Biotechnology company Bharat Biotech on Friday received the Drugs Controller General of India’s approval to conduct phase 2 clinical trials of its nasal vaccine against Covid-19, the Centre said.
Unlike most vaccines that are administered by injection through the muscle or subcutaneous layer (the layer of skin between the dermis and the epidermis) route, intranasal vaccines are given as a nasal spray and offer a needle-free approach.
The intranasal vaccine developed by Bharat Biotech is the first of its kind to receive approval for phase 2 clinical trial in India, according to the Department of Biotechnology.
The first phase of the vaccine’s trial, involving participants aged 18 to 60, has been completed. “The company [Bharat Biotech] reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, has been well tolerated,” the biotechnology department said.
The department added that no adverse events were reported during the vaccine’s phase 1 clinical trial. “Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies,” it said. “The vaccine was able to elicit high level of neutralising antibodies in animal studies.”
Dr Renu Swarup, the secretary of the Department of Biotechnology, said the department was committed to developing safe and effective Covid-19 vaccines in India.
India has administered more than 52 crore coronavirus vaccine doses since the beginning of the inoculation drive on January 16. The country has approved five vaccines for emergency use so far – Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna, and Johnson & Johnson’s single-dose shot.