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Recombinant shingles vaccine approved for listing

Recombinant shingles vaccine approved for listing

Release time:
2019/05/27
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  Recently, in order to implement the spirit of the executive meeting of the State Council, the State Food and Drug Administration has continued to accelerate the clinical registration of overseas urgently needed drugs imported from China. The State Drug Administration has conditionally approved the reorganization of herpes zoster vaccine (English name: Herpes zoster vaccine (recombinant, adjuvanted)) Import registration application for the prevention of herpes zoster in adults 50 years and over.

 
Shingles is an infectious disease caused by the varicella-zoster virus. It usually appears as a rash that appears on one side of the body with pain and itching. It can last for two to four weeks, and the risk of disease increases with age. high. A common complication is postherpetic neuralgia, which can last from months to years, seriously affecting the normal work and life of the patient. In China, nearly 3 million adults are affected by herpes zoster every year. Due to the lack of effective prevention and treatment methods for the disease in China, the State Food and Drug Administration and the National Health and Health Commission have included the recombinant shingles vaccine in the first batch of 48 clinically-needed new drugs to speed up the review and approval process. In order to improve the efficiency of the review, the Drug Review Center of the State Food and Drug Administration has conducted a lot of in-depth and detailed communication and exchange work with the applicant, and held two expert consultation meetings to conduct collective research to scientifically evaluate overseas data (including the Asian subgroup), in Under the premise of fully demonstrating the safety and effectiveness, combined with the characteristics of the product itself, conditionally approve the listing of this product.
 
This product uses DNA recombination technology to express varicella zoster virus glycoprotein E in Chinese hamster ovary cells. It is made by culturing, harvesting, purifying and lyophilizing. It has good protective effect on herpes zoster and is suitable for 50 Prevention of herpes zoster in adults and older. This product has two doses of immunization program and intramuscular injection. Common adverse reactions include pain, redness, swelling, and myalgia, fatigue, headache, fever, and gastrointestinal symptoms. The State Food and Drug Administration, while conditionally approving the listing of this product, requested an application for the problem that the product has been listed overseas but lacks comprehensive domestic epidemiological data, and whether the use of new adjuvants will lead to potential immune-mediated disease risks. People continue to do post-marketing research in an all-round way, carry out pharmacovigilance in a timely manner, update clinical safety and effectiveness data at home and abroad, and improve instruction manuals to fully ensure the safety, effectiveness, and controllability of patients' medication.
 
Since the release of the first batch of clinically-needed overseas market drug catalogs, the State Food and Drug Administration has approved the registration of 15 varieties for import. In the next step, the State Food and Drug Administration will continue to implement the relevant requirements for deepening the reform of the drug review and approval system, continue to accelerate the listing of clinically-needed drugs in China, and better meet the people's drug demand.