New Delhi: The Drugs Controller General of India (DCGI) is yet to give its approval to the Bharat Biotech’s vaccine for children aged 2-18 years. Amid reports of COVAXIN getting the drug controller’s nod, Minister of State for Health Bharati Pravin said, “The evaluation is still going on. There is some confusion and the talks are underway with the experts’ committee. Till now Drugs Controller General of India (DCGI) hasn’t approved it.”
Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and has provided their positive recommendations.
Previously it was reported that the DCGI has approved COVAXIN for usage on kids.
The recomendations come a day after an AIIMS professor claimed that the latest trials show that the safety and immunogenicity of India’s indigenous Covid-19 vaccine–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), on Monday 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.”
Dr Rai was the principal investigator of COVAXIN trials on children. “At first, we finished the examination of people aged between 12- 18 years and then subsequently other groups. Covaxin’s vaccine safety and immunogenicity are almost the same.”
Dr Rai noted that globally it is observed that in children, SARS-CoV-2 isn’t fatal. “Only a very mild infection is present. In a few children, it’s milder than the common cold. Currently, we don’t have any justification on whether Zydus Cadila, Bharat Biotech, Pfizer or Moderna…which is the mildest. These vaccines are reducing the severity of the infection but not the infection,” he had said.
(With inputs from ANI)