After media reports stated that Bharat Biotech’s Covaxin has been approved for children between the age groups 2-18, the Health Ministry has denied it.
In a statement, MoS Health Bharti Pawar stated that the evaluation process is still underway and approval for vaccinating children in 2-18 age group with Bharat Biotech’s Covaxin is yet to be granted.
The evaluation is still going on. There is some confusion & the talks are underway with the experts' committee. Till now Drugs Controller General of India (DCGA) hasn't approved it: MoS Health, Dr Bharati Pravin Pawar on approval to Covaxin for 2-18 years age group pic.twitter.com/unQGG4QXdB
— ANI (@ANI) October 12, 2021
Pawar stated that the DCGI approval for Bharat Biotech’s Covaxin for children in 2-18 age groups is yet to come and talks are underway.
Earlier today, media reports had stated that Bharat Biotech’s indigenously made Covid-19 vaccine Covaxin has been granted approval for its usage on children belonging to the age group 2 to 18.
The Subject Expert Committee on Covid-19 gave its nod to Covaxin for children in the 2-18 years age group, many news reports on October 12 had stated.
#BREAKING | Covaxin for Children!
— News18 (@CNNnews18) October 12, 2021
Subject Expert Committee Sends Recommendation To DCGI. pic.twitter.com/kAUvS8SxA2
Earlier this month, the Hyderabad-based Bharat Biotech submitted the trial data of the Phase-2 and Phase-3 trials of Covaxin on children to the Drugs and Comptroller General of India (DCGI).
According to the reports, the gap between two doses for children has been pegged at 20 days.
As per reports, Bharat Biotech has to provide updated prescribing information/package Insert (PI), Summary of Product Characteristics (SmPC) and factsheet.
Additionally, the organisation is also mandated to submit safety data including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per the requirement of New Drugs & Clinical Trials Rules, 2019.
AIIMS doctor says safety and immunogenicity of Covaxin among children same as those in adults
Recently, an AIIMS professor had claimed that the trial data of Covaxin asserted that the safety and immunogenicity of Covaxin are almost the same in children, as adults above 18-years of age.
Speaking to ANI, Dr Sanjay K Rai, a professor at Centre for Community Medicine, All India Institute of Medical Sciences (AIIMS), said, “Covaxin`s trial was done on three age groups. The first group examined was between 12 -18 years, the second group was between 6- 12 years and the third age group was between 2-6 years.”
This report has been updated from an earlier version with the latest information.
