The US Food and Drug Administration (FDA) today approved updated versions of COVID-19 vaccines, which paves the way for distribution to pharmacies and doctors' offices but complicates access for young children.
The much-anticipated approval comes as COVID activity rises across most US states, though at lower levels than last summer at this time. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced the approvals on X, saying the series of actions achieved four of his goals, which included rescinding emergency use authorizations (EUAs) that he said were used in the past to justify broad mandates. He also noted that the steps are designed to provide access to those who want the vaccines, especially high-risk people.
Today's marketing authorizations cover the Moderna vaccine for people ages 6 months and older, Pfizer for people ages 5 and older, and Novavax for people ages 12 and older. "These vaccines are available for all patients who choose them after consulting with their doctors," Kennedy said.
Health officials have been worried about the public's access to COVID vaccines for the upcoming respiratory virus season, given changes to US policy under the leadership of Kennedy, a long-time vaccine skeptic. Earlier this year, in a unilateral decision without input from vaccine advisers, he announced that COVID vaccination was no longer recommended for healthy children and pregnant women. Shortly after, the CDC updated its immunization schedule to partly reflect Kennedy's position, saying that children ages 6 months to 17 years may receive the vaccine based on parent preference and the clinical judgment of healthcare providers.
For adults, federal officials still recommend the vaccine for seniors, with more limited use to those younger than 65 with underlying health conditions, with the caveat for shared decision making based on doctors' advice.
Also, more concerns surfaced after a member of the CDC's reconstituted vaccine advisory panel, Retsef Levi, PhD, who is known to be critical of COVID vaccines, was recently tapped to lead a sweeping new review of COVID shots.
IDSA says narrowed guidance risks lives
The Infectious Diseases Society of America (IDSA) said today that the FDA's narrowed labeling indications ignore science and put millions of American lives at risk.
IDSA President Tina Tan, MD, said IDSA is working with other medical societies to finalize updated recommendations for COVID vaccination in both healthy and immunocompromised adults as part of more comprehensive respiratory virus guidance for the fall and winter, which it expects to release 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," she said. "However, pharmacists' ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access."
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.
The IDSA also called on insurers to continue covering COVID vaccines consistent with medical society recommendations, and it urged Congress to conduct strong oversight of the Administration's decision to restrict Americans' freedom to choose vaccination ahead of the respiratory virus season.
Clearance complicates access for youngest kids
Pulling the EUA for the Pfizer vaccine removes from the US market the only COVID vaccine approved for all children. For children, today’s authorization for Pfizer limits the use to those ages 5 and older. The Moderna vaccine is approved only for children with one or more health conditions, which could put pressure on supplies of the Moderna vaccine.
Though uptake in pediatric age-groups remains low, young children ages 6 to 23 months old are the hardest-hit group for severe disease.
Last week, the American Academy of Pediatrics published an update to its recommended childhood immunization schedule, emphasizing in a break from new CDC recommendations that all children in that age-group be vaccinated. It also recommended a single dose for kids ages 2 through 18 years old in certain risk groups as well as for those whose parent or guardian desires them to have vaccine protection.
Vaccine available to patients in coming days
In line with FDA guidance, the updated mRNA COVID vaccines are designed to protect against the LP.8.1 sublineage of the JN.1 virus.
In a statement, Pfizer said shipping will begin immediately to ensure robust supply and rapid access to pharmacies, hospitals, and clinics across the country.
Meanwhile, Moderna said the approvals apply to both the Spikevax vaccine mNexspike. The company expects that the updated vaccines will be available in the coming days. The FDA approved mNexspike, the company’s next-generation vaccine, in June. It allows for a smaller dose than the original Moderna vaccine and is designed to be refrigerator-stable, which could ease distribution and allow immunization in broader settings.
Novavax, the maker of the protein-based COVID vaccine, today said it would work with its partner Sanofi to provide access for eligible people this fall. The vaccine is indicated for people ages 65 and older and those ages 12 to 64 who have at least one underlying health condition that puts them at increased risk for severe COVID infection.
