Regulatory approval of COVID-19 vaccine for restricted use in clinical trial mode

Covaxin is India's first indigenous vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), developed through a collaboration between Bharat Biotech and the National Institute of Virology, which is a branch of the Indian Council of Medical Research, the Indian official authority for medical research. The development team isolated a strain of SARS-CoV-2 from patients with asymptomatic infection and developed a vaccine on a Vero cell-line manufacturing platform to deliver the inactivated coronavirus strain. On Jan 3, 2021, the vaccine was granted approval “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode”,1 which raised several concerns across the scientific society.2