HomeNewsTrendsHealthZydus Cadila gets DCGI nod to initiate Phase-3 clinical trials for COVID-19 vaccine

Zydus Cadila gets DCGI nod to initiate Phase-3 clinical trials for COVID-19 vaccine

The company will now be initiating Phase III clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement.

January 04, 2021 / 08:42 IST

Drug firm Zydus Cadila on Sunday said it has received DCGI approval to initiate Phase III clinical trials of its COVID-19 vaccine ZyCoV-D.

The company will now be initiating Phase III clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement.

ZyCoV-D was found to be safe, well-tolerated and immunogenic in phase I and II clinical trials, it added.

The phase II study of ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose-escalation, multi-centric, randomised, double-blind placebo-controlled study, the drug firm said.

The trial has reviewed by an independent data safety monitoring board (DSMB) and reports were submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.

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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"We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine,” Zydus Group Chairman Pankaj R Patel said.

The launch of the Phase 3 trial will determine the efficacy of the company’s vaccine in preventing COVID-19, which continues to pose a major threat world over, he added.

The Drug Controller General of India (DCGI) on Sunday granted emergency approval to Serum Institute and Bharat Biotech for their respective vaccines.

Follow our full coverage of the coronavirus pandemic here.

PTI
first published: Jan 3, 2021 05:46 pm

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