Sputnik COVID Vaccine Gets Approval in India: What Does This Mean?

3 min read
Sputnik COVID Vaccine Gets Approval in India: What Does This Mean?

On Monday 12 April, Russia's Sputnik V becomes the third vaccine to be green lit for emergency use in India.

“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,” read a statement released by the company.

The decision comes after a long wait.

The Central Drugs Standard Control Organization's (CDSCO) Subject Expert Committee (SEC) had previously held a meeting on Wednesday, 24 February, to discuss Dr Reddy’s Laboratories application seeking emergency use approval (EUA) for Russia’s Sputnik V. vaccine.

The committee had then deferred the decision seeking additional data on immunogenicity of the vaccine from the applicant Dr Reddy’s Laboratories.

The company presented the safety data of the second phase of trials and the interim data of the third phase during the meeting with the expert panel and has been awaiting verdict ever since.


What Is the Sputnik Vaccine?

Registered by Russia on 11 August 2020, Russia's COVID-19 Vaccine Sputnik V is developed by the Gamaleya National Research Institute of Epidemiology and Microbiology,

Back in February, The Lancet found Sputnik V to be 91.6 per cent effective. In an interim analysis of the Phase III clinical trial, Sputnik V showed strong efficacy, immunogenicity and safety results.

Sputnik V is one of only three clinically tested vaccines in the world (including Pfizer and Moderna) with an efficacy of 91.6 per cent as per Lancet’s findings.

Sputnik V which started rolling out it's vaccines for public use in Russia in December 2020.

The vaccine is currently being administered for emergency use in 59 countries.

Who is Producing the Vaccine to India?

In January, they received approval from the Drugs Control General of India (DCGI) to conduct phase III clinical trial for the Sputnik V vaccine.

In September 2020, Dr Reddy’s Laboratory partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India.

And in October, Dr Reddy’s signed an agreement to conduct phase 1 and 3 bridging studies in India.

Other than Dr Reddy's Laboratory, Russian Direct Investment Fund (RDIF) has tied up with a host of Indian pharmaceutical players such as Hetero Biopharma, Gland Pharma, Stelis Biopharma and Vichrow Biotech for the production of vaccine doses.

With a production capacity of 850 million doses in the country, Sputnik V will provide a major shot in the arm in the fight against COVID-19.

What This Decision Means for India?

This welcome news comes at a time when the country is grappling with a second, perhaps even more severe, wave of COVID.

Amidst the surge in cases, reports of vaccine shortage in the country have also been surfacing.

Having a third vaccine for public use in the country could mean bolstering the vaccination drive, and reducing the strain on the production of the two vaccines that are currently in use.

Sputnik V has also announced that in partnership with the five above mentioned pharmaceutical companies, it aims to produce more than 850 million doses per year.

Apart from Sputnik, India has approved two other covid vaccines for emergency use — Serum-Oxford’s Covid-19 vaccine Covishield and Bharat Biotech’s Covaxin. It also happens to the vaccine with the highest efficacy to be approved in India.

How Does Sputnik Compare to Covishield and Covaxin?

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against Covid-19 based on the established human adenoviral vector platform.

The Oxford-AstraZeneca vaccine, being manufactured by Serum Institute (SII) here as ‘Covishield’, is also a viral vector vaccine.

In comparison, Bharat Biotech's Covaxin (BBV152) is an inactivated COVID-19 vaccine.

All three vaccines require 2 doses.

While Sputnik’s efficacy is 91.6 per cent, Covishield is 62-90 per cent while the clinical efficacy of Covaxin was found to have an efficacy of 81 percent in its phase 3 clinical trial.

When Can We Expect to Get the Vaccine?

In India, the Sputnik Vaccine is reportedly under trial in around 1,600 people between 18 and 99.

Further information about the rollout is awaited.

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