Updates on COVID Vaccine Guidance

(Sept. 15, 2025) New York State and the Centers for Medicare & Medicaid Services have taken steps recently to support access to the COVID vaccine.  The New York State Commissioner of Health has issued additional non-patient-specific, standing orders to support administration of the 2025-26 COVID vaccines, and CMS has updated Medicare formularies to cover the 2025-26 COVID vaccines under Part B. 

As reported last week, New York State has responded to the limited federal Food & Drug Administration (FDA) approvals of the updated COVID vaccines and the lack of recommendations from the CDC's Advisory Committee on Immunization Practices (ACIP) by issuing an executive order, guidance, and standing non-patient-specific orders, authorizing the prescribing and administration of the current COVID vaccines to patients outside of the age and health condition restrictions of the FDA approval.  The Commissioner's non-patient specific orders are available here, and the Department of Health guidance is here.  

As a result of the Health Commissioner's recent release of three more non-patient-specific orders for the administration of the 2025-26 vaccines, all four of the 2025-26 vaccines are now covered by such an order. These standing orders authorize pharmacists to administer the vaccine consistent with FDA approvals and ACIP recommendations.  In addition to the non-patient-specific orders, as previously reported, the Executive Order and Department of Health guidance authorize pharmacists to issue patient-specific orders and administer the vaccine "off-label" to patients who do not meet the criteria outlined in the FDA approvals -- i.e. individuals under age 65 who do not have high-risk medical conditions.  

The CDC's ACIP typically drafts federal recommendations for CDC approval and is scheduled to meet on September 18-19, when it will review and make recommendations on the COVID-19 vaccines, as well as the measles/mumps/rubella vaccine and the hepatitis B vaccine.  More information about the ACIP meeting is available here. 

This resource from the Post-Acute and Long Term Care Medical Association provides more information for clinicians.  LeadingAge New York will keep members informed of developments related to vaccine recommendations and access. 

Contact: Karen Lipson, klipson@leadingageny.org.