Moderna’s LP.8.1-adapted COVID-19 vaccine has been recommended by the European Medicines Agency (EMA)’s human medicines committee.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the updated formulation of Spikevax be approved to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six months and older.
The adaption follows recent guidance from various global health authorities, including the EMA’s Emergency Task Force (ETF), which recommended that vaccines for the 2025-2026 vaccination season target the LP.8.1 strain.
LP.8.1 derives from the JN.1 descendent lineage KP.1.1.3, with the earliest sample collected at the beginning of July 2024. Its spread has been increasing at a faster rate than other variants since February this year and it is now showing the largest prevalence globally, according to the ETF’s guidance published in May.
The CHMP’s decision on Moderna’s new formulation was supported by a mix of manufacturing and preclinical data, alongside clinical, non-clinical and real-world evidence on the company’s COVID-19 vaccines.
Moderna’s chief executive officer, Stéphane Bancel, said: “The CHMP’s positive opinion on our updated COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1 is an important milestone in our ongoing effort to protect people across the EU.
“COVID-19 continues to place a significant burden on vulnerable populations and healthcare systems. Updated vaccines can be an important tool for protecting individuals and societies.”
The European Commission will now review the CHMP’s recommendation as it makes a final decision on the vaccine for the 2025-2026 season.
Vaccines targeting respiratory illnesses are a key focus area for Moderna, which presented positive results from a late-stage study of its seasonal influenza (flu) vaccine candidate mRNA-1010 earlier this month. It said it is planning to present full results from the trial at an upcoming medical conference and will “engage with regulators on filing submissions for mRNA-1010”.
The company is also developing a combination vaccine for COVID-19 and flu, which could alleviate the impact of both viruses while potentially simplifying immunisation practices for healthcare providers and patients.