REG - GSK PLC - Sanofi-GSK COVID booster vaccine approved by EU

GSKAnnouncement

10/11/2022 18:15

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RNS Number : 0591G  GSK PLC  10 November 2022

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

·   Strong immune response against all tested variants of concern

·   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
(https://www.gsk.com/en-gb/company/)

 

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                      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 2021, GSK's Q3 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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