Bharat Biotech gets approval to conduct phase 2/3 trials of covaxin vaccine on children

The Covaxin vaccine developed by domestic pharmaceutical giant Bharat Biotech Hyderabad to prevent the spread of the coronavirus epidemic, has also now got permission to conduct trials on vaccine used for in two-year-old to 18-year-olds. The official sources said the committee of experts had recommended that clinical trials be conducted on them in the second and third stages.

Bharat Biotech recently applied for permission to conduct Covaxin clinical trials on 2 to 18 year olds. The Subject Expert Committee on Covid -19 of the Central Drugs Standard Control Organization (CDSCO) met on Tuesday and held discussions. The committee then recommended that the vaccine be used for clinical trials on children aged 2-18 years, sources said.

However, the committee stipulated that Bharat Biotech should submit the safety data of the second phase clinical trials and DSMB recommendations to CDSCO before conducting the third phase experiments. The clinical trials will be conducted at various locations, including Delhi AIIMS, Patna AIIMS, Nagpur Meditrina Institute of Medical Sciences.

It is well known that the Covaxin vaccine, developed by India Biotech in collaboration with ICMR, is being given to all those above 18 years of age in the ongoing vaccination process in the country. Although two vaccines are available in the country, children do not yet have the corona vaccine. Meanwhile, America has got permission to vaccinate the children with Pfizer vaccine.