FDA Approves Updated COVID Vaccines for Fall, With Shots Expected Within Days
The Food and Drug Administration has approved a new round of updated COVID-19 vaccines for the 2026-27 season, clearing the way for the shots to begin reaching pharmacies and health care providers across the United States within days.
The updated vaccines are intended to provide protection against more recently circulating versions of the coronavirus as the country heads into the fall and winter respiratory-virus season. The FDA had previously recommended that manufacturers update their vaccines for the 2026-27 season based on the evolution of the virus.
The approvals cover updated vaccines from Moderna and Pfizer-BioNTech, with eligibility continuing to focus broadly on people 65 and older and younger individuals whose medical conditions put them at increased risk of severe COVID-19.
Moderna announced Thursday that the FDA approved its updated 2026-27 formulations of both Spikevax and mNEXSPIKE. The new versions target the JN.1-lineage XFG subvariant of SARS-CoV-2, which the company said is intended to more closely match circulating strains.
Under the FDA-approved indications, Spikevax is available for everyone 65 and older, as well as people from 6 months through age 64 who have at least one underlying condition that places them at high risk for severe COVID-19.
Moderna’s mNEXSPIKE is approved for people 65 and older and for those ages 12 through 64 with at least one underlying medical condition that puts them at increased risk of severe illness.
Pfizer-BioNTech’s updated Comirnaty vaccine has also been cleared for the coming season, with the formulation designed to target a more current coronavirus lineage. The vaccine is approved for adults 65 and older and for people ages 5 through 64 who have at least one underlying condition associated with a heightened risk of severe COVID-19.
The new shots are expected to become available shortly, with manufacturers preparing to ship supplies to pharmacies and other vaccination sites in the coming days. Moderna said its updated vaccines would be available in the United States imminently.
The approvals come as federal health officials continue to move away from the sweeping COVID vaccination policies used during the height of the pandemic and toward a more targeted approach focused on older Americans and people considered more vulnerable to serious complications from the virus.
Age remains one of the strongest risk factors for severe COVID-19, while the Centers for Disease Control and Prevention identifies numerous medical conditions that can increase a person’s chances of becoming seriously ill. The CDC notes that its list of higher-risk conditions is not exhaustive.
The FDA’s action concerns whether the vaccines are approved for use and in which populations. Separate federal recommendations governing who should actually receive the shots are issued through the CDC’s immunization process, meaning FDA approval and CDC vaccination recommendations are distinct steps.
The updated formulations reflect the now-routine process of revising COVID vaccines as the virus evolves, similar in concept to the regular updating of influenza vaccines. The FDA’s vaccine advisory committee met in May to discuss which SARS-CoV-2 strains should be targeted by vaccines used beginning this fall.
Four COVID-19 vaccines currently have FDA-approved products in the United States: Pfizer’s Comirnaty, Moderna’s Spikevax and mNEXSPIKE, and Novavax’s Nuvaxovid.
The arrival of the latest shots comes more than six years after the COVID-19 pandemic began and as the federal government continues dismantling some of the emergency regulatory framework established during the crisis.
In June, the Department of Health and Human Services determined that circumstances no longer justify the COVID-19 emergency-use declaration for drugs and biological products. The declaration is scheduled to terminate in June 2027, after which remaining products relying solely on COVID emergency-use authorization would no longer be covered by that authority.
The FDA’s latest approvals, however, involve fully licensed vaccines rather than a return to the broad emergency authorizations that characterized the early years of the pandemic.
For Americans seeking the updated shot, supplies are expected to begin arriving shortly, though eligibility, insurance coverage and recommendations may vary depending on age, medical history and subsequent federal guidance.
{Matzav.com}
