Preliminary results of the phase 1human clinical trial suggests that India’s first indigenously developed vaccine against novel coronavirus, is safe, according to a report. COVAXIN, an inactivated vaccine against SARS-CoV-2 (the virus that causes COVID-19 disease), developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) is expected to enter the next phase of testing next month.
Except for AIIMS Delhi – one of the 12 centres for the Bharat Biotech vaccine – where phase 1 trials are still underway, most of the other 11 centres have completed the process. AIIMS Delhi has only recruited 16 candidates for the vaccine human trials phase 1.
Initially, AIIMS Delhi was supposed to recruit 100 candidates for the vaccine trials. The total candidate recruitment for phase 1 Bharat Biotech trials in 12 centres is 375.
Sources at the AIIMS centre said that the phase 2 human trials will likely begin in the first week of September. The findings of phase 1 trials will be submitted soon. Preliminary results of Phase 1 clinical trials showed that Covaxin is safe, sources associated with the Phase1 trial have confirmed.
The Health Ministry had said that three vaccine candidates against COVID-19 are currently in different phases of clinical testing – this includes Bharat Biotech-ICMR’s COVAXIN, Zydus Cadila’s ZyCoV-D, and the Oxford/AstraZeneca’s candidate ChAdOx1 nCoV-19 (called Covishield in India) being tested and manufactured by the Pune-based Serum Institute. Serum Institute has been granted permission by the DCGI to conduct the phase 2/3 clinical trials in India and the world’s largest vaccine maker is likely to start the trial soon.