The European Medicines Agency has recommended approval of a bivalent vaccine to protect against two sub-variants of the SARS-CoV-2 virus. The authorisation is for an updated booster shot developed by Pfizer Inc and BioNTech SE to protect people against the omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. The new vaccine is to be used in people aged 12 years and older who have received at least a primary course of vaccination to prevent Covid-19.
The EMA recommendation, announced on 12 September, comes less than a month after the US Food and Drug Administration gave an emergency use authorisation for the same bivalent vaccine and a similar one produced by Moderna Inc. Moderna is expected to seek European authorisation for its vaccine before the end of September.
The EMA based its recommendation on clinical data generated from tests of a version of the Pfizer/BioNTech vaccine directed against the omicron subvariant BA.1 as well as investigational vaccines against other variants of concern. The agency’s positive opinion was also based on data on the vaccine’s quality and the process used to manufacture it which confirmed that it met EU standards. In addition, immunogenicity data from laboratory studies provided supportive evidence that the new bivalent vaccine triggered adequate immunity against all of the strains that it targets.
The EMA’s opinion must be confirmed by the European Commission before going on to the market.
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