According to a story in the Welt Am Sonntag (WAS) newspaper, the launch of the vaccine developed by German pharmaceutical company BioNTech for the Omicron coronavirus type may be postponed because of a dispute with the regulator over the licencing procedure.
Ugur Sahin, the chief executive of BioNTech, does not intend to submit any more clinical trials, WAS said, citing the Financial Times. However, the regulator should still determine by the end of June whether or not to authorise the new vaccine.
According to Sahin, who was quoted by WAS, the rationale for this was that the new COVID-19 vaccine could be given in three months if the approval “should go through the same regulatory process as other flu vaccinations.”
Klaus Cichutek, the director of the Paul Ehrlich Institute (PEI), the German medical watchdog, told the newspaper that there was no justification to take a chance by skipping the regular regulatory procedure while making arrangements for the upcoming pandemic wave.
The PEI chief informed WAS that “Mr. Sahin insists that only animal evidence be given for approval of alternative vaccinations,” adding that while this may be done in an emergency, there was none at the time.
Vaccine manufacturers may be granted first licences for improved COVID-19 vaccinations in September, as per PEI and the European Medicines Agency (EMA), if the vaccine manufacturers demonstrate in human trials that they are superior to current vaccines.