New Delhi, January 8: 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. Bharat Biotech Soon to Conduct Trials of Nasal Vaccine Against COVID-19; What Is an Intranasal Vaccine? All You Need to Know.
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.
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