UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of December 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
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
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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
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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
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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 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 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 10µg
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.
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GSK enquiries:
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Simon Moore
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+44 (0) 20 8047 5502
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(London)
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Kristen Neese
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+1 804 217 8147
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(Philadelphia)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Analyst/Investor enquiries:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Sonya Ghobrial
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+44 (0) 7392 784784
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(Consumer)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Frannie DeFranco
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+1 215 751 4855
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(Philadelphia)
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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:
No.
3888792
Registered Office:
980
Great West Road
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)
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: December
15, 2021
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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