The European Medicines Agency (EMA) is currently investigating one of the current Omikron variants BA.4 and BA.5 adapted corona vaccine from BioNTech/Pfizer. This was done as part of a rolling review process, a spokesman for the authority said on request. Results are already evaluated if complete study data are not yet available and no approval of the vaccine has yet been applied for.
The spokesman continued to date with an application for admission from Biontech/Pfizer for the adapted vaccine. The EMA will evaluate the application with a view to the quickest possible decision in autumn. So far, however, there is no clinical study on the adapted vaccine. It is also unclear whether this is necessary for approval.
The German pharmaceutical company BioNTech and its US partner Pfizer had stated that the adapted vaccine could be delivered as early as September, provided that the necessary approvals are available by then. BioNTech/Pfizer has already received emergency approval for the an BA from the US Food and Drug Administration (FDA).4 and BA.5 adapted corona vaccine has been applied for.
In addition, the EMA announced an extraordinary meeting of its committee for human medicinal products (CHMP) for deciding on applications from Biontech/Pfizer and the US company Moderna for approval of a vaccine adapted to subtype BA.1. This variant no longer plays a role in Germany. However, the hope is that this vaccine also works better against the currently circulating variants.
