Covaxin manufacturer- Bharat Biotech has submitted the trial data for children in the 2-18 years age group to the Drugs and Comptroller General of India (DCGI). The company’s chairman and managing director Dr Krishna Ella told India Today on Saturday.
Bharat Biotech has completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September. The company has now submitted the trial data for DCGI’s approval.
Meanwhile, the final approval for Bharat Biotech’s Covaxin as per the WHO guidance document on the evaluation of Emergency Use Listing is estimated to be completed by October end.
Dr Krishna Ella told India Today that the organisation has submitted all the data to the WHO and has done the requisite work, he added that Bharat Biotech has received past approval for their other vaccines and are used to the approval process. The company had reportedly submitted all documents required for the listing to the WHO by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.
If WHO grants the EUA of Covaxin, it would enable its recipients to travel abroad without mandatory quarantine. Talking about the travel advisories that require individuals vaccinated with Covaxin to undergo quarantine, Dr Krishna Ella said, I don’t know why countries are indulging in such nationalism.
However, the chairman of Hyderabad-based Bharat Biotech refused to comment on the row over the UK’s recently announced travel norms that made quarantine and negative Covid-19 test mandatory for travellers from India.
Further talking about booster shots, Dr Ella told India Today that Bharat Biotech is looking at nasal vaccines as booster shot.
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