Sanofi, GlaxoSmithKline Start Phase 1/2 Trial of Covid-19 Vaccine Candidate
September 03 2020 - 2:01AM
Dow Jones News
By Pietro Lombardi
Sanofi SA and GlaxoSmithKline PLC are enrolling more than 400
people to start the Phase 1/2 clinical trial of their Covid-19
vaccine candidate, with a goal of moving to Phase 3 by the end of
the year and requesting regulatory approval in the first half of
next year.
The French pharmaceutical major said Thursday that the companies
are targeting the production of up to a billion doses next
year.
Preclinical studies were promising, it said.
The Phase 1/2 trial is a randomized, double blind and
placebo-controlled trial which will evaluate the safety,
tolerability and immune response of the Covid-19 vaccine candidate.
First results are expected in early December, which would allow the
companies to kick off a Phase 3 trial in December.
For the current trials, 440 people are being enrolled.
The U.S. Department of Health and Human Services is supporting
the development of the vaccine, including with funding.
Write to Pietro Lombardi at pietro.lombardi@dowjones.com;
@pietrolombard10
(END) Dow Jones Newswires
September 03, 2020 01:46 ET (05:46 GMT)
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