Moderna said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for its updated Covid-19 vaccine, Spikevax, in the European Union (EU).
Spikevax is said to have spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunisation to prevent Covid-19 produced by SARS-CoV-2 in patients of age six months and above.
Following the CHMP’s positive opinion, the European Commission will decide whether to approve the modified Covid-19 vaccine from Moderna for use in the fall and winter of 2023.
The positive opinion follows the advice of authorities and international public health organisations to create monovalent XBB.1.5 Covid-19 vaccines for immunisation programmes in 2023.
Moderna has produced clinical results for its monovalent XBB.1.5 vaccine candidate, which demonstrates an immune response against XBB.1.5, XBB.1.16, and XBB.2.3.2 sublineages as well as variations BA.2.86, EG.5, and FL.1.5.1.
Moderna CEO Stéphane Bancel said: “The CHMP’s positive recommendation for our updated Covid-19 vaccine is a key milestone given we see increasing transmission of SARS-CoV-2 across Europe.
“Our updated Covid-19 vaccine generates a strong human immune response against circulating variants, including BA.2.86, EG.5, and FL.1.5.1, and will be a critical tool for protection.
“We are working with governments across Europe to include our updated Covid-19 vaccine in national vaccination programmes, to ensure a diversified portfolio that provides vaccine choice and access to single dose vial formats, which can limit waste.”
Moderna has thus far submitted regulatory applications around the world and secured authorisations for its updated Covid-19 vaccine in the US, Canada, Japan, and Taiwan.
Spikevax has now become the second shot to be used in the EU countries’ vaccination campaign this autumn, Reuters reported.
Earlier this month, the European Commission approved an updated Covid-19 vaccine from Pfizer and its German partner BioNtech for the same population. The approval was based on the positive opinion from the CHMP.
