BioNTech to Seek Covid-Vaccine Regulatory Clearance in 2020

BioNTech of Germany expects to seek regulatory clearance for a covid-19 vaccine this year, a media report says.
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BioNTech  (BNTX) - Get Report shares rose after the German biopharmaceutical company’s chief executive said that it and partner Pfizer PFE will likely seek regulatory clearance of their coronavirus vaccine candidate by year-end.

BioNTech, which originally focused on cancer, is one of 17 companies that have begun human trials on coronavirus vaccines around the world, The Wall Street Journal reports. 

The company was founded in 2008 by the CEO, Ugur Sahin, and his wife, Özlem Türeci. Both are physicians.

BioNTech hopes to begin Phase III trials, the final step in testing, by the end of July, The Journal reports. 

The company expects to complete that stage by year-end, allowing it to query global regulators for clearance to market the drug.

BioNTech’s tieup with the New York drug giant Pfizer applies to the U.S. It has other partnerships around the world, such as one with China’s Shanghai Fosun Pharmaceutical, The Journal reports. 

Pfizer holds about a 1% stake in BioNTech and collaborates in developing the new vaccine, the Journal reported.

BioNTech can have several hundred million doses of its vaccine made prior to regulatory approval, and over 1 billion by the end of next year, Sahin told The Journal.

Still, given the coronavirus’s global rage, about a decade would be needed to provide worldwide immunity to covid-19, even if several companies launched a vaccine simultaneously, Sahin said.

More than 555,000 people have died worldwide from the coronavirus, according to Johns Hopkins University.

BioNTech American depositary receipts recently traded at $67.61, up 3.1%, and nearly doubled year to date. Pfizer shares at last check traded at $33.55, up 0.3%.