美国 FDA 在美国批准了 3-抗原乙型肝炎疫苗

StephenW

美国 FDA 在美国批准了 3-抗原乙型肝炎疫苗
2021 年 12 月 1 日 • 美国中部标准时间下午 12:01
（精准接种）

总部位于马萨诸塞州的 VBI 疫苗公司今天宣布，美国食品和药物管理局 (FDA) 已批准 PreHevbrio™ 疫苗用于预防 18 岁及以上成人由所有已知乙型肝炎病毒 (HBV) 亚型引起的感染。

PreHevbrio 包含 S、pre-S2 和 pre-S1 HBV 表面抗原。

它是美国唯一获批的成人 3 抗原 HBV 疫苗，在以色列以 Sci-B-Vac® 品牌出售。

VBI 预计将于 2022 年第一季度在美国推出 PreHevbrio，并已与 Syneos Health 合作以确保商业准备就绪。

乙型肝炎基金会高级副总裁、公共卫生学博士、公共卫生硕士 Chari Cohen 在一份新闻稿中表示，“拥有更多的疫苗选择将有助于我们有效扩大疫苗接种，确保更多人免受乙型肝炎感染，并实现 2030 年目标在美国消除乙型肝炎”

PreHevbrio 的批准基于两项 3 期临床研究 PROTECT 和 CONSTANT 的结果，其数据分别于 2021 年 5 月发表在《柳叶刀传染病》和 2021 年 10 月发表在《美国医学会杂志》网络上。

在美国以外，VBI 继续支持欧洲药品管理局对欧盟上市许可申请的持续审查。

VBI 预计将在 2022 年完成向英国药品和保健品监管局和加拿大卫生部提交的监管申请。

VBI 是一家位于马萨诸塞州剑桥市的生物制药公司，以免疫学为驱动力，追求强大的疾病预防和治疗。
—
凯伦·麦克洛里·哈克特

StephenW

U.S. FDA Approved 3-Antigen Hepatitis B Vaccine in the U.S.
December 1, 2021 • 12:01 pm CST
(Precision Vaccinations)

Massachusetts-based VBI Vaccines Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved the PreHevbrio™ vaccine for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older.

PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens.

It is the only Approved 3-antigen HBV vaccine for adults in the U.S. and is commercially available in Israel under the brand name Sci-B-Vac®.

VBI expects to make PreHevbrio available in the U.S. in the first quarter of 2022 and has partnered with Syneos Health to ensure commercial readiness.

Chari Cohen, DrPH, MPH, Senior Vice President of the Hepatitis B Foundation, stated in a press release, “Having more vaccine options will help us effectively expand vaccine uptake, ensure more people are protected from hepatitis B infection, and reach the 2030 goal of eliminating hepatitis B in the U.S.”

The approval of PreHevbrio was based on the results from two Phase 3 clinical studies, PROTECT and CONSTANT, data from which were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021.

Outside of the U.S., VBI continues to support the European Medicines Agency’s ongoing review of the marketing authorization application for the E.U.

And VBI expects to complete regulatory submissions to the U.K.’s Medicines and Healthcare products Regulatory Agency and Health Canada in 2022.

VBI is a biopharmaceutical company located in Cambridge, MA, driven by immunology to pursue powerful prevention and treatment of disease.
—
Karen McClorey Hackett