[新闻] WHO批准泰国产AZ疫苗列入紧急使用清单

楼主: j1300000 (JSL)   2021-10-15 16:04:15
完整标题:
WHO approves Siam Bioscience’s AstraZeneca vaccine for emergency use
发稿单位:Thai PBS
发稿时间:2021.10.14
撰 稿 者:无
原文连结:https://bit.ly/2YQ0xN4
The World Health Organization (WHO) has approved Siam Bioscience Company
Limited, a Thai company, as a qualified production site for AstraZeneca
vaccine and added the company to its Emergency Use Listing (EUL).
A letter, dated October 11th, from Dr. Rogério Gaspar, director of the WHO’
s Regulation and Prequalification Department, addressed to Dr. Etleva
Kadilli, director of the Supply Division of UNICEF, reads as follows:
“We are pleased to inform you of the positive recommendation of an
alternative manufacturing site, Siam Bioscience Co., Ltd. , 99 Moo 4,
Banmai, Bangyai, Nonthaburi 11140, Thailand, for the AstraZeneca (COPVID-19
vaccine suspension for injection.
This site includes the manufacturing of drug substance and drug product.
This recommendation is based on the data reviewed by the WHO and the positive
opinion issued by the Australia Therapeutic GoodsAdministration (TGA), which
is the regulatory authority of record for this vaccine.
Therefore, Siam Bioscience Co., Ltd. is added to the list of alternative
manufacturing sites forAstraZeneca AB, as part of the EUL, granted to the
company.”
Wholly owned by a subsidiary of the Crown Property Bureau, Siam Bioscience
was established in 2009 to preserve and continue what the late King Bhumibol
Adulyadej started in support of the Thai people’s health and wellbeing.
Its main products are biopharmaceuticals, to reduce Thailand’s dependence on
imported active ingredients and medicines, strengthening public health and
facilitating sustainable health care.
In November 2020, Siam Bioscience, Siam Cement Group, AstraZeneca and Public
Health Ministry signed a letter of intent to commit to making COVID-19
vaccine available in Southeast Asia. A production agreement was subsequently
signed between AstraZeneca and Siam Bioscience.
Millions of doses of the AstraZeneca vaccine, produced by Siam Bioscience,
have already been delivered to the Ministry of Public Health.
AstraZeneca官网也有公告,这个紧急使用授权是立即生效的,不过WHO官网上的清单好像
还没有更新就是了。
台湾目前也没看到主流新闻媒体有相关报导,所以先贴泰国公共媒体的英文报导出来给大
家看。
之前有看到一些规定比较严格的国家会认产地,这次WHO把泰国产AZ疫苗列入EUL后,至少
能确定在台湾打到的AZ疫苗都是有WHO认证的,有出国需要的人应该会比较安心。

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