Press Release: Sanofi and GSK’s next-generation COVID-19 booster
vaccine VidPrevtyn® Beta approved by the European Commission
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 fall-winter
COVID-19 vaccination campaigns in Europe
Paris,
November
10,
2022. After the European Medicines Agency’s
Committee for Medicinal Products for Human Use (CHMP) adopted a
positive opinion for VidPrevtyn® Beta, the vaccine was approved by
the European Commission, as a booster for the prevention of
COVID-19 in adults 18 years of age and older. Designed to provide
broad protection against multiple variants, the protein-based
COVID-19 booster vaccine is based on the Beta variant antigen and
includes GSK’s pandemic adjuvant. VidPrevtyn Beta is indicated as a
booster for active immunization against SARS_CoV_2 in adults who
have previously received an mRNA or adenoviral COVID vaccine.
Shipments of VidPrevtyn Beta are ready to be distributed to
European countries as per Advance Purchase Agreements.
Thomas TriompheExecutive Vice
President, Vaccines, Sanofi“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.”
Philip
DormitzerGlobal Head of Research and Development
Vaccines, GSK“This EC approval is an important step in providing
further vaccine solutions to Europe for the coming winter. Our
protein-based, adjuvanted vaccine candidate has the potential to
make an important contribution to public health as the pandemic
evolves further.”
In registration studies, carried out at times
when Omicron strains were predominantly circulating, the vaccine
induced a strong immune response against multiple variants.
Registration studies included a Phase 3 primary efficacy trial
(VAT08 Stage 2) and two separate immunogenicity studies, including
one comparative study with approved mRNA booster as
comparatori,ii.
About VidPrevtyn BetaVidPrevtyn 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. 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).
About COVIBOOST Immunogenicity & Safety
StudyThe independent COVIBOOST (VAT013) study 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 neutralizing
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 study, which included 247 adult subjects
(18-73 years-old), all three vaccines also elicited neutralizing
antibodies against the Omicron BA.1 variant, with highest responses
generated by the Sanofi-GSK next-generation candidate, one month
after injection. VidPrevtyn Beta also elicited around 2.5 times
more neutralizing antibodies against Omicron BA.1 and, in an
exploratory analysis, against BA.4 / BA.5 strains than mRNA
COVID-19 booster comparator.
About the VAT02 Immunogenicity & Safety
StudyImmunogenicity studies included VAT02 Cohort 2 and COVIBOOST
which evaluated the booster formulation modelled on the Beta
variant and including GSK’s pandemic adjuvant. In the Phase 3 VAT02
Cohort 2 study, the vaccine induced (at day 15 following booster
vaccination) a significant boost in antibody titers above baseline
against multiple variants of concern (13-fold increase against D614
parent virus, 34-fold increase against the COVID-19 Beta strain) in
18-55 years-old adults previously primed with mRNA COVID-19
vaccines. In the VAT02 cohort 2 study, reactions were mostly mild
to moderate, transient and self resolutive.
About the VAT08 Stage 2 Efficacy & Safety
StudyThe VAT08 Phase 3 Stage 2 study 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 study was
the first ever to report efficacy data in an Omicron
environment.
Across all the above-mentioned studies, the
Sanofi-GSK bivalent next-generation vaccine candidate was
well-tolerated, with an acceptable safety profile.
About BARDA supportResearch and development for
VidPrevtyn are supported by U.S. federal funds from the Biomedical
Advanced Research and Development Authority (BARDA), Administration
for Strategic Preparedness and Response at the U.S. Department of
Health and Human Services under Contract # HHSO100201600005I, and
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 partnershipIn the
collaboration between the two companies, Sanofi provides its
recombinant antigen and will be the marketing authorization holder.
GSK contributes with its pandemic adjuvant, both established
vaccine platforms that have proven successful against
influenza.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.comEvan Berland | + 1 215
432 0234 | evan.berland@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69
36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comPriya Nanduri | +1
617 764 6418 | priya.nanduri@sanofi.com Nathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
Sanofi Forward-Looking
StatementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates regarding the marketing and other potential of the
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“plans” and similar expressions. Although Sanofi’s management
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generally beyond the control of Sanofi, that could cause actual
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in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
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and development, including future clinical data and analysis of
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impact that COVID-19 will have on us, our customers, suppliers,
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“Risk Factors” and “Cautionary Statement Regarding Forward-Looking
Statements” in Sanofi’s annual report on Form 20-F for the year
ended December 31, 2021. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
i
https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-24-05-29-02-2468538ii
https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-13-05-30-00-2460833
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