Covaxin are approved for emergency use in children aged 2-18 years
Hyderabad-based Bharat Biotech completed the Covaxin Phase-2 and Phase-3 trials of children under the age of 18 in September and submitted the test data to the Drug and Control General of India (DCGI) earlier this month.
"After extensive consultation, the committee recommended granting market recognition of the vaccine to those aged 2 to 18 years for prohibited use in emergency situations," the panel said in a statement.
The vaccine made in India is given in two doses with an interval of 20 days between the first and second dose.
In a report, the clinical trial data submitted by Bharat Biotech was fully reviewed by the Central Drug Standard Control System (CDSCO) and SEC, who gave positive recommendations.
"This is one of the first global approvals for Covid-19 vaccines for 2 to 18 year olds. We truly thank Bharat Biotech DCGI, Course Expert Panel and CDSCO for their expeditious review process. , "Said the vaccine developer.
However, emergency use authorization is subject to certain conditions. Covaxin developer Whole Virion will continue the study according to the approved clinical trial protocol for the inactivated corona virus vaccine.
It should provide updated referral information / package insertion (PI), product attribute summary (SmPC) and fact sheet.
Meanwhile, WHO has not yet granted emergency use authorization to covaxin. Bharat Biotech is said to have submitted all the documents required for listing to the WHO by July 9, and the WHO review process, which will take close to six weeks, began by the end of July.
In August, India approved emergency use of ZyCov-D's Covid-19 vaccine for children 12 to 18 years of age. The vaccine was developed by the pharmaceutical company Zydus Cadila and is the world's first recognized DNA vaccine.
Post a Comment
Thanks for Reading..♥Keep Supporting..🙏