By Ishani Panda
“Every cloud has a silver lining.” This quote seemingly suits the most at a time when the entire world has left us in a usual way of living and taking refuge in our homes to save ourselves from the deadly coronavirus.
Amidst all the fear and confusion that has Infused among the mindsets of the common people while the virus itself capturing its virulent over the earth, a ray of hope has finally emerged among the people.
The first made-in-India coronavirus vaccine may be launched by August 15, with the Indian Council of Medical Research (ICMR) fast-tracking efforts to develop “Covaxin“ in partnership with Bharat Biotech International Limited.
Hyderabad-based Bharat Biotech, which is one of seven Indian companies involved in the indigenous production of a vaccine for the novel coronavirus, received the green signal from the Central Drugs Standard Control Organisation (CDSCO) to begin human trials of ‘Covaxin’ last week.
The vaccine candidate was developed in collaboration with ICMR’s National Institute of Virology (NIV). NIV isolated a strain of the novel coronavirus from an asymptomatic Covid-19 patient and transferred it to BBIL early in May.
The firm then used it to work on developing an “inactivated” vaccine a vaccine that uses the deadly virus at its high-containment facility in Hyderabad.
“Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus,” said the company, adding that inactivated vaccines usually have a proven safety record.
After having undergone a series of pre-clinical testing, involving multiple animal trials, the firm approached the drug control authorities i.e. CDSCO, for an approval to proceed to the next level of testing, consisting of human clinical trials.
Covaxin, having received the approval from the authorities are scheduled to start their trials in July. Bharat Biotech India (BBIL) will be helpful in two phases.
Phase I will be conducted in small groups of individuals, where the dosage of the vaccine will be determined. The concerned personnel will study the effectiveness and side effects of the vaccine in accordance with the number of dosages.
Phase II will comprise of a larger group of people where they will be organized and categorized according to certain characteristics such as age and sex. To check for its safety and efficacy for the human trials, the Covaxin vaccine was first tested on mice and guinea pigs.
It was only after its safety was evaluated on animals that the Central Drugs Standard Control Organisation (CDSCO) gave the go-ahead to conduct human trials for the COVID-19 vaccine candidate from India.
This is as per a letter written as internal communication by ICMR to Bharat Biotech asking for fast-tracking of the indigenous vaccine with an aim to launch by August 15.
“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” the letter says.
“The collaboration with and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project,” Krishna Ella, Chairman and MD of Bharat Biotech told the Indian Express.
Stating that the proactive support and guidance from the Central Drugs Standard Control Organisation has enabled approvals to the project, Krishna Ella said, “Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
Bharat Biotech said it accelerated objective in completing the comprehensive pre-clinical trials, which were expedited through national regulatory protocols.
The company claimed that the results from these studies were promising and showed extensive safety and effective immune responses.
The company has been instrumental in developing an eco-friendly recombinant and a naturally attenuated strain derived Rotavirus vaccine called ROTAVAC. They were one of the first to develop vaccines for viral diseases like Chikungunya and Zika.
However, this announcement has put the Bharat Biotech under scrutiny by various experts since giving a time-limit of a month for the vaccine to be ready is laughable since it is absolutely short.
Nowhere in the world, where the vaccine trials are far ahead of the Indian counterparts claim that the vaccine can be ready before one year.
Phase 1 of a clinical trial is usually small and is used to determine its safety profile. Phase 2, on the other hand, employs a bigger sample size and looks at the immune responses triggered by the vaccine.
However, a vaccine is deemed safe to be commercially available only after Phase 3 – a much larger efficacy trial involving thousands of participants.
The trial document for Covaxin does not mention Phase 3. Even for Phase 1 and Phase 2, there appears to be some confusion over the sequence to be followed.
Although the information regarding the vaccine launch can be under scrutiny yet it gives hope to people that life will return to normalcy if it gets launched by August. It gives hope that it can give freedom from the Coronavirus by being launched on Independence Day.
The lockdown period which has given rise to various domestic violence and mental health issues will decrease drastically and will bring back the old but better face of India.