Moderna Inc. (NASDAQ:MRNA) on Tuesday released preliminary immunogenicity data for the 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.
The update follows a media report on Friday that Trump administration health officials intend to link the vaccines to 25 child deaths. This assertion is reportedly based on unverified submissions to the Vaccine Adverse Event Reporting System.
The data from an ongoing Phase 4 trial evaluating the safety, tolerability, and immunogenicity of the 2025-2026 formula of Spikevax showed, on average, greater than an 8-fold increase in neutralizing antibodies against the LP.8.1 variant in individuals 12 through 64 years with at least one underlying condition and all adults 65 years of age and older.
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The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified.
Recent surveillance data from the U.S. Centers for Disease Control and Prevention (CDC) shows the U.S. wastewater viral activity for COVID-19 is high, and LP.8.1 and its familial strains, XFG and NB.1.8.1, continue to dominate.
The preliminary analysis confirms Moderna’s updated COVID-19 vaccine is a match to the currently top circulating strains in the U.S.
These clinical findings also reinforce preclinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the 2025-2026 formula of Spikevax, which is approved by the FDA for individuals 6 months through 64 years who are at high risk for COVID-19 infection and all adults 65 years of age and older.
Recently, Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) reported topline Phase 3 results for their LP.8.1-adapted monovalent COMIRNATY (2025-2026 Formula) in high-risk adults.
Among 100 participants, the vaccine generated a ≥4-fold increase in neutralizing antibodies against the LP.8.1 sublineage within 14 days, with a safety profile consistent with prior formulations. All participants had previously received the KP.2-adapted vaccine at least six months earlier.
In August, Health and Human Services Secretary Robert F. Kennedy Jr. announced on social media that the emergency use authorizations for COVID-19 vaccines have now been rescinded.
MRNA Price Action: Moderna shares were up 2.85% at $24.56 at the time of publication on Tuesday. The stock is trading near its 52-week low of $23.15, according to Benzinga Pro data.
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