Bharat Biotech, a Hyderabad - based pharmaceutical company submitted to DCGI on Saturday, the trial data on Covaxin for children in the 2-18 years age group.
Indigenously developed Covid-19 vaccine Covaxin, by manufacturer Bharat Biotech, submitted its trial data for children in the 2-18 years age group to the Drugs and Controller General of India (DCGI), the company’s chairman and managing director Dr. Krishna Ella to news media .
Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age were successfully completed by Bharat Biotech in September and have now submitted the trial data for DCGI's approval.
On the other hand, the guidance document on the evaluation of Emergency Use Listing for Covid-19 vaccines by WHO shows that the final approval is estimated to be completed by this month for Bharat Biotech’s Covaxin.
"The firm submitted all the data to the WHO and have done the requisite work" as quoted by Dr. Krishna Ella on Saturday. He said that Bharat Biotech has received past approval for their other vaccines and are used to the approval process. He, however, refused to comment on the timeline.
Bharat Biotech had reportedly submitted required documents to the WHO by July 9, and the WHO review process had commenced by July-end and will take close to six weeks.
The EUA of Covaxin would enable its recipients to travel abroad without mandatory quarantine if granted.
Dr. Krishna Ella said, “I don’t know why countries are indulging in such nationalism", expressing about the travel advisories that require individuals vaccinated with Covaxin to undergo quarantine.
But, Bharat Biotech Chairman refused to comment on the row over UK's rigid travel norms that made quarantine and negative Covid-19 test mandatory for travelers from India.
Dr. Krishna Ella said that Bharat Biotech is looking at nasal vaccine as booster shot as the conversation around the booster doses of Covid-19 vaccines gain momentum.
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