Bharat Biotech seeks DCGI’s approval for trials of nasal vaccine for COVID-19

Bharat Biotech has sent a proposal to the Drugs Controller General of India to conduct phase 1 trials of a nasal vaccine for COVID-19. As per the official, the application has been sent to the drug regulatory body and the matter is yet to be taken up.

In recent, COVID-19 vaccines of Bharat Biotech’s ‘COVAXIN’ and Serum Institute’s ‘Covishield’ were granted permission by DGCI for the restricted use in an emergency situation on January 3, 2021.

This came a day after Bharat Biotech had announced the successful completion of volunteer enrolment for COVAXIN’s phase 3 clinical trials. The Union Health Minister, Dr. Harsh Vardhan had also informed that both the vaccines for COVID-19 are on the verge of being available in India.

"Bharat Biotech sent an application to DCGI (Drugs Controller General of India) for conducting the phase 1 trials of nasal vaccine against #COVID19, matter yet to be taken up," says a Government official. pic.twitter.com/b9gJzuJ1Qc

— ANI (@ANI) January 8, 2021

Significance of nasal vaccine:

A nasal vaccine for the COVID-19 as proposed by Bharat Biotech will save on medical equipment like syringes and will also save time taken for the vaccination of the candidate.

Bharat Biotech’s ‘COVAXIN’:

The indigenous vaccine has been developed by Bharat Biotech in collaboration with ICMR- Indian Council of Medical Research- NIV- National Institute of Virology.

The vaccine has also been evaluated in approx. 1,000 subjects in Phase 1 and Phase II clinical trials along with promising immunogenicity and safety results and with acceptance in international scientific journals.

COVAXIN is an inactivated and highly-purified 2 dose vaccine. It has been manufactured in a Vero cell manufacturing platform along with an excellent safety track record of more than 300 million doses.