The Food and Drug Administration has approved updated COVID-19 vaccines for fall 2025, but limited their use to adults 65 and older and younger individuals with underlying health conditions.

The decision eliminates the broad vaccination framework that recommended shots for all Americans aged 6 months and older. Health and Human Services Secretary Robert F. Kennedy Jr. announced the narrowed vaccine approvals on August 27.

Under the new authorization framework, COVID-19 vaccines are now limited to specific high-risk populations :

• Adults 65 and older receive unrestricted access to all three available vaccines
• Children and adults under 65 must have at least one underlying health condition that increases severe COVID-19 risk
• Healthy children under 5 no longer have access to any authorized COVID-19 vaccine

The Pfizer-BioNTech vaccine lost its emergency use authorization for children under 5, leaving no COVID-19 vaccine option for healthy young children. Previously, this was the only vaccine authorized for the youngest age group.

The Moderna Spikevax vaccine remains available for children as young as 6 months, but only for those with underlying health conditions. The Novavax vaccine is restricted to individuals 12 and older with similar health-based limitations.

The policy changes create significant financial barriers for families seeking vaccination outside the restricted guidelines. Without federal recommendations, insurance companies may no longer cover COVID-19 vaccines for individuals who don’t meet the new criteria.

According to CDC pricing data, COVID-19 vaccines can cost more than $140 for those without insurance coverage.

The American Academy of Pediatrics expressed serious concern about the FDA’s decision, calling it “deeply troubling”. AAP President Susan Kressly warned that the restrictions create “dangerous vulnerability for children and their families” as respiratory virus season approaches.

“Any parent who wants their child vaccinated should have access to this vaccine; today’s unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children,” Susan Kressly, the president of the American Academy of Pediatrics.

The American Academy of Pediatrics (AAP) published evidence-based vaccination guidelines on Aug. 19, advocating for COVID-19 vaccination in young children despite the Centers for Disease Control and Prevention’s more restrictive guidance under Health Secretary Robert F. Kennedy Jr.

The AAP strongly recommends COVID-19 vaccination for all children ages 6 to 23 months unless they have a known allergy to the vaccine or its ingredients. This recommendation is based on compelling evidence showing that infants and children in this age group face the highest risk for severe COVID-19 disease among all pediatric populations.

According to the AAP’s analysis, children ages 6 to 23 months have hospitalization rates comparable to adults aged 50-64 years, with more than half of hospitalized children having no underlying health conditions. Recent data shows that infants under 6 months have COVID-19 hospitalization rates of 48 per 100,000, nearly seven times higher than older children and more than double the rate for adults under 50.

For children and adolescents ages 2 through 18 years, the AAP recommends a single dose of age-appropriate COVID-19 vaccine for those in specific risk categories:

• Children at high risk of severe COVID-19 due to underlying medical conditions
• Residents of long-term care facilities or congregate settings
• Children who have never been vaccinated against COVID-19
• Those with household contacts at high risk for severe COVID-19

The AAP also cites that vaccines should remain available for children ages 2-18 who don’t fall into these risk groups but whose parents desire vaccination protection.

The AAP’s recommendations are supported by extensive safety data showing that COVID-19 vaccines are very safe for all pediatric populations. 

The Infectious Diseases Society of America issued an even stronger condemnation.

Tina Tan, President, IDSA wrote, “COVID-19 vaccines remain our best tool to prevent severe disease, hospitalization and death due to COVID-19 — for healthy adults, children, pregnant patients and others at higher risk. The scientific evidence continues to strongly support broad vaccination far beyond the limited populations outlined in the Food and Drug Administration’s new label. By narrowing its approval, FDA has made a decision that completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans’ choice to be protected and increasing the risk of severe outcomes from COVID. 

“The American Academy of Pediatrics recently reaffirmed its recommendation for vaccination in children, and IDSA is working with other medical societies to finalize updated guidelines for COVID vaccination in both healthy and immunocompromised adults as part of our comprehensive respiratory virus guidance for this fall and winter. IDSA’s recommendations are expected to be released in September. 

“Physicians can still provide COVID vaccines off-label, and IDSA strongly urges doctors to continue recommending and administering vaccination to their patients based on the best available science. However, pharmacists’ ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access. 

IDSA calls on insurers to continue covering COVID vaccines consistent with multiple medical society recommendations and scientific evidence, and we urge Congress to conduct strong oversight of the Administration’s decision to restrict Americans’ freedom to choose vaccination as we approach the upcoming respiratory virus season.”