PremiumHyderabad-based Bharat Biotech, which received emergency use approval for its coronavirus vaccine 'Covaxin' on Sunday from India's drug regulator, virtually addressed a press conference today.
In the press conference, the chairman Dr Krishna Ella addressed several queries on row over the vaccine's approval when it was still under "clinical trial mode."
To that, he said that its vaccine is safe and the company is conducting trials in more than 12 countries apart from India. “We are not a company without experience in vaccines. We have tremendous experience in vaccine."
Ella said that the company expects to release the efficacy data of Covaxin's Phase 3 trials, which are currently ongoing, by March.
He also mentioned that there has been no interim analysis of the efficacy in the Phase 3 trials has been done so far and added that there was 100% protection in Covaxin animal trials.
Ella also mentioned that Covaxin vaccine was the "only vaccine for 12 years and above, age group. He also said that the company plans to do clinical trials in children as well.
"Covaxin is a purely inactivated virus vaccine. I am confident that Covaxin will be effective against the UK mutant virus strain," he added.
Meanwhile, the drug regulator has also allowed Bharat Biotech to conduct its trials on children who are above the age of 12 years.
The Covid-19 vaccine has already been used for children above 12 in the last round and has been found safe. The Hyderabad-based firm is conducting Phase 3 trials in India.
About the availability of vaccine doses, Ella said, "Currently, we have 20 million doses. We are aiming to achieve 700 million doses capacity in four facilities -- three in Hyderabad and one in Bengaluru" He also informed that the company was "encountering so many problems including related to logistics."
The DCGI had on Sunday said that Covishield, the COVID-19 vaccine being manufactured by Serum Institute of India, and Bharat Biotech's Covaxin have been granted permission for restricted use in an emergency situation.
However, the green light from the Centre raised concerns from several critics, including Congress leaders, saying that Bharat Biotech's COVID-19 vaccine approval for restricted use is "premature" and can prove dangerous.
The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date, DCGI V G Somani said earlier.
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