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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided positive opinion for Moderna's updated Covid-19 vaccine, Spikevax, which specifically targets the SARS-CoV-2 variant JN.1.
The EMA CHMP recommendation for the Covid-19 vaccine is grounded in a comprehensive evaluation, including manufacturing and preclinical data. Credit: Mufid Majnun from Pixabay.
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This recommendation will aid in the potential authorisation of the vaccine for use in individuals aged six months and older to prevent Covid-19 in the upcoming 2024-2025 autumn/winter season.
The CHMP’s positive opinion is grounded in a comprehensive evaluation, including manufacturing and preclinical data, as well as earlier clinical, non-clinical, and real-world evidence confirming the vaccine’s efficacy and safety.
The recommendation follows guidance from the EMA’s Emergency Task Force (ETF) issued in April this year, which advised updating Covid-19 vaccines to combat the JN.1 family of Omicron subvariants for the upcoming vaccination campaign.
The EMA validated the ETF’s guidance in July, leading to the current CHMP endorsement.
Following this development, the European Commission is expected to make a final decision on the vaccine’s authorisation.
Moderna’s vaccine targeting the JN.1 variant has already been approved in Taiwan, Japan and the UK, with a separate formulation for the KP.2 variant receiving approval in the US.
Regulatory reviews for Moderna’s updated vaccines targeting either the KP.2 or JN.1 variants are ongoing in various jurisdictions.
In addition to these approvals, Moderna is actively participating in the European Union’s procurement process for mRNA Covid-19 vaccines, led by the European Commission’s Health Emergency Preparedness and Response Authority (HERA).
Moderna CEO Stéphane Bancel said: “The CHMP’s positive recommendation for our updated Covid-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 is a key milestone, demonstrating our commitment to protecting citizens across the European Union.
“As respiratory diseases increase during the winter months, it is crucial for people to protect themselves by getting vaccinated with an updated Covid-19 vaccine that provides enhanced neutralising antibody responses to JN.1 and its descendant lineages.”
