European Commission approves Sanofi Pasteur’s innovative Quadrivalent Recombinant Influenza Vaccine, Supemtek®▼, for the prevention of influenza in adults aged 18 years and older
European Commission approves Sanofi Pasteur’s innovative Quadrivalent Recombinant Influenza Vaccine, Supemtek®▼, for the prevention of influenza in adults aged 18 years and older
* Supemtek is the first and only recombinant influenza vaccine approved in the European Union for the prevention of influenza in adults aged 18 years and older
* A Phase 3 efficacy trial demonstrated improved protection against influenza compared to standard-dose influenza vaccine (QIVe), and reduced the relative risk of laboratory-confirmed influenza-like illness by an additional 30% (3.2% v 2.2%, absolute reduction of 1%) in adults aged 50 years and older1,
* In a further trial of 18-49 year-old adults, Supemtek showed comparable immunogenicity, safety and tolerability to standard dose QIVe2
* Supemtek contains three times more HA antigen than standard-dose vaccines
Reading, UK – November 17, 2020 – The European Commission has granted a marketing authorisation for Supemtek®▼ (Quadrivalent Recombinant Influenza Vaccine) for the prevention of influenza in adults aged 18 years and older. It is the first and only recombinant influenza vaccine now approved in the European Union.
Supemtek is produced using recombinant technology, which allows an exact match to the key component of the influenza strains recommended by the World Health Organization, avoiding the risk of viral mutations. Supemtek also contains three times more antigen than both egg-based and cell-based standard-dose vaccines. This increased amount of antigen and the use of recombinant technology provide improved protection against influenza, in those aged 50 and older. In comparison with a standard-dose egg-based quadrivalent influenza vaccine, Supemtek reduced the relative risk of influenza like illness by 30% (1% absolute reduction) for adults aged 50 years and older and had a similar safety profile1,2.
The authorization is based on clinical data demonstrating safety, immunogenicity and efficacy of Supemtek in two Phase 3 randomised controlled trials[1],[2] involving more than 10,000 patients. Specifically, the relative efficacy of Supemtek was demonstrated in a Phase 3 multicentre (40 outpatient centres in the US, involving more than 9,000 adults), randomised controlled efficacy trial. In the other Phase 3 study of 1,350 18-49 year old adults, Supemtek showed comparable immunogenicity, safety and tolerability to standard-dose, egg-based quadrivalent-inactivated influenza vaccine1,2.
“Supemtek is the first and only flu vaccine to use recombinant technology, and demonstrates Sanofi Pasteur’s commitment to continued innovation,” said Hugo Fry, General Manger, Sanofi Pasteur UK & Ireland “We are in the middle of a second wave of COVID-19, and more than ever, it is critical that flu vaccination uptake is high in priority populations to reduce a double burden applying pressure on an already-stretched NHS. Moving forward, Supemtek could provide UK health authorities with an important new option to prevent influenza and reduce the burden on public health and the NHS.”
Flu is a significant burden, killing an average of 17,000 people in the UK per year.[3] Recent data also show that influenza infection can increase the risk of heart attack by up to 10 times, and the risk of stroke by up to 8 times in the days following confirmed infection – demonstrating that the burden of influenza goes beyond its well-known respiratory complications.[4]
Sanofi Pasteur expects the vaccine to be recommended as part of the 2021/22 tripartite letter published by NHS England. Outside the EU, Supemtek is also approved in the U.S. under the tradename Flublok Quadrivalent®.
About recombinant technology
The recombinant technology is a new way of producing influenza vaccines which differs substantially from the two other technologies currently in use (egg-based and cell-based technologies) and it avoids the risk of viral mutations during production that may potentially lower vaccine efficacy. It ensures the exact match to the haemagglutinin active ingredient of the influenza strains recommended by the World Health Organization every year for producing influenza vaccines.
As the leading manufacturer of influenza vaccines, Sanofi Pasteur is supporting health authorities in their efforts to strengthen influenza vaccination campaigns in the unique context of COVID-19. For the 2020/2021 influenza season, the company is delivering 2.6 million additional doses of flu vaccine to support the UK government’s expanded programme at a time of urgent public health need.
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About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
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Andea Welch Vaccines Communications Lead +44 (0) 7725 765377
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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. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. 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, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. |
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