Moderna has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, specifically targeting the SARS-CoV-2 variant LP.8.1. The submission follows FDA guidance recommending that COVID-19 vaccines be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant.
The pharmaceutical company's latest application continues its ongoing efforts to adapt COVID-19 vaccines to address evolving variants of the virus. If approved, the new formula would be indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older.
Targeting Emerging Variants
The LP.8.1 variant belongs to the JN.1 lineage of SARS-CoV-2, which has become increasingly prevalent in recent months. By focusing on this specific variant, Moderna aims to provide more targeted protection against currently circulating strains of the virus.
"Our submission aligns with the FDA's recommendation to update COVID-19 vaccines to better match circulating variants," a Moderna representative stated. "This approach follows the established model used for seasonal influenza vaccines, where formulations are regularly updated to address the most prevalent strains."
Safety Profile and Considerations
The safety profile for the new formula is expected to be consistent with previous versions of Spikevax. Healthcare providers administering the vaccine will need to continue monitoring for potential adverse reactions, including rare cases of myocarditis and pericarditis, which have been observed particularly in males 18 through 24 years of age within the first week following vaccination.
Common adverse reactions reported in clinical trials of previous Spikevax formulations included injection site pain, headache, fatigue, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, injection site swelling, erythema, and fever.
mRNA Platform Adaptability
Moderna's ability to rapidly develop updated vaccine formulations highlights the flexibility of its mRNA technology platform. Unlike traditional vaccine development, which can take years, mRNA vaccines can be redesigned relatively quickly to target new viral variants.
"The mRNA platform allows us to respond efficiently to the evolving nature of SARS-CoV-2," explained a senior scientist at Moderna. "By updating the vaccine to target the LP.8.1 variant, we're leveraging the adaptability of our technology to address the virus as it changes."
Regulatory Timeline
While Moderna has submitted its application, the FDA will now review the data before making a decision on authorization. The timing of this submission suggests Moderna is preparing for potential distribution ahead of the 2025-2026 respiratory virus season.
If authorized, the updated vaccine would be available for healthcare providers to administer to eligible individuals as part of ongoing COVID-19 immunization efforts. The company has not yet disclosed production volumes or distribution timelines, which would likely follow FDA authorization.
Evolving Vaccination Strategy
The submission of this updated formula reflects the evolving approach to COVID-19 vaccination. As the virus continues to mutate, vaccine manufacturers are adapting their products to maintain effectiveness against circulating strains.
Public health experts note that regular updates to COVID-19 vaccines may become standard practice, similar to annual influenza vaccine updates. This approach acknowledges the endemic nature of SARS-CoV-2 and the need for ongoing protection against the virus.
Broader Portfolio Development
Moderna continues to expand its portfolio beyond COVID-19 vaccines. The company is leveraging its mRNA platform to develop therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, and autoimmune conditions.
This broader development strategy positions Moderna as more than just a COVID-19 vaccine manufacturer, with multiple candidates in various stages of clinical development across several therapeutic areas.
As the regulatory review process unfolds, healthcare providers and potential vaccine recipients will await further information on the effectiveness of the LP.8.1-targeting formula against current and emerging SARS-CoV-2 variants.
