Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for their 2025-2026 COVID-19 vaccine formulas, Spikevax® and mNEXSPIKE®. These updated vaccines are designed to target the LP.8.1 variant of SARS-CoV-2, which is the currently circulating strain. The company expects the vaccines to be available in the U.S. within the coming days. This approval is a crucial step in ensuring that the American public has access to updated protection for the upcoming respiratory virus season, which is especially important given that COVID-19 was responsible for up to four million outpatient visits and nearly half a million hospitalizations last year.

The updated Spikevax formula is approved for individuals aged 6 months through 64 years who have at least one underlying condition that places them at high risk for severe COVID-19, as well as all adults 65 years of age and older. Similarly, the new mNEXSPIKE vaccine is approved for individuals 12 through 64 years of age with high-risk underlying conditions and all adults 65 and older. The composition of these new vaccines aligns with the guidance from the U.S. FDA, which had advised that COVID-19 vaccines should be developed with a monovalent JN.1 lineage, with a preference for the LP.8.1 variant. Moderna has already secured regulatory approvals for its updated vaccines in several other countries, including Canada, Europe, Japan, and Switzerland, with additional applications under review worldwide.

Both mNEXSPIKE and Spikevax are mRNA vaccines designed to protect against COVID-19. While they offer significant protection, it is important to note that vaccination may not protect every individual. A key safety consideration is the risk of a severe allergic reaction, which is a rare but possible side effect that usually occurs within an hour of vaccination. Additionally, cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been reported, most commonly in males aged 12 to 24. Individuals should seek immediate medical attention if they experience symptoms such as chest pain, shortness of breath, or a fast heartbeat following vaccination.

The most common side effects reported in clinical trials for both vaccines include injection site reactions like pain and swelling, as well as general side effects such as fatigue, headache, muscle pain, chills, and fever. Some fainting and febrile seizures have also been reported. Patients are advised to inform their healthcare providers about any allergies, previous severe reactions to COVID-19 vaccines, a history of myocarditis or pericarditis, bleeding disorders, fever, or an immunocompromised state. Patients who are pregnant, breastfeeding, or have recently received another COVID-19 vaccine should also consult their provider before receiving a dose.