HHS Directive on Bivalent COVID-19 Vaccine Booster Doses for Individuals Ages 12 Years and Older

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

HHS Secretary Becerra issue this directiveon September 2, 2022:

As of September 2, 2022, CDC COVID-19 Vaccination Program enrolled providers shall make immediately available and administer, upon request, a single booster dose of:

  • Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals ages 12 and older at least two months after receipt of any monovalent primary series or monovalent booster dose of any COVID-19 vaccine, under the EUA issued by FDA; or
  • Moderna COVID-19 Vaccine, Bivalent for individuals ages 18 years and older at least two months after receipt of any monovalent primary series or monovalent booster dose of any COVID-19 vaccine, under the EUA issued by FDA.
  • Bivalent booster recommendations are without regard to the number of previous monovalent booster doses received.

In addition, CDC COVID-19 Vaccination Program enrolled providers shall continue to make available the monovalent COVID-19 mRNA Vaccines to those 6 months and older for their primary series, and for boosters for ages 5-11. There shall be no disposal of the monovalent COVID-19 mRNA Vaccines at this time outside of the usual parameters.

All CDC COVID-19 Vaccination Program enrolled providers must comply with this Directive as specified in updated CDC COVID-19 vaccination provider requirements posted at: https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.

This Directive also applies to all awardees and recipients of HHS grant and cooperative agreement funds, including grants to states and U.S. territories that have been awarded to support, implement, and expand COVID-19 vaccination programs nationwide.

This Directive should be read and implemented consistent with other existing direction from HHS and CDC, including the COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations (Playbook) guidance document; prior directives from the HHS Secretary and supplements and addenda to vaccine distribution and vaccine prioritization; the CDC Provider Agreement and related guidance; and any workplan, application, jurisdiction vaccination plan, or other submission from an awardee or recipient of CDC grants or cooperative agreements related to COVID-19 vaccine activities. To the extent that this Directive directly conflicts with those documents, this Directive shall be read to replace and supersede those documents.