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12月31日,国务院联防联控机制发布,国药集团中国生物新冠灭活疫苗已获得国家药监局批准附条件上市。

China announced it has granted conditional market approval for its first COVID-19 vaccine during a Thursday news conference.

在发布会上,国家药品监督管理局副局长陈时飞介绍,国药集团中国生物新冠灭活疫苗已获得国家药监局批准附条件上市。已有数据显示,保护率为79.34%,实现安全性、有效性、可及性、可负担性的统一,达到世界卫生组织及国家药监局相关标准要求。后续,疫苗免疫的持久性和保护效果还需持续观察。

The inactivated vaccine, which got the approval from the National Medical Products Administration (NMPA), is developed by the Beijing Biological Products Institute Co., Ltd. under the China National Biotec Group (CNBG), which is affiliated with Sinopharm. The interim results of its phase-3 clinical trials show 79.34 percent efficacy against COVID-19, meeting the standards of the World Health Organization and the NMPA, according to a press conference by the State Council joint prevention and control mechanism against COVID-19.



12月25日,工作人员在国药集团中国生物北京生物制品研究所的新冠病毒灭活疫苗分包装车间内检查产品包装质量。新华社记者 张玉薇 摄 图源:新华网


01
疫苗价格如何?
在发布会上,国家卫健委副主任、国务院联防联控机制科研攻关组疫苗研发专班负责人曾益新表示,疫苗的基本属性是公共产品,价格可能会根据使用规模的大小有所变化,但是一个大前提是,为全民免费提供

"This vaccine will be provided free of charge to all Chinese people," said Zeng Yixin, deputy head of the National Health Commission (NHC), at the press conference.
02
新冠变异病毒对疫苗的使用效果是否有影响?
发布会上,徐南平表示,科研攻关组召开多次会议,专家认为目前没有证据证明新冠变异病毒会对疫苗的使用效果造成实质性影响,但需要高度关注。
There is currently no evidence to prove that existing genetic mutations in the novel coronavirus can have a substantial effect on the potency of COVID-19 vaccines, Xu Nanping, vice-minister of science and technology, said in a news briefing on Thursday.
徐南平表示,病毒变异每天都在发生,病毒长期传播可能会产生一些变化,这种变异现在对疫苗使用没有产生影响,但是未来有可能产生影响,我们就当做它一定会产生影响来进行科技工作部署。我们有信心来应对病毒变异对疫苗使用效果产生的影响,我们一定会为老百姓提供安全、有效、可及的疫苗。
03
我国重点人群接种疫苗超300万剂次,安全性良好
发布会上,曾益新介绍新冠疫苗重点人群接种工作情况。他表示,我国疫苗研发始终属于全球第一方阵:
  • 自12月15日正式启动重点人群接种工作以来,目前累计接种超过300万剂次
  • 接种结果充分证明我国疫苗安全性良好,发生了一定比例的不良反应,总的发生率与常规接种的灭活疫苗接近。
  • 主要表现是局部疼痛、硬结,轻度发热比例大概不到0.1%过敏等比较严重的情况为百万分之二,这些情况经过及时处理都得到很好的治疗。
  • 接下来将全面推进老年人和有基础疾病的人群进行接种,后续再开展其他普通人群的接种,未来符合条件的群众都将实现“应接尽接”。
On Dec 15, China officially launched a vaccination program for this winter-spring period targeting a number of key groups, including those engaged in handling imported cold-chain products, customs officers, medical workers and people working in public transport and fresh markets. In the past 15 days, the number of doses of vaccination among the key groups exceeded 3 million.
"The 3 million vaccine doses, plus the previous 1.5 million doses, fully prove that Chinese vaccines are safe," Zeng noted.
After the COVID-19 vaccines are approved to enter the market, especially when production capacity increases, China will comprehensively vaccinate senior citizens, people with underlying conditions, and the general public in an orderly manner, the NHC official said.

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综合:中国日报 新华社央视新闻
编辑:严琦 值班首编:张薇薇
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