EMA recommends approval of adapted vaccine targeting Omicron variants

13 September 2022

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2.

This vaccine, Comirnaty Original (Omicron BA.4-5), is an adapted version of the mRNA COVID-19 vaccine Comirnaty from Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX). The jab is for use in people aged 12 years and above who have received at least a primary course of vaccination against COVID-19.

The recommendation will further extend the arsenal of available vaccines to protect people against COVID-19 as the pandemic continues and new waves of infections are anticipated in the cold season, according to the EMA. Assessment of the available data on this adapted vaccine will enable its deployment in European countries' autumn vaccination campaigns.

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