Hyderabad (Telangana) [India], January 4 (ANI): Bharat Biotech Chairman and Managing Director Dr Krishna Ella said on Monday that the company has tremendous experience in vaccines, takes science seriously and Covaxin is simple two doses.
He responded to criticism in certain circles following emergency use authorisation to the vaccine and said,"Indian companies do not deserve this backlash".
Addressing a press conference via video conferencing a day after DGCI gave Covaxin emergency use authorisation for use against COVID-19, Dr Ella said many people were gossiping "everything in different directions to just backlash on Indian companies".
He said emergency authorization has been earlier given to vaccines abroad without completion of phase 3 trials.
Dr Ella said the company's work touches 123 countries and has extensive experience and extensive publication in review journals.
"Now that vaccine is being politicized, I want to state very clearly that none of my family members is associated with any political party. Many people are gossiping everything in different directions to just backlash on 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 authorization for Liberia and Guinea," he said.
"Even the US government says emergency authorization can be given if a company has good immunization data. Merck's Eloba vaccine got authorization for emergency use even before the completion of the phase-III trial. Johnson and Johnson did trials on 87 people and got the emergency license," he added.
Dr Ella said Bharat Biotech is not just conducting clinical trials in India but has done clinical trials in more than 12 countries including the UK.
"We are doing clinical trials in Pakistan, Nepal, Bangladesh, and other countries. We are not just an Indian company. We are truly a global company," he stated.
He said Bharat Biotech is the only Indian company that has got extensive experience and extensive publication in review journals.
"We are not a company without experience in vaccines. We have tremendous experience in vaccines. We are touching 123 countries. We are the only company that has got such extensive experience and extensive publication in review journals," he stated.
He advised critics to have the patience to read the articles the company has published on the internet.
"More than 70 articles have been published in various international journals," he said.
Dr Ella also said that Bharat Biotech is soon going to include children in clinical trials. "Covaxin is simple two doses. We take science very seriously not just a product."
He said the "company currently has 20 million doses" and is 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," the Chairman said.
Dr Ella said the cost of vaccines may be a little higher in the beginning but as the scale of production increases, the price will be controlled by the market.
"We are proud to say that we have the only BSL-3 production facility in the world, even the US doesn't have it. We are here to help any of public health emergencies in any part of the world," he added.
Elaborating on DCGI's approval of "restricted use in an emergency situation in clinical trial mode", Dr Ella said, "without placebo, we keep vaccinating people at an open level and then monitor the safety and efficacy."
Earlier, Bharat Biotech had said in a release 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.
Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
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 had on Sunday criticised the government for COVID-19 vaccines being given emergency use authorisation without completion of phase 3 trials. (ANI)