FDA COVID-19 Vaccine Recommendations for 2025
The FDA recommends that all individuals aged ≥6 months should receive the 2024-2025 COVID-19 vaccine formulation targeting Omicron JN.1 lineage strains (JN.1 and KP.2) to protect against severe COVID-19-associated illness and death. 1, 2
Approved and Authorized Vaccines for 2024-2025
The FDA has approved and authorized the following 2024-2025 COVID-19 vaccines:
Moderna and Pfizer-BioNTech (KP.2 strain):
- FDA-approved for persons aged ≥12 years
- FDA-authorized under Emergency Use Authorization (EUA) for children aged 6 months–11 years
Novavax (JN.1 strain):
- FDA-authorized under EUA for persons aged ≥12 years
Vaccination Recommendations by Population
For Persons Without Moderate or Severe Immunocompromise:
- Ages 5-11 years: 1 dose of 2024-2025 COVID-19 vaccine (Moderna or Pfizer-BioNTech) 1
- Ages ≥12 years: 1 dose of 2024-2025 COVID-19 vaccine (Moderna, Novavax, or Pfizer-BioNTech) 1
- Exception: Unvaccinated persons choosing Novavax should receive 2 doses of 2024-2025 Novavax vaccine, 3-8 weeks apart 1
- Ages 6 months-4 years: Initial multidose vaccination series including at least 1 dose of 2024-2025 COVID-19 vaccine 1
For Persons With Moderate or Severe Immunocompromise:
- All ages ≥6 months: At least 1 dose of 2024-2025 COVID-19 vaccine 1
- Unvaccinated ages 6 months-11 years: 3-dose series of 2024-2025 mRNA COVID-19 vaccine (same manufacturer) 1
- Unvaccinated ages ≥12 years: Either 3 doses of 2024-2025 mRNA COVID-19 vaccine (same manufacturer) or 2 doses of 2024-2025 Novavax COVID-19 vaccine 1
Timing Considerations
- For previously vaccinated individuals: Administer 2024-2025 COVID-19 vaccine ≥8 weeks after the last COVID-19 vaccine dose 1, 2
- Additional doses may be administered based on clinical judgment, with at least 2 months between doses 2
Effectiveness of 2024-2025 COVID-19 Vaccines
The 2024-2025 COVID-19 vaccines have demonstrated effectiveness against COVID-19-associated outcomes:
- Among adults aged ≥18 years, vaccine effectiveness (VE) against COVID-19-associated emergency department/urgent care visits was 33% during the first 7-119 days after vaccination 3
- Among immunocompetent adults aged ≥65 years, VE against COVID-19-associated hospitalization was 45-46% during the first 7-119 days after vaccination 3
- Among adults aged ≥65 years with immunocompromising conditions, VE was 40% during the first 7-119 days after vaccination 3
Cost-Effectiveness Considerations
Economic modeling demonstrates that COVID-19 vaccines are most cost-effective in adults aged ≥65 years, who experience the highest rates of severe COVID-19 (incremental cost-effectiveness ratio of $23,308 per quality-adjusted life year) 1, 2. Cost-effectiveness is less favorable but still present in younger age groups, with improved cost-effectiveness when considering higher vaccine impact, higher hospitalization risk, greater quality of life impact, and lower vaccine cost 1.
Important Clinical Considerations
- Accurate documentation of previous COVID-19 vaccination history is essential to determine the appropriate 2024-2025 vaccination schedule 2
- Unnecessary delays in vaccination may leave individuals vulnerable to infection and severe outcomes 2
- The 2024-2025 COVID-19 vaccines are specifically designed to target currently circulating SARS-CoV-2 strains (Omicron JN.1 lineage) 1
The FDA and CDC will continue to evaluate new evidence as it becomes available and may update recommendations as needed.