Covaxin, the indigenous vaccine developed by Bharat Biotech against Covid-19 in collaboration with ICMR, is 200 per cent safe, company’s chairman and managing director Dr Krishna Ella said on Monday. He also noted that it has shown less than 10 per cent adverse reaction in trials so far.
Addressing a press conference on Monday, Dr Ella hit back at critics and said that the approvals have been granted on the basis of conditions set up by the Central Drugs Standard Control Organisation (CDSCO) 2019.
“The CDSCO guidelines issued in 2019 state: If your platform is proven, safe and phase 1 and 2 data is available then you can license the product,” Dr Ella said.
“Covaxin has shown less than 10 per cent adverse reactions, while others have 60 per cent to 70 per cent adverse reactions. I can assure our vaccine is 200 per cent safe,” Dr Ella said. His remarks came a day after DGCI granted permission for restricted emergency use of Covaxin.
On remarks that Covaxin is a “back-up vaccine”, he said that “it is a vaccine, and not a backup”. He added that “people should be responsible before making such statements.”
Dr Ella claimed that Covaxin was facing flak because there is a tendency to slam Indian companies. “There is a lot of backlash against Indian companies. It is not acceptable to us. I don’t know why Indian companies are
targeted by everyone in the world,” he said.
He said that the criticism against Covaxin just because it was an Indian vaccine was undue and hurtful. “India can innovate; it’s not a copycat country. We don’t deserve a backlash because we are an Indian company In India, we do everything systematically and yet we get bashing from the news media. A company has branded our vaccine as water. It hurts as a scientist and we don’t deserve that. Why is nobody questioning the UK trials? Because, Indian trials are easy to be bashed,” Dr Ella said.
“Many people just gossiping, it’s just a backlash against Indian companies. That is not right for us. We don’t deserve that. Merck’s Ebola vaccine never completed a human clinical trial at all but WHO gave emergency authorisation for Liberia and Guinea,” the Bharat Biotech CMD said.
“Even US government says emergency authorisation can be given if a company has good immunisation data. Merck’s Eloba vaccine got authorisation for emergency use even before completion of phase 3 trial. Johnson & Johnson did trials on 87 people and got emergency licence,” he said.
Dr 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. We are encountering so many problems including related to logistics.”
“We will roll out the vaccine as early as possible. Batches have been sent to Kasauli government testing lab already,” he added.
Bharat Biotech had said in a release earlier that Covaxin is a highly purified and inactivated two-dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
Covid-19 vaccines of Serum Institute of India and Bharat Biotech were granted permission for restricted use in an emergency situation by the Drugs Controller General of India (DCGI) on Sunday.
Some Congress leaders have criticised the government for emergency use authorisation given to Covid-19 vaccines without completion of phase 3 trials.