Centre approves Russia's Sputnik V Covid-19 vaccine for emergency use

Russia’s Sputnik-V vaccine against Covid-19 on Monday was recommended for emergency use authorisation (EUA) in India by a panel of experts of the country’s drug regulator.

The recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) came on a day when India reported the highest ever – 1.68 lakh – Covid-19 cases in a single day and amid opposition clamour for approval for more vaccines to bridge the demand-supply gap.

If approved by the Drug Controller General of India, Sputnik-V would be the third Covid-19 vaccine to be deployed in the country’s vaccination drive to control the raging pandemic that has claimed more than 1.70 lakh lives across the country. The health ministry also said India now had 948 cases of the UK, South Africa, and Brazil strains of the coronavirus.

Developed by Gamaleya Research Institute of Russia, the Sputnik-V vaccine has 91.6 per cent efficacy as per the interim results of the Phase-3 trials published in The Lancet medical journal.

While government sources confirmed the SEC go-ahead for EUA to Sputnik-V, there was no official statement from the Health Ministry in this regard.

However, BJP General Secretary B L Santosh took to Twitter to announce the recommendation for EUA for Sputnik-V.

“SputnikV vaccine has been approved for emergency use in India after bridge study by Reddy Labs,” Santosh said.

In its last meeting on April 1, the SEC of CDSCO sought more data on Sputnik’s clinical trial in India conducted by Dr Reddy’s Laboratories. The data was sought on six specific points including “unblinded data of all Serious Adverse Events and RT-PCR Covid-19 positive cases along with causality analysis reported till date for further examination”.

In addition, the regulators sought data on “package insert, fact sheet including indication, dosage, schedule, contra-indications, warning, precautions and storage conditions.”

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Last year, the Russian manufacturers signed their first agreement with Dr Reddy’s Laboratories to conduct the clinical trial in India and distribute 100 million doses of the vaccine that would be shipped to the Hyderabad-based pharmaceutical company.

Subsequently, the Russians have signed agreements with Hetero Biopharma, Virchow Biotech, Stelis Biopharma, Gland Pharma, and Panacea Biotech to use their vaccine manufacturing capacity for the production of 950 million doses of Sputnik vaccine in India.