Bharat Biotech’s Covaxin, which has been in the eye of the storm following approval by Drugs Controller General of India (DCGI) without completion of Phase 3 trials, has been defended by company’s chairman Dr Krishna Ella in an interview with a television channel. Ella slammed the critics and said the emergency use authorization to Covaxin has been granted only after the conditions set by Central Drugs Standard Control Organisation (CDSCO) were fulfilled.
Dr Ella added that Covaxin is safe for use even in children and he would not mind getting it administered to his six-year-old grandson. He said Bharat Biotech’s vaccine is safe for children between the ages 2-12. He said the company would send a proposal to DCGI and subject expert committees. He expressed hope that the company should to be able to hold small clinical trials so that the vaccine can be given to children without any issues.
Talking about the efficacy of Covaxin, which is yet to be established, Dr Ella said the data about the same should be available in four months. For the uninitiated, several health expert and opposition leaders had hit out at govt for granting emergency use authorisation the vaccine even before completion of last-phase trials.
Congress leader Anand Sharma had said emergency use authorisation of Covaxin should is a serious matter of concern as no country has approved a vaccine without completing the phase 3 trials and subsequent analysis of data. He said according to Bharat Biotech’s application before the expert panel, the phase 3 trial of Covaxin are yet to be completed. The data on on vaccine’s safety and efficacy has not been reviewed, which is a mandatory requirement.
Congress leader Shahshi Tharoor had also echoed his Sharma’s sentiments and called approval of Covaxin as premature He urged Union Health Minister Dr Harsh Vardhan to issue a clarification on matter.