COVID-19 Vaccine (recombinant, adjuvanted) (Sanofi)

GSK plc (LSE/NYSE: GSK) has announced the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) authorised Sanofi's SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults aged 18 and above in Great Britain, following the European Commission licence last month, which included Northern Ireland. This SARS-CoV-2 spike protein (B.1.351 strain) vaccine is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received a mRNA or adenoviral COVID-19 vaccine, and the use of this vaccine should be in accordance with official recommendations(1). The approval is based on results from two separate immunogenicity trials, including one comparative trial with an approved mRNA booster as a comparator(1,2,3). In these registrational immunogenicity trials, carried out at times when the Omicron variant was predominantly circulating, the vaccine induced a neutralising antibody response against all tested variants of concern.(1,2,3) This vaccine is based on the Beta variant spike antigen and includes GSK's adjuvant. Across the registrational trials, the vaccine candidate was generally well-tolerated, with an acceptable safety profile.(1) This booster vaccine was developed jointly by Sanofi and GSK. Rebecca Catterick, General Manager, Sanofi Vaccines, UK & Ireland: "Today's approval validates our research in developing a novel solution for the COVID-19 pandemic. VidPrevtyn Beta will be an important new option to help protect populations against COVID-19." Phil Dormitzer, Global Head of Vaccines R&D, GSK: "The approval from MHRA of our protein-based, adjuvanted vaccine is a vital step for providing further vaccine solutions to Great Britain this winter. Boosters have an important role in protecting people from COVID-19." About COVID-19 in the UK COVID-19 continues to circulate in the UK and remains a public health concern. According to the Office for National Statistics, COVID-19 was the eighth-leading cause of death in England and the seventh leading cause in Wales as of October 2022(4). Epidemiological analysis from the UK Health Security Agency indicates that Omicron BA.5 has become the dominant SARS-CoV-2 variant in the UK. As of November 2022, variant BA.5, including all sub-lineages, was found in more than 75% of all sequenced samples in the UK(5). The UK Health Security Agency reports increasing prevalence of COVID-19 this winter and recommends a booster for those at high risk of complications of COVID-19 infection(6). About VidPrevtyn Beta VidPrevtyn Beta is a monovalent, recombinant-protein COVID-19 vaccine developed by Sanofi, modelled on the Beta variant spike antigen and includes GSK's pandemic adjuvant. The same recombinant-protein technology is used in Sanofi's approved seasonal flu vaccines. The approval by the MHRA is valid in Great Britain only. This SARS-CoV-2 spike protein (B.1.351 strain) vaccine was approved via the European Commission (EC) Decision Reliance Route. The EU licence includes the territory of Northern Ireland. About VAT00013 (COVIBOOST) Immunogenicity & Safety Study The independent COVIBOOST (VAT00013) study conducted by the Assistance Publique - Hpitaux de Paris (AP-HP) investigated Sanofi's SARS-CoV-2 spike protein (B.1.351 strain) vaccine following primary vaccination with two doses of COVID-19 mRNA vaccine (tozinameran). The SARS-CoV-2 spike protein (B.1.351 strain) vaccine generated a higher immune response (as measured by neutralising antibody titres) than the COVID-19 mRNA vaccine (tozinameran) booster or the Sanofi original vaccine candidate, both of which target the original D614 parent strain. In this study, which assessed 247 adult participants 18 years of age and older, all three vaccines elicited neutralising antibodies against the Omicron BA.1 variant, with highest responses generated by the SARS-CoV-2 spike protein (B.1.351 strain) Sanofi vaccine, one month after injection. About the VAT00002 Immunogenicity & Safety Study The Phase 3 VAT00002 Cohort 2 study included 543 participants 18 years of age or older boosted with Sanofi's SARS-CoV-2 spike protein (B.1.351 strain) vaccine following previous priming with mRNA or adenovector COVID-19 vaccines. Sanofi's SARS-CoV-2 spike protein (B.1.351 strain) vaccine induced (at day 15 following booster vaccination) a significant boost in neutralizing antibody titres as compared to pre-booster against multiple variants of concern (with Geometric Mean Titres Ratio (GMTR, fold increase) against the B.1.351 strain ranging from 38.5 to 72.3, and from 14.5 to 28.6 for the D614G strain in adults previously primed with mRNA or adenovector COVID-19 vaccines, respectively). In the VAT00002 cohort 2 study, adverse reactions were mostly mild to moderate, transient, and self-resolutive. About BARDA support Research and development for Sanofi's SARS-CoV-2 spike protein (B.1.351 strain) vaccine 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 is the marketing authorisation holder. GSK contributes with its pandemic adjuvant. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.

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 Triomphe, Executive Vice President, Vaccines, Sanofi, siad: "Today's approval validates our research in developing a novel solution for the COVID-19 pandemic. As were ready to start first shipments, VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19." Philip Dormitzer, Global Head of Research and Development Vaccines, GSK, mentioned: "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 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 Sanofis 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 - Hpitaux de Paris (AP-HP) investigated VidPrevtyn Beta following primary vaccination with two doses of Pfizer-BioNTechs Comirnaty vaccine (BNT162b2). VidPrevtyn Beta generated a higher immune response (as measured by neutralizing antibody titers) than Pfizer-BioNTechs 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 GSKs 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. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples 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