DCGI Approves Emergency Use Of COVAXIN On Children Between 2 To 18 Years Old Age Group

After days of clinical trials, the Hyderabad based Bharat Biotech International Private Limited manufactured COVAXIN, received emergency approval for children.

On the 12th of October, the Subject Expert Committee on the Wuhan virus, also known as the Novel Coronavirus (COVID-19,) approved the emergency use of COVAXIN for children between 2 years to 18 years. The decision of the expert committee came after Bharat Biotech completed Phase II and Phase III trials of the COVID-19 vaccine on children below 18 years. Bharat Biotech's COVAXIN is one of the vaccines being used in India for mega vaccine drives. Now, the vaccine is also approved for emergency use on children.

According to sources, in September, the Hyderabad based Bharat Biotech submitted a detailed report of the trials conducted on children to the Drugs and Comptroller General of India (DCGI.) After a month of study, the DCGI and the expert committee approved the use and released an official statement. The Statement read, “After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18."

The made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose. The emergency use authorisation, however, is subject to certain health conditions and doctor's approval.

With this, the DCGI has approved emergency use of two vaccines against the Wuhan virus. One is Gujarat based Zydus Cadila manufactured Plasmid DNA vaccine, ZyCoV-D and now COVAXIN. However, ZyCov-D is restricted to children above 12 years old, whereas COVAXIN could be used on children between 2 years to 12 years old for emergency usage.

Although the aforementioned vaccines have been approved for children, it is yet to be included in the vaccination drive and roll out for all.

Stay tuned for further updates.