New COVID-19 Vaccines After May 25,2024
Yes, new COVID-19 vaccines have been approved after May 25,2024. The FDA approved and authorized 2024-2025 COVID-19 vaccines in August 2024, which target currently circulating Omicron JN.1 lineage strains (JN.1 and KP.2). 1, 2
New 2024-2025 COVID-19 Vaccines
- On August 22,2024, the FDA approved the 2024-2025 COVID-19 vaccines by Moderna and Pfizer-BioNTech (based on the KP.2 strain) for persons aged ≥12 years and authorized these vaccines for children aged 6 months–11 years under Emergency Use Authorization (EUA) 1
- On August 30,2024, the FDA authorized the 2024-2025 COVID-19 vaccine by Novavax (based on the JN.1 strain) for use in persons aged ≥12 years under EUA 1
- These new vaccines replace the previous 2023-2024 Formula monovalent XBB.1-strain COVID-19 vaccines that had been recommended since September 2023 3
Rationale for Updated Vaccines
- SARS-CoV-2 continues to evolve, and since winter 2023–2024, Omicron JN.1 lineage strains (including JN.1 and KP.2) have been widely circulating in the United States 1
- The effectiveness of previous COVID-19 vaccines wanes over time, necessitating updated formulations 1
- During September 2023–May 2024, vaccine effectiveness (VE) against COVID-19–associated hospitalization among adults aged ≥18 years was 49% at 7–59 days after 2023-2024 vaccination, declining to 14% at 120–179 days after vaccination 1
Current Recommendations
- The Advisory Committee on Immunization Practices (ACIP) recommends 2024–2025 COVID-19 vaccination with an FDA-approved or authorized vaccine for all persons aged ≥6 months 1, 2
- For most people who have completed a previous COVID-19 vaccination series, a single dose of the 2024-2025 COVID-19 vaccine is recommended 1
- The recommended minimum interval between the last COVID-19 vaccine dose and the 2024-2025 vaccination is generally 8 weeks 1, 2
- Special considerations apply for individuals who are moderately or severely immunocompromised, who may require additional doses 1
Vaccine Platforms Available
- Moderna (mRNA vaccine, KP.2-strain based) 1, 2
- Pfizer-BioNTech (mRNA vaccine, KP.2-strain based) 1, 2
- Novavax (protein subunit vaccine, JN.1-strain based) for individuals ≥12 years 1, 2
Clinical Implications
- COVID-19 continues to cause thousands of hospitalizations and hundreds of deaths in the United States each week, with highest rates among adults aged ≥75 years, followed by infants aged <6 months and adults aged 65–74 years 1
- The 2024-2025 COVID-19 vaccines are designed to provide additional protection against severe COVID-19–associated illness and death from currently circulating strains 1
- 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 1
Important Considerations
- The Bridge Access Program, which previously covered 2023-2024 COVID-19 vaccines for adults without health insurance, ended in August 2024 and will not cover the 2024-2025 COVID-19 vaccines 1
- Vaccine safety monitoring continues, with two statistical signals identified during the 2023-2024 season: Guillain-Barré syndrome among persons aged ≥65 years and ischemic stroke among adults aged ≥50 years, though evidence remains inconclusive 1
- Any potential risks must be weighed against the benefits of preventing COVID-19 and its potentially serious complications 1
Conclusion
The approval and authorization of the 2024-2025 COVID-19 vaccines represent the most recent update in COVID-19 vaccination strategy, designed to address the evolving SARS-CoV-2 virus and provide continued protection against severe disease and death.