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EMA: Rolling evaluation of Pfizer/BioNTech’s updated coronavirus vaccine begins

The European Medicines Agency (EMA) announced today that it has started the rolling evaluation of a variant-adapted Covid-19 vaccine from Pfizer and BioNTech.

The bivalent (or bivalent) vaccine targets two strains of the SARS-CoV-2 virus that causes Covid-19, the original strain identified in China and Omicron’s BA.4/5 substrains, which are currently behind most cases of disease manifestation.

Rolling evaluation means that the EMA reviews the evidence as it becomes available and the process continues until sufficient data is gathered to officially launch the vaccine.

While existing vaccines continue to offer adequate protection against hospitalization and death, the effectiveness of Covid-19 vaccines has declined as the virus has evolved.

European Union officials are planning to use bivalent vaccines during the autumn vaccination campaign, as most cases in Europe are now linked to the BA.5 variant.

The EMA expects the updated vaccines to be approved in September, but has said it is open to using the vaccines intended for the older BA.1 variant in the autumn vaccination campaign, given that vaccines against the newer BA.4 variants and BA.5 are behind in their clinical development.

Source: Capital

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