Updated COVID-19 Vaccines Are Approved, But Population Restrictions Concern Experts

The FDA has authorized updated COVID-19 vaccines for the 2025–2026 respiratory virus season but has markedly reduced the populations eligible to receive them. The decision, announced August 27, reflects a pivot away from universal vaccination toward a strategy concentrated on older adults and individuals with underlying risk factors that increase their risk for severe infection.¹

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3 Vaccines, Limited Use

Pfizer’s updated Comirnaty formulation, targeting the SARS-CoV-2 sublineage LP.8.1, was approved on the day of the FDA announcement, but administration is limited to adults aged 65 and older and for individuals aged 5 to 64 years with underlying health conditions.² The FDA also revoked its emergency use authorization (EUA) for Comirnaty in children younger than age 5, removing the only available Pfizer option for that age group.¹ Spikevax, the COVID-19 vaccine from Moderna, was approved in its updated formulation in July and retained its indication for children as young as 6 months, but only if they have significant medical vulnerabilities.¹ Novavax's Nuvaxovid, a protein-based, non-mRNA COVID-19 vaccine, was first approved in May for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.³

The broad recommendation for universal annual vaccination against the SARS-CoV-2 virus for all Americans aged 6 months and older established in 2021, has been rescinded.

"Science, Safety, Common Sense"

Health and Human Services Secretary Robert F. Kennedy Jr. defended the shift, writing on social media site X, “The American people demanded science, safety, and common sense. This framework delivers all three.”^1,4 Medical organizations reacted quickly, warning that the narrowed recommendations may leave children and families without adequate protection. Susan J. Kressly, MD, president of the American Academy of Pediatrics (AAP), called the move “deeply troubling,” adding, “As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families. Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing.”⁵ The AAP continues to recommend annual COVID-19 vaccination for all children 6 months to 23 months and for older children with underlying conditions.⁵

Proof of Risk Factors Required

Experts also flagged practical barriers that may complicate uptake for those who remain eligible. Under the new rules, younger adults and children must prove they have at least one qualifying health condition. “This makes things much more complicated, and when things get complicated we see vaccine uptake go down,” said Andy Pekosz, PhD, a virologist at Johns Hopkins University told the Associated Press.¹ Dr. William Schaffner, a Vanderbilt University vaccines expert, noted that the restrictions “can’t help but create barriers to vaccinations” and cause confusion for patients, physicians, and pharmacists.⁴

No More Free Vaccines?

There may also be issues with insurance coverage, as payers typically base decisions on recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP). Any forthcoming guidance from that body, however, may be heavily scrutinized. In June Kennedy replaced the entire panel with his own selection of physicians and researchers, many known to be skeptical of vaccines.⁶ The committee is scheduled to meet in mid-September, although the agenda has not yet been released. Depending on the outcome, some patients may face out-of-pocket costs estimated at $150 or more for vaccination or may need to seek clinicians willing to provide shots “off-label.”¹

COVID-19 Remains a Threat

Infectious disease specialists are extremely concerned, underscoring that COVID -19 continues to pose a threat to public health and so the health care infrastructure. Preliminary CDC estimates for 2024 attribute 47,500 US deaths to COVID-related causes. “Down the line, this will really stress our health workforce,” Amanda Jezek of the Infectious Diseases Society of America, warned. “The public health impacts here are very worrisome.”¹

Restricting immunization against COVID-19 for the youngest Americans is very poorly timed. According to CDC data, only 23% of adults and 13% of individuals under 18 received a COVID-19 vaccine last year.⁷ “Our healthcare system is now solidly anti-children and anti-science,” Fatima Khan, co-founder of the Protect Their Future advocacy group, said in an interview with The Guardian. Kahn echoes the fear expressed by AAP President Kressly. “The data are clear: young children – especially infants – remain highly vulnerable to severe illness and hospitalization from COVID-19. By restricting access to safe, evidence-based vaccines, federal leaders are choosing ideology over science.”⁷

The updated vaccines from Pfizer and Moderna are expected to ship within days, with Novavax’s protein-based vaccine anticipated in early fall.^2,4,8 Whether eligible patients will be able to readily access them—and whether providers can navigate the new regulatory and insurance hurdles—remains uncertain as the respiratory virus season begins.