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COVID Vaccine Sputnik Light: Centre directs stakeholders to fast-track approval process for single-dose COVID-19 shot

COVID Vaccine: An application for regulatory approval for Sputnik Light is expected to be filed in the next couple of weeks.

May 28, 2021 / 11:24 AM IST
The two-dose Sputnik V had received the Indian drug regulator's permission for restricted emergency use with certain conditions on April 12. Representative Image

The two-dose Sputnik V had received the Indian drug regulator's permission for restricted emergency use with certain conditions on April 12. Representative Image

As the government continues to weigh its options on Pfizer's indemnity request, it is hoping to launch the single-dose Sputnik Light vaccine in India soon.

The Centre has directed all stakeholders, including the Russian manufacturer and its Indian partners, to fast-track the application and regulatory approval procedures for the COVID-19 vaccine.

An application for regulatory approval for Sputnik Light is expected to be filed in the next couple of weeks, the Indian Express reported, citing sources.

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Sputnik Light is likely to become the first single-dose vaccine to be launched in India.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Drugs Controller General of India (DCGI) informed other participants that the application for regulatory approval of Sputnik Light is expected to be filed in the next 2-3 weeks, the report said.

Read: UNICEF signs deal to procure up to 220 million doses of Sputnik V vaccine

At a meeting chaired by the Cabinet Secretary recently, it was suggested to immediately convene a meeting with all concerned stakeholders, including the Department of Biotechnology Secretary, Drugs Controller General of India (DCGI), the Ministry of External Affairs representatives, the Union Health Ministry officials, RDIF (Russian Direct Investment Fund) and domestic manufacturers, to expedite the regulatory approvals for Sputnik Light.

According to RDIF,  the single-dose Sputnik Light vaccine demonstrated 79.4 percent efficacy as per analyzed data taken from 28 days after the injection was administered as part of Russia’s mass vaccination program between 5 December 2020 and 15 April 2021.

Read: COVAX faces shortfall of 190 million doses, India’s 'terrible surge’ severely hits supply

The two-dose Sputnik V had received the Indian drug regulator's permission for restricted emergency use with certain conditions on April 12. Dr Reddy's Laboratories is importing the vaccine for use in India.

Amid the shortage of vaccines, the government is in talks to secure foreign jabs, including Russia's Sputnik vaccines, while talks are also underway for COVID-19 vaccines developed by US majors Pfizer and Moderna.

India has so far administered over 20 crore doses so far since the launch of its vaccination drive on January 16. Currently, three COVID vaccines are used in India -- Covishield manufactured by the Serum Institute, Covaxin by Bharat Biotech and Russian-made Sputnik V.

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first published: May 28, 2021 11:24 am
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