20/06/2022 (Agence Europe) – The European Medicines Agency (EMA) has started a rolling review of a Spikevax vaccine against SARS-CoV-2 adapted to specific variants of the coronavirus (the original strain and the variant of concern Omicron or B.1.1.529). The rolling review of this messenger RNA vaccine developed by Moderna will initially focus on chemistry, manufacturing and control aspects as well as non-clinical data. The final composition of the vaccine will be linked to the recommendations of the World Health Organization (WHO), the International Coalition of Medicines Regulatory Authorities (ICMRA) and other regulatory bodies, including the EMA. The EMA had previously announced the evaluation of a suitable vaccine developed by Pfizer and BioNTech (see EUROPE 12974/7). (EV)