Approval to Covaxin for children aged between 2-18 years awaited after evaluation of data

New Delhi: After the evaluation of data Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for children between 2-18 years old, according to official sources.

Bharat Biotech, the manufacturer of Covaxin, has submitted data for clinical trials in the age group of 2-18 years to Central Drugs Standard Control Organisation (CDSCO). The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee and has provided their positive recommendations.

Earlier, Dr. Sanjay K Rai, a professor at Centre for Community Medicine, All India Institute of Medical Sciences (AIIMS) had claimed almost similar data.

Dr Sanjay K Raisaid, “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.”

Notably, 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. However, the final results of these trials are awaited. We had already carried out trials on the adult population. For children, we are waiting for the results,” said the doctor.

Meanwhile, India’s COVID-19 vaccination coverage has crossed 95 crores.

The nationwide vaccination drive started in India on January 16 with the healthcare workers (HCWs) and the frontline workers getting inoculated in the first phase.

The next phase of COVID-19 vaccination commenced from March 1 for people over 60 years of age and those aged 45 and above with specified co-morbid conditions.

The country launched vaccination for all people aged more than 45 years from April 1.

The government then decided to expand its vaccination drive by allowing everyone above 18 to be vaccinated from May 1.