Sanofi-GSK Covid-19 Vaccine Set for Large-Scale Trials After Positive Results
By Jenny Strasburg
Sanofi SA and GlaxoSmithKline PLC said their Covid-19 vaccine
candidate showed positive interim trial results and is expected to
move into large-scale human trials soon, putting the long-delayed
shot on track for potential regulatory approval later this
France's Sanofi and GSK, based in the U.K., said Monday the
two-dose shot produced strong antibody responses in phase-two
trials with 722 volunteers. A single dose generated high levels of
antibodies in volunteers with evidence of prior Covid-19 infection,
the companies said, suggesting the vaccine could be useful as a
booster for people already vaccinated with other shots.
Now the companies plan to begin pivotal phase-three trials,
which will involve more than 35,000 people, and use two
formulations: one targeting the original Covid-19 strain that
circulated last year, and the second aimed at the strain that was
originally detected in South Africa.
Sanofi and GSK fell behind other vaccine makers last year when
they abandoned previous human trials after a miscalculation in the
manufacturing process resulted in erroneously lower doses.
Their partnership combines a Sanofi-owned antigen -- a protein
from the coronavirus that triggers an immune response -- and a
GSK-owned adjuvant, a molecule used in some vaccines to boost the
level of protection. The mis-dosing required the vaccine to be
reformulated for new clinical trials.
The vaccine's long development delay raised questions among
investors and health officials about the shot's potential role in
fighting the pandemic, given the availability of other vaccines
already proven effective. U.S. and European officials previously
expected the shot to play a core role in vaccination campaigns by
early this year.
Sanofi and GSK said Monday they see a need for additional
vaccines to fight new virus variants and provide boosters to renew
protection from prior vaccinations.
One challenge for the companies might be recruiting tens of
thousands of trial volunteers who haven't already been vaccinated,
with an adequate mix of ages, geographic locations and other
factors that regulators consider when evaluating large-scale trial
results, analysts at UBS said in a research note Monday.
The drugmakers didn't provide detailed efficacy results from the
smaller-scale trails, but said volunteers in all age groups,
ranging from 18 to 95 years old, showed disease-fighting antibody
levels comparable to those generated by natural Covid-19 infection.
The companies said the full interim trial results will be reviewed
by independent researchers and published.
The vaccine can be stored using normal refrigeration, an
advantage compared with ultracold temperature requirements of some
GSK is also working with German biotechnology company CureVac NV
to help manufacture a vaccine that uses a different technology
called messenger RNA.
GSK is also helping manufacture doses of a vaccine by U.S.
company Novavax Inc. that is in the final stage of testing.
Additionally, GSK is collaborating with Canada's Medicago Inc.,
a biotech firm partly owned by Marlboro cigarette maker Philip
Morris International Inc., on a plant-derived Covid-19 vaccine that
is in late-stage trials.
Write to Jenny Strasburg at email@example.com
(END) Dow Jones Newswires
May 17, 2021 08:16 ET (12:16 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Historical Stock Chart
From Jun 2021 to Jul 2021
Historical Stock Chart
From Jul 2020 to Jul 2021