Pfizer, BioNTech's Covid-19 Vaccine Candidates Get Fast-Track Designation
July 13 2020 - 7:42AM
Dow Jones News
By Dave Sebastian
Pfizer Inc. and BioNTech SE said two of their four Covid-19
investigational vaccine candidates got fast-track designation from
the U.S. Food and Drug Administration that will expedite
review.
The companies said the candidates, BNT162b1 and BNT 162b2, are
the most advanced among the BNT162 program that is in early
clinical studies in the U.S. and Germany.
In premarket trading Monday, Pfizer shares rose 1.5% to $34.34,
and BioNTech's ADRs were up 5.1% at $73.99.
Researchers earlier this month said Pfizer and BioNTech's
vaccine candidate showed promising signs of working in an
early-stage study. Healthy adult volunteers given the vaccine
candidate had higher levels of antibodies four weeks after being
vaccinated and seven days after getting a second dose, compared
with the antibody levels in recovered Covid-19 patients who didn't
get the shots, the researchers reported.
The companies said they expect a later-stage study as soon as
later this month and anticipate enrolling up to 30,000
participants. If the studies are successful and the vaccine gets
regulatory approval, Pfizer and BioNTech said they expect to make
up to 100 million doses by the end of the year and more than 1.2
billion doses by the end of 2021.
The companies expect early data from the German study of
BNT162b1 to be released this month.
About 13 million people worldwide have contracted Covid-19, and
about 4.4% of those people have died, according to data collected
by Johns Hopkins University.
Write to Dave Sebastian at dave.sebastian@wsj.com
(END) Dow Jones Newswires
July 13, 2020 07:27 ET (11:27 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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