India’s 1st COVID-19 vaccine gets human trial approval

NEW DELHI, India

India’s first COVID-19 vaccine got the approval for human trials from the country’s drug regulator, as number of coronavirus-related cases and deaths continues upward, a drug company announced.

The vaccine, named COVAXIN, has been developed by Bharat Biotech compnay, in collaboration with the Indian Council of Medical Research and the National Institute of Virology (NIV).

The indigenous, inactivated vaccine was developed from a SARS-CoV-2 strain, which was isolated by the NIV and transferred to the company’s BSL-3 High Containment facility located at Hyderabad city in southern India, Bharat Biotech said in a statement.

“Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic,” said Suchitra Ella, joint managing director of the company.

The permission to initiate Phase I & II Human clinical trials came after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

Human clinical trials are scheduled to start across India in July.

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

With 18,522 new coronavirus cases registered over the past 24 hours, India's nationwide tally on Tuesday morning topped 566,800, according to the Health Ministry data. Of these, the last 120,000 cases were reported in the last week.

Meanwhile, the death toll in the country reached 16,893 with 418 more fatalities, while a total of 334,821 patients have recovered.

Amid the surge, several states including eastern states of Jharkhand and West Bengal, and northeastern Assam and Manipur have re-imposed partial or full lockdown.

"It was mentioned that presently eight states - Maharashtra, Delhi, Gujarat, Tamil Nadu, Telangana, Uttar Pradesh, Andhra Pradesh, and West Bengal - contribute 85.5 percent active caseload and 87 percent total deaths in India," read a Health Ministry statement.

The government on Monday announced the second phase of the country's gradual emergence from restrictions in what is called “Unlock2".

The worst-hit areas will continue to remain under strict restrictions.

souce from:https://www.aa.com.tr/en/asia-pacific/india-s-1st-covid-19-vaccine-gets-human-trial-approval/1894363