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EU regulator starts review on Pfizer-BioNTech’s omicron-adapted vaccine

EU regulator starts review on Pfizer-BioNTech’s omicron-adapted vaccine

The new version of the BioNTech/Pfizer coronavirus vaccine, modified for the most recent omicron subvariant, is currently the subject of a rolling review, according to a statement from the European Medicines Agency (EMA) on Tuesday.
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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