The U.S. Food and Drug Administration (FDA) recently approved updated COVID-19 vaccines. While this information was shared by Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., through announcements on social media, the FDA has yet to issue proactive communication about the updated labels. The updates narrow the indications to adults 65 and older and for children and adults with “high-risk” conditions. Though the FDA has not defined high-risk, the vaccine labels reference the CDC’s list of “high risk” conditions, which covers most adults in the U.S. While physicians can still vaccinate people who do not fall into the established categories, the new limits and confusion around them is making it harder for some patients to access vaccines.

The California Medical Association (CMA) is deeply concerned that this action is not guided by science, and will only create confusion for patients and barriers to access.  At a time when physicians are working to maintain trust in vaccines and prepare for another respiratory virus season, these changes makes that work more difficult. Notably, the new FDA labels do not align with the COVID vaccine recommendations from the American Academy of Pediatrics or the American College of Obstetrics and Gynecology.

Adding to the uncertainty, the CDC’s Advisory Committee on Immunization Practices (ACIP) — the body that develops national vaccine recommendations — has yet to vote on its guidance for this season. The panel’s controversial overhaul by HHS Secretary Kennedy., raises serious questions about whether its recommendations will further restrict access. ACIP is scheduled to meet on September 18-19.

Details on the Vaccines

The FDA’s approval covers three updated COVID-19 vaccines. Each vaccine is restricted to people 65 and older or to younger patients with qualifying medical conditions that put them at higher risk of severe illness.

Vaccine availability is expected soon. Representatives from Moderna and Pfizer have said their updated vaccines will ship almost immediately, with doses expected to reach physician offices and pharmacies within days. Sanofi, which markets the Novavax shot, has indicated its vaccine will be available in early fall.

What This Means for Physicians

CMA urges physicians to continue relying on their clinical judgment and evidence-based recommendations from trusted specialty societies. Irrespective of the definition of “high risk,” physicians may prescribe the vaccines “off label.”

Several of national groups are already stepping in to provide clarity. AAP and ACOG recently released updated immunization guidance broadly recommending COVID-19, flu, and RSV vaccines for patients this season, and IDSA and ACP are expected to release updated recommendations soon.

What You Can Do Now

Physicians can take several important steps to prepare their practices and support patients this season. First, stay informed by following guidance from your specialty society and urging insurers and health systems to align with those evidence-based recommendations. Just as important, reassure patients that COVID-19 vaccination remains safe and effective—even if FDA approval has been narrowed. Finally, consider how these changes may affect your practice operations, particularly for children, pregnant patients, and other high-risk groups, and adjust outreach, scheduling, and patient communication to ensure continued access.

What CMA is doing

CMA has consistently condemned politically motivated attacks on science and continues to stand with national partners calling for the restoration of independent vaccine advisory bodies. California physicians will not abandon evidence-based standards of care.

As the fall respiratory illness season approaches, updated recommendations from groups such as AAP and ACOG offer a clear reminder that science-driven preventive care remains essential. CMA will continue to support physicians with timely updates and resources, and to advocate aggressively for coverage policies and state protections that safeguard patient access to critical vaccines.