Recommendations
As part of the new policy, the FDA revoked its emergency use authorizations, which made COVID vaccines available to nearly all Americans ages 6 months and older during the pandemic.
The FDA now restricts updated COVID shots to adults 65 and older as well as people younger than 65 who have at least one underlying medical condition that makes them more susceptible to severe illness.
For people under 65 with these underlying medical conditions, each vaccine brand is approved for a different age range:
- Pfizer-BioNTech (Comirnaty) for ages 5 through 64 years
- Moderna (Spikevax) for ages 6 months through 64 years
- Novavax (Nuvaxovid) for ages 12 months through 64 years
Who Is Considered High Risk for Severe COVID-19?
The Centers for Disease Control and Prevention (CDC) says that older Americans are at highest risk of getting very sick from COVID-19. More than 81 percent of COVID-19 deaths occur in people over age 65.
Other conditions and behaviors that increase the risk of severe COVID-19 include but are not limited to:
- Cancer
- Chronic kidney disease
- Chronic liver disease
- Chronic lung disease
- Cystic fibrosis
- Dementia
- Diabetes
- Disabilities
- Heart conditions
- HIV
- Being overweight or having obesity
- Smoking
- Having a compromised immune system
Pregnant women also face an increased risk of severe COVID-19, according to the American College of Obstetricians and Gynecologists (ACOG). ACOG strongly urges women who are pregnant to get vaccinated for their own health and the health of their babies, who can receive protective maternal antibodies in utero.
In spring 2025, however, Kennedy announced that the CDC no longer recommends the COVID-19 vaccine for healthy pregnant women.
Policy Shift May Especially Affect Young Children
Prior to this announced FDA change, federal health officials had broadly recommended COVID vaccines for all people older than 6 months, including healthy children.
Now the FDA under Secretary Kennedy no longer advises the shots for healthy children, but says that the decision to get the vaccine should be a result of “shared clinical decision-making” between parents and pediatricians.
Anyone can get an ‘off label’ updated COVID vaccine, including for their children, if their doctor agrees. But fewer physicians may be willing to go against FDA recommendations, says Andrew Pavia, MD, chief of the division of pediatric infectious diseases, adjunct professor of medicine at the University of Utah in Salt Lake City, and spokesperson for the Infectious Diseases Society of America.
“I expect this action by the FDA and RFK Jr. will restrict access substantially, and it’s not driven by any change in the safety data or effectiveness,” says Dr. Pavia.
“If we have a major surge in the virus this winter, I fully expect that we will see more kids getting significantly ill with COVID,” he adds.
When Will the Vaccines Be Available and Will Insurers Pay?
“The updated vaccine should be starting to be distributed fairly soon,” says Pavia.
Pfizer announced that shipping will begin immediately “to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country.”
The CDC has not yet issued its endorsement for the FDA’s new COVID-19 vaccine policy, a decision that typically triggers insurance coverage.
Pavia says that if the CDC goes along with the new FDA guidelines, insurance companies may decide not to cover the cost of vaccination for healthy children and adults under age 65.
The scheduling on this is up in the air. The CDC has been in turmoil since the White House fired CDC director Susan Monarez, PhD.
“Lord only knows when CDC action on this will come,” says Pavia.
Without insurance, a COVID shot can cost up to $140, according to the CDC’s vaccine price list.
Even for people who meet the new criteria and are willing to pay out of pocket, it may prove difficult to find a place to get vaccinated. CVS, the nation’s top pharmacy chain, will not be offering the updated shots in 16 states until the CDC weighs in. CVS says its pharmacists are legally unable to give the shots without the recommendation of the Advisory Committee on Immunization Practices, a panel that guides CDC decision-making.
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