Bharat Biotech Formulated COVID-19 Vaccine and gets approval for human trials

Bharat Biotech Formulated COVID-19 Vaccine and gets approval for human trials

Coronavirus Latest Updates- On Monday, Bharat Biotech, a Hyderabad vaccine major announced that it’s become the country’s first COVID-19 vaccine candidate. Their drug, COVAXIN, is the first drug to get approval for phase I and II of human trials. 

The Drug Controller General of India (DCGI) gave the go-ahead and the company has been collaborating with the National Institute of Virology and Indian Council of Medical Research.

Bharat Biotech to start human trials for first indigenous Covid-19 vaccine from July

These human clinical trials of the vaccine are scheduled to start in various parts of the country in the month of July. The National Institute of Virology isolated and transferred the SARS-CoV-2 strain to the vaccine maker.

The SARS-CoV-2 strain is the main culprit behind the novel coronavirus and its effects.

The inactivated indigenous vaccine has been manufactured and developed at the Bio-Safety Level 3 High Containment facility of the company. It’s located in Genome Valley in Hyderabad. 

According to the vaccine maker, human clinical trials of the experimental COVID-19 are scheduled to start across the country in July 2020.

The Drug Controller General of India, Ministry of Health and Family Welfare, and Central Drugs Standard Control Organisation granted permission to initiate the first few phases of human trials.

This decision was taken after the company generated results from preclinical studies where the safety and immune response was demonstrated.

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech says, “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 have enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

The company’s objective of finishing comprehensive preclinical studies has been accelerated. Results were not compromised, however, as they are quite promising.

Mrs. Suchitra Ella, Joint Managing Director says, “Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. 

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Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling the future pandemics.”

Bharat Biotech has a proven track record in developing several vaccines for rabies, rotavirus, polio, Chikungunya, Japanese Encephalitis, and Zika. They achieved this by developing the technologies for the Vero cell culture platform.

India’s total number of coronavirus cases have reached around 550,000 cases on Monday evening, according to the Health Ministry. On the other hand, novel coronavirus has claimed 500,000 lives worldwide and has infected around 10 million people.

In order to battle this and shift our lives back to normal, there have been leading vaccines in other countries as well. For example, Oxford University has developed ‘ChAdOx1 nCoV-19’ in under three months. 

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The vaccine candidate is currently going through phase 1 of clinical trials on volunteers who are healthy. These volunteers have been injected with the vaccine to test and check the safety parameter.

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