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India’s vaccine maker starts phase III trials of COVID-19 vaccine Covaxin
NEW DELHI, Nov 17, 2020 (BSS/XINHUA) – Indian vaccine maker Bharat Biotech said it has started phase III trials of its COVID-19 vaccine Covaxin.
“Phase 3 clinical trial of Covaxin takes off as the largest efficacy trial ever conducted in India, with about 26,000 participants,” the vaccine maker said in a statement issued Monday.
The trials are conducted in partnership with India’s top health research body, the Indian Council of Medical Research (ICMR). The trial has been registered at clinical trials registry and approved by the Drugs Controller General of India.
Reports said Covaxin has been evaluated in 1,000 subjects in phase I and phase II clinical trials, with promising safety and immunogenicity data.
“The benchmark for the efficacy of our anti-COVID-19 vaccine is 60 percent. We will be conducting the largest Phase 3 trial for Covaxin, and the efficacy results should be available by early April-May, 2021,” Sai Prasad, executive director of Bharat Biotech International Limited, was quoted by a local newspaper as having said last month.
On Tuesday, a member of the National Institution for Transforming India (NITI) Aayog (commission), V K Paul, said at least five vaccines are under trial in the country, of which two are in phase III stage.
India’s federal health minister recently said the COVID-19 vaccine would likely be available in India by early next year.
The development of COVID-19 vaccine is still in progress.
India is in the grip of an ongoing COVID-19 pandemic and the cases are increasing with each passing day.
India’s federal health ministry Tuesday said the number of COVID-19 cases in India reached 8,874,290 and the death toll rose to 130,519.
Globally India is the second worst-hit country by the COVID-19 pandemic.
BSS/XINHUA/SSS/1955 hrs