Pfizer Inc.'s (PFE) - Get Pfizer Inc. Report coronavirus vaccine development partner, BioNTech SE (BNTX) - Get BioNTech SE Report, said Tuesday that it could file for Emergency Use Approval from the U.S. Food & Drug Administration as early as next week.
Germany-based BioNTech posted a third-quarter loss of €351 million as research and development expenses rose more than three-fold from last year to €227.7 million as its work with Pfizer on a coronavirus vaccine -- known as BNT162b2 -- ramped up over the three months ending in September.
The pair said yesterday that the vaccine candidate reached a 90% efficacy rate in late-stage trials that involved more than 43,000 patients, with Pfizer CEO calling it the 'most significant medical advance of the past 100 years'.
BioNTech said Tuesday that its submission to the U.S. FDA could come as early as the third week of November when the required safety milestone for the drug has been achieved.
“Yesterday’s announcement regarding the first interim analysis from our global Phase 3 trial for our COVID-19 vaccine candidate, BNT162, is a watershed moment for both our company and scientific innovation. These data bring us one step closer to a potential solution for the current global pandemic,” said CEO Ugur Sahin. “We have initiated the first rolling regulatory submission processes for our COVID -19 vaccine program in the EU, the UK and Canada and we are continuing to work with our partners to scale-up production capacity to prepare for a potential global launch of our COVID -19 vaccine if approved."
BioNTech's U.S.-listed shares were marked 6% higher on the Nasdaq in early trading at $110.82 each. Pfizer shares, meanwhile, jumped 1.5% to $39.75 each following yesterday's 7.7% surge.
Pfizer and BioNTech dosed half of their 43,538 trial participants with a placebo, and the other half with their vaccine candidate, on two separate occasions. Of the 94 confirmed cases of COVID-19 that resulted from the blinded trial, the pair said, more than 90% came from the placebo group.
Pfizer said it saw no serious safety concerns from its ongoing trial, the only major study not linked to the U.S. government's 'Operation Warp Speed' program, and expects to have as many as 1.3 billion doses produced next year if and when the drug is ultimately approved by regulators.
Pfizer received 'fast track' designation from the FDA in July based on preliminary data from Phase 1 and Phase 2 studies. Its Phase III trial should be concluded in early December, Pfizer said, with analysis from around 164 infections.
"We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen," said Pfizer CEO Albert Bourla.