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Covaxin Receives Approval for Booster Vaccine Trial | India News


HYDERABAD: Indigenous Covid-19 Covaxin vaccine will now be tested for a booster dose, to be given six months after the second injection.
Bharat Biotech has received subject matter expert committee (SEC) approval for this. The SEC, which advises the Controller General of Drugs of India (DCGI), recommended that Bharat Biotech conduct the booster dose study only on Phase II trial participants after they have taken 6 mcg of Covaxin.
The committee has also directed the company to follow the subjects for at least six months after the administration of the third dose. SEC approval for the booster dose study came after Bharat Biotech requested amendments to the approved phase II trial protocol to allow the administration of a booster dose six months after the second dose.

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