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Bharat Biotech seeks DCGI's nod to conduct trials of nasal COVID-19 vaccine

ANI | Updated: Jan 08, 2021 17:02 IST

New Delhi [India], January 8 (ANI): The Bharat Biotech International Limited has sent a proposal to the Drugs Controller General of India (DCGI) for conducting the phase 1 trials of a nasal vaccine against COVID-19, informed a government official on Friday.
"Bharat Biotech sent an application to DCGI for conducting the phase 1 trials of a nasal vaccine against COVID-19. The matter is yet to be taken up," the official said.
A nasal vaccine could save on medical equipment, such as syringes, and save time taken for vaccination.
COVID-19 vaccines of Serum Institute of India's 'Covishield' and Bharat Biotech's 'Covaxin' were granted permission for restricted use in an emergency situation by the DCGI on January 3.
This comes a day after Bharat Biotech announced the successful completion of volunteer enrolment for phase-3 clinical trials of 'Covaxin.'
The indigenous vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
COVAXIN has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals, the company had said in a statement.
COVAXIN is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, it had added.
Union Health Minister Dr Harsh Vardhan had asserted that the COVID-19 vaccines 'Covishield' and 'Covaxin' are on the verge of being available in the country. (ANI)