Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial
17 Mai 2021 - 7:30AM
Sanofi and GSK COVID-19 vaccine
candidate demonstrates
strong immune
responses across all
adult age groups in Phase
2 trial
- Adjuvanted recombinant COVID-19
vaccine candidate triggered strong neutralizing antibody responses
in all adult age groups
- High immune response after a single
dose in patients with prior infection shows strong booster
potential
- Global Phase 3 study expected to
start in the coming weeks
PARIS and LONDON
– May
17,
2021 – The Sanofi and GSK
adjuvanted recombinant COVID-19 vaccine candidate achieved strong
rates of neutralizing antibody responses, in line with those
measured in people who have recovered from COVID-19, in all adult
age groups in a Phase 2 study with 722 volunteers. A global pivotal
Phase 3 study is expected to start in the coming weeks.
The Phase 2 interim results showed 95% to 100%
seroconversion following a second injection in all age groups (18
to 95 years old) and across all doses, with acceptable tolerability
and with no safety concerns. Overall, the vaccine candidate
elicited strong neutralizing antibody levels that were comparable
to those generated by natural infection, with higher levels
observed in younger adults (18 to 59 years old). After a single
injection, high neutralizing antibody levels were generated in
participants with evidence of prior SARS-CoV-2 infection,
suggesting strong potential for development as a booster
vaccine.
“Our Phase 2 data confirm the potential of this
vaccine to play a role in addressing this ongoing global public
health crisis, as we know multiple vaccines will be needed,
especially as variants continue to emerge and the need for
effective and booster vaccines, which can be stored at normal
temperatures, increases”, said Thomas Triomphe, Executive Vice
President and Global Head of Sanofi Pasteur. “With these favorable
results, we are set to progress to a global Phase 3 efficacy study.
We look forward to generating additional data and working with our
partners around the world to make our vaccine available as quickly
as possible.”
Roger Connor, President of GSK Vaccines added:
“These positive data show the potential of this protein-based
adjuvanted vaccine candidate in the broader context of the
pandemic, including the need to address variants and to provide for
booster doses. We believe that this vaccine candidate can make a
significant contribution to the ongoing fight against COVID-19 and
will move to Phase 3 as soon as possible to meet our goal of making
it available before the end of the year.”
Based on these positive Phase 2 interim results,
the companies plan to initiate a global Phase 3, randomized,
double-blind study with the 10µg dose, in combination with GSK’s
pandemic adjuvant, in the coming weeks. This Phase 3 trial is
expected to enroll more than 35,000 adult participants from a broad
range of countries and will assess the efficacy of two vaccine
formulations including the D614 (Wuhan) and B.1.351 (South African)
variants.
In parallel, the companies intend to conduct
booster studies with various variant formulations in order to
assess the ability of a lower dose of the vaccine to generate a
strong booster response regardless of the initial vaccine platform
received.
Pending positive Phase 3 outcomes and regulatory
reviews, the vaccine is expected to be approved in the fourth
quarter of 2021.
More about the Phase 2
studyThe Phase 2 study interim
results show that the adjuvanted recombinant vaccine candidate
triggered strong immune response amongst adults of all age groups
with 95% to 100% seroconversion rates and neutralizing antibodies
that were comparable to those generated by natural infection. The
high titers observed in the non-naïve population after one dose of
the vaccine candidate also suggest it may have strong potential for
use as a booster vaccine. Full results of the Phase 2 study will be
published in a peer-reviewed journal.
The randomized, double-blind,
multi-center-dose-ranging study was conducted in healthy adults
aged 18 years of age and older, including those with high risk
medical conditions, to evaluate the safety, reactogenicity, and
immunogenicity of two injections given 21 days apart, with 3
antigen dose levels of 5, 10 and 15 µg. Beginning in February 2021,
the study enrolled 722 volunteers in the U.S. and Honduras. It
included equivalent numbers of adults 18 to 59 years and those 60
years and above.
This effort is supported by federal funds from
the Biomedical Advanced Research and Development Authority, part of
the office of the Assistant Secretary for Preparedness and Response
at the U.S. Department of Health and Human Services in
collaboration with the U.S. Department of Defense Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense under Contract # W15QKN-16-9-1002.
About the Sanofi / GSK
partnershipIn the partnership between the two Companies,
Sanofi provides its recombinant antigen and GSK contributes its
pandemic adjuvant, both established vaccine platforms that have
proven successful against influenza. The recombinant technology
combined with GSK’s adjuvant is designed to offer the advantages of
stability at temperatures used for routine vaccines, making it
easily implementable and easier to distribute at a global scale
through existing infrastructures where vaccines are stored at
normal refrigerator temperature. It also offers the potential to
generate high and sustained immune responses, and the potential to
prevent virus transmission.
Shots on goal in the
fight against the COVID-19 pandemicIn addition to the
adjuvanted recombinant protein-based vaccine in collaboration with
GSK, Sanofi is developing a messenger RNA vaccine in partnership
with Translate Bio. In March 2021, Sanofi and Translate Bio
initiated a Phase 1/2 clinical trial of their mRNA COVID-19 vaccine
candidate, in order to assess safety, immune response and
reactogenicity, after preclinical data showed high neutralizing
antibody levels. First results are expected in the third quarter of
2021.
Sanofi is also committed to providing
manufacturing support to other vaccine producers. The company
recently announced it will manufacture up to 200 million doses of
Moderna’s COVID-19 vaccine for the U.S., starting in September
2021. Earlier this year, Sanofi also announced the company will
provide support to BioNTech for 125 million doses for the European
Union. In February, Sanofi said it would support Johnson &
Johnson for the production of its COVID-19 vaccine at a rate of
approximately 12 million doses per month.
In addition to developing its two COVID-19
vaccines, Sanofi is the only company to leverage its manufacturing
capacity and expertise for three different COVID-19 vaccines to
support the global vaccines supply and help combat the
pandemic.
Find out more about our COVID-19 vaccine
candidates.
About GSKGSK is a science-led
global healthcare company with a special purpose: to help people do
more, feel better, live longer. GSK is the leading manufacturer of
vaccines globally. For further information please
visit www.gsk.com.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
Media Relations ContactsAshleigh
KossTel: +1 (908) 205-2572Ashleigh.Koss@sanofi.com Sandrine
GuendoulTel.: +33 (0)6 25 09 14 25MR@sanofi.com Nicolas
KressmannTel.: +1 (732)
532-5318Nicolas.Kressmann@sanofi.com |
Investor Relations Contacts ParisEva
Schaefer-JansenArnaud Delepine Investor Relations
Contacts North AmericaFelix LauscherFara BerkowitzSuzanne
Greco IR main line:Tel.: +33 (0)1 53 77 45
45investor.relations@sanofi.com |
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