Bharat Biotech to come up with Phase-3 efficacy data of Covaxin in two weeks: Chairman Krishna Ella

Ella said the company is in the process of ramping up Covaxin production capacity to 40 million doses per month, with the commissioning of third manufacturing site by end of this week.

February 23, 2021 / 07:26 AM IST
Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.

Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.

Bharat Biotech on February 22 said that it will be coming up with Phase-3 efficacy data of its COVID-19 vaccine Covaxin in next two weeks.

The Covaxin was given restricted emergency use approval under clinical trial mode by India drug regulator Drug Controller General of India (DCGI) without phase-3 efficacy data. The approval was based on safety and immunogencity data of Phase-1 and Phase-2 trials, and of the hypothesis that the vaccine works on the mutant strains including UK variant.

"Unfortunately we have missed the efficacy time points, have done the Phase 2 and Phase 3 combined, we would have captured the efficacy faster," said Krishna Ella, Chairman and Managing Director of Bharat Biotech, speaking at BioAsia 2021.

"Anyways we should be coming out in two week with efficacy data," Ella added.

Ella said the company is in the process of ramping up Covaxin production capacity to 40 million doses per month, with the commissioning of third manufacuting site by end of this week.

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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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The company has already commissioned two manufacturing facilities.

Ella said his company is keen to be part of COVAX.

"The moment we come out with Phase-3 data if everything is alright, then I think we really want to be part of COVAX," Ella said.

COVAX is co-led by Gavi, the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI). The agency was formed to guarantee fair and equitable access to the vaccine for every country in the world. COVAX currently includes more than 190 participating economies.

Nasal vaccine clinical trial

Ella said the Bharat Biotech is also planning to launch the phase-1 clinical trial of its nasal COVID-19 vaccine by end of this week.

New variants

Ella said that Bharat Biotech can produce an updated version of Covaxin which is capable of neutralising South African strain in 15 days.

"If the ICMR has got a South African strain, if they give it, I can plug in immediately in the manufacturing. I can make a product quickly. We're not going to change the manufacturing process," Ella added.

Covaxin has found to be effective against the UK variant.

Ella said Covaxin will be good for vaccinating children, as it is based on inactivated platform which is used for making polio vaccines used in infant and child polio immunisation.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Feb 22, 2021 08:08 pm

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