COVID vaccines no longer widely authorized in U.S.

The FDA just approved a new round of updated Covid vaccines for the fall, but fewer Americans will be eligible for the shots for the first time. 

The agency, under the guidance of Health and Human Services Secretary Robert F. Kennedy Jr., issued the approvals for the new Covid vaccines only for people 65 and older or who have underlying health conditions.

In previous years, the annual Covid booster shot was approved widely, not just cleared for specific populations. The change could affect insurance coverage for the shots and means that patients seeking the new vaccines may now need to have them prescribed by a doctor off-label. 

The government also revoked the emergency use authorizations used to make the Covid vaccines widely available since they were first developed in the pandemic’s early days. That change will likely make the updated shots, which target the dominant JN.1 variant of the virus, more difficult to obtain. 

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy said in an update on X. “The American people demanded science, safety, and common sense.”

Kennedy said that the changes reflect his promise to end mandates while keeping Covid vaccines available to “people who want them, especially the vulnerable.” With new obstacles in place that limit vaccines for healthy Americans, that may not prove to be true.

Children’s vaccine access will change 

On X, Kennedy said that children six months old and above can obtain the Moderna vaccine, while the Pfizer/BioNTech vaccine is available above age 5 and the Novavax version is approved for ages 12 and up. The new criteria limiting the FDA’s vaccine recommendations to people with underlying health conditions also apply to children.

Under the now-rescinded emergency use authorization, Pfizer’s Covid shot was available for children under age 5. The Moderna vaccine will now be the only option for parents wishing to vaccinate young children. 

The American Academy of Pediatrics continues to recommend the Covid vaccine in all children from six months old to 23 months old unless they have relevant allergies. The group, the main  professional association of pediatricians in the U.S., also recommends a single dose of the vaccine in children two and up for individuals at high risk of severe Covid-19, those living in a long-term care facility and those living with someone else at high risk for severe Covid-19. The organization also recommends one vaccine dose for anyone from age two to 18 who has never received the vaccine. 

The pediatric group’s vaccine advice split with the CDC’s guidance, which scaled back its recommendations after Trump took office. “It differs from recent recommendations of the Advisory Committee on Immunization Practices of the CDC, which was overhauled this year and replaced with individuals who have a history of spreading vaccine misinformation,” the organization said in a press release earlier this month.

With the rise of the anti-vaccine movement in the U.S., childhood vaccination has become a particular flashpoint in recent years. National vaccination rates are falling and previously controlled diseases like measles are roaring back. Once a fringe belief in the U.S., vaccine skepticism is now a mainstream political view, buoyed by a proliferation of health misinformation and cash flush organizations riding the wave of post-pandemic resentment.

Those groups and their followers have a champion in Kennedy, who founded the Children’s Health Defense, a prominent anti-vaccine activist organization that saw its revenues spike as the pandemic swept the globe. Kennedy now shapes U.S. vaccine policy as the nation’s top public health official.