Since the COVID-19 outbreak majority of the countries have been in a race to develop a vaccine to prevent its spread. We had already put out an article regarding this. Now the National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR) in collaboration with Bharat Biotech India (BBIL) has had its vaccine Covaxin™ approved by the Central Drugs Standard Control Organisation (CDSCO) to conduct human trials.
In a press release on BBIL's website, Dr. Krishna Ella, Chairman and Managing Director said:
“We are proud to announce COVAXIN™, India’s first indigenous vaccine against COVID-19.The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
Covaxin™ has been under pre-clinical testing (i.e. testing on animals such as guinea pigs and mice) to see if it is safe before the firm approached CDSCO for approval to move on to human trials.
But what initiated the controversies around the drug was due to a letter, issued by the Director-General of ICMR Dr. Balram Bhargava who said:
“This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the government. The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine. It is envisaged to launch the vaccine for public health use latest by 15 August, 2020, after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project.”
The fact that the drug will be ready for public use by August 15th has baffled many medical experts around the country. A vaccine needs to complete three phases of testing and the expected duration of the trial, according to the government’s official clinical trial registry, is one year and three months before it becomes available for public use. Experts feel that even if a need for a vaccine is grave, the compromise on the safety and the usability of the drug is larger when compared to it, the reason being it may further cause various other health issues. But the spokespersons from BBIL has refused to comment on a deadline.
It is worth noting that the vaccine for HIV is still in phase 3 of its clinical trial even after three decades of its research (source), we will have to wait until a clear clarification of this is provided by the ICMR and whether the vaccine, Covaxin™ will be available for public use by August 15th.