EU approves Moderna’s updated COVID-19 vaccine for 2025-2026 season

CAMBRIDGE - The European Commission has granted marketing authorization for Moderna’s (NASDAQ:MRNA) updated COVID-19 vaccine Spikevax targeting the SARS-CoV-2 variant LP.8.1, the company announced Wednesday. The $12.4 billion biotech company, which InvestingPro analysis shows is currently undervalued, has seen its shares decline over 21% year-to-date.

The authorization applies to individuals six months of age and older across all 27 EU member states, plus Iceland, Liechtenstein and Norway. The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Despite recent challenges reflected in its weak gross profit margins, InvestingPro data shows Moderna maintains a strong balance sheet with more cash than debt.

"We appreciate the EC’s timely review and are pleased that our updated COVID-19 vaccine will be available to protect the public against currently circulating strains," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release statement.

The updated vaccine formulation aligns with guidance from global health authorities that recommended COVID-19 vaccines target the LP.8.1 strain for the 2025-2026 vaccination season.

According to the company, doses will be available for eligible populations ahead of the upcoming vaccination season. The most common side effects reported for Moderna’s COVID-19 vaccines include injection site pain, headache, fatigue, myalgia and chills.

Moderna noted that additional regulatory applications for its updated COVID-19 vaccines targeting LP.8.1 are under review in other countries around the world.

In other recent news, Moderna has achieved significant regulatory milestones and advancements in its vaccine portfolio. The U.S. Food and Drug Administration (FDA) granted full approval to Moderna’s COVID-19 vaccine, Spikevax, for children aged 6 months to 11 years who are at increased risk, expanding its market reach beyond the previous Emergency Use Authorization. This approval follows the FDA’s earlier authorization of Moderna’s mNEXSPIKE vaccine for adults 65 and older and those aged 12-64 with risk factors. Brookline Capital Markets has reiterated a Buy rating for Moderna, setting a price target of $198.00, reflecting confidence following the FDA’s recent approval.

In another development, Pfizer and BioNTech have appealed a UK ruling that found their COVID-19 vaccine infringed on one of Moderna’s patents. Additionally, Moderna’s flu vaccine program has shown positive Phase III results, leading William Blair to maintain its Market Perform rating for the company. The data from this program has demonstrated superiority over existing flu vaccines, potentially boosting demand for Moderna’s mRNA-1010 vaccine. These developments underscore Moderna’s expanding influence in the vaccine market.

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