The DCGI (Drug Controller General of India) has given a nod for a potential COVID-19 vaccine, the first to be developed in India, COVXIN, which is set to for Phase I and II human clinical trials.
The trials are set to start across the country in July.
COVAXIN has been developed by Hyderabad-based Bharat Biotech, in association with ICMR (Indian Council for Medical Research).
According to an NDTV report, it is an inactivated vaccine which created from a strain of the infectious SARS-CoV-2 virus and has shown promise in preclinical studies, demonstrating extensive safety and effective immune responses.
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.
A leading manufacturer of vaccines and generic medicines, India, is expected to play a key role in the global race to find a vaccine for the contagious COVID-19, with several institutes working on different drugs.
The government had informed in May that as many as 30 groups were working on a vaccine. Further, a top scientific advisor to the government had said efforts that normally took 15 years and cost US$300 million were being condensed into a 12-month period.
Reportedly, similar efforts are being mounted across the globe, with a number of different drugs in different stages of trial. Last week, the World Health Organisation (WHO) had said that the AstraZeneca’s vaccine was probably the leading candidate.
The Britain-based firm has already begun large-scale, mid-stage human trials of the drug developed by researchers at University of Oxford.
Other possible vaccines being tested include one by American firm Moderna, which is scheduled to go into Phase III clinical trials from mid-July.
US-based biopharmaceutical firm Gilead Sciences Inc. had said last month that a five-day course of its antiviral drug Remdesivir showed a modest benefit to patients with moderate COVID-19 symptoms.
The intravenous drug was the first to show improvement in the condition of COVID-19 patients in formal clinical trials, news agency Reuters had reported.
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