Sputnik V approval Health

Expert panel approves Russia's Sputnik V COVID-19 vaccine in India

Vials containing Russia's Sputnik V vaccine for COVID-19 are seen at the San Marino State Hospital, in San Marino on April 9, 2021.   | Photo Credit: AP

Russia’s COVID vaccine — Sputnik V — has been recommended for emergency use authorisation in India following a meeting of the Subject Expert Committee (SEC) on Monday, The Hindu has confirmed. 

If approved by the Drug Controller General of India (DCGI), Sputnik-V would be the third vaccine to be made available in India after Serum Institute of India’s Covishield, developed by Oxford-AstraZeneca, and Bharat Biotech’s Covaxin.

The Hindu had reported, on April 4, that this vaccine was likely to be cleared for public use within 7-10 days.

The recommendation comes amid the recent record surge of fresh COVID cases — the highest since the beginning of the pandemic last year. India has also on Monday reported a total of 948 cases with UK, South Africa and Brazil variants of the COVID virus, according to the Health Ministry.

Sputnik V, developed by Russia’s Gamaleya Research Institute of Epidemiology and Microbiology, claims to be one of the three vaccines in the world with efficacy of over 90%.

“The vaccine’s efficacy is confirmed at 91.6% based on the analysis of data on 19,866 volunteers, who received both the first and second doses of the Sputnik V vaccine or placebo at the final control point of 78 confirmed COVID-19 cases,” noted the information released on the vaccine’s official website.

It adds that the vaccine supplies for the global market will be produced by Russian Direct Investment Fund (RDIF) international partners in India, Brazil, China, South Korea and other countries.

While Dr. Reddy’s will market the vaccine in India, RDIF has tied up with other Indian companies — Hetero Biopharma, Gland Pharma, Stelis Biopharma and Virchow Biotech — to produce 850 million doses of Sputnik V in the country every year.

“RDIF jointly with partners and manufacturers is ramping up the production of Sputnik V. The cost of one dose of the vaccine for international markets is less than $10 (Sputnik V is a two dose vaccine). The (freeze-dried form) of the vaccine can be stored at a temperature of +2 to +8 degrees Celsius, which allows for easy distribution worldwide, including hard-to-reach regions,” noted the website.

Dr. Reddy’s Labs, which is conducting a trial on the Sputnik V’s suitability on India, had previously applied, on February 19, for emergency use authorization of the vaccine and in the last meeting on April 1, the Committee had asked Dr. Reddy's to submit data “on unblinded data of all the serious adverse events and RT-PCR COVID-19 positive cases along with causality analysis reported till date for further examination.” Regulators also sought data on contraindications, storage conditions, dosage and schedule etc., said an official.

Meanwhile the Indian Medical Association (IMA) has welcomed the recommendation for the approval of the third vaccine. National president Dr. J.A. Jayalal in a statement said, “Vaccination is the sole resource for developing safety amongst citizens. The Association welcomes the third vaccine to safeguard our citizens. We appeal to the government to fasten the vaccination drive for to ensure greater coverage and protection.”

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Printable version | May 11, 2021 11:29:53 AM | https://www.thehindu.com/sci-tech/health/expert-panel-recommends-granting-approval-to-covid-19-vaccine-sputnik-v-for-emergency-use-in-india/article34301838.ece

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