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Unfair to accuse us of inexperience, Covaxin Phase-3 efficacy data by March: Bharat Biotech Chairman Krishna Ella

The Drugs Controller General of India on January 3 approved Bharat Biotech's COVID-19 vaccine 'Covaxin' for conducting trials on children above the age of 12 years.

January 05, 2021 / 02:09 PM IST

Bharat Biotech Chairman Krishna Ella on January 4 said that it is unfair to accuse the company of inexperience as it is a global entity with experience in manufacturing vaccines in emergency situations when efficacy data is not available. The company's COVID-19 vaccine Covaxin's efficacy data will be released by March 2021, he stated.

Responding to criticism over conditional approval granted to Covaxin, Ella said Bharat Biotech doesn’t deserve this backlash. "We have experience in bringing vaccines in emergency situations when efficacy data is not available," Ella said, adding, "It is not correct to say that we are not transparent with data. We have manufactured more than 16 vaccines and we don't deserve this backlash."

DCGI grants Bharat Biotech permission to conduct vaccine trials on children above 12: Report

He said the Drugs Controller General of India (DCGI)'s 2019 guidelines says if a vaccine platform is established and approved, it can be cleared for trial. He mentioned multiple examples where emergency authorisation was given based only on the immunogenicity data.

On the issue of trials, he said: "Covaxin Phase-3 trials are on-going, it's a 2-dose schedule and 24,000 people vaccinated so far... We have 20 million doses, will have 500 million dose capacity by end of 2021."


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 Bharat Biotech chief said in his defence that all the company's vaccine samples have been validated by NIV Pune, and the process is fully transparent. "Have published five articles on the vaccine. We are in no way inferior to Pfizer when it comes to publications, as it has zero publications. Safety data for Covaxin shows less than 10 percent side effects in trials."

Ella added that volunteers came forward without any financial incentives.

The DCGI on January 3 approved Bharat Biotech's COVID-19 vaccine 'Covaxin' for conducting trials on children above the age of 12 years. Ella even mentioned that no interim analysis of efficacy in Phase-3 has been done so far, while DCGI used animal challenge study data for approval of the vaccine.

Currently, the Hyderabad-based firm is conducting Phase-3 trials and yet to complete late-stage human clinical trials in India.
Moneycontrol News
first published: Jan 4, 2021 06:43 pm
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