EU officially accepts Pfizer B meningococcal vaccine Tremenba listing application
May 26, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)]; Pfizer, the US pharmaceutical giant, recently announced that the European Medicines Agency (EMA) has accepted the marketing approval application (MAA) for the meningococcal vaccine type B (Tensenba (Meningococcal Group B Vaccine), a group B meningococcal vaccine). In the EU, Trumenba's regulatory review process was officially launched.
Trumenba was developed for people aged 10 years and older to prevent invasive meningococcal disease caused by the B serogroup Neisseria meningitidis serogroup B (MenB). It is estimated that on a global scale, MenB's annual incidence of invasive meningococcal disease ranges from 20,000 to 80,000 cases and may result in death or long-term disability, including brain damage and hearing loss.
The submission of Trumenba MAA is based on data from a large global clinical project involving approximately 20,800 adolescents and adults. The data showed that Trumenba induced a consistent sustained immune response against a variety of pathogenic MenB strains with good safety and tolerability.
In the United States, Trumenba was approved by the FDA in October 2014 to become the first B-type meningococcal vaccine in the US market, but its population is limited to 10-25 years old. Currently, Pfizer is advancing research on related vaccines and is working to expand the population of Trumenba. Trumenba is reviewed and accelerated for approval through the FDA's breakthrough therapy identification and priority review process. The approval of Trumenba was based on a serum bactericidal immune response to four strains of MenB in the United States, but the effectiveness of this vaccine against other MenB strains has not been confirmed. As part of the accelerated approval process, Pfizer will complete its ongoing research to confirm the effectiveness of Trumenba on multiple B serogroup strains.
Meningitis is easily misdiagnosed and, although rare, can have serious consequences. Sometimes, despite appropriate treatment, the mortality rate is as high as 10% within 24 hours after onset. On the other hand, about 20% of survivors will have permanent disabilities, such as brain damage, hearing impairment or physical disabilities. In developed countries, type B meningitis is particularly high in infants. Meningococcal is the leading cause of bacterial meningitis. Five major meningococcal (A, B, C, W-135, Y) have caused most cases worldwide, and vaccination is the best measure to reduce the burden of the disease.
Shower Gel,Shower Cream,Shower Foam,Body Shower Gel
Wuxi Keni Daily Cosmetics Co.,Ltd , https://www.wxkenidaily.com