On September 11, 2023, the Food and Drug Administration (FDA) updated the emergency use authorizations (EUAs) for Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines (2023-2024 formulations) for use in children 6 months through 11 years. The FDA updated the approvals of Moderna’s 2023-2024 mRNA COVID-19 vaccine, SPIKEVAX, and Pfizer’s 2023-2024 mRNA COVID-19 vaccine, COMIRNATY, for use in those 12 years and older. In addition, the FDA withdrew authorization for the use of bivalent mRNA COVID-19 vaccines as they should no longer be used.

On September 12, 2023, the CDC’s Advisory Committee on Immunization Practices (ACIP) met and reviewed the 2023-2024 COVID-19 vaccine safety and efficacy data. The CDC will be updating their Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States. Guidance for the use of these vaccines includes the following:

• Individuals 5 years and older regardless of previous vaccination are eligible to receive a single dose of the 2023-2024 COVID-19 vaccine at least 2 months since the last dose of any COVID-19 vaccine.
• The bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. Bivalent Novavax vaccine remains authorized for use for those 12 years and older and may still be administered if it is determined that the individual should not wait for a 2023-2024 Novavax COVID-19 vaccine or receive a 2023-2024 mRNA COVID-19 vaccine.  

• Children 6 months through 4 years of age are eligible for 2023-2024 mRNA COVID-19 vaccines. The number of doses depends on their prior vaccination status as well as previous COVID-19 vaccine product they received. These children should complete their series using the same brand (Moderna or Pfizer-BioNTech) of COVID-19 vaccine. See CDC Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States for specific scenarios.
• People who are moderately or severely immunocompromised should complete a 3-dose initial series of COVID-19 vaccine and receive at least one dose of the 2023-2024 COVID-19 vaccine and should review the CDC Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States for considerations for 1 or more additional doses of 2023-24 COVID-19 vaccine.

• COVID-19 vaccine ordering has transitioned away from the federal distribution. Providers seeking vaccines should reach out to their distributors or the manufacturers to order commercial vaccine. Providers enrolled in the vaccines for children program (VFC) can order through their usual process for ordering VFC vaccines. Federally supported health centers may order vaccines though the CDC’s Bridge Access Program (BAP) for vaccinating uninsured and underinsured individuals. For additional questions about COVID-19 Vaccine Commercialization, see COVID-19 Vaccine Commercialization FAQs.For Providers within the commercial market: 
• Moderna: Providers can order through McKesson, Cardinal, and AmeriSource Bergen distributors or directly with Moderna at www.modernadirect.com and 1-866-MODERNA / 1-866-663-3762. 
• Pfizer: Providers may work with wholesalers or directly with Pfizer for minimum quantities at https://primecontracts.pfizer.com and 1-800-666-7248. 
• Novavax: Novavax will be available to order through your dedicated distributor. For more information on product purchasing, email Novavax CA Regional Business Director, Nidal Naser at nnaser@novavax.com.

• California Vaccines for Children Program: Providers will soon be able to order Pediatric COVID-19 vaccines for VFC-eligible patients through myVFCVaccines. 
• Providers with bivalent vaccine may dispose of these discontinued products in pharmaceutical waste containers or comingled pharmaceutical/sharps waste containers. Follow local regulations and practice protocols for the disposal of regulated medical waste.