Bharat Biotech gets approval to conduct vaccine trials on children above 12

Bharat Biotech has received approval to conduct its trials on children who are above the age of 12 years. Before this, the company also got emergency approval for its Covid-19 vaccine only in “clinical trial mode”. Already the vaccine has been used for children above 12 in the last round and has been found safe. In the meantime, the Hyderabad-based firm is conducting Phase 3 trials.  As of now, the government has stated that the vaccination drive was intended only for adults. However, this offers hope that in the case of sufficient data, then it can be extended completely to children in the future.

Prior to this, Union Health Minister Dr Harsh Vardhan had elucidated yesterday that emergency approval for Covaxin is different from the one given for Serum Institute’s Covishield. This is due to the fact that Covaxin’s use will be in clinical trial mode. In this mode, all the recipients will be tracked and supervised as if they are participating in a trial. The government’s go ahead for Covaxin had become a political controversy which stretched late into the evening. Covaxin is yet to finish clinical trials and submit data on efficiency. Congress had demanded that its use should be avoided till the clinical trials are done.

Dr Harsh Vardhan had criticised stating that congress was politicizing a “critical issue”. He further added that the government was following “science-backed protocols” to give approval. As per Dr Harsh Vardhan, Covaxin is more probable to work against the mutant strains on the virus.

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