Europe's first recombined influenza vaccine! Sanofi's 4-price vaccine Supertek has been approved by the European Union to prevent influenza ≥ 18-year-olds!

November 20, 2020 // -- Sanofi recently announced that the European Commission (EC) has approved Supermtek (quadrivalent recombinant influenza vaccine) for use in adults 18 years and older to prevent influenza.
it's worth noting that Supemtek is the first and only recombinant influenza vaccine currently approved by the European Union, containing three times more antigens than the standard dose of egg- and cell-based vaccines.
of antigens and the use of recombinant technologies have improved the ability to protect against influenza, especially among older people aged 50 and over.
Phase 3 efficacy trial showed that Supemtek's ability to protect against influenza improved compared to the standard dose of the egg-based teteal flu vaccine, reducing the risk of influenza in adults aged 50 and over by an additional 30 percent.
Sanofi predicts that Supemtek's first launch in Europe is expected during the 2022/2023 flu season, with some countries likely to see an accelerated supply as early as the 2021/2022 flu season.
outside the European Union, Supemtek has also been approved in the United States, with a product called Flublok Quadravalent ®.
approval is based on data from two Phase 3 randomized controlled trials.
two trials involving more than 10,000 patients confirmed The safety, immunogenicity and effectiveness of Supertek.
specifically, Supemtek's relative efficacy was confirmed in a phase 3 multi-center (40 outpatient centers in the United States, involving more than 9,000 adults) and randomized controlled efficacy trials.
in the context of the COVID-19 pandemic, influenza prevention remains a public health priority," said Thomas Triomphe, director of Sanofi Pasteur, a government agency.
the European Commission's approval of Supertek today supports our strong commitment to advancing influenza vaccine technology.
with Supertek, we have provided European health authorities with an additional and innovative solution that has proven to enhance the ability to prevent influenza and its potentially serious complications, as well as the burden of influenza on the health system.
, the annual number of influenza-related deaths is between 290,000 and 650,000, and hospitals are burdened with about 10 million flu-related hospital admissions.
latest data also show that the flu can increase the risk of heart attack tenfold and stroke by eight times in the week after an influenza infection, suggesting that the burden of influenza goes beyond well-known respiratory complications.
Supemtek is produced using recombinant technology that perfectly matches the key ingredients of the influenza strain recommended by the World Health Organization (WHO).
recombination technology is a new way to produce influenza vaccines, a far from the other two technologies currently in use (egg-based and cell-based) because it avoids the risk of virus mutations that reduce the effectiveness of the vaccine.
technology ensures a perfect match to the key ingredients of the influenza strain recommended annually by the World Health Organization (WHO) for the production of influenza vaccines.
Sanofi is also using recombinant technology to develop a vaccine for the new coronavirus pneumonia (COVID-19), developed in collaboration with GlaxoSmithKline (GSK) and supported by the U.S. Biomedical Advanced Research and Development Agency (BARDA).
the two companies announced in September that they would begin a phase 1/2 clinical trial of their adulation recombinant COVID-19 candidate vaccine, with preliminary results expected by December 2020 to support the launch of key Phase 3 studies by the end of the year.
if the data is sufficient to apply for a permit, Sanofi and GlaxoSmithKline plan to ask regulators for approval in the first half of 2021.
() Origin: European Commission approves Supemtek ® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older