State Issues Last General COVID-19 Vaccination Guidance to Providers

On May 23, 2023, the State issued updated guidance for COVID-19 vaccination providers, acknowledging the authorization and recommendation of the single bivalent vaccine, linking to updated clinical considerations, providing updated Centers for Disease Control and Prevention (CDC) immunization schedules regarding patient population and health status, and providing updates on vaccine storage.

Additional provisions of relevance include the following:

• All inventory of monovalent vaccine should be disposed of as medical waste and reported as unused in the New York State Immunization Information System (NYSIIS).
• All Janssen vaccines have expired and may no longer be administered.
• All immunocompetent individuals over age 6 who received a monovalent vaccine and a bivalent vaccine dose are fully vaccinated. Individuals 65+ have the option to receive an additional bivalent vaccine dose four months after their last bivalent.

Important links are provided below:

• Updated Guidance for Vaccination Providers
• Screening and Consent Forms for Children and Adults
• Information for Providers Regarding Vaccine Screening and Consent Form
• Vaccination guidance going forward: CDC Interim Clinical Considerations for Use of COVID-19 Vaccines

Providers are encouraged to review the guidance's Summary of Recent Changes:

• Effective April 18, 2023: The Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna bivalent mRNA vaccines to simplify the vaccination schedule by authorizing ONLY bivalent vaccines to be used for all doses administered to individuals 6 months and older. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. Dispose of any monovalent Moderna and Pfizer-BioNTech vaccine doses that are in inventory as medical waste and report unused doses as wastage in NYSIIS.
• On April 22, 2023: The Centers for Disease Control and Prevention (CDC) updated its interim clinical considerations with respect to bivalent COVID-19 vaccine recommendations for individuals 6 months and older.
• On April 22 and May 1, 2023: The CDC updated vaccine schedules for those eligible to receive a COVID19 vaccine, by age, immunocompetency status, and vaccine product. These changes were made to reflect recent FDA EUAs for bivalent formulations of the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines.
  • For immunocompetent individuals aged 6 months and older who previously received both a monovalent mRNA vaccination series and a bivalent mRNA dose, their vaccination is complete. No additional doses are indicated at this time.
  • Individuals aged 65 years and older without immunocompromise have the option to receive 1 additional bivalent mRNA vaccine dose at least 4 months after their first dose of bivalent mRNA.
  • Immunocompromised individuals who previously received a bivalent COVID-19 mRNA vaccine have the option to receive an additional bivalent COVID-19 mRNA vaccine dose 2 months after their first. Further additional dose(s) may be administered as determined by individual’s healthcare providers, personal preference, and clinical scenario. Any additional doses should be administered at least 2 months after their last bivalent vaccine dose.
  • Unvaccinated and immunocompromised individuals ages 6 months and older are recommended to receive 3 bivalent mRNA doses at this time.
  • For more information regarding any of the scenarios above please visit the CDC’s Interim Clinical Considerations.
• Storage and handling guidance has been updated to reflect updated guidance regarding mRNA bivalent vaccines.
• As of May 6, 2023, all Janssen COVID-19 vaccine purchased by the United States Government has expired. Janssen vaccines may no longer be administered.
• For detailed clinical guidelines regarding the administration of the COVID-19 vaccines, providers should refer to the CDC Interim Clinical Considerations here: Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC.
• NOTICE: As of May 23, 2023, NYSDOH will discontinue updating this guidance document for the New York State COVID-19 Vaccination Program. Providers should stay up-to-date on COVID-19 vaccination guidance by visiting the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC.

Contact: Meg Everett, meverett@leadingageny.org, 518-867-8871