The European Medicines Agency Ema has started the review procedure continues for a ‘2 in 1’ version of Spikevax *, the Covid vaccine from Modern, adapted to offer better protection against specific variants of Sars-CoV-2. This was announced by the EU regulatory body, specifying that the rolling review concerns a “bivalent vaccine” or “targeted at two strains” of the pandemic coronavirus: “The original strain and the Omicron variant“.
The cyclical review – explains the EMA in a note – will initially focus on preclinical laboratory data and information relating to the production of the vaccine (chemistry, manufacturing and controls, Cmc). As the US company progresses in the development of the bivalent product, the agency will receive more data, including data on the immune response against the parent strain of Sars-CoV-2 and the variant of concern Omicron. The rolling review will allow the EMA to evaluate the information step by step, as soon as it becomes available. The evaluation will continue as long as there is sufficient data for an official authorization application, which the regulatory body will notify.
The composition of adapted Covid vaccines will ultimately depend on the recommendations of public health authorities and the World Health Organization (WHO), as well as the considerations of regulatory bodies such as EMA itself and other members of the International Coalition of Medicines Regulatory Authorities (Icmra ). These organisms are working closely together to determine the appropriate strains for adapted vaccines, the EMA reiterates.
The launch of this cyclical review – he concludes – is one of the ways in which the EU authorities are working to ensure that EU member states have timely access to updated Covid vaccines, which they may need to combat Sars-CoV variants. -2 current and emerging.
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