Limited Period Offer:Be a PRO for 1 month @Rs49/-Multiple payment options available. Know More
you are here: HomeNewsIndia

COVID-19: Serum Institute to begin Covovax vaccine's phase 3 trial by mid-May

The ICMR and SII are jointly performing a phase-2/3 observer-blind, randomised, controlled study to determine the safety and efficacy of the Covovax vaccine.

May 04, 2021 / 03:45 PM IST
The COVID-19 vaccination drive in India commenced on January 16. (Image: AP)

The COVID-19 vaccination drive in India commenced on January 16. (Image: AP)

Serum Institute's second COVID-19 vaccine, Covovax, is likely to go into phase-3 trial later this month. Serum Institute has partnered with Novavax to develop the second coronavirus vaccine.

The Data Safety Monitoring Board has reviewed the safety data of the phase-2 trial, which comprised of 200 participants, and has given its recommendation, the Indian Express reported.

Track this LIVE blog for latest updates on coronavirus pandemic

The Drugs Controller General of India (DGCI) has also given its approval for the phase-3 trial, the report said.

Serum Institute is conducting the trials in collaboration with the Indian Council of Medical Research (ICMR).

Close

COVID-19 Vaccine

Frequently Asked Questions

View more
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.

View more
Show

Dr Abhijit Kadam, coordinating principal investigator from ICMR-National AIDS Research Institute of the trial, said that tentatively phase-3 should start by mid-May.

Read | Covid vaccine production and availability: What we know so far

"There are 19 sites across the country, four of them in Pune. Researchers across these sites said the process of recruiting volunteers for the larger phase-3 trial will begin soon," he said, as quoted by the newspaper.

The ICMR and SII are jointly performing a phase-2/3 observer-blind, randomised, controlled study to determine the safety and efficacy of the Covovax vaccine.

Covovax has been developed by US-based Novavax. It has signed a pact with SII, wherein the latter would produce about 1 billion doses of Covovax for supply to India and other countries.

Read: When should you get hospitalised? Health Ministry lists signs and symptoms

The Novavax vaccine, which uses different technology from the doses already widely licensed around the world, is a protein-based vaccine engineered from the genetic sequence of the first strain of the coronavirus.

It can be stored at a temperature between 2 and 8 degrees Celsius (35 - 46.4 degrees Fahrenheit).

Earlier, SII CEO Adar Poonawalla had said that the firm plans to launch the vaccine by September.

"Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India. It has been tested against African and UK variants of COVID-19 and has overall efficacy of 89 percent. Hope to launch by September 2021," Poonawalla has said in a tweet in March.

Click here for Moneycontrol's full coverage of the COVID-19 pandemic
Moneycontrol News
first published: May 4, 2021 03:45 pm

stay updated

Get Daily News on your Browser
Sections