Sanofi and Britain's GSK said a global Phase III trial would start
in the coming weeks and involve more than 35,000 adults, with the
hope of seeing the vaccine approved by the fourth quarter after
having initially targeted the first half of this year before a
setback.
Sanofi and GSK last December were forced to restart their trial when
the vaccine showed a low immune response in older adults as a result
of a weak antigen formulation.
Sanofi and GSK shares were little changed in early trading.
"The Phase II interim results showed 95% to 100% seroconversion
following a second injection in all age groups and across all doses,
with acceptable tolerability and no safety concerns," Sanofi said.
Seroconversion refers to the vaccine's ability to prompt the body to
produce antibodies against the coronavirus, as measured by blood
readings. Later mass trials will be based on real infections.
"Interestingly, we also observed that our vaccine generated a higher
antibody response in those with previous COVID-19 infection, we are
analysing this further as it may suggest our vaccine could serve as
a potential booster, regardless of what vaccine someone may have
received (beforehand)," Su-Peing Ng, Sanofi's global head of medical
for vaccines, told reporters.
Ng said the vaccine had not been tested against so-called variants
in the Phase II trial but that the Phase III study would be
assessing it against various strains including a virus lineage known
as B.1.351 first detected in South Africa.
But Sanofi, Ng said, has conducted parallel studies evaluating its
vaccines against variants, with results expected to be published
soon.
GSK and Sanofi's vaccine candidate uses the same technology as one
of Sanofi's seasonal influenza vaccines. It will be coupled with an
adjuvant, a substance that acts as a booster to the shot, made by
GSK.
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'QUITE A POTENTIAL'
Some 162.75 million people have been reported to
be infected by the coronavirus in more than 210
countries and territories since the first cases
were identified in China in December 2019, while
economies have taken a hit and restrictions have
turned daily life upside down.
The United States and Europe have embarked on mass vaccinations
programmes in the past months, raising hopes of a gradual reopening,
although the virus is still in circulation in many regions, with
variants causing concern.
Last month, the European Union executive's President Ursula von der
Leyen said protein-based COVID-19 vaccines such as the one developed
by Sanofi and GSK offered "quite a potential", a positive signal as
the bloc develops its purchasing strategy for the next two years.
Sanofi's shot, however, even if approved, will come long after ones
from Pfizer/BioNTech and Moderna, which have produced efficacy
results of more than 90%.
So far, Sanofi has purchasing agreements with the United States, the
EU, Britain and Canada, as well as with the World Health
Organization-backed COVAX facility.
The company has pledged to help other drugmakers this year, striking
"fill and finish" deals for vaccines made by Pfizer/BioNTech,
Moderna and Johnson & Johnson.
In addition to its vaccine project in collaboration with GSK, Sanofi
is working on a mRNA candidate with U.S. company Translate Bio for
which it has started clinical trials.
(Reporting by Matthias Blamont; editing by Louise Heavens and Jason
Neely)
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