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The European Medicines Agency has reviewed Biontech and Moderna applications and recommended their vaccines adapted to Omicron subline BA.1.
The European Medicines Agency Ema has approved the use of more advanced corona vaccines. Ema announced that the recommendation applies to over 12-year-olds who already have primary immunization. The EU Commission must now formally approve Ema’s decision.
The Ema Committee for Medicinal Products for Human Use (CHMP) meeting was about applications from pharmaceutical companies Biontech/Pfizer and U.S.-based Moderna for approval of so-called bivalent vaccines. They are intended to protect the original Sars-CoV-2 and the omicron subline BA.1. Currently, the omicron sublines BA.4 and BA.5 are circulating. Still, experts believe the adapted vaccines will also be more effective against the dominant omicron sublines.
How valid is the fourth vaccination?
Studies have shown that the vaccines “Comirnaty Original/Omicron BA.1” (Biontech/Pfizer) and “Spikevax Bivalent Original/Omicron BA.1” (Moderna) could induce a robust immune response in already vaccinated people against the Omikron variant BA.1 and the wild type of coronavirus, the Ema statement said. The side effects of the adapted vaccines are comparable to those of the original vaccines, it said. They are usually mild, and of short duration, it said. “Adapted vaccines can extend protection against different virus variants and contribute to optimal protection against covid-19 as the virus continues to evolve,” the drug agency wrote.
In mid-August, the British Medicines Agency gave the green light for Moderna’s so-called bivalent corona vaccine, which, like the Biontech vaccine, is effective against both the original coronavirus strain and the omicron subvariant BA.1. In the U.S., the Food and Drug Administration (FDA) on Wednesday approved two adapted vaccines targeting the BA.4 and BA.5 subtypes from Moderna and from Biontech/Pfizer via emergency approval. The manufacturers have also submitted a marketing authorization for these vaccines in the EU, but no decision has been made. Ema stated that the applications are currently under review. The Federal Ministry of Health expects these vaccines to be available in a few weeks.
- source: spiegel.de/picture: pixabay.com
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