(Image source from: indiatvnews.com)

Bharat Biotech gets approval from DCGI to takes India’s first Covid-19 vaccine candidate- Covaxin, for human trials of phase 1 and 2.

The world has been Covid-19 regressively for the past 6 months. The deadly virus which has spread over the entire world has taken over the lives of the people. The virus which is said to originate in the Wuhan city of China has infected over 10 million people worldwide. The coronavirus has been spreading like wild fire from one person to another. This has forced people to be locked down in the safety of their homes and maintain social distancing.

The virus has brought such unprecedented times that the world is busy with just finding a proper cure or treatment for it. Thought there have different treatments used around the world and the recovery rate is also around 50%, the scientists all around the world have been working tirelessly to find a vaccine. While the recovery rate is high, there have been more than 500 thousand deaths as well because of the virus. There are over 140 candidates around the world of which around 10 have entered the human trial phase. Covaxin is the first vaccine candidate from India to enter the phase 1 and 2 of the human trial stage.

This vaccine is developed by Bharat Biotech in collaboration with the prestigious institute, the National Institute of Virology (NIV) and the research Centre, Indian Council of Medical Research (ICMR). The good news is the vaccine has received approval from the Drug Controller general of India (DCGI) to conduct both phase 1 and phase 2 of human trials. The first stage the making of vaccine and the pre-clinicaltrials of this vaccine on animals like monkey and mice have been done. After this comes the human trial stages which is also divided into 3 phases. The Covaxin has gotten the approval for humantrials which are scheduled to start across the country in July 2020.

This was announced by the company Bharat Biotech on Monday. The development was started in NIV, Pune and then transferred to the manufacture unit of Bharat Biotech I Hyderabad. The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.

The approval for human trials of the vaccine from the Drug Controller General of India and Ministry of Health and family Welfare was only granted after Bharat Biotech submitted the results of preclinical studies which demonstrate the safety and immune response.

Dr. Krishna Ella, who is the chairmanand Managing Director of Bharat Biotech, could not contain the excitement while sharing the news to the world. During the announcement Dr. Ella was seen appreciating both ICMR and NIV for their collaboration and also showed gratitude towards DCGI and CDSCO for the approval. The company accelerated its objective in completing the comprehensive preclinical studies. Results from these studies have been promising, showing extensive safety and effective immune responses.

Bharat Biotech is the only BSL-3 containment facility for manufacturing and testing in India. The track record of Bharat Biotech in development of vaccines has been insane. Bharat Biotech uses Vero cell culture platform in development of vaccines which have been path breaking for vaccine developments of Polio, Rabies, rotavirus, Zika, Japanese Encephalitis and Chikungunya. The research and expertise of development during the epidemics has definitely proven as a plus point while manufacturing the vaccine for H1N1 pandemic.

According to the Health Ministry, India’s total coronavirus cases reached 5,48,318 as of Monday evening. Worldwide, the novel coronavirus has now claimed at least 501,847 lives and infected as many as 10,161,240 people.

By Deepika Agarwal