Indias first COVID-19 vaccine COVAXIN gets nod for human trials

Vaccination

A Hyderabad-based company called Bharat Biotech has achieved this success in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology, Pune.

The clinical trials of the experimental COVID-19 vaccine in humans are scheduled to begin in July 2020, Bharat Biotech said in a note.

The Phase 1 and 2 clinical trials of the CanSino's vaccine candidate showed it has the potential to prevent diseases caused by the coronavirus, which has killed half a million people globally, but its commercial success can not be guaranteed, the company said. A vaccine has to prove its effectiveness in "Phase 3" human test where thousands of participants are recruited in order to be cleared for sale. The vaccine was developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility, which is located in the Genome Valley. Furthermore, the support and the guidance from CDSCO had enabled approvals to the project, Ella stated.

According to Major General Chen Wei, who led the vaccine's development, the vaccine is based on a similar Ebola vaccine that he previously produced, and will join the range of drugs owned by the People's Liberation Army (PLA) for use in major outbreaks.

Vaccine development is a lengthy process which often takes years and has many challenges, explains E. Sreekumar, chief scientific officer at the Rajiv Gandhi Centre for Biotechnology (RGCB) in Kerala.

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According to a statement released by the firm on Monday, a strain of the infectious SARS-CoV-2 virus was isolated in NIV, Pune and transferred to Bharat Biotech.

The first clinical trial of China's first COVID-19 mRNA vaccine is underway in east China's Hangzhou City.

China first announced it had been permitted to test its potential Covid-19 vaccine on humans last week. Over a dozen vaccine candidates are now in development around the world, including several from China.

She also said: "I think AstraZeneca (their partner drug company) certainly has a more global scope at the moment in terms of where they are doing and planning their vaccine trials". Phase one trials are small-scale, usually involving few participants, to assess whether the vaccine is safe for humans. However, all of them are in pre-clinical stage as of now. He said the FDA is committed to expedite a covid-19 vaccine, but "will not cut corners in our decision-making". As of Tuesday, more than 10 million cases of the virus have been recorded worldwide, leading to over half a million deaths.

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