Bharat Biotech Managing Director Dr Krishna Ella on Monday defended the emergency use authorisation granted to its COVID-19 vaccine Covaxin by the Drugs Controller General of India (DCGI). However, there seems to be no clarity on how the vaccine will be administered and monitored in the "clinical trial mode" with Dr Ella giving contradictory answers on the issue.
When asked to clarify what "clinical trial mode" entails for the vaccine, Dr Ella said that the vaccine will be rolled out in an open label without placebos with those receiving the vaccine being monitored. However, when asked how that would translate on ground, Dr Ella said, "We need to understand that. We will talk with regulatory bodies to know how to operate it. This is the first time it is being done in India. We don't have full knowledge of that yet."
The move to grant Bharat Biotech an emergency use authorisation has been criticised by experts who cite the lack of sufficient data on Covaxin's safety and efficacy. On Monday, Dr Ella pushed back against criticism stating that efficacy data for Covaxin's phase three trials will be released by March.
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He further attacked critics for not scrutinising the data provided for the Oxford-AstraZeneca vaccine as they have for Covaxin while adding that Bharat Biotech is being unfairly targetted for being an Indian company. "We are not a company without experience in vaccines. We have tremendous experience in vaccines. It's just backlash against Indian companies. That is not right. We don't deserve it," he said.
Congress MP Shashi Tharoor in a tweet had questioned the manner in which EUA was granted to Bharat Biotech. Dr Ella stated that his company was well-within their rights to seek emergency use authorisation under CDSCO's New Drugs and Clinical Trials Rules since its phase 1 and 2 data has showcased efficacy and safety. "The 2019 Gazette notification states that if is a proven and safe platform and has good pre-clinical trial data, you can get an emergency license," he said.
"It is based on our extremely good and proven technology platform. It is based on extremely good efficacy data on animals and on on good immunogenicity data from phase II trials. Apart from these, it is also based on extremely good neutralization and T-cell response in both human and animals. All these parameters mattered and not just on the phase 2 clinical trials data," he added.
Dr Ella said that according to data, Covaxin will provide protection against COVID-19 for 120 days but hypothesised that it could last up to a year. He also stated that the limit for interim analysis has been set at 43 patients. The Hyderabad-based pharmaceutical company has also received DCGI's approval administer Covaxin to children over the age of 12 which will be conducted in partnership with its US partner Ocugen.
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Bharat Biotech will also provide indemnification against any adverse effects to Covaxin to the 26,000 participants already enrolled in its trials. Dr Ella, however, did not specify if the indemnification will be extended to those who receive the vaccine once it is rolled out in the clinical trial mode suggested by the CDSCO.
Dr Ella stated that Bharat Biotech currently has 20 million doses of Covaxin available and is targetting to produce 700 million doses by later this year.
As of January 4, 2021, India has reported 1,03,40,469 total COVID-19 cases and 1,49,649 deaths due to the disease.