COVAXIN® was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability.
The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally.
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该疫苗由灭活的SARS-CoV-2抗原配制而成，采用单剂量瓶以及5、10和20剂的多剂量瓶形式。
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
COVAXIN® was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e.
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免疫战略咨询专家组建议为所有18岁及以上年龄组接种两剂疫苗，剂量间隔为四周。
The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.
COVAXIN® was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.
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关于孕妇接种疫苗的现有临床试验数据尚不足以评估疫苗在怀孕期间的安全性或效力；
Available data from clinical trials on vaccination of pregnant women are insufficient to assess vaccine safety or efficacy in pregnancy; however, initial studies were reassuring.
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不过，初步研究令人鼓舞。
The vaccine has been given to over 120 000 pregnant women in India, with no short-term adverse effects noted.
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印度已有超过12万名孕妇接种了该疫苗，未发现短期不良反应。
Further studies in pregnant women are planned.
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紧急使用列表程序评估在突发公共卫生事件中新卫生产品的适用性。
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies.