An expert panel of India’s drugs regulator on Monday recommended emergency use approval of Russia’s Sputnik V coronavirus vaccine, according to officials, paving the way for the country to have access to a third vaccine at a time when several regions are reporting shortages and as infections continue to surge.
The recommendation, issued by the subject expert committee (SEC), now awaits a formal approval by the drugs controller general of India (DCGI), who heads the Central Drugs Standards Control Organisation (CDSCO). SEC analysed data from Sputnik V’s full clinical trials in Russia as well as a smaller bridging study in India.
“The final decision on the approval will be of the drugs controller general of India. Normally, the drugs controller adheres to the SEC recommendations. The vaccines for initial use might be imported but it is for the companies to decide eventually. It always helps to have multiple options to choose from when you are trying to control a pandemic,” said a senior government official, asking not to be named.
The vaccine’s efficacy is pegged at 91.6% based on the final assessment of clinical trials in Russia, where roughly 20,000 people were part of the Phase 3 study. In India, the vaccine is being tested in 1,600 people in a phase 2/3 trial meant as a “bridging study” that all foreign-made pharmaceutical products need to undergo.
{{/usCountry}}The vaccine’s efficacy is pegged at 91.6% based on the final assessment of clinical trials in Russia, where roughly 20,000 people were part of the Phase 3 study. In India, the vaccine is being tested in 1,600 people in a phase 2/3 trial meant as a “bridging study” that all foreign-made pharmaceutical products need to undergo.
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The bridging study in India is being carried out by Dr Reddy’s Laboratories, which also has a contract to distribute 100 million doses once the final approvals are in place.
The Russian Direct Investment Fund (RDIF), which is marketing the vaccine globally, is expected to supply the first doses to Dr Reddy’s shortly after the approval.
According to a pharma industry representative asking not to be named, India is yet to formalise any procurement order with Dr Reddy’s. “Dr Reddy’s is in talks with the government regarding procurement for a few months but nothing has been formalised yet. The modalities of distribution will be worked out only after they see the contours of approval granted to them,” said this person.
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A spokesperson for Dr Reddy’s said the company is yet to receive confirmation of emergency use authorisation (EUA) from the government. “Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against Covid,” said the company in a statement.