FDA Approves and Authorizes for Emergency Use Updated COVID-19 Vaccines and De- authorizes Administration of 2023-2024 COVID-19 Vaccines
Background
On August 22, 2024, the U.S. Food and Drug Administration (FDA) issued approval and granted emergency use authorization (EUA) to both Moderna and Pfizer-BioNTech for their updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. This is to provide the public with an updated mRNA COVID-19 vaccine formulary that more closely targets currently circulating variants and provides better protection against serious illness and complications from COVID-19.
In addition, from correspondence received from the Centers for Disease Control and Prevention (CDC) on August 23, 2024, all 2023-2024 mRNA COVID-19 vaccines are no longer authorized for use in the United States, regardless of age. Administration of any 2023-2024 mRNA COVID-19 vaccines are now considered vaccine administration errors and must be reported to the Vaccine Adverse Event Reporting System (VAERS). To minimize the risk of vaccine administration errors, providers should:
- Remove all 2023–2024 mRNA COVID-19 vaccines from storage units immediately, even if they are not expired.
- Once all inventory is fully accounted for, delete 2023–2024 mRNA COVID-19 vaccine listings from the available vaccine inventory in your Immunization Information System, as applicable.
- Return all unused 2023–2024 mRNA COVID-19 vaccines to CDC’s centralized distributor using the normal process for returning spoiled/expired vaccines.
On August 30, 2024, the FDA amended Novavax’s COVID-19 Vaccine EUA to include their 2024-2025 vaccine formula. The Novavax COVID-19, Adjuvanted (2024-2025 formula) includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2 for use in individuals 12 years of age and older. In addition to this authorization, FDA also de-authorized the 2023-2024 Novavax COVID-19 Vaccine, Adjuvanted for use in the United States. The 2024-2025 Novavax COVID-19 Vaccine, Adjuvanted is available to the following individuals:
- Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses of this updated vaccine, 3 weeks apart.
- Individuals who have been vaccinated only with one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least 3 weeks after the previous dose.
- Those who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of the Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least 2 months after the last dose of a COVID-19 vaccine.
The CDC has published updated Interim Clinical Considerations, including vaccine administration guidance by age group and previous COVID-19 vaccine history. In addition to this, the CDC has updated guidance on reporting vaccine adverse events and errors to the Vaccine Adverse Event Reporting System (VAERS).
This technical bulletin summarizes the updated and simplified use of the updated 2024-2025 COVID-19 vaccines, including eligibility, doses and schedule. In all age groups, COVID-19 vaccine doses from the same manufacturer should be administered whenever recommended; see Interchangeability of COVID-19 vaccines for circumstances in which doses from different manufacturers may be considered.
People who are not moderately or severely immunocompromised
Initial vaccination
Ages 6 months–4 years
- 2 doses of 2024–2025 Moderna or 3 doses of 2024–2025 Pfizer-BioNTech
Ages 5-11 years
- 1 dose of 2024–2025 Moderna or 1 dose of 2024–2025 Pfizer-BioNTech
Ages 12 years and older
- 1 dose of 2024–2025 Moderna or 1 dose of 2024–2025 Pfizer-BioNTech or 2 doses of 2024-2024 Novavax
Received previous doses of a COVID-19 vaccine
Ages 6 months–4 years
- 1 or 2 doses of 2024–2025 mRNA vaccine from the same manufacturer as administered for initial vaccination, depending on the vaccine and the number of prior doses
Ages 5-11 years
- 1 dose of 2024–2025 Moderna or 1 dose of 2024–2025 Pfizer-BioNTech
Ages 12 years and older
- 1 dose of 2024–2025 Moderna or 1 dose of 2024–2025 Pfizer-BioNTech or 1 dose of 2024-2024 Novavax
- Additional dose: An additional dose of 2024–2025 COVID-19 vaccine for people ages 65 years and older who are not moderately or severely immunocompromised is NOT currently recommended.
People who are moderately or severely immunocompromised
Initial vaccination
Ages 6 months-11 years
- 3 doses of 2024–2025 Moderna or 3 doses of 2024–2025 Pfizer-BioNTech
- Additional doses: Children who are moderately or severely immunocompromised, ages 6 months to 11 years, may receive 1 additional dose of 2024–2025 mRNA COVID-19 vaccine from the same manufacturer as the initial series at least 2 months after the last 2024–2025 mRNA vaccine dose.
Ages 12 years and older
- 3 doses of 2024–2025 Moderna or 3 doses of 2024–2025 Pfizer-BioNTech or 2 doses of 2024-2025 Novavax
- Additional doses: People who are moderately or severely immunocompromised, ages 12 years and older, may receive 1 additional dose of any 2024–2025 COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer-BioNTech, regardless of the manufacturer for the initial series) at least 2 months after the last 2024–2025 vaccine dose.
Received previous doses of a COVID-19 vaccine
- Recommended COVID-19 vaccine and number of 2024–2025 doses for people who are moderately or severely immunocompromised are based on age and vaccination history.
Vaccine Information Fact Sheets & Prescribing Information
Pfizer-BioNTech’s Vaccine Information Fact Sheets have been updated for Recipients and/or Caregivers and Healthcare Providers, which are available for reference.
Comirnaty Prescribing Information sheets are available for reference.
Moderna’s Vaccine Information Fact Sheets have also been updated for Recipients and/or Caregivers and Healthcare Providers which are available for reference.
Spikevax Prescribing Information sheets are available for reference.
Novavax’s Vaccine Information Fact Sheets have been updated for Recipients and/or Caregivers and Healthcare Providers, which are available for reference.
Questions
For updated guidance, review the Division of Public and Behavioral Health Technical Bulletin web page regularly. Email nviz@health.nv.gov for other questions regarding COVID-19 vaccination.