The FDA has approved a new Pfizer meningococcal vaccine whose simpler dosing schedule is expected to make it easier for children and young adults to get fully vaccinated to protect against a rare infection that can quickly become fatal within 24 hours.

FDA批准了一种新的辉瑞脑膜炎球菌疫苗，预计其更简单的给药方案可以使儿童和年轻人更容易接种疫苗，以防止在24小时内迅速致命的罕见感染。

Five groups of Neisseria meningitidis bacteria are the most common cause of meningococcal disease, which causes infections of the lining of the brain and spinal cord as well as the blood. For those who survive serious cases of the infection, the effects can still be long lasting.

五组脑膜炎奈瑟球菌细菌是脑膜炎球菌病的最常见原因，其引起脑和脊髓以及血液内层的感染。对于那些在严重感染病例中幸存下来的人来说，效果仍然可以持久。

Pfizer already had four of the culprit bacterial groups covered with a vaccine called Nimenrix. Another Pfizer vaccine called Trumenba covers the fifth group of bacteria. Penbraya, the meningococcal vaccine approved by the FDA on Friday, combines Nimenrix and Trumenba in a single shot. The regulatory decision covers use of this new vaccine in those ages 10 through 25.

辉瑞已经有四个罪魁祸首细菌群覆盖了一种名为Nimenrix的疫苗。另一种名为Trumenba的辉瑞疫苗涵盖了第五组细菌。Penbraya是FDA周五批准的脑膜炎球菌疫苗，它将Nimenrix和Trumenba一次性结合。监管决定涵盖10至25岁年龄段使用这种新疫苗。

Penbraya is administered as two intramuscular injections given six months apart..

Penbraya以相隔六个月的两次肌内注射给药。。

Penbraya is a bacterial vaccine. It works by what’s called active immunization, in which the immune system is prompted to produce antibodies against target pathogens. FDA approval of the new Pfizer vaccine is based on the results of clinical trials that compared Penbraya to currently available meningococcal vaccines.

Penbraya是一种细菌疫苗。它通过所谓的主动免疫起作用，其中免疫系统被提示产生针对靶病原体的抗体。FDA批准新的辉瑞疫苗是基于将Penbraya与目前可用的脑膜炎球菌疫苗进行比较的临床试验结果。

Results showed this vaccine was “noninferior,” meaning it was not worse at eliciting an immune response versus the comparator vaccines..

结果显示这种疫苗“不逊色”，这意味着与对照疫苗相比，引发免疫反应的效果并不差。。

“In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, senior vice president and head, vaccine research and development at Pfizer, said in a prepared statement..

“在单一疫苗中，Penbraya有可能通过在最少的射击中提供最广泛的脑膜炎球菌覆盖率来保护更多的青少年和年轻人免受这种严重和不可预测的疾病的侵害，”辉瑞公司疫苗研究与开发高级副总裁兼主管Annaliesa Anderson在准备好的声明中说。。

The Phase 3 study for Penbraya enrolled more than 2,400 patients from the U.S. and Europe. The most common adverse reactions were pain at the injection site, fatigue, headache, injection site redness, muscle pain, injection site swelling, joint pain, and chills. The vaccine’s label also cautions that Guillain-Barré syndrome, an immune response that damages nerves, has been reported after dosing of other meningococcal vaccines..

Penbraya的3期研究招募了来自美国和欧洲的2400多名患者。最常见的不良反应是注射部位疼痛，疲劳，头痛，注射部位发红，肌肉疼痛，注射部位肿胀，关节疼痛和发冷。该疫苗的标签还警告说，在给予其他脑膜炎球菌疫苗后，已经报道了格林-巴利综合征，一种损害神经的免疫反应。。

The next step for Penbraya is a recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. This vaccine is the first agenda item for the committee’s next meeting, scheduled for this Wednesday.

Penbraya的下一步是疾病控制和预防中心免疫实践咨询委员会的建议。这种疫苗是本周三召开的委员会下一次会议的第一个议程项目。

Pfizer isn’t the only company trying to offer protection against meningococcal infection with fewer shots. GSK’s pentavalent meningococcal vaccine candidate is a combination of that company’s approved vaccines, Bexsero and Menveo. In March of this year, the British pharmaceutical giant reported Phase 3 results showing this vaccine candidate, administered as two doses six months apart, was non-inferior to the two approved GSK meningococcal vaccines..

辉瑞并不是唯一一家试图以较少的镜头提供针对脑膜炎球菌感染的保护的公司。葛兰素史克的五价脑膜炎球菌候选疫苗是该公司批准的疫苗Bexsero和Menveo的组合。今年3月，英国药业巨头报告了第3阶段的结果，显示该候选疫苗间隔6个月两次给药，不逊于两种批准的GSK脑膜炎球菌疫苗。。

Photo: BSIP/Universal Images Group, via Getty Images

照片：BSIP/通用图像组，通过Getty图像

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