All you need to know about the Sputnik V Covid-19 vaccine

In the analysis that included data on 19,866 volunteers, it has been found that the vaccine efficacy was 91.6%

Drugs Controller General of India (DCGI) has granted permission for the restricted emergency use of the Russian Covid-19 vaccine 'Sputnik V' with certain conditions, paving the way for a third vaccine to be available in the country.

First greeted with scepticism, experts have since been convinced of the effectiveness of the Sputnik V, with positive results being published in The Lancet medical journal. It was the first Covid-19 vaccine to be registered in the world.

The vaccine is easy to store with the Russian Direct Investment Fund noting that the storage temperature of Sputnik V at 2-8 degree C, means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.

Sputnik-V is 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.

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The DCGI had in January given the emergency use authorisation for two Covid-19 vaccines -- Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.

The vaccine has been registered in India under the emergency use authorization procedure based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr. Reddy’s Laboratories.

According to a PTI report, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.

How effective is it?

The Russian Covid-19 vaccine Sputnik-V has been found to have 91.6 per cent efficacy in the phase-III clinical trial, the results of which have been published in the top medical journal Lancet.

The vaccine is indicated for active immunisation to prevent Covid-19 in individuals aged 18 years and above and is to be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days.

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The phase-III or efficacy trial of the vaccine was carried out in 25 hospitals in Russia on 21,977 adults who received two doses of the vaccine at a gap of 21 days between September and November.

In the analysis that included data on 19,866 volunteers, who received both the first and second doses of the vaccine or placebo, it has been found that the vaccine efficacy was 91.6 per cent. In a sub-group of 60 plus population, the efficacy was 91.8 per cent.

Does it work against mutant variants?

A Russian trial testing the effectiveness of revaccination with the Sputnik V shot to protect against new mutations of the coronavirus is producing strong results, researchers said.

In January, President Vladimir Putin ordered a review by March 15 of Russian-produced vaccines for their effectiveness against new variants spreading in different parts of the world.

"(A) recent study carried out by the Gamaleya Centre in Russia showed that revaccination with Sputnik V vaccine is working very well against new coronavirus mutations, including the UK strain of coronavirus," said Denis Logunov, a deputy director of the centre, which developed the Sputnik V shot.

However, it is less effective against the South African variant but still does better than other vaccines, the lead scientist behind it was cited as saying.

"With regards to the 'South African' strain, the effectiveness of the antibodies produced by Sputnik V, like all other vaccines, against it declines," Alexander Gintsburg said, according to a Reuters report.

How does the vaccine work?

Sputnik V is an adenovirus-viral vector vaccine. It uses a modified version of the virus that cannot replicate and this has been inserted with the spike protein of the SARS-CoV-2 virus. This is expected to bring about an immune response in the body.

However, there is one factor that makes the vaccine unique. Sputnik V is a two-vector vaccine. This means that the vaccine uses two different kinds of adenovirus vectors rAd26 for the first dose, and rAd5 for the second dose. This is said to be more efficient.

Both doses of the vaccine are given with a gap of 21 days.

Which countries have approved the Sputnik V so far?

Apart from India, Sputnik V has also been approved in Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San-Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala, Moldova, Slovakia, Angola, Republic of the Congo, Djibouti, Sri Lanka, Laos, Iraq, North Macedonia, Kenya, Morocco, Jordan, Namibia, Azerbaijan, Philippines, Cameroon, Seychelles, Mauritius, Vietnam, Antigua and Barbuda, Mali and Panama.

(With inputs from agencies)