Nov 20, 2020 / Bio Valley BIOON / –Sanofi recently announced that the European Commission (EC) has approved Supemtek (Quadrivalent Recombinant Influenza Vaccine, Quadrivalent Recombinant Influenza Vaccine) for use from 18 years of age Adults, prevent the flu.
It is worth mentioning that Supemtek is currently the first and only recombinant influenza vaccine approved by the European Union, containing three times more antigens than standard egg and cell-based vaccines. The increase in the number of antigens and the use of recombinant technology have improved protection against influenza, especially in the elderly population 50 years and older. Phase 3 efficacy trials showed that, compared to the standard dose of quadrivalent egg-based influenza vaccine, Supemtek has improved protection against influenza, reducing the risk of influenza in adults 50 years and older in an additional 30%.
Sanofi predicts that the first Supemtek launch in Europe is expected to take place during the 2022/2023 flu season, and some countries may receive an accelerated supply as early as the 2021/2022 flu season. Outside the European Union, Supemtek is also approved in the United States under the trade name Flublok Quadravalent®.
This approval is based on data from 2 phase 3 randomized controlled trials. These two trials involved more than 10,000 patients, confirming the safety, immunogenicity, and effectiveness of Supemtek. Specifically, the relative efficacy of Supemtek was confirmed in a multicenter phase 3 trial (40 outpatient centers in the United States, involving more than 9,000 adults), randomized controlled efficacy trial.
Sanofi Pasteur Director Thomas Triomphe said: “In the context of the COVID-19 pandemic, preventing influenza remains a public health priority. The approval of Supemtek by the European Commission today supports us in the Advancing Influenza Vaccine Technology With the help of Supemtek, we have provided European health authorities with an additional innovative solution that has been shown to improve the ability to prevent influenza and its potentially serious complications, as well as the burden placed on it. influenza represents for the medical system. “
Globally, the number of influenza-related deaths is between 2.9 and 65 million per year, and the burden on hospitals is approximately 10 million influenza-related hospitalized patients. Recent data also shows that within a week after influenza infection, influenza can increase the risk of heart attack by 10 times and the risk of stroke by 8 times, indicating that the burden of influenza exceeds the known respiratory complications.
Supemtek is produced using recombinant technology and matches the key components of the influenza virus strain recommended by the World Health Organization (WHO). Recombinant technology is a new method of influenza vaccine production, which is very different from the other two technologies currently used (egg-based technology and cell-based technology), because it avoids the risk of mutation of the virus, which reduces the risk of virus mutation. The effectiveness of the vaccine. This technology can ensure a perfect match with the key components of the influenza virus strain recommended by the World Health Organization (WHO) for the production of influenza vaccine each year.
Sanofi is also currently using recombination technology to develop a vaccine against novel coronavirus pneumonia (COVID-19). The vaccine was developed in cooperation with GlaxoSmithKline (GSK) and has been approved by the US Agency for Advanced Biomedical Research and Development (BARDA) support. The two companies announced in September the start of phase 1/2 clinical trials of their COVID-19 adjuvant recombinant vaccine candidates, and are expected to obtain preliminary results in December 2020 to support the initiation of key phase 3 studies earlier. from the end of this year. If this data is sufficient to apply for a license, Sanofi and GlaxoSmithKline plan to apply for regulatory approval in the first half of 2021. (Bioon.com)
原文 出处 ： The European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults over 18 years of age
