EMA委员会规则有利于VBI疫苗乙型肝炎

StephenW

     
EMA Committee Rules Favorably on VBI Vaccine for Hepatitis B
by Daniela Semedo, PhD

A committee of the European Union's drug regulatory agency has given its blessing to Sci-B-Vac, a vaccine for hepatitis B developed by Massachusetts-based VBI Vaccines.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive review for Sci-B-Vac, a licensed third-generation vaccine with proven efficacy and safety in more than 300,000 hepatitis B patients. The vaccine is currently approved for use in 15 countries.

Francisco Diaz-Mitoma, MD, PhD, VBI’s chief medical officer, said Sci-B-Vac "has an extensive safety and efficacy track record" in 22 clinical studies involving more than 4,000 children and adults.

“We are encouraged by the feedback received by the CHMP at EMA, and believe VBI is now well-positioned to advance its pivotal studies in Europe to obtain registration and licensure of Sci-B-Vac," Diaz-Mitoma said in a Feb. 7 press release.

According to the company, the CHMP also gave its support to move Sci-B-Vac into Phase 3 clinical trials. In addition, the EMA also agreed that product information and data from ongoing studies supports such Phase 3 clinical trials, as well as the filing of a market authorization application (MAA) for Sci-B-Vac.

Pharmaceutical companies must submit MAAs to the London-based EMA in order to market a newly developed medicinal product in the EU's 28 member states.

VBI also said it may conduct pivotal Phase 3 clinical trials with the U.S. Food and Drug Administration (FDA) and Health Canada. More information about these clinical trials will be made available once VBI holds formal discussions with these agencies.

Sci-B-Vac is a vaccine that mimics all three surface antigens of the hepatitis B virus (HBV), offering high levels of anti-HBV antibodies and a rapid onset of protection. Unlike second-generation hepatitis B vaccines— which contain only one surface antigen — Sci-B-Vac contains the surface antigen as well as the pre-S1 and pre-S2 surface antigens.

VBI says that by mimicking three HBV surface antigens, Sci-B-Vac may help the immune system react with antibodies that can identify one or more components of the HBV, offering a better protection. Moreover, the vaccine can be given at lower doses than competing hepatitis B vaccines, and is free of next-generation adjuvants.

VBI has research operations in Canada as well as research and manufacturing facilities in Israel. According to the World Health Organization, 240 million people are chronically infected with hepatitis B, and more than 780,000 people die every year due to complications related to the virus.

StephenW

EMA委员会规则有利于VBI疫苗乙型肝炎
作者：Daniela Semedo，博士

欧洲联盟药物管理机构的一个委员会给予了它的祝福Sci-B-Vac，一种由马萨诸塞州VBI疫苗开发的乙型肝炎疫苗。

欧洲药品管理局（EMA）人用药物制品委员会（CHMP）对Sci-B-Vac（一种获得许可的第三代疫苗，已在超过300,000例乙型肝炎患者中证明有效和安全）进行了积极评价。该疫苗目前已批准在15个国家使用。

VBI首席医疗官Francisco Diaz-Mitoma博士说，Sci-B-Vac在22项涉及4000多名儿童和成人的临床研究中具有广泛的安全性和有效性记录。

“我们对CHMP在EMA收到的反馈感到鼓舞，并且相信VBI现在在欧洲推进其在欧洲的关键研究，以获得Sci-B-Vac的注册和执照，”Diaz-Mitoma在2月。 7新闻稿。

根据该公司，CHMP还支持将Sci-B-Vac转入第3阶段临床试验。此外，EMA还同意，正在进行的研究的产品信息和数据支持此类3期临床试验，以及为Sci-B-Vac提交市场授权申请（MAA）。

制药公司必须向位于伦敦的EMA提交MAA，以便在欧盟28个成员国推广新开发的药品。

VBI还表示，它可能与美国食品和药物管理局（FDA）和加拿大卫生部进行关键的3期临床试验。一旦VBI与这些机构进行正式讨论，将会提供有关这些临床试验的更多信息。

Sci-B-Vac是一种模拟乙型肝炎病毒（HBV）的所有三种表面抗原的疫苗，提供高水平的抗HBV抗体和快速起效的保护。与仅含有一种表面抗原的第二代乙型肝炎疫苗不同--Sci-B-Vac含有表面抗原以及前S1和前S2表面抗原。

VBI说，通过模拟三种HBV表面抗原，Sci-B-Vac可以帮助免疫系统与可识别HBV的一种或多种组分的抗体反应，提供更好的保护。此外，疫苗可以以比竞争性乙型肝炎疫苗更低的剂量给予，并且不含下一代佐剂。

VBI在加拿大拥有研究业务，以及在以色列的研究和制造设施。根据世界卫生组织，2.4亿人长期感染乙型肝炎，每年有超过78万人死于与病毒有关的并发症。