Key Points :
- Covaxin is the first innate vaccine applicant by India to battle against the novel coronavirus, developed by Bharat Biotech India (BBIL), Hyderabad-based biotechnology firm working cooperatively with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
- Having undergone a series of pre-clinical trials and testings on animals, the pharma company got an approval from CDSCO, to proceed to the next level of testing, consisting of human clinical trials.
- With the safe success of Phase I and II, Phase III is due to take place in November.
The world is on a spurt to contain the new mutation of the virus known as SARS-CoV-2 which has emerged from the family of coronaviruses. No country or island is left untouched with this disease. Worldwide cases are on the rise. Each country is doing their level best to curb the spread of the virus. The scientist and researcher fraternity is in a race to find a cure to this disease. Almost 300 vaccines are in the developmental stage. However only few vaccines have been given the green flag to continue further as of now.
Covaxin is the first innate vaccine applicant by India to battle against the novel coronavirus, developed by Bharat Biotech India (BBIL), Hyderabad-based biotechnology firm working cooperatively with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Covaxin is classified under the category of inactivated vaccines, which indicates that the virus pathogen is ‘deactivated’ and has no prospect of infecting a person or multiplying in number, as it is already dead.The vaccine just serves the immune system as a dead virus and mounts an antibody response towards the virus.As per the firm’s statement,“The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.”
Having undergone a series of pre-clinical trials and testings on animals, the pharma company got an approval from CDSCO, to proceed to the next level of testing, consisting of human clinical trials.In July, BBIL conducted its Phase I and Phase II of the trials on humans. Doctors at Institute of Medical Sciences and SUM Hospital, collected blood samples of volunteers who were infused with the experimental shot of Covaxin. Dr E Venkata Rao,one of the doctors conducting the trials,recorded a spike in the production of antibodies in the participants, soon after receiving the dose. Lab samples also found that participants did not suffer from any side-effects after the immunization shot.Since there were no possible side effects to the vaccine candidate, the drug authority control has hence permitted BBIL to conduct the final phase of trials.
With the safe success of Phase I and II, Phase III is due to take place in November. Phase III is usually the most crucial stage where thousands of people are involved. Although the vaccine is sanctioned at stage three, the fight is not over yet. The vaccine will be under close observation and its use on patients will be heavily supervised.As per the firm, the trial would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites, consisting of Delhi, Mumbai, Patna and Lucknow, and 10 other cities.It is said, that the volunteers will receive two doses of the experimental vaccine in a gap of 28 days. The vaccine is most likely to be launched by June 2021 as per Bharat Biotech.
