Food and Drug Administration response to vaccine safety-vaccine, issues vaccine-IT information

Out of the cold chain of vaccines safe? Vaccine management system and international law are the same in China? Quality of domestic and imported vaccines there is no difference? Vaccine safety issues of social concern, the State food and Drug Administration posted 26th scientific knowledge to respond.

Question 1 from the cold chain of vaccines are safe and effective?

Vaccines out of the cold chain are not normally in the short term safety and effectiveness issues

Food and Drug Administration noted that, from a legal perspective, the vaccine cold chain conditions for transport and storage must be out of cold chain conditions for transport and storage is a serious offence, Act itself is not tolerated. From a scientific perspective, vaccines out of the cold chain are not normally in the short term safety and effectiveness issues. This depends on the stability of the vaccine prior to listing to it through the rigors of testing and challenging tests.

Stability testing, namely a vaccine before the approval, through long-term stability tests to make sure the vaccine is valid. In accordance with the relevant technical requirements, stability test requirements will lose at least 6 months validity as a vaccine. For example provided an instruction is valid for two years, actual stability test must be more than 2.5 years.

Challenge test is a thermal stability test under extreme conditions, a different vaccine, under the condition of high temperature at 37 degrees Celsius for 1-4 week. If storage 1-4 week, vaccines meet quality standards, can only be shipped.

Question 2 do our vaccine management system differ from the international

China quality management system in line with international standards?

Food and Drug Administration said that according to who assessments of national vaccine management system requirements, improving vaccine quality management system on the basis of national vaccine regulatory covers 6 functions: public licensing, postmarketing Regulation (including the monitoring of adverse reactions after vaccination), regulatory inspections, lot release, laboratory management and regulation of clinical trials, ranging from vaccine research and development to all aspects of the use. 2011 China through the who national vaccine regulatory system to assess for the first time, means China′s vaccine quality management system in line with international standards. Maturity with the vaccine management system continuous improvement, continuous improvement, in 2014, China has successfully adopted the system of complex assessments.

According to the introduction, through the who vaccine management system to evaluate vaccine production enterprise applies for who′s vaccine prequalification vaccine procurement by international organizations such as the United Nations preconditions. At present, the limited liability company Chengdu Institute of biological products in the production of Japanese encephalitis live attenuated vaccine with hualan biological production of flu vaccine prequalification, in United Nations procurement plan.

Question 3 domestic and imported vaccine quality difference?

Quality standards match international standards, some indicators better than international standards

According to the food and Drug Administration introduced, listing all vaccines must comply with the national drug standard, including the People′s Republic of China Pharmacopoeia and Drug Administration promulgated the national drug standards. Listed drugs, whether domestic or imported products, during the term of the security and validity of indexes may not be lower than the pharmacopoeia requirements. For years, China as the world′s largest vaccine producers and users, in vaccine research and development, production and quality control of accumulated experience, vaccine quality standards continue to improve, you can stand next to the international level, some indicators are even better than international standards, such as vaccine safety testing program.

In 2013, after rigorous evaluation who expert group, China has become the WHO Collaborating Centre for Biological Standardization and evaluation, more deeply involved in the work on the international standard of biological products, vaccines in China to further improve the quality standard of play a positive role.

Question 4 the listed countries will test?

Drug regulators regularly postmarket surveillance sampling

Food and Drug Administration noted that the listing of the vaccines also face random testing. Biologics, including vaccines, drug regulators regularly postmarket surveillance sampling, the samples pulled from circulation in the market, testing the vaccine quality. From years of postmarket surveillance and vaccine lot release sampling, listed vaccine safety and efficacy of the product is stable and controllable.

食药监总局回应疫苗安全问题 - 疫苗,问题疫苗 - IT资讯

脱离冷链的疫苗是否安全？我国疫苗管理体系与国际是否相同？国产疫苗与进口疫苗质量有无差别？针对社会关心的疫苗安全问题，国家食品药品监管总局26日发布科普知识予以回应。

问题1 脱离冷链的疫苗是否安全有效？

疫苗短期内脱离冷链一般不会产生安全性和有效性的问题

食药监总局指出，从法律层面讲，疫苗必须在冷链条件下运输储存，脱离冷链条件进行运输储存是严重的违法行为，行为本身是不可容忍的。从科学层面讲，疫苗短期内脱离冷链一般不会产生安全性和有效性的问题。这有赖于疫苗在上市前要经过苛刻的稳定性试验和挑战试验。

稳定性试验，即一种疫苗在批准上市前，要经过长期稳定性试验来确定疫苗有效期。按有关技术的要求，在稳定性试验要求的基础上至少要减掉6个月，才能作为疫苗的有效期。比如一个药物说明书上规定有效期为两年，实际经稳定性试验验证的时间一定要超过两年半。

挑战试验，是一种在极端条件下的热稳定性试验，将不同的疫苗，在37摄氏度高温条件下放置1—4周。如果储存1—4周，疫苗质量符合标准，才可以出厂。

问题2 我国的疫苗管理体系与国际有区别吗

中国疫苗质量管理体系符合国际标准？

食药监总局表示，根据世卫组织国家疫苗管理体系评估要求，在完善的疫苗质量管理体系的基础上，国家疫苗监督管理涵盖了6项职能：上市许可、上市后监管（包括接种后不良反应监测）、批签发、实验室管理、监管检查和临床试验监管，覆盖了从疫苗研发到使用的各个环节。2011年中国首次通过世卫组织国家疫苗管理体系评估，意味着中国疫苗质量管理体系符合国际标准。随着我国疫苗管理体系成熟度持续改进、不断完善，我国于2014年顺利通过了该体系的复评估。

据介绍，通过世卫组织疫苗管理体系评估也是疫苗生产企业申请世卫组织疫苗预认证获得联合国等国际组织疫苗采购的前提条件。目前，我国成都生物制品研究所有限责任公司生产的乙型脑炎减毒活疫苗和华兰生物生产的流感疫苗已通过疫苗预认证，纳入联合国采购计划。

问题3  国产与进口疫苗质量有区别吗？

质量标准可比肩国际水平，有些指标优于国际标准

据食药监总局介绍，所有上市疫苗必须符合国家药品标准，包括《中华人民共和国药典》和药监部门颁布的国家药品标准。在我国上市的药品，无论国产或进口制品，在其有效期内各项安全性和有效性指标均不得低于药典要求。多年来，中国作为世界上最大的疫苗生产国和使用国，在疫苗研发、生产和质量控制方面不断积累经验，疫苗质量标准不断提高，可以比肩国际水平，有些指标甚至优于国际标准，如疫苗安全性检测项目。

2013年，经过世卫组织专家组严格考评，中国成为世卫组织生物制品标准化和评价合作中心，更深入地参与到国际生物制品标准的制定工作中，对我国疫苗质量标准的进一步提高起到积极作用。

问题4  疫苗上市后国家还会检查吗？

药品监管部门定期组织上市后监督抽验

食药监总局指出，疫苗上市后还要面对随机抽验。药品监管部门对包括疫苗在内的生物制品定期组织上市后监督抽验，即从市场流通环节抽取样品，检验疫苗质量。从多年的疫苗批签发和上市后监督抽验情况可见，我国上市疫苗产品的安全性和有效性是稳定可控的。