Sanofi and GSK announce positive preliminary booster data for their
COVID-19 vaccine candidate and continuation of Phase 3 trial per
independent Monitoring Board recommendation
Sanofi and GSK announce positive
preliminary booster data for their COVID-19 vaccine candidate and
continuation of Phase 3 trial per independent Monitoring Board
recommendation
- Positive booster data show that neutralizing antibodies
increased across all primary vaccines received (mRNA or adenovirus)
in a 9- to 43-fold range and for all age groups tested, with a good
safety and tolerability profile
- Phase 3 trial continues to accrue number of events needed for
analysis as populations around the world are increasingly exposed
to COVID-19 variants; results expected in Q1, 2022
- Companies intend to file booster data with regulatory
authorities following the Phase 3 results
PARIS – December 15, 2021 -
Sanofi and GSK announced today that a single booster dose of their
recombinant adjuvanted COVID-19 vaccine candidate delivered
consistently strong immune responses. Preliminary results from the
VAT0002 clinical trial investigating the safety and immunogenicity
of the booster showed neutralizing antibodies increased 9- to
43-fold regardless of the primary vaccine received (AstraZeneca,
Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all age
groups tested. The booster was well tolerated, with a safety
profile similar to currently approved COVID-19 vaccines. This is
the most comprehensive booster trial to date to explore boosting
across different vaccine technologies used for primary
vaccination.
The ongoing global Phase 3 trial, VAT0008,
includes regular reviews by an independent Data Safety Monitoring
Board (DSMB). During its last review, the DSMB identified no safety
concerns and recommended the trial to continue into early 2022 to
accrue more data.
Regulatory authorities require Phase 3 efficacy
to be demonstrated in “naive” populations, i.e. participants who
have never been infected by the COVID-19 virus (seronegative). The
Phase 3 trial recruited most participants in Q3 2021, coinciding
with a significant increase in the number of people infected by the
COVID-19 virus globally due to the Delta variant. To provide the
necessary data to regulatory authorities for the booster vaccine
submission, the trial will continue to accrue the number of events
needed for analysis, with results expected in Q1, 2022.“These
preliminary data show we have a strong booster candidate, whatever
primary vaccine you have received.” said Thomas Triomphe, Executive
Vice President, Sanofi Pasteur. “This is consistent with our
efforts to provide relevant responses to evolving public health
needs. While pursuing a phase 3 trial is a challenge in a quickly
shifting pandemic environment, we look forward to seeing the
results to support submissions of our booster vaccine as quickly as
possible.”
Roger Connor, President of GSK Vaccines, added:
“As the pandemic threat continues with the current dominant Delta
variant and Omicron rapidly gaining ground, booster vaccines will
continue to be needed to help protect people over time. The initial
booster data are promising, and we await the phase III results to
determine the next steps on making protein-based adjuvanted
COVID-19 vaccines available."In parallel, Sanofi continues its
contribution to global public health needs with the manufacturing
of up to half a billion doses from BioNTech/Pfizer, Moderna, and
Johnson & Johnson vaccines.
About the booster trial
(VAT0002)
The VAT0002 extension trial is the most
comprehensive heterologous booster trial conducted to date. In the
first cohort of this trial, the four most-widely approved COVID-19
primary vaccines using mRNA and adenovirus vector technologies were
boosted with the Sanofi/GSK protein-based adjuvanted vaccine
candidate after full primary vaccination to assess its safety
profile and immunogenicity.
Participants in the first cohort (n=521) had
previously been vaccinated with the approved dosing schedule of an
authorized COVID-19 mRNA vaccine (Moderna, Pfizer/BioNTech,) or
adenovirus vector vaccine (AstraZeneca, Johnson & Johnson,).
This preliminary analysis includes data from trial participants who
received one 5µg booster dose of the adjuvanted recombinant protein
vaccine targeting the D614 parent virus, between four and ten
months after a complete primary vaccination schedule.
The trial is ongoing across sites in multiple
countries, including the U.S., France, and the UK. To address the
emergence of COVID-19 variants of concern, additional trial cohorts
are assessing the boosting potential of monovalent and bivalent
vaccine formulations also containing the Beta (B.1.351) variant.
More data from this trial are expected during the first half of
2022. The Omicron variant was not circulating during the trial.
Using sera from booster trial participants, testing is underway to
establish the ability of the vaccine candidate to cross-neutralize
against Omicron.
About the Phase 3 efficacy trial
(VAT0008)
The primary endpoint of this ongoing Phase 3,
randomized, double-blind, placebo-controlled trial is the
prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with
secondary endpoints of preventing severe COVID-19 disease and
infection. Stage one of the trial is assessing the efficacy of a
vaccine formulation containing the spike protein against the
original D614 (parent) virus in more than 10,000 participants
>18 years of age, randomized to receive two doses of 10µg
vaccine or placebo at day 1 and day 22 across sites in the US,
Asia, Africa and Latin America. A second stage in the trial is
evaluating a second bivalent formulation, adding the spike protein
of the B.1.351 (Beta) variant.
These efforts are 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 and GSK
collaboration
In the collaboration 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.
About GSK
GSK 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.
Media Relations
ContactsSandrine GuendoulTel.: + 33 6 25 09 14
25Sandrine.Guendoul@sanofi.com – mr@sanofi.com
Sally BainTel.: +1 (781)
264-1091Sally.Bain@sanofi.com
Investor Relations Contacts
ParisEva Schaefer-JansenArnaud DelepineNathalie Pham
Investor Relations Contacts North
AmericaFelix Lauscher
Tel.: +33 (0)1 53 77 45
45investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact
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