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 November 2022
Commission
File Number 001-15170
GSK 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: 10 November 2022, London UK
Sanofi and GSK's next-generation
COVID-19 booster vaccine VidPrevtyn Beta approved by the European
Commission
●
First
and only next-generation protein-based adjuvanted COVID-19 booster
approved in Europe
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Strong
immune response against all tested variants of
concern
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Ready
to supply for autumn and winter COVID-19 vaccination campaigns in
Europe
After the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) adopted a positive opinion
for VidPrevtyn
Beta, the
vaccine has been approved by the European Commission as a booster
for the prevention of COVID-19 in adults 18 years of age and
older. Next-generation
COVID-19 vaccines are based on a variant-adapted approach, using a
strain other than the parental strain of SARS-CoV-2 (D614
strain). The vaccine is based on the Beta variant antigen and
includes GSK's pandemic adjuvant. The vaccine is indicated as
a booster for active immunisation against SARS-CoV-2 in adults who
have previously received a mRNA or adenoviral COVID-19 vaccine.
Shipments of the vaccine are ready to be distributed to European
countries as per the Advance Purchase
Agreements.
Thomas Triomphe, Executive Vice President, Sanofi
Vaccines: "Today's
approval validates our research in developing a novel solution for
the COVID-19 pandemic. As we're ready to start first
shipments, VidPrevtyn
Beta will
be an important new option to protect populations against multiple
strains of COVID-19."
Phil Dormitzer, Global
Head of Vaccines R&D, GSK: "The
approval from the European Commission is an important step in
providing further vaccine solutions to Europe for the coming autumn
and winter. Our protein-based, adjuvanted vaccine has the potential
to make an important contribution to public health as the pandemic
evolves further."
In registrational trials, carried out at times when the Omicron
variant was predominantly circulating, the vaccine induced a strong
immune response against multiple variants. Registration trials
included a Phase III primary efficacy trial (VAT08 Stage 2) and two
separate immunogenicity trials, including one comparative trial
with an approved mRNA booster as a comparator.
About VidPrevtyn
Beta
VidPrevtyn Beta is
a monovalent, recombinant-protein next-generation COVID-19 vaccine
developed by Sanofi, modelled on the Beta variant and including
GSK's pandemic adjuvant. The same recombinant-protein technology is
used in Sanofi's approved seasonal flu
vaccines.
About COVIBOOST immunogenicity and safety trial
The independent COVIBOOST (VAT013) trial conducted by the
Assistance Publique - Hôpitaux de Paris (AP-HP)
investigated VidPrevtyn
Beta following primary
vaccination with two doses of Pfizer-BioNTech's Comirnaty vaccine
(BNT162b2). VidPrevtyn
Beta generated a higher
immune response (as measured by neutralising antibody titers) than
Pfizer-BioNTech's booster or the Sanofi-GSK first-generation
booster, both of which target the original D614 parent strain. In
this trial, which included 247 adult subjects (18-73 years old),
all three vaccines also elicited neutralising antibodies against
the Omicron BA.1 variant, with highest responses generated by the
Sanofi-GSK next-generation, one month after
injection. VidPrevtyn
Beta also elicited around
2.5 times more neutralizing antibodies against Omicron BA.1 and in
an exploratory analysis BA.4 / BA.5 strains than the mRNA COVID-19
booster comparator.
About the VAT02 immunogenicity and safety trial
Immunogenicity trials included VAT02 Cohort 2 and COVIBOOST which
evaluated the booster formulation modelled on the Beta variant,
including GSK's pandemic adjuvant. In the Phase III VAT02 Cohort 2
trial, the vaccine-induced (at day 15 following booster
vaccination) a significant boost in pseudo-neutralising titers
above baseline against multiple variants of concern (titers after
boosting were 13 times the titers before boosting against D614G
parent virus, and 34 times the titers before boosting against the
COVID-19 Beta strain) in 18-55 years-old adults previously primed
with mRNA COVID-19 vaccines. In the VAT02 Cohort 2 trial, reactions
were mostly mild to moderate, transient, and
self-resolutive.
About the VAT08 Stage 2 efficacy and safety
trial
The VAT08 phase III Stage 2 trial is a randomized, double-blind,
placebo-controlled trial investigating primary vaccination with a
bivalent COVID-19 vaccine containing both parental (D614) and Beta
strains. The results showed a 64.7% efficacy against
symptomatic SARS-CoV-2 infection in adults, regardless of their
SARS-CoV-2 infection status prior to vaccination, and 75.1%
efficacy in participants previously infected with SARS-CoV-2. This
trial was the first ever to report efficacy data in an Omicron
environment.
Across all the trials mentioned above, the Sanofi-GSK
next-generation vaccine was well-tolerated, with an acceptable
safety profile.
About BARDA support
Research and development for the vaccine are supported by U.S.
federal funds from the Biomedical Advanced Research and Development
Authority (BARDA), 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
and the National Institute of Allergy and Infectious Diseases
(NIAID).
About the Sanofi and GSK partnership
In the collaboration between the two companies, Sanofi provides its
recombinant antigen and will be the marketing authorisation holder.
GSK contributes with its pandemic adjuvant, both established
vaccine platforms that have proven successful against
influenza.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com/company
GSK enquiries
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Media:
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James Dodwell
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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 2021, GSK's Q3 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8 9GS
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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GSK plc
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(Registrant)
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Date: November
10, 2022
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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 GSK plc
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