TIDMGSK
RNS Number : 7153V
GlaxoSmithKline PLC
15 December 2021
Issued: 15 December 2021, London, UK
GSK and Sanofi announce positive preliminary booster data for
their COVID-19 vaccine candidate and continuation of phase III
trial per independent Monitoring Board recommendation
-- Positive booster data show that neutralising 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 III trial continues to accrue the 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 III results
GlaxoSmithKline plc (LSE/NYSE: GSK) and Sanofi 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
neutralising 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 III 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 III efficacy to be
demonstrated in naïve populations, i.e. participants who have never
been infected by the COVID-19 virus (seronegative). The phase III
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 III 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."
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 authorised
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 5ug 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 US, 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 III efficacy trial (VAT0008)
The primary endpoint of this ongoing phase III, randomised,
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, randomised to receive two doses of 10ug vaccine or placebo at
day one 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 US
Department of Health and Human Services in collaboration with the
US Department of Defense Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense under
Contract # W15QKN-16-9-1002.
About the GSK / Sanofi collaboration
In the collaboration between the two companies, GSK contributes
its pandemic adjuvant, and Sanofi provides its recombinant antigen,
both established vaccine platforms that have proven successful
against influenza.
GSK commitment to tackling COVID-19
GSK's response to COVID-19 has been one of the broadest in the
industry, with potential treatments in addition to our vaccine
candidates in development with partner organisations.
GSK is collaborating with several organisations on COVID-19
vaccines by providing access to our adjuvant technology. We are
working with Sanofi, Medicago and SK bioscience to develop
adjuvanted, protein-based vaccine candidates. The use of an
adjuvant can be of particular importance in a pandemic since it may
reduce the amount of vaccine protein required per dose, allowing
more vaccine doses to be produced and contributing to protecting
more people in need.
GSK is also working with mRNA specialist CureVac N.V. to jointly
develop next-generation, optimised mRNA vaccines for COVID-19 with
the potential to address multiple emerging variants in one
vaccine.
GSK is also exploring treatments for COVID-19 patients,
collaborating with Vir Biotechnology to investigate monoclonal
antibodies that could be used as therapeutic or preventive options
for COVID-19.
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
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us .
GSK enquiries:
Simon Moore +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor Nick Stone +44 (0) 7717 (London)
enquiries: 618834
James Dodwell +44 (0) 20 8047 (London)
2406
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
Mick Readey +44 (0) 7990 (London)
339653
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Josh Williams +44 (0) 7385 (London)
415719
Frannie DeFranco +1 215 751 4855 (Philadelphia)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described in the Company's
Annual Report on Form 20-F for 2020, GSK's Q3 Results and any
impacts of the COVID-19 pandemic.
Registered in England & Wales:
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Registered Office:
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Brentford, Middlesex
TW8 9GS
References
1. Moderna: VRBPAC briefing document, 14 October 2021. Accessed
17/11/21.Available at: Vaccines and Related Biological Products
Advisory Committee October 14-15, 2021 Meeting Briefing Document-
Sponsor (Moderna) (fda.gov)
2. Pfizer: VRBPAC briefing document, 17 September 2021. Accessed
17/11/21.Available at: Vaccines and Related Biological Products
Advisory Committee September 17, 2021 Meeting Briefing Document-
Sponsor (fda.gov)
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