Biontech completes application for updated vaccine
Biontech and Pfizer could soon launch a vaccine that could protect against the current Omikron variants BA.4 and BA.5. Now the decision lies with the EMA.
Biontech and Pfizer have completed their application for approval of 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 supplement, all other components of the vaccine 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 had recently announced that on September 1st the competent committee would consider the applications from Biontech/Pfizer and the US company Moderna wants to decide on the approval of their vaccines adapted to the BA.1 subtype. 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.