BioNTech’s and Pfizer’s COVID-19 vaccine Comirnaty has so far been used in the European Union on the basis of conditional marketing authorization. That will change: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended full marketing authorization for the vaccine. The European Commission is now making the final decision on this standard approval.
The final approval for Comirnaty should therefore not be long in coming: „A decision is expected shortly,” reports BioNTech on Friday. This standard approval will include all indications and formulations of Comirnaty that are approved in the European Union, including the bivalent vaccines, according to the Mainz-based biotech company.
However, the news comes as no surprise and has little impact on BioNTech’s share price. In the US pre-market, the biotech stock is currently trading at $142.01, but there is overall pressure on global share prices on today’s big expiry day. BioNTech’s shares (WKN: A2PSR2, ISIN: US09075V1026, Chart ) closed yesterday’s NASDAQ trading at $144.14, down 1.64 percent.