NEW DELHI: Hyderabad-based vaccine manufacturer Bharat Biotech on Wednesday got ‘in principle’ approval from the country’s drug regulator to test nasal COVID-19 vaccine as a booster shot.
India’s drug regulator DCGI on Wednesday granted approval to Bharat Biotech for conducting late-stage trials of its nasal COVID-19 vaccine to be used as a booster shot, according to news agency ANI.
According to reports, DCGI’s Subject Expert Committee (SEC) has granted ‘in principle’ approval to Bharat Biotech for the conduct of ‘Phase III superiority study & Phase III booster dose study’ for its intranasal COVID vaccine.
The DCGI has also directed the vaccine maker to submit protocols for approval. The Covaxin manufacturer has earlier proposed the booster dose for those who have been already been inoculated against COVID with Covishield and Covaxin vaccines.
Bharat Biotech aims to conduct clinical trials on 5,000 subjects (50 per cent vaccinated with Covishield and 50 per cent vaccinated with Covaxin). This comes at a time when 243 new cases of highly transmissible Covid variant Omicron were detected in the last 24 hours, taking India`s Omicron tally to 2,135 cases. Of these, 828 people have recovered from the new strain so far.
Maharashtra and Delhi continue to be the worst-hit states with this new variant.
Among the states and union territories (UTs) that have reported the Omicron infection so far, Maharashtra tops the list with 653 cases of this variant. Of them, 259 patients have been discharged as per the health ministry data on Wednesday. The state alone has reported 85 new Omicron cases in the last 24 hours.
With 82 cases of Omicron variant detected in the last 24 hrs, Delhi`s tally has reached 464. The national capital has the second-highest cases of Omicron infection. However, 57 of them have been discharged from the hospital. Delhi is followed by Kerala with 185 Omicron cases. The Union health ministry on Wednesday morning said that the Omicron infection has so far spread into 24 states and UTs.