MHRA authorises VidPrevtyn® Beta▼ in Great Britain, Sanofi’s COVID-19 booster vaccine

READING, ENGLAND–(BUSINESS WIRE)–FOR PROACTIVE USE WITH UK MEDICAL AND TRADE MEDIA ONLY

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorized 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 an immune 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 registration 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 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 spread 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 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 license includes the territory of Northern Ireland.

About VAT00013 (COVIBOOST) Immunogenicity & Safety Study 1,2

The independent COVIBOOST (VAT00013) study conducted by the Assistance Publique – Hôpitaux 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 neutralizing 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 neutralizing 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 1,3

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 US federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response at the US Department of Health and Human Services under Contract # HHSO100201600005I, and in collaboration with the US 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 authorization holder. GSK contributes with its adjuvant.

About Sanofi

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 potentially life-saving vaccine protection to millions of people globally, while bringing sustainability and social responsibility at the center of our ambitions.

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 the 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.

References

1 VidPrevtyn Beta – Summary of Product Characteristics (SmPC) Available at: https://www.ema.europa.eu/en/documents/product-information/vidprevtyn-beta-epar-product-information_en.pdf Last accessed: December 2022

2 Assistance Publique – Hôpitaux de Paris (AP-HP). Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNAVaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults (COVIBOOST) (VAT013). Data on File.

3 Sanofi. Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older (VAT00002) Cohort 2 Study. Data on File.

4 Office for National Statistics (ONS). November 23, 2022. Monthly mortality analysis, England and Wales: October 2022. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/monthlymortalityanalysisenglandandwales/latest Last accessed: December 2022

5 UK Health Security Agency (UKHSA). November 25, 2022. SARS-CoV-2 variants of concern and variants under investigation in England – Technical briefing 48. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1120304/technical-briefing-48-25-november-2022-final.pdf Last accessed: December 2022

6 national flu and COVID-19 surveillance reports, COVID-19 surveillance up to the end of week 47. Available at: https://www.gov.uk/government/news/national-flu-and-covid-19-surveillance-reports-published Last accessed: December 2022

Date of preparation: December 2022

Document number: MAT-XU-2205410 (V2.0)

Leave a Comment