NEW DELHI: Bharat Biotech MD Krishna Ella on Tuesday refuted criticism surrounding his company's coronavirus vaccine saying that Covaxin is "200% safe" and it is being "targeted by everyone in the world" for being an Indian company's product.
Questions were raised after the national drug regulatory agency granted emergency use approval to the indigenous coronavirus vaccine even though not sufficient data on the latter's efficacy and safety were available.
Today, Ella asserted that it is a global practice to issue an emergency medical license. "Even the US says that if you have good immunisation data, emergency authorisation can be done," he said.
Among the critics of the vaccine was noted virologist Shahid Jameel who said he does not believe that eventually, Covaxin would turn out to be safe and show more than 70% efficacy.
"I say this based on the platform, which is widely used and Bharat Biotech's own track record of successfully making inactivated viral vaccines," Jameel said.
The virologist also said his concerns are based on the processes adopted for approving the vaccine and also on the utterances of people in responsible positions.
The Bharat Biotech MD referred to a 2019 notification by national drug regulator Central Drugs Standard Control Organisation. He said that the guidelines in the notification state that if it is a proven and safe platform technology and good pre-clinical trial data is available then you can get an emergency license for the product.
Ella said that Covaxin showed 10% adverse reaction as compared to 60-70% adverse reactions shown by other vaccines. He alleged that volunteers who took Astrazeneca vaccine were given 4g Paracetamol tablets to suppress these reactions.
"We haven’t given paracetamol to any volunteer. I can assure our vaccine is a 200 % safe," he said.
Ella also refuted reports terming Covaxin as a "backup". "It is a vaccine. It is not a backup. People should be responsible before making such statements," he said.
On Monday, All India Institute of Medical Sciences director Randeep Guleria said Bharat Biotech's vaccine has been given approval only in emergency situations as a backup.
"If there is a surge in cases then we may need larger doses of vaccine then we may go with Bharat Biotech's vaccine. The Bharat Biotech vaccine is more of a backup," Guleria said.
Virologist Jameel also questioned the use of the word "backup" while granting approval to Covaxin. "Does this mean that if needed, a vaccine of unproven efficacy would be used?" he asked.
Ella claimed that Covaxin was being deliberately targeted because it is an Indian product.
"Many people just gossiping. It's just a backlash against Indian companies. That is not right for us. We don't deserve it. Merck's Ebola vaccine never completed a human clinical trial at all, but WHO gave emergency authorisation for Liberia and Guinea," he said.
The virologist also raised concerns over the lack of data provided by Bharat Biotech. He said the biggest concern is that "sidestepping" processes and poor/complex communication will fuel vaccine hesitancy in India.
"Give me one week's time, I will give you confirm data, Ella said.
Ella said that Bharat Biotech is a global company conducting trials in over 12 nations, 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 said.
(With inputs from agencies)