Covaxin , India’s first COVID-19 vaccine candidate, set for human trials

A potential COVID-19 vaccine, the first to be developed in India, has been given DCGI (Drug Controller General of India) approval for Phase I and II human clinical trials that are scheduled to start across the country in July.

Developed by Hyderabad-based Bharat Biotech, in association with ICMR (Indian Council for Medical Research), COVAXIN is an inactivated vaccine, created from a strain of the infectious SARS-CoV-2 virus, that has shown promise in preclinical studies, demonstrating extensive safety and effective immune responses.

Drug manufacturers around the world are racing to develop a vaccine against the novel coronavirus; a novel virus is one that has never previously been identified in humans, making the task of creating a vaccine that much harder.

India, a leading manufacturer of vaccines and generic medicines, is expected to play a key role in this race, with several institutes working on different drugs.

In May the government said as many as 30 groups were working on a vaccine. A top scientific advisor to the government said efforts that normally took 15 years and cost US$300 million were being condensed into a 12-month period.

Similar efforts are being mounted across the world, with a number of different drugs in different stages of trial. Last week the World Health Organisation (WHO) said AstraZeneca’s vaccine was probably the leading candidate.

The British 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.

China’s military has been given permission to use a vaccine candidate developed in association with CanSino Biologics. According to Reuters the drug showed some promise in early clinical trials. The Ad5-nCoV is one of the eight vaccine candidates developed by Chinese firms to move into human trials.

Early last month US-based biopharmaceutical firm Gilead Sciences Inc. said a five-day course of its antiviral drug Remdesivir showed a modest benefit to patients with moderate COVID-19 symptoms.

The drug, which is administered intravenously, was the first to show improvement in condition of COVID-19 patients in formal clinical trials, according to news agency Reuters.

As pharma firms scramble to find that big breakthrough, which could mean millions in profits and millions of lives saved, experts have warned that early vaccines may come with limitations on what they can do.

The pandemic has already claimed over five lakh victims worldwide, including 16,475 in India. There are over 1.01 crore confirmed cases, including nearly 5.5 lakh in India – the fourth worst-affected country. – NDTV

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