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SII gets DCGI nod to manufacture drug substance, test it for developing jab against Omicron         

Looking to undertake vaccine research against the Omicron variant, Director, Government and Regulatory Affairs at SII, Prakash Kumar Singh, recently had submitted an application to the DCGI for grant of permission to manufacture Drug substance of SARS-CoV-2 rS Protein Recombinant Spike Nanoparticle Vaccine (Omicron Variant) for examination test and analysis.

December 31, 2021 / 07:33 PM IST
Representative Image (AFP)

Representative Image (AFP)

India’s drug regulator on December 31 approved Serum Institute of India’s proposal to manufacture a drug substance for new Covid vaccine against Omicron variant of coronavirus and carry out its testing and analysis, official sources said.

The move assumes significance in view of the country reporting a rise in daily new COVID-19 cases which include the Omicron variant.

Looking to undertake vaccine research against the Omicron variant, Director, Government and Regulatory Affairs at SII, Prakash Kumar Singh, recently had submitted an application to the Drugs Controller General of India (DCGI) for grant of permission to manufacture Drug substance of SARS-CoV-2 rS Protein (COVID-l9)Recombinant Spike Nanoparticle Vaccine (Omicron Variant) for examination test and analysis.

“As you are aware, the new coronavirus variant ‘Omicron’ has already been reported in more than 60 countries and is spreading very fast worldwide and in our country also. Our CEO Adar C Poonawalla is very much concerned about the protection of citizens of our country and world at large against coronavirus and its new variants, and we are relentlessly working on the development of SARS-CoV-2 rS Protein (COVID-19) Recombinant Spike Nanoparticle Vaccine (Omicron Variant),” an official source quoted Singh as having said in the application.

Development of this vaccine shall be another example of vaccine production strength of India in line with the clarion call of Prime Minister Narendra Modi “Making in India for the World” and shall further keep our country’s flag flying high globally, he said.

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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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After the review of their application, DCGI has given permission to manufacture SARS-CoV-2 rS Drug Substance (Omicron Variant) for Examination, Test and Analysis (for SIIPL Hadapsar site), an official source informed.
PTI
first published: Dec 31, 2021 07:33 pm
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