InvestorQ : What is the status of the emergency approval of the Russian vaccine, Sputnik, that is being tested and marketed by Reddy Labs in India?
Rashi Mehra made post

What is the status of the emergency approval of the Russian vaccine, Sputnik, that is being tested and marketed by Reddy Labs in India?

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Archita Jajjoo answered.
10 months ago
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The Subject Expert Committee or the SEC was specifically appointed by the Central Drugs Standard Control Organization or CDSCO to give the expert and considered opinion on whether a particular vaccine candidate for COVID-19 should be given the approval to go ahead or not. This has been the standard format followed by the CDSCO in all the previous cases including the Astra Zeneca vaccine and also the Pfizer vaccine.

In its latest report after studying the data on trials submitted by Reddy Labs, the SEC of the CDSCO has asked Reddy Labs to present more data of immunogenicity while evaluating its application for Emergency Use Authorisation of the Russian COVID vaccine. Reddy Labs is the official Indian partner to test Sputnik V in India and seek necessary regulator approvals as well as manufacture and market the same.

Sputnik V is a vaccine candidate manufactured by RDIF of Russia and has already secured emergency use approval from a number of countries. Reddy Labs, it may be recollected, had partnered with RDIF of Russia way back in Sep-20 to conduct comprehensive clinical trials on stratified samples of individuals of Sputnik V and the distribution rights in India. It is currently in Phase 3 clinical trials.

In the meanwhile, the SEC of CDSCO has also instructed the Hyderabad-based Bharat Biotech headed by Sridhar Ella to submit efficacy data of COVAXIN before seeking its trial on children. COVAXIN is the only COVID drug that is entirely developed indigenously in India as a joint venture between Bharat Biotech and the National Institute of Virology, Pune. This is the second vaccine candidate that is already approved, apart from COVISHIELD of Astra Zeneca.

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