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Bharat Biotech’s COVAXIN, India’s first indigenous vaccine against coronavirus. (Swarajya Magazine)
Hyderabad-based vaccine maker Bharat Biotech has said that Phase-1 clinical trials of its new intranasal single dose vaccine for COVID-19 will begin from February or March this year, reports The Economic Times.
Recently, the Drug Controller General of India (DCGI) issued Emergency Use Authorisation approval to Covaxin, a COVID-19 vaccine developed by Bharat Biotech.
Along with Covaxin, Bharat Biotech is actively working on developing a single dose intra nasal vaccine for COVID-19.
"BBV154 (intranasal COVID-19 vaccine), preclinical testing has been completed for toxicology, immunogenicity and challenge studies. These studies have been conducted in the USA and India. Phase I human clinical trials will commence during Feb-March 2021," Bharat Biotech was quoted as saying in an email reply to news agency PTI.
Bharat Biotech chairman Krishna Ella had earlier said that the company is focusing on the intranasal vaccine as the existing vaccines require two dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add up to pollution.
"One drop of vaccine in each of the nostrils is sufficient,” Ella was quoted as saying.
“The intranasal vaccine candidate has shown unprecedented levels of protection in mice studies and the technology and data having been already published in the prestigious scientific journal 'Cell' and in an editorial in 'Nature',” the company had said.
Bharat Biotech added that after receiving the necessary regulatory approval, further stages of clinical trials will be conducted in India and then large-scale manufacturing of the vaccine will be undertaken at its facility located in Genome Valley of Hyderabad.