HYDERABAD: Bharat Biotech has faced a lot of backlash after the recent EUA decision. The Drugs Controller General of India (DCGI) provided Emergency Use Authorization (EUA) to ‘Covishield’ by Oxford-AstraZeneca and manufactured by Serum Institute of India and to ‘Covaxin’ by Bharat Biotech.
Many have questioned the efficiency of Covaxin. Public health experts have expressed their concerns over this COVID-19 vaccine. Hyderabad based Bharat Biotech is still in the phase-III trial. Before the data from phase-III trials were out, Covaxin was given Emergency approval. This is being seen as more of a political decision than a thought-out scientific one.
Bharat Biotech founder and chairman Dr Krishna Ella addressed all these questions during a virtual press conference on Monday. He said they do not deserve this kind of backlash. Ella said Bharat Biotech has done 200% honest trials. "We do 200% honest clinical trials and yet we receive a backlash. If I am wrong, tell me. Some companies have branded me 'water'. I want to deny that. We are scientists,” he added.
Ella also took a dig at the Pune based Serum Institute of India. Without naming SII, he said “There is an Indian company which got a license based on international data in phase III clinical trial data. Did anybody question them?” AstraZeneca-Oxford during Covishield trials gave paracetamol tablets to its candidates before giving vaccine shots to suppress any adverse reactions. Bharat Biotech did no such thing. “Whatever adverse reaction is captured it is exactly 100% even if it is good or bad. It is captured in real-time,” he added. If we did anything like that, we would have been shut down by Indian regulators.
People have questioned the lack of efficiency data present in the public domain. There is not much information about trial reports and results on public domain. The concern over Covaxin is “antibody dependent enhancement” which can be observed after Phase-III trials.
We made all the information public. Ella said that Bharat Biotech has published all the information on public domain. People just have to go and read it. “We are the only company to have published various articles on our Covaxin trial and safety. Everything is transparent,” added the Bharat Biotech chairman.
The vice-chair of the board of Coalition for Epidemic Preparedness Innovations (CEPI), Dr Gagandeep Kang questioned the decision made by Drug Controller General of India (DCGI). “'I don't think we should be approving a vaccine (Covaxin) that has no efficacy data. All the global candidates have submitted Phase-III data before getting approval,” said Kang.
Bharat Biotech founder Ella answered that, “We would be ready with phase 3 data in some days because we are conducting a large phase III clinical trial in the country with about 25,800 volunteers. At least 24,000 have been vaccinated so far. Why no one is questioning the other Indian company which has done phase 3 trial in 1,000-odd people in India.”
Kang spoke on the Covaxin’s efficiency against Coronavirus UK strain. “It will be a stretch to say the vaccine will work against the UK strain of COVID,” added Kang.
DCGI said the approval for Covaxin is differently conditional in clinical trial mode. All the recipients of this vaccine will be tracked and closely monitored. AIIMS chief Dr Randeep Guleria suggested that the approval of Covaxin could be to ensure that India has a backup vaccine.
Replying to AIIMS chief Guleria’s statement, Ella said that “It is a vaccine. It is not a back-up. People should be responsible before making such statements.”
Bharat Biotech currently has 20 million Covaxin doses ready and can provide for the immunization procedure.