Hope for Pneumococcal Pneumonia Patients as FDA Grants Priority Review of Pfizer's Vaccine Candid...

肺炎球菌肺炎患者的希望随着FDA批准优先审查辉瑞公司的疫苗Candid.。。

2020-12-10 04:00:12 BioSpace

本文共1254个字,阅读需4分钟

Repelsteeltje/Shutterstock Pfizer is one step closer to receiving approval for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate after the Food and Drug Administration (FDA) on Wednesday granted priority review of a Biologics License Application (BLA) for the invasive disease and pneumonia vaccine. The investigational 20vPnC candidate was designed by Pfizer to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults. The vaccine includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine[Diphtheria CRM197 Protein]). The 20 serotypes in 20vPnC are responsible for most of the currently circulating pneumococcal disease in the U.S. as well as across the globe. Approval of the vaccine would be welcomed news for healthcare providers, as pneumococcal pneumonia causes hundreds of thousands of deaths and millions of episodes in adults aged 70 and older per year globally. “The FDA’s acceptance of our application for 20vPnC is yet another significant milestone in Pfizer’s continuing efforts to help protect adults against pneumococcal disease,” according to a statement made by Kathrin U. Jansen, Ph.D., Pfizer’s Senior Vice President and Head of Vaccine Research and Development. “If approved, 20vPnC will cover more serotypes responsible for the majority of pneumococcal disease than any other pneumococcal conjugate vaccine currently licensed or currently in late-stage clinical development. Importantly, 20vPnC has shown to induce immune memory, which provides protection and efficacy against non-bacteremic pneumonia, particularly in older adults.” The regulatory submission for 20vPnC includes data from Pfizer’s clinical program in adults, including Phase I and II trials studies as well as three Phase III trials (NCT03760146, NCT03828617, and NCT03835975). Data from these trials describe the safety and immunogenicity of the vaccine candidate, which the company hopes will support licensure for an indication for prevention of invasive disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years or older. To date, Pfizer’s three Phase III trials have recruited over 6,000 adults. The study cohorts also include several adults over the age of 65, a particularly vulnerable patient population. In addition, these studies included vaccine-naïve adults as well as adults who had received pneumococcal vaccination prior to entry. Earlier this year, Pfizer said its Phase III study of 20vPnC achieved the primary immunogenicity objectives of non-inferiority for the 20 serotypes in adults 60 years and older at one month after vaccination. The company also noted that the vaccine was comparable to other licensed pneumococcal vaccines on the market. Pfizer has been on a lengthy trajectory toward full approval of the vaccine. In September 2018, the FDA granted Breakthrough Therapy Designation for 20vPnC for preventing invasive disease and pneumonia associated with Streptococcus pneumoniae serotypes in adults. Previously, the FDA also granted the vaccine candidate Fast Track designation. Also, the agency granted Breakthrough Therapy Designation for 20vPn for a pediatric indication. But Pfizer isn’t the only pharmaceutical making headway in the fight against pneumococcal disease. In September 2020, Merck announced positive safety, tolerability and immunogenicity results of the company’s investigational 15-valent pneumococcal conjugate vaccine candidate, V114, in two Phase III studies. In one study, the vaccine was non-inferior to Pfizer’s PCV13, the existing 13-valent pneumococcal conjugate vaccine, in regard to the 13 serotypes targeted by both vaccines. In addition, Merck’s vaccine was superior for serotypes 22F and 33F, both of which are not targeted by PCV13.
Repelsteeltje/Shutterstock 周三,美国食品药品监督管理局(FDA)对侵袭性疾病和肺炎疫苗的生物制剂许可申请(BLA)进行了优先审查,辉瑞公司离其20价肺炎球菌结合疫苗(20VPNC)的候选产品获得批准又近了一步。 研究的20VPNC候选药物由辉瑞公司设计,用于预防成人肺炎链球菌血清型引起的侵袭性疾病和肺炎。该疫苗包括针对Prevnar 13®(肺炎球菌13价结合疫苗[白喉CRM197蛋白])中已经包括的13种血清型的荚膜多糖结合物。20VPNC中的20种血清型是目前在美国以及全球流行的肺炎球菌疾病的主要原因。 疫苗的批准对医疗保健提供者来说将是一个受欢迎的消息,因为肺炎球菌肺炎每年在全球造成数十万人死亡,并在70岁及以上的成年人中导致数百万次发作。 辉瑞高级副总裁兼疫苗研发主管Kathrin U.Jansen博士在一份声明中说:“FDA接受我们20vPNC的申请是辉瑞继续努力帮助保护成年人免受肺炎球菌疾病的又一个重要里程碑。”“如果获得批准,20VPNC将比任何其他目前获得许可或目前处于临床开发后期的肺炎球菌结合疫苗覆盖更多导致大多数肺炎球菌疾病的血清型。重要的是,20VPNC已经证明可以诱导免疫记忆,这对非菌血症肺炎提供了保护和效力,特别是在老年人中。“ 20VPNC的监管提交包括辉瑞成人临床项目的数据,包括I期和II期试验研究以及三个III期试验(NCT03760146,NCT03828617和NCT03835975)。这些试验的数据描述了候选疫苗的安全性和免疫原性,该公司希望这些试验将支持许可用于预防18岁或以上成人中由肺炎链球菌血清型引起的侵袭性疾病和肺炎球菌肺炎的适应症。 迄今为止,辉瑞的三个III期试验已经招募了6000多名成年人。研究队列还包括几个65岁以上的成年人,这是一个特别脆弱的患者群体。此外,这些研究包括未接种疫苗的成年人以及在入境前接受过肺炎球菌疫苗接种的成年人。今年早些时候,辉瑞公司表示,其20VPNC的III期研究在60岁及60岁以上成人接种后一个月达到了20种血清型无劣效的主要免疫原性目标。该公司还注意到,该疫苗可与市场上其他许可的肺炎球菌疫苗相媲美。 辉瑞一直在漫长的轨道上完全批准该疫苗。2018年9月,FDA授予20VPNC突破性治疗名称,用于预防成人肺炎链球菌血清型相关的侵袭性疾病和肺炎。此前,FDA还授予该疫苗候选快速通道指定。此外,该机构授予了20VPN的突破性治疗指定,用于儿科适应症。 但辉瑞并不是唯一在对抗肺炎球菌疾病方面取得进展的制药公司。2020年9月,默克公司宣布了该公司的调查性15价肺炎球菌结合疫苗候选者,V114在两项III期研究中的阳性安全性,耐受性和免疫原性结果。在一项研究中,就两种疫苗所针对的13种血清型而言,该疫苗并不逊色于辉瑞公司的PCV13,即现有的13价肺炎球菌结合疫苗。此外,Merck公司的疫苗对血清型22F和33F更为优越,这两种血清型均不是PCV13的靶向。

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文