EU authority examines variant vaccine from Pfizer/Biontech

drug
EU authority examines variant vaccine from Pfizer/Biontech

Corona vaccine from Biontech/Pfizer

Ampoules with the Corona vaccine from Biontech/Pfizer. Photo: Robert Michael/dpa-Zentralbild/dpa/Symbolbild

© dpa-infocom GmbH

The EU medicines agency EMA has initiated the rapid testing procedure for a corona vaccine from the manufacturers Pfizer and Biontech that has been adapted to virus variants. The vaccine is intended to provide more targeted protection against the omicron variant of the virus, for example, as the EMA announced in Amsterdam on Wednesday. So far, no vaccine has been approved in the EU that also targets variants of the corona virus.

The EU medicines agency EMA has initiated the rapid testing procedure for a corona vaccine from the manufacturers Pfizer and Biontech that has been adapted to virus variants. The vaccine is intended to provide more targeted protection against the omicron variant of the virus, for example, as the EMA announced in Amsterdam on Wednesday. So far, no vaccine has been approved in the EU that also targets variants of the corona virus.

The rapid procedure is intended to ensure that the health authorities of the EU countries have adapted vaccines in good time before a possible new wave of infections in autumn. Booster vaccinations could then target current variants of the virus.

The EMA said that data on chemical composition, production and controls would first be checked. As soon as the manufacturers submitted clinical data, the experts would also evaluate the effectiveness. According to the EMA, details on the specific virus variants against which the vaccine is intended to protect are not yet available.

According to the accelerated review process, data from tests and studies are continuously evaluated, even if all the data is not yet available and no application for approval has yet been submitted. It is not known how long this will take.

The American manufacturer Pfizer and its German partner Biontech also want to start the approval process with the US drug authority FDA in the next few weeks.

On June 8, the US company Moderna presented the first data on the effectiveness of its adapted corona vaccine “mRNA-1273.214”. It is a combination of the original Spikevax vaccine and a vaccine candidate tailored to Omicron. The 437 subjects who had received the new preparation as a second booster had significantly more neutralizing antibodies after one month than after a booster vaccination with the conventional preparation, especially against Omikron. Moderna had announced that it would submit the data to the regulatory authorities in the coming weeks.

dpa

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