Status of Fall 2025 COVID-19 Vaccine
The Fall 2025 COVID-19 vaccine is not yet available or approved, as the most recent approved vaccines are the 2024-2025 COVID-19 vaccines which target the Omicron JN.1 lineage strains (JN.1 and KP.2). These current vaccines were approved and authorized by the FDA in August 2024 and are recommended by the Advisory Committee on Immunization Practices (ACIP) for all persons aged ≥6 months 1.
Current Vaccine Status (2024-2025)
The most recent COVID-19 vaccines available are:
Moderna and Pfizer-BioNTech vaccines: FDA approved on August 22,2024, targeting the KP.2 strain
- Approved for persons aged ≥12 years
- Authorized under Emergency Use Authorization (EUA) for children aged 6 months-11 years 1
Novavax vaccine: FDA authorized on August 30,2024, targeting the JN.1 strain
- Authorized under EUA for persons aged ≥12 years 1
Effectiveness of Current Vaccines
The 2024-2025 COVID-19 vaccines have demonstrated effectiveness against currently circulating strains:
Among adults aged ≥18 years, vaccine effectiveness (VE) against COVID-19-associated emergency department/urgent care visits was 33% (95% CI = 28%-38%) during the first 7-119 days after vaccination 2
Among immunocompetent adults aged ≥65 years, VE against COVID-19-associated hospitalization was 45-46% during the first 7-119 days after vaccination 2
Among adults aged ≥65 years with immunocompromising conditions, VE was 40% (95% CI = 21%-54%) during the first 7-119 days after vaccination 2
Expected Timeline for Fall 2025 Vaccines
While the Fall 2025 COVID-19 vaccine has not yet been developed or approved, the pattern of COVID-19 vaccine updates suggests:
- SARS-CoV-2 continues to evolve, requiring regular updates to vaccine formulations
- The FDA and ACIP typically review and approve updated vaccine formulations annually
- The strain selection for the Fall 2025 vaccine will likely be based on predominant circulating variants in early-mid 2025
Importance of COVID-19 Vaccination
COVID-19 continues to cause significant morbidity and mortality:
In 2023, there were 44,059 COVID-19-associated deaths in persons aged ≥65 years, 5,634 among persons aged 20-64 years, 125 among persons aged 1-19 years, and 58 among infants aged <1 year 3
COVID-19 vaccination averted approximately 68,000 hospitalizations during the 2023-24 respiratory season 2
Safety Considerations
The ACIP continues to monitor vaccine safety:
Two statistical signals were identified for mRNA COVID-19 vaccines during the 2023-2024 season:
- Guillain-Barré syndrome (GBS) among persons aged ≥65 years (evidence inconclusive)
- Ischemic stroke among adults aged ≥50 years (no clear and consistent evidence of safety problem) 1
These potential risks must be weighed against the benefits of preventing COVID-19 and its serious complications 1
Recommendations
While awaiting the Fall 2025 COVID-19 vaccine:
The current recommendation is for all persons aged ≥6 months to receive the 2024-2025 COVID-19 vaccine to protect against severe COVID-19-associated illness and death 1, 2
ACIP will continue to evaluate new evidence and update recommendations as needed 1
Future vaccine formulations will likely continue to target the most prevalent circulating strains to provide optimal protection