Pfizer meningococcal vaccine is again approved for breakthrough therapy
April 24, 2018 Source: WuXi PharmaTech
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)];Today, Pfizer announces that its B-type meningococcal vaccine, TRUMENBA®, has received a FDA-issued breakthrough therapy for active immunization against meningococcal meningitis B (MenB) in children aged 1 to 9 years. Invasive disease caused. This is the first breakthrough therapy for the MenB vaccine to protect children as young as 1 year old. The vaccine was awarded a breakthrough therapy in 2014 to help young people between the ages of 10 and 25 prevent MenB and was approved by the FDA in the same year to become the first approved MenB vaccine in the United States.
The majority of cases of invasive meningococcal disease worldwide are attributable to the six serotypes of Neisseria meningitidis (A, B, C, W, X and Y). Among them, serotypes A, B, C, W and Y accounted for 90% of all invasive meningococcal disease (IMD), and most American and European adolescent diseases were caused by MenB. As of 2016, MenB had the greatest impact among adolescents (32%) and infants (20%), followed by children aged 1 to 4 (12%) and children aged 5 to 10 (4%). These children also need a suitable vaccine to prevent MenB.
TRUMENBA consists of two recombinant lipidation factor H binding protein (fHBP) variants from serotype B Neisseria meningitidis, which are derived from fHBP subfamily A and subfamily B, respectively (A05 and B01, respectively). fHBP is one of the many proteins found on the surface of meningococcus that helps bacteria escape the host's defenses. The susceptibility of serotype B meningococcus to complement-mediated antibody-dependent killing after TRUMENBA inoculation depends on the antigenic similarity of the bacteria and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococcus.
In April 2017, based on data from Phase 3 studies, TRUMENBA received FDA approval as a three-dose vaccine for adolescents aged 10 to 25. This makes it the only MenB vaccine in the United States to receive full approval. Based on individual exposure and susceptibility to MenB, TRUMENBA can be administered to adolescents between the ages of 10 and 25 as two to three doses of vaccine. Currently, a study confirming the effectiveness of the two-dose regimen is underway.
In an October 2014 approval letter, Pfizer was asked to assess the safety and effectiveness of TRUMENBA for children as young as one year old. Currently, Phase 2 studies for this age group have been successfully completed, and these data support the breakthrough therapeutic approval of the vaccine.
“Although children between the ages of 1 and 9 develop invasive serotype B disease and this uncommon disease may have life-changing and long-term consequences, there is no approved MenB vaccine for this age group in the United States,†Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Vaccine Research, Pfizer Science and Clinical Affairs, said: "We look forward to working closely with the FDA to achieve our goals and expand the reach of those who may benefit from TRUMENBA."
We congratulate Pfizer's vaccine for re-establishing breakthrough therapy and expect it to protect young children as soon as possible.
Reference materials:
[1] Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9Years
[2] Pfizer official website
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