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印度的药物监管机构拒绝将紧急用途授权授予烟囱灯
金属科学
金属科学

印度的药物监管机构拒绝将紧急用途授权授予烟囱灯

俄罗斯的Sputnik v疫苗的一批货物。照片:路透社/ Manaure Quintero / File照片

新德里/海德拉巴:印度的药物监管机构拒绝将紧急使用授权授予单剂量Covid-19疫苗烟囱光线,同时裁定了该国俄罗斯疫苗的第3阶段试验的必要性。

根据7月30日举行的主题专家委员会(SEC)会议的建议,该会议已被印度(DCGI)的药物控制人员(DCGI)批准,Sputnik-Light与Sputnik v的组件-1和其安全相同在这里的试验中,印度人口中的免疫原性数据已经在审判中产生,似乎不充分的数据和理由进行单独的类似试验。

According to the SEC recommendations, which were uploaded on the Central Drugs Standard Control Organisation (CDSCO) website on Thursday, Dr Reddy’s Laboratories had submitted a proposal to the DCGI seeking market authorisation of Sputnik-Light, along with the interim safety and efficacy data generated from the phase 1/2 clinical trials in Russia, and presented the protocol for conducting the phase-3 clinical trial of the vaccine in India before the committee.

CDSCO的秘书审议申请,注意到Sputnik-Light与Sputnik V的组件-1相同。

此外,该公司已经在该国产生了组件-1的安全性和免疫原性数据。

委员会还指出,俄罗斯普鲁尼克光的第3阶段疗效试验正在进行,尚未生成疗效数据,读取秒的建议。

“经过详细审议,委员会建议该公司应在俄罗斯在俄罗斯进行的烟囱光的第3阶段临床试验的安全性,免疫原性和疗效数据,以便考虑授予MA的补助金(市场授权)) 在国内。

“此外,由于印度人群中的组件-1的安全性和免疫原性数据已经在另一次审判中生成,似乎在进行单独的类似审判时似乎不足,”建议读书“。

In a statement, a spokesperson of Dr Reddy’s Laboratories said: “In view of the fact that (1) Sputnik-Light is the first-dose component of Sputnik V and Dr Reddy’s has already generated the safety and immunogenicity data on the first-dose component in India through its clinical trial and (2) a phase-3 efficacy trial is currently underway in Russia on Sputnik-Light, the SEC recommended that: Dr Reddy’s should submit the safety, immunogenicity and efficacy data from the phase-3 clinical trial of Sputnik-Light in Russia to the SEC for its consideration of Market Authorisation of Sputnik-Light in India.

“Further, the SEC also observed that in view of the safety and immunogenicity data already generated by Dr Reddy’s in India on the first-dose component of Sputnik V (in other words, Sputnik-Light), there was no need for a separate phase-3 trial of Sputnik-Light in India.”

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