InvestorQ : Why has the Expert Group not approved the Russian COVID vaccine, Sputnik-V?
Neelam Naik made post

Why has the Expert Group not approved the Russian COVID vaccine, Sputnik-V?

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Anu Biswas answered.
8 months ago
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The expert group that takes the final decision on the approval of COVID vaccines has sought more data on safety, efficacy and logistics before it can approve the vaccine. As a result, no approval was given to Sputnik V which it was taken up for discussion on 01 April. One of the challenges in logistics in the Russian Sputnik-V vaccine is that the cold chain requirements were at -25 degrees, which is not available on commercial scale.

In an earlier submission, Dr Reddy Laboratories which is the official partner for Sputnik had averred that the vaccine required minus 18 degrees Celsius. DRL has partnered with RDIF of Russia not only for conducting clinical trials of the vaccine candidate but is also responsible for distribution of the vaccine domestically. The Phase-3 studies concluded on 21 February and had undergone a bridge trial in India on a sample of 1600 candidates.

In the first meeting, DRL had indicated that they were working on a new version of Sputnik-V which could be stored between 2 and 8 degrees Celsius. However, the new version is apparently not ready, forcing the expert panel to put off the approval.

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