Simplified Chinese
Recombinant zoster vaccine approved for market launch.
Release date:
2019-05-27
Author:
Article/Excerpted from the National Medical Products Administration
Source:
Abstract
Recently, in order to implement the spirit of the State Council Executive Meeting, the National Medical Products Administration has continued to expedite the import registration of urgently needed drugs already approved for marketing overseas. The NMPA has conditionally approved the import registration application for a recombinant, adjuvanted herpes zoster vaccine, intended for the prevention of shingles in adults aged 50 years and older.
Herpes zoster is an infectious disease caused by the varicella–zoster virus, typically presenting as a painful, pruritic rash that appears on one side of the body and may persist for two to four weeks. The risk of developing the condition increases with age. A common complication is postherpetic neuralgia, which can last from several months to several years and significantly impairs patients’ ability to work and carry out daily activities. In China, nearly 3 million adults are affected by herpes zoster each year. Given the lack of effective preventive and therapeutic measures in the country, the National Medical Products Administration, in collaboration with the National Health Commission, has included the recombinant zoster vaccine among the first batch of 48 urgently needed new drugs, thereby expediting the review and approval process. To enhance review efficiency, the Center for Drug Evaluation of the NMPA engaged in extensive, in-depth, and meticulous communication with the applicant and convened two expert advisory meetings for collective deliberation, scientifically evaluating overseas data—including data from Asian subpopulations. On the basis of thorough evidence demonstrating safety and efficacy, and taking into account the product’s specific characteristics, the vaccine was granted conditional marketing authorization.
This product is manufactured using recombinant DNA technology, expressing the varicella‑zoster virus glycoprotein E in Chinese hamster ovary cells. After cultivation, harvesting, purification, and lyophilization, it has demonstrated good protective efficacy against herpes zoster and is indicated for the prevention of shingles in adults aged 50 years and older. The recommended immunization schedule consists of two doses administered by intramuscular injection. Common adverse reactions include pain, erythema, and swelling, as well as myalgia, fatigue, headache, fever, and gastrointestinal symptoms. Concurrent with its conditional approval, the National Medical Products Administration has stipulated that, given the lack of comprehensive domestic epidemiological data despite the product’s prior marketing overseas and concerns about whether the novel adjuvant may increase the risk of potential immune‑mediated adverse events, the applicant must continue to conduct thorough post‑marketing studies, promptly implement pharmacovigilance activities, update domestic and international clinical safety and efficacy data, and revise the product labeling to ensure patient safety, efficacy, and controllable risks.
Since the release of the first list of urgently needed drugs for clinical use that are already marketed overseas, the National Medical Products Administration has approved the import registration of 15 products. Moving forward, the NMPA will continue to implement the requirements for deepening reform of the drug review and approval system, further accelerating the availability of clinically urgent medicines in China to better meet the public’s needs for safe and effective medications.
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