Ema, the European drug agency, today recommended the authorization of Pfizer Biontech’s new bivalent vaccine, also adapted to Omicron 4 and 5, as well as the so-called Wuhan virus. The new adapted Comirnaty vaccine is intended for people aged 12 and above. The position taken by the CHMP, ie the commission that analyzes drug dossiers for approval, has been sent to the European Commission, which will give the final indication, applicable in the various Member States.
Only a few days ago, on the first of September, Ema had authorized the bivalent products adapted to Omicron 1 which in these hours are also starting to be administered in our country. It is difficult to understand the strategies of the company, which will soon be delivering the new vaccines (Aifa’s via libbera is expected this week in Italy). He probably feared that Ema would not approve Omicron 4 and 5 (because there is not yet a specific clinical study of efficacy but only safety and immune response data). So he first requested the green light for the Wuhan / Omicron 1 vaccine. The fact is that Pfizer will soon distribute the new product and there is the possibility that many are waiting for the vaccine to be available, even if according to the experts, vaccines with Omicron 1 already protect against subsequent sub-variants of coronavirs. “This recommendation – writes the agency – will further extend the arsenal of vaccines available to protect people from Covid-19 while the pandemic continues and new waves of infections are expected in the cold season”.
After the indication of the European Commission, Aifa will have to give its approval to use by us too, which will happen this week. Then the deliveries of the company can start. The director of Aifa, Nicola Magrini, said that “the new vaccine will be available in 2-3 weeks. It has been approved with the same criteria on the basis of which it was approved in the United States, ie only with data on animals and which it means that a new approval technique has been standardized as for the flu vaccination. But the timing remains fundamental: that is, you have to get vaccinated with the vaccine that is currently available “.
Like the other one, the new vaccine is suitable for those aged 12 and over and who have already undergone a vaccination course. It can therefore only be used as a booster, in the form of a third or fourth dose. For its decision, the CHMP “took into account all available data on Cominarty and its updated vaccines, including the recently authorized bivalent Wuhan / Omicron 1, as well as on investigational vaccines against other variants.