Covaxin: India's first Coronavirus vaccine candidate approved for human trials. Here's all you need to know

With over 6,00,000 cases of Coronavirus, India ranks as the fourth highest affected country in the world. While the numbers continue to rise, a ray of hope has appeared with India’s first COVID 19 vaccine candidate, developed by Bharat Biotech India (BBIL), Hyderabad-based biotechnology firm working closely with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

India's drug control authority, the Central Drugs Standard Control Organisation (CDSCO) has allowed BBIL to hold Phase I and II of human clinical trials, which are scheduled to start across India in July.

Covaxin is the first indigenous vaccine candidate to fight against the novel coronavirus, created and developed by BBIL. It is the first vaccine candidate to be approved for human trials.

According to the firm, “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.”

Also known as an inactivated virus, the virus has no possibility of infecting a person or multiplying in number, as it is already dead. However, when presented to the immune system, the dead viruses has the ability to activate the antibodies that can fight against these viruses.

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 help 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 dosage.

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 Central Drugs Standard Control Organisation (CDSCO) gave the go-ahead to conduct human trials for the COVID-19 vaccine candidate from India.

Approval of a vaccine, usually undergoes four stages. Pre-clinical testing, Phase I and II and lastly Phase III. Phase three is usually the most difficult stage where thousands of people are involved. However, although the vaccine is approved at stage three, the battle is not over yet. The vaccine will be under close observation and its use on patients will be heavily monitored.

According to BBIL, “At the moment we are not sure how the vaccine is going to perform in the humans, as clinical trials are about to commence. Based on the success results of phase I and phase II, we will progress to the larger clinical trials. Thereafter, the licensure timelines will be set out upon receiving regulatory approvals”.

Apart from Bharat Biotech, Zydus Cadila, Pune-based Serum Institute of India and other four or five home-grown vaccines are in their early stages of development. Panacea Biotec, another company indulged in developing a vaccine, is still in the pre-clinical stage.

Having secured an approval for human trials, Covaxin has reached a more advanced phase. Not only is BBIL in close contact with locally developed institutes, but they are also in a global collaboration with Thomas Jefferson University and the University of Wisconsin-Madison and vaccine maker FluGen.

However, considering the global race to developing a vaccine, India is still at a struggling stage. AstraZeneca with its vaccine candidate “ChAdOx1-S” in collaboration with the University of Oxford is already at phase III trials. Apart from Covaxin, atleast six other vaccine candidates have made it to Phase I/II trials and another five are in Phase I trials globally.