Krishna Ella, Chairman and Managing Director of Bharat Biotech, has come out in defence of his company's coronavirus vaccine Covaxin as it faced doubts after receiving emregency use authorisation in India. Covaxin, along with Covishield, were approved for emergency use by the Drug Controller General of India (DCGI) on Sunday. Granting emergency use authorisation to Covaxin drew a flurry of questions as the jab is still undergoing Phase 3 trials.
Responding to backlash aimed at Covaxin, Ella said: "Why is no one questioning Uk trials? Because Indian trials are easy to bash. Some company branded me as water. It hurts me as a scientist and we don't derserve that."
During a press conference on Monday, the Bharat Biotech CMD questioned why no questions were raised on emergency use authorisation to Covishield even though only safety data for the jab was submitted and not immunogenicity data. "They have given licence based on UK data. Where is their India data," Ella questioned.
Defending Covaxin, Ella said that his company has tremendous experience in developing vaccines. He added that more than 70 articles on data related to the coronavirus vaccine have been published in various 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," Ella said.
"Many people say that I am not transparent in my data. I think people should have patience to read on the internet and how many articles we have published. More than 70 articles have been published in various international journals," he further added.
Ella mentioned that trials for Covaxin are underway in India as well as 12 other countries, including the United Kingdom, Pakistan, Nepal and Bangladesh. Ella alleged that some quarters are targeting Bharat Biotech because it's an Indian company.
"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," Ella said.
The Bharat Biotech Chairman noted that it is common practice around the world to grant emergency use authorisation to vaccines if they show promise in earlier stages of testing.
"Merck's Ebola vaccine never completed a human clinical trial at all but WHO gave emergency authorisation for Liberia and Guinea... Even US government says emergency authorisation can be given if a company has good immunisation data. Merck's Ebola vaccine got authorisation for emergency use even before completion of Phase 3 trial. Johnson & Johnson did trials on 87 people and got emergency licence," Ella said.
"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 the public health emergency in any part of the world," Ella said, adding that Bharat Biotech is in no way inferior to Pfizer.
Targeting adverse events in competitors' COVID-19 vaccines, Ell pointed out that Oxford-AstraZeneca gave volunteers 4 grams of paracetamol, whereas Pfizer's vaccine saw cases of Bell's palsy during trials. He also hit out at AIIMS Director Dr Randeep Guleria for suggesting that Covaxin should be used as back-up.
"It is a vaccine. It is not a backup. People should be responsible before making such statements," Ella said.
In response to a question over efficay against the UK strain of coronavirus, Ella said that the strain changes frequently but that shouldn't affect the manufacturing cost of the vaccine.