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 vaccineVidPrevtyn® 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.
Executive Vice President, Vaccines, Sanofi
“Today’s approvalvalidates 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.”
Global 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 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. 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 Study
The 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 Study
Immunogenicity 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 Study
The 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 support
Research 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 partnership
In 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.
We 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
Sandrine Guendoul | + 33 6 25 09 14 25 | firstname.lastname@example.org
Victor Rouault | + 33 6 70 93 71 40 | email@example.com
Sally Bain | + 1 617 834 6026 | firstname.lastname@example.org
Evan Berland | + 1 215 432 0234 | email@example.com
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | firstname.lastname@example.org
Arnaud Delépine| + 33 6 73 69 36 93 | email@example.com
Corentine Driancourt | + 33 6 40 56 92 21 | firstname.lastname@example.org
Felix Lauscher | + 1 908 612 7239 | email@example.com
Priya Nanduri | +1 617 764 6418 | firstname.lastname@example.org
Nathalie Pham | + 33 7 85 93 30 17 | email@example.com
Sanofi Forward-Looking Statements
This 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 product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed 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 regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “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.
AttachmentTo view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
DNO Initiates Share Buyback Program8.12.2022 20:47:01 CET | Press release
Oslo, 8 December 2022 – DNO ASA, the Norwegian oil and gas operator (the "Company"), today announced the initiation of a share buyback program (the "Program") through which the Company will repurchase up to 53,107,326 shares, representing approximately five percent of total shares outstanding, for a maximum total consideration of USD 80 million. The Program will be conducted in accordance with article 5 of the Market Abuse Regulation (EU) No 596/2014, as adopted in the Norwegian Securities Trading Act of 2007, ancillary regulations and the Oslo Stock Exchange's Guidelines for buyback programmes and price stabilisation of February 2021. Buyback transactions will be executed at market prices on the Oslo Stock Exchange. The Program will be managed by Arctic Securities AS, which will make its trading decisions in relation to the Program independently of the Company; this may result in DNO acquiring shares through periods where the Company otherwise would have been restricted from doing so.
Park Place Technologies Acquires CentricsIT Global Services Division8.12.2022 20:35:38 CET | Press release
Purchase Strengthens Park Place as Global Leader for all IT Infrastructure Solutions, as Economy and Skills Gap Challenges Impact Global Business. CLEVELAND, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Park Place Technologies, the leading global data center and networking optimization firm, has acquired the TPM and Professional Services assets of CentricsIT, an IT services provider based in Atlanta, Georgia. The demand for Professional Services is growing globally, driven by economic conditions and skills gaps. Park Place’s Professional Services offering will benefit from the acquisition with greater capabilities in IMAC, ITAD, Remote Hands, and deployment services, including cabling, wi-fi surveys, data center installs and refreshes, and network installations. Park Place clients will benefit from a state-of-the-art Professional Services portal developed by CentricsIT that provides real-time project status, reporting, and collaboration tools. Park Place’s Project Management Office function will
Lumina Datamatics Acquires UK-based Sunrise Setting Ltd.8.12.2022 20:15:35 CET | Press release
MILTON KEYNES, United Kingdom, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Lumina Datamatics UK Ltd. signed a definitive agreement to acquire a controlling stake in UK-based Sunrise Setting Ltd., a boutique company based in Brixham, UK, supporting academic and other publishers including non-publisher organizations to produce more than 500 publications each year. “The acquisition of Sunrise Setting Ltd. deepens our commitment to our current customers, and also fits with our strategic growth plan. Sunrise Setting Ltd.’s customers will benefit greatly from our broad range of publishing and technology solutions. The depth and experience of Sunrise Setting Ltd. will enhance Lumina Datamatics’ presence in the UK and EU regions and will help us gain a competitive advantage in the publishing space,” said Sameer Kanodia, Managing Director & CEO of Lumina Datamatics. “There is clear alignment with our company offerings and we are looking forward to taking advantage of the synergies resulting from our coll
BioGX Launches 'pixl™' Portable qPCR Platform Ex-US With Expanded Test Menu for Infectious Diseases8.12.2022 20:00:00 CET | Press release
BIRMINGHAM, Ala., Dec. 08, 2022 (GLOBE NEWSWIRE) -- BioGX, a global provider of easy molecular diagnostic solutions since 2007, announced the Ex-US commercial release of its portable pixl™ qPCR real-time PCR platform for use with BioGX CE-IVD marked assays, enabling global access and complementing the recent US FDA EUA expanded use of Xfree™ COVID-19 Direct RT-PCR on the pixl. The pixl instrument is a benchtop 4-channel, 16-well, RT-PCR instrument that supports rapid turnaround times for batches of up to 16 samples, with integrated results interpretation on a device with the compact footprint of a touchpad. "pixl, combined with our unique Xfree chemistry, offers a low-cost direct-sample-to-answer PCR solution on a portable, compact device. pixl will provide broader access to clinical laboratories for decentralized PCR testing, enabling faster, better, low-cost near-patient molecular diagnostics," said Shazi Iqbal, Ph.D., CEO of BioGX. This platform was previously CE-IVD marked and can
Notification under Chapter 9, Section 10 of the Finnish Securities Market Act: holdings of The Goldman Sachs Group, Inc. in Nokia Corporation exceeded 5%8.12.2022 19:00:00 CET | Press release
Notification under Chapter 9, Section 10 of the Finnish Securities Market Act: holdings of The Goldman Sachs Group, Inc. in Nokia Corporation exceeded 5% Nokia Corporation Stock Exchange Release 8 December 2022 at 20:00 EET Notification under Chapter 9, Section 10 of the Finnish Securities Market Act: holdings of The Goldman Sachs Group, Inc. in Nokia Corporation exceeded 5% According to a notification received under Chapter 9, Section 5 of the Finnish Securities Market Act (FSMA) by Nokia Corporation, the direct and indirect holdings of The Goldman Sachs Group, Inc. in Nokia have on 2 December 2022 exceeded 5% of the total number of shares and voting rights of Nokia. According to the notification received by Nokia, the holdings of The Goldman Sachs Group, Inc. in Nokia on 2 December 2022, directly and through its controlled undertakings and funds was equivalent to a total of 293,966,891 shares, corresponding to approximately 5.22% of the total number of shares and voting rights of Nok