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EU regulator begins review on BioNTech/Pfizer’s latest coronavirus jab

European Medicine Agency to assess data on ongoing clinical trials of omicron-adapted vaccine

Agnes Szucs  | 09.08.2022 - Update : 10.08.2022
EU regulator begins review on BioNTech/Pfizer’s latest coronavirus jab


The European Medicines Agency (EMA) announced on Tuesday that it has started the rolling review on the new version of the BioNTech/Pfizer’s coronavirus vaccine, adapted to the latest omicron subvariant.

The producers begin clinical trials on the latest version of its Comirnaty jab, a so-called bivalent vaccine, targeting the original strain of the coronavirus and the BA.4/5 Omicron subvariants.

The fast-spreading BA.4 and B.5 subvariants are responsible for most of the coronavirus infections in Europe at the moment.

Under the rolling review procedure, the EU regulator will gather the test results as soon as they are available to speed up the authorization process once trials are over and the pharma companies formally apply for an EU marketing license.

Last month, BioNTech/Pfizer demanded the authorization of another adapted Comirnaty vaccine, developed to protect against the original virus and the BA.1 omicron subvariant.

A clinical study with the involvement of 1,234 people above the age of 56 years proved “substantially higher neutralizing antibody responses against Omicron BA.1 when compared to the companies’ current COVID-19 vaccine,” BioNTech/Pfizer said in June about the slightly older product.

The companies expect to roll out both the adapted vaccines by October.

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