China NMPA Conditionally Approves Recombinant Zoster Vaccine for Adults Aged 50 and Older

On May 22, the National Medical Products Administration conditionally approved the import registration application for the recombinant zoster vaccine (English name: Herpes zoster vaccine (recombinant, adjuvanted)). This vaccine is indicated for the prevention of herpes zoster in adults aged 50 years and older.

Herpes zoster is an infectious disease caused by the varicella-zoster virus, typically presenting as a painful and pruritic rash on one side of the body that lasts two to four weeks, with the risk of infection increasing with age. A common complication is postherpetic neuralgia, where pain can persist for months to years, severely impacting patients' normal work and daily life.

Currently, nearly 3 million adults in China are affected by herpes zoster each year. Due to the lack of effective prevention and treatment measures for this disease in China, the National Medical Products Administration, in conjunction with the National Health Commission, has included the recombinant herpes zoster vaccine in the first batch of 48 new drugs urgently needed for clinical use, so as to accelerate the review and approval process.

It is reported that the recombinant zoster vaccine is a novel recombinant vaccine developed by GSK. It consists of the glycoprotein E (gE) of the varicella-zoster virus combined with the novel adjuvant AS01B. The safety and efficacy of this vaccine were validated in a comprehensive Phase III clinical trial, in which Shingrix demonstrated greater than 90% efficacy in preventing herpes zoster across all age groups. The vaccine was first approved for marketing in Canada in September 2017, received FDA approval in October of the same year, and was also approved for marketing in the European Union and Japan in late March of this year.

With the full demonstration of safety and efficacy by the Center for Drug Evaluation of the National Medical Products Administration and the applicant, this product is expressed in Chinese hamster ovary cells to produce varicella-zoster virus glycoprotein E, and is manufactured through cultivation, harvesting, purification, and lyophilization. It provides good protective efficacy against herpes zoster and is suitable for the prevention of herpes zoster in adults aged 50 years and older. The immunization schedule consists of two doses administered via intramuscular injection. Common adverse reactions include pain, redness, swelling, as well as myalgia, fatigue, headache, fever, and gastrointestinal symptoms.

The National Medical Products Administration (NMPA) stated that, while granting conditional approval for the marketing of this product, it requires the applicant to continue conducting comprehensive post-marketing studies. This is in response to concerns such as the lack of comprehensive domestic epidemiological data despite the product’s overseas availability, and the potential risk of immune-mediated diseases associated with the use of a novel adjuvant. The applicant is required to promptly carry out pharmacovigilance activities, update clinical safety and efficacy data both domestically and internationally, and refine the package insert, thereby fully ensuring that the medication is safe, effective, and has controllable risks for patients.