FDA Limits Updated COVID-19 Vaccine Approval to Higher-Risk Groups

09/3/2025

The US Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Moderna, Pfizer, and Novavax. The updated vaccines are designed to target newer coronavirus strains, including the XFG COVID-19 variant (also known as Stratus). However, the FDA has approved these vaccines only for people considered at higher risk of severe illness from COVID.

Who is eligible for the updated vaccine?

• People 65 and older
• People 6 months through 64 years with at least one underlying health condition that raises COVID risk (such as lung, heart, or kidney disease; obesity; cancer; HIV; pregnancy; or a weakened immune system)
• Children 6 months to 4 years (Moderna), but only if they have an underlying condition
• Children 5+ (Pfizer) and 12+ (Novavax), again, only if they have an underlying condition

Healthy children under 5 are no longer authorized to receive Pfizer’s vaccine, and healthy kids ages 6 months–11 years can only get vaccinated if they have a qualifying health condition. Likewise, healthy adults under 65 are no longer directly eligible—though doctors may still prescribe the vaccine “off-label” (i.e., outside the FDA’s official approval).

What if you are not eligible but want the vaccine?

Doctors may prescribe it off-label, but not all will—some fear liability. Insurance coverage for off-label vaccinations is uncertain.

Pharmacies are also restrictive:

• CVS and Walgreens require prescriptions in some states
• Some may allow patients to check a box confirming eligibility
• Others may require a doctor’s note or proof of a qualifying condition
• Pharmacists may be unwilling to give shots outside FDA criteria

The CDC is expected to issue new recommendations in the coming weeks, which may further shape access.

Are COVID shots still free?

• For people who meet FDA criteria and have insurance: yes. (That would only change if the CDC stopped recommending the shots for older adults and high-risk groups.)
• For off-label vaccinations: uncertain—depends on insurers and future CDC guidance. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet September 18–19 to discuss and potentially vote on updated vaccine recommendations.

Why this matters

The FDA’s decision rescinds the broader emergency use authorizations that had previously allowed wider access. Critics, including pediatric and infectious disease experts, warn the change could leave children and families unprotected. Meanwhile, COVID levels continue to rise and hospitalization rates remain highest among children under 5 and seniors.

Breaking from the CDC, the American Academy of Pediatrics recently recommended Covid-19 shots for infants and young children. The American College of Obstetricians and Gynecologists has also reaffirmed its support for vaccination during pregnancy.

Anyone who wants a COVID-19 vaccine should talk with their healthcare provider to discuss their options and whether an updated vaccine is appropriate. You can also visit www.vaccinefinder.org to locate clinics and pharmacies offering vaccines near you.

References

• CNN – FDA approves updated Covid-19 vaccines for limited groups as US cases continue to rise
• The New York Times – Can You Still Get the Covid Shot?
• PBS News Hour – Epidemiologist breaks down new restrictions on COVID shots
• The Guardian – What you need to know about Covid vaccines in the US this fall