The European Medicines Agency (EMA) is currently testing a Corona vaccine from Biontech/Pfizer that has been adapted to the current Omicron variants BA.4 and BA.5. This is done as part of a rolling review process, a spokesman for the authority said on request. Results are already evaluated if no complete study data is available and approval of the vaccine has not yet been applied for.
The spokesman said that an application for approval from Biontech/Pfizer for the adapted vaccine was expected shortly. The EMA will evaluate the application with a view to making a decision as quickly as possible in the autumn. So far, however, there has been 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 said that the adapted vaccine could be delivered as early as September, provided the necessary approvals have been obtained by then. Biontech/Pfizer has already applied to the US Food and Drug Administration (FDA) for emergency use authorization for the corona vaccine adapted to BA.4 and BA.5.
In addition, the EMA announced an extraordinary meeting of its Committee for Medicinal Products for Human Use (CHMP) on September 1st to decide on applications from Biontech/Pfizer and the US company Moderna for approval of a vaccine adapted to the BA.1 subtype. In Germany, this variant no longer plays a role. However, the hope is that this vaccine will also work better against the variants currently in circulation. (dpa/dam)