DCGI give emergency approval to Covaxin for children above 2 years of age

DCGI give emergency approval to Covaxin for children above 2 years of age

FPJ BureauUpdated: Tuesday, October 12, 2021, 10:54 PM IST
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NEW DELHI: The Hyderabad-based pharma major Bharat Biotech's Covaxin has got authorisation for emergency in children in the age group of 2 to 18 years from the Drugs Controller General of India (DCGI).

Bharat Biotech had submitted the trial data of phase 2 and 3 of Covaxin on children in the beginning of this month to the apex body. The vaccine will be administered in two doses with 20 days of interval.

The vaccine tested on children is the same formulation as used on adults, but separate trials were needed to guarantee safety and efficacy on younger recipients. Data on these trials has not been made public yet, but tests were conducted on 1,000+ children across the country. The trial on kids showed similar efficacy rates as that on adults – that is, 77.8%.India is slowly turning its focus towards vaccinating children against the coronavirus, having administered nearly 96 crore doses to adults.Dr Randeep Guleria, chief of Delhi's AIIMS, has stressed that children in the two-18 age group must be vaccinated "because that's the only way to get rid of the pandemic".

As schools re-open and students (and teaching and non-teaching staff) return to classrooms, concerns have been expressed over a spike in cases and the possibility of children being infected, as well as the need to also vaccinate adults working at schools.Incidentally, the World Health Organisation has not yet granted emergency use authorisation to Covaxin.

The WHO said last week that it will carry out the risk and benefit assessment next week and take a final call on the much approval.Without WHO nod, Covaxin will not be accepted as a valid COVID-19 vaccine by most countries around the world. This means Indians who received the jab will be forced to quarantine when travelling abroad, unlike those who received SII's Covishield.

Meanwhile, Covid-19 infections are falling by the day, logging 14,313 in the past 24 hours ending at 8 am on Tuesday, which is 3819 less than the previous day and the lowest in the past 224 days; the active cases have come down to 2,14,900, the lowest since March 2020, with a drop of 12,447 in 24 hours.

The daily deaths are down to 181, including the highest 84 in Kerala and 36 in Maharashtra. As many as 26,579 people recovered in the past 24 hours. The recovery rate is 98.04 which is the highest since March 2020.

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