BioNTtech in Conflict with Regulator Over New COVID Vaccine Approval - WAS

The launch of German drugmaker BioNTech’s vaccine adapted to the Omicron coronavirus variant may be delayed due to a disagreement with the regulator over the approval process, the Welt Am Sonntag (WAS) newspaper reported on Saturday.

The regulator should still decide by the end of June whether or not to approve the new vaccine but BioNTech Chief Executive Ugur Sahin does not plan to submit any new clinical trials, WAS reported, citing the Financial Times.

The reason for this was that the approval “should go through the same regulatory process as ordinary flu vaccines”, which would allow the new COVID-19 vaccine to be delivered in three months, WAS cited Sahin as saying.

The head of the German medical regulator, Paul Ehrlich Institute (PEI), Klaus Cichutek, told the newspaper there was no reason to risk bypassing the standard regulatory process during preparations for the next pandemic wave.

“Mr. Sahin demands that only animal data be submitted for approval of variant vaccines,” the PEI chief told WAS, adding this could be done in an emergency but there was no emergency at the moment.

According to the PEI and the European Medicines Agency (EMA), first approvals for updated COVID-19 vaccines could be given in September if the drugmakers prove their superiority over existing vaccines in human trials, WAS reported.

BERLIN (Reuters)