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CDSCO panel recommends emergency use authorisation for SII's COVID vaccine Covovax

Prakash Kumar Singh, director, Government and Regulatory Affairs at Serum Institute of India (SII) had submitted an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation for Covovax for restricted use in emergency situations.

December 27, 2021 / 10:40 PM IST
Representative Image (AFP)

Representative Image (AFP)

An expert panel of the country’s central drug authority has recommended granting emergency use authorisation to Serum Institute of India’s COVID-19 vaccine Covovax’ with certain conditions, official sources said on Monday.

Prakash Kumar Singh, director, Government and Regulatory Affairs at Serum Institute of India (SII) had submitted an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation for Covovax for restricted use in emergency situations.

"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) reviewed the emergency use authorisation (EUA) application for the second time on Monday and after detailed deliberation recommended granting emergency use authorisation to Covovax,” an official source said.

Noting the vaccine is the technology transfer of Novavax vaccine, the DCGI recently had sought to know the approval status of the application with regulatory authorities in the country of origin that is the USA.

The apex drug regulator had also asked the Serum Institute to provide details on Matrix component used in the vaccine.

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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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On November 27, the Subject Expert Committee on COVID-19 had evaluated and deliberated on SII’s application and sought additional data from the pharma company.

The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.

The government had recently permitted the export of 2 crore doses of COVID-19 vaccine Covovax to Indonesia produced in India by SII, as the jab had not yet been approved for emergency use in the country, official sources had said.

The DCGI office had granted SII permission to manufacture and stock Covovax on May 17.

Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled the vaccine doses.

In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

The World Health Organisation had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.
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