Covaxin, a proposed COVID-19 vaccine, is the end product of the partnership between the Indian Council of Medical Research (ICMR) and Bharat Biotech, a Hyderabad-based biotechnology company. The Phase-1 trials of Covaxin showcase safe and reliable results. Researchers from ICMR, Bharat Biotech, All India Institute of Medical Sciences (AIIMS, New Delhi and Patna) and other institutes had participated in the analyses. These results have appeared on medRxiv, a preprint server, titled as ‘A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine-BBV152’.
.#COVAXIN, India's indigenous #CovidVaccine vaccine, being developed by @ICMRDELHI in partnership @BharatBiotech has shown encouraging results in the Phase-1 human clinical trials. Read more here: https://t.co/GTSaaJl3b3 @MoHFW_INDIA @NHPINDIA @DeptHealthRes pic.twitter.com/Su3WBHdEyW
— ICMR (@ICMRDELHI) December 16, 2020
The Observations
The Phase-1 placebo-controlled randomised, double-blind trial on the safety and immunogenicity of three different formulations of BBV152 showed the trial results on 375 participants, with just one adverse event during the trial, which was then discovered to be unrelated to the vaccine.
The vaccine was found to be well-tolerated in all dose groups; It generates immune response; Reactogenicity (the property of a vaccine to produce standard, ‘expected’ adverse reactions) was absent in most participants; the majority of the adverse events were mild and sorted out.
The paper states that, to date, 180 vaccine candidates are being developed to prevent COVID-19. The SARS-CoV-2 virus strain was isolated from a COVID-19 patient and transferred to Bharat Biotech, which grew and replicated the virus and then developed the vaccine candidate at its Bio-Safety Level-3 (BSL-3) high containment and manufacturing facility. It is to be noted that the trial was conducted on volunteers from different geographic locations and socio-economic conditions.
Currently, Bharat Biotech is holding Phase-3 trials of its vaccine and has applied to the Drugs Controller General of India for an emergency use authorisation. On the other hand, Pfizer, Serum Institute of India have also sought emergency use authorisation for the COVID-19 vaccines they are developing.
