Panel grants emergency-use approval to Russia-made Covid vaccine Sputnik V

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On September 2020, Direct Reddy and Russian investment funds (RDIF) signed partnerships to conduct clinical trials of Sputnik V vaccines and rights to distribution in India

A medical specialist holds a vial of Sputnik V vaccine.
A medical specialist holds a vial of Sputnik V vaccine.

A committee under the Indian drug regulator is reviewed and approves the application of Russian emergency use – artificial Coronavirus Sputnik Vacine V on Monday based on strong immunogenicity data.

Medication Controller General India will formally approve vaccines based on emergency use based on expert panel recommendations.

In the previous meeting, the Subject Expert Committee (SEC) from the Central Medicine Standard Organization (CDSCO) searched for more data from the Laboratory of Dr. Reddy, who was conducting a clinical trial for the Covid-19 vaccine made by Russia locally. The efficacy of the vaccine was set at AT91.6% based on the final control point of the clinical trial in Russia.

Sputnik V is the next front runner for approval in India,

after Bharat Biotech Covaxin developed jointly by the Indian Medical Research Council, and Oxford-Astrazeneca vaccine produced locally by the Indian Serum Institute with the Covishield brand name.

Both vaccines are currently approved for use in India for Covid-19 National Immunization Program. India launched the Nationwide Covid-16 immunization drive on January 16, 2021, and has since given at least 100 million doses of Covid-19 vaccine.

On September 2020,

Direct Reddy and Russian investment funds (RDIF) signed a partnership to conduct clinical trials of Sputnik V vaccines and rights to distribution in India.

Sputnik V developed by Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Ministry of Health and became the first registered vaccine in the world against Covid-19 based on an established human adenoviral vector platform.

In the 144th meeting held on February 24 – to examine the proposal related to Covid-19 under the accelerated approval process, CDSCO SEC asked the company that presented the case for the authorization of emergency use, to return with Indian special immunogenicity data.

“The company presented a proposal for giving permission to import (marketing authorization) for the emergency use of a combined vector GAM Covid Vaccine (component one and component two) along with the safety & immunogenicity data from phase II phase II / III clinical trials in India and temporary safety, properties & Immunogenicity data from phase III clinical trials abroad, “said seconds at the previous meeting to consider sputnik applications, according to the minutes of the published meeting.

“After the detailed deliberation, the committee recommends that the company must submit immunogenicity data and the safety of phase II and III trials according to the protocol approved for further consideration of the committee. Furthermore, the company was asked to present the data more clearly,” recommended the committee.

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