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Wiesbaden, Germany – The Seqirus Quadruple Influenza Cell (QIVc) has received a favorable opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for people aged 9 and over . Subject to the final decision of the European Commission, Seqirus, the world leader in influenza prevention, plans to launch the vaccine in Germany and other European countries for the 2019/20 influenza season.
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The quadrivalent influenza vaccine was first approved in the United States in 2016 and protects against four strains of the influenza virus – strains A (H3N2), A (H1N1) and two strains B. The vaccine is manufactured with innovative cell technology, so that changes due to adaptations to chicken eggs, as they occur in conventional manufacturing processes, are avoided. Therefore, according to the US Centers for Disease Control (CDC), the new quadruple vaccine could better match circulating viruses than traditional egg-based influenza vaccines, potentially offering better protection in certain seasons.[1]
"We are delighted with this positive opinion, which brings us closer to the introduction of this innovative technology in Europe," said Gordon Naylor, president of Seqirus. "We are ready to work with health authorities and vaccine providers to make the new vaccine available as quickly as possible, helping to reduce the high number of deaths and hospital stays badociated with influenza in Europe." . "
In June of this year, the US Food and Drug Administration filed data for a retrospective badysis[*] showed that cell-based influenza vaccines for the 2017/18 season were badociated with fewer hospital and physician visits compared to standard influenza vaccines.[2] Seqirus is collaborating with scientific partners to gather additional data on the practices of the same period and will publish them in the coming weeks. The increased availability of cell-based vaccines in future influenza seasons in the United States and Europe will allow further research on their efficacy.
Seqirus produces the quadrivalent vaccine at its ultramodern plant in North Carolina, United States. This was built in collaboration with the US government to reduce a potential threat during an influenza pandemic.[3] The company was able to increase production quickly and is now the world's largest manufacturer of cell-based vaccines. In the United States, the country will produce more than 20 million doses of the quadruple vaccine this season and will have the capacity to cope with increased demand and will also allow Europe to access the vaccine. The quadrivalent vaccine complements the European Seqirus portfolio, which includes an adjuvanted influenza vaccine for people over 65 years of age.
The European Commission is expected to follow up on the CHMP recommendation for the approval of the vaccine by the end of the year.
Seasonal Influenza Information
Seasonal flu is a highly contagious common infectious disease that can cause serious illness and life-threatening complications in many people. The European Center for Disease Prevention and Control (ECDC) estimates that between 15,000 and 70,000 people die of influenza each year in Europe. He recommends the annual vaccine as the most effective method of influenza prevention.
About Seqirus
Seqirus is part of CSL Limited, headquartered in Melbourne, Australia. The CSL Group employs over 20,000 people in offices in more than 60 countries.
Seqirus, founded on July 31, 2015, combines Novartis Vaccines' influenza immunization activities with bioCSL. It leads you. at. Behringwerke's long tradition of influenza vaccination continues. As one of the world's leading players in the field of influenza vaccination, Seqirus makes a significant contribution to global healthcare.
Seqirus has state-of-the-art manufacturing facilities in the United States, United Kingdom and Australia and manufactures egg and cell-based influenza vaccines as well as proprietary adjuvants. With leading R & D facilities, a broad portfolio of differentiated products and distribution capabilities, the company is represented in more than 20 countries.
For more information, visit www.seqirus.com "> www.seqirus.com and http://www.csl.com.
[*]Non-interventional, non-interventional observational studyreferences
1. Centers for Disease Control (CDC). Cell-based influenza vaccines. November 2016. https://www.cdc.gov/flu/protect/vaccine/cell-based.htm access October 2018. 2. Centers for Disease Control and Prevention (CDC). advisory Slides of the Immunization Practices Committee (ACIP) Presentation: June 2018 in a meeting. https://www.cdc.gov/vaccines/acip/meetings/slides-2018-06.html Access October 2018. 3. This project was funded in whole or in part with federal funding. funds of the badistant secretary for the preparation and Response, Advanced Biomedical Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I
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