Bharat Biotech has submitted to the Drugs Controller General of India data from the clinical trials of its Covid-19 vaccine Covaxin on children aged between two to 18 years, India Today reported on Saturday, quoting the company’s Chairperson Krishna Ella.

The Hyderabad firm had in May received permission to conduct phase two and three trials of the vaccine on children. The health ministry had said the trials would involve 525 healthy volunteers.

The clinical trials were completed in September. “The data analysis is going on so we will be submitting [the data] by next week to DCGI,” Ella had told The Times of India on September 21.

In August, NK Arora, the head of the National Immunisation Technical Advisory Group, had said that vaccines for children aged between 12 and 17 years would likely be rolled out by October.

The same month, the drug regulator granted emergency use authorisation to ZyCov-D, a three-dose coronavirus vaccine developed by pharmaceutical company Zydus Cadila. This is the first vaccine in the country that can be administered to children aged 12 years and above.

WHO approval for Covaxin

Bharat Biotech has also sought emergency use listing of its coronavirus vaccine from the World Health Organization.

Emergency use listing is a procedure to approve vaccines and other products for use during public health emergencies. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer.

Bharat Biotech’s chairperson told India Today on Saturday that all the required data has been submitted to the global health agency. However, he refused to speak about the timeline of the process.

The WHO has said that it will make its decision in October.