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Bharat Biotech submits data from Covaxin’s trials on children to DCGI: Report

Bharat Biotech International Limited, which has developed Covaxin, India’s first indigenous vaccine against the coronavirus disease (Covid-19), has reportedly submitted data from the jab’s trials on children to the Drugs Controller General of India (DCGI). “We have submitted the data from trials on volunteers in the age group of 2-18 to the DCGI,” Dr Krishna Ella, the Hyderabad-based firm’s chairman and managing director, told India Today on Saturday.

The development comes after the biotechnology company, last month, completed phase 2/3 trials of Covaxin on kids. Bharat Biotech was expected to submit data to the drugs regulator “very soon.

At present, citizens below 18 years of age are not eligible for the nationwide vaccination drive against the viral illness. Of the six vaccines to have received emergency use authorisation (EUA) from the DCGI thus far, only one, ZyCoV-D, will be applicable to an age group below 18, having received approval to be administered on everyone aged 12 and above.

ZyCoV-D is the country’s second home-made shot against Covid-19. The jab has been prepared by Zydus Cadila, located in Ahmedabad.

Though a countrywide inoculation drive for children is yet to be announced, fears over a potential third wave of infections have triggered calls in this regard. The reopening of schools in most states amid the declining second wave has only added to those calls.

Thus far, more than 900 million doses of Covid-19 vaccines have been administered across the country since the exercise began on January 16 this year, according to the Union health ministry’s dashboard. Of these, 7,376,846 were used in the last 24 hours. On at least five occasions, more than 10 million beneficiaries were jabbed in a single-day, including more than 20 million shots on September 17, Prime Minister Narendra Modi’s 71st birthday.