Two experimental COVID-19 vaccine jointly developed by German Biotech firm BioNTech and US pharmaceutical gaint Pfizer have received "fast track" designation from the US drug regulator FDA, Reuters quoted the companies as saying. The candidates, BNT162b1 and BNT162b2, are the most advanced of the at least four vaccines being assessed by the companies in ongoing trials in the United States and Germany.
The companies said BNT162b1 showed potential against the virus and was found to be well tolerated in early-stage human trials. Early data from the German trial of BNT162b1 “are expected to be released in July,” the two said.
Pfizer and BioNTech earlier this month reported phase 1/2 trial data showing that all trial participants who received 10 micrograms (mcg) or 30 mcg of an mRNA vaccine candidate generated antibodies that were 1.8 times and 2.8 times higher, respectively, than the average of a group of patients who had confirmed prior infections.
If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they expect to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by 2021-end, reuters reported.
The companies said they expect to begin a large trial with up to 30,000 participants as soon as later this month, if they receive regulatory approval.
The fast track status by the Food and Drug Administration is granted to speed up the review of new drugs and vaccines that show the potential to address unmet medical needs.
Meanwhile, shares of Pfizer Inc. PFE, 2.19% rallied 2.3% and of BioNTech SE BNTX, 9.28% jumped 5.3% in premarket trading Monday, after the companies said two of their vaccine candidates to protect against the virus that causes COVID-19 received Fast Track designation