End of COVID-19 Program
COVID-19 Vaccine Updates:2023-2024 Products and Recommendations by Jill Johnson on September 18, 2023.
Effective September 11, 2023, Bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
September 11, 2023, the FDA terminated authorization of bivalent mRNA COVID-19 vaccines (FDA announcement). Following that action, administration of a bivalent mRNA COVID-19 vaccine now constitutes a vaccine error and should be reported to
Vaccine Adverse Event Reporting System (VAERS). Before the September 11th announcement, a bivalent dose was recommended for all age groups (with additional doses optional or recommended for some populations).
The COVID-19 vaccine program opened in December of 2020, but with the de-authorization of the bivalent Moderna and Pfizer mRNA vaccines, that program is concluded permanently.
Advisory Committee on Immunization Practices (ACIP) met on September 12, to make recommendations for the updated, monovalent mRNA vaccines. Recommendations from that meeting are reflected in the updated Interim Clinical Considerations. The OIP Immunization Protocol will be updated to reflect the changes on CDC approval.
Disposal of Bivalent mRNA COVID-19 Vaccines
Please dispose of any bivalent mRNA COVID-19 vaccines in your storage inventory according to your organization's policy for medical waste disposal. Also, remember to record wasted doses in the
Non-mRNA COVID-19 Vaccines: Novavax
Updated Novavax has also been authorized by FDA.
COVID-19 Vaccine Information
For now, the best place to find information on these vaccines is the CDC website:
Also relevant information will be incorporated into the
VFC Provider Materials as COVID vaccines are now part of the VFC Program.
Emergency Use Authorization fact sheets
Vaccine Information Statements (VIS)
For the licensed products for ages 12 and older VIS are not yet available
Information for providers can be found in the package inserts:
For informing patients about licensed products that do not yet have a VIS, the CDC states:
The law does not require that a vaccine be withheld if a VIS for it does not yet exist. Until a VIS is available for a particular vaccine, a provider may use the manufacturer's package insert, written FAQs, or any other document – or produce their own information materials – to inform patients about the benefits and risks of that vaccine. Once a VIS is available it should be used; but providers should not delay use of a vaccine because of the absence of a VIS.
Vaccine Information Statement | Frequently Asked Questions | VIS | CDC
Updated COVID-19 Protocols
OHA has posted updated
immunization protocol and
immunization pharmacy protocol covering the updated 2023-2024 COVID-19 vaccine. Doses should begin arriving in clinics and pharmacies within the next few days. Bivalent doses are no longer approved for use in the United States. For patients ≥12 years of age that refuse mRNA vaccines, updated Novavax COVID-19 vaccine is now authorized, though not preferred. If you have any questions regarding the protocols, please contact the Immunization Program Help Desk at 1-800-980-9431.