Biontech and Pfizer have completed their approval application for a corona vaccine adapted to the current Omicron variants BA.4 and BA.5 at the European Medicines Agency EMA.
As the Mainz-based company and its US partner announced on Friday, half of the vaccine candidate consists of the previous vaccine Comirnaty and the other half of a messenger molecule (mRNA) that is tailored to the spike protein of subtypes BA.4/5. Except for this addition, all other components of the vaccine are unchanged.
According to the two manufacturers, pre-clinical data showed that a booster vaccination with the BA.4/5-adapted agent elicited a “strong neutralizing antibody response” against these subtypes as well as against subtypes BA.1/2 and the original wild-type strain. In addition to preclinical, quality and manufacturing data, the application is based on data from a phase 2/3 study of the BA.1 matched vaccine candidate. The companies had already submitted an application for approval for this vaccine candidate in July. BA.1 no longer plays a role in Germany.
The EMA recently announced that the responsible committee wants to decide on the applications from Biontech/Pfizer and the US company Moderna for approval of their vaccines adapted to the subtype BA.1 on September 1st. At the same time, the EMA is already testing the vaccine from Biontech/Pfizer that has been adapted to BA.4/5. Biontech and Pfizer had already applied to the US drug agency FDA for emergency approval for the corona vaccine adapted to BA.4/5 on Monday.
Biontech
