Sunday, July 4, 2021

Covaxin gets nod for trial of booster shot – ET HealthWorld


Hyderabad: Indigenous Covid-19 vaccine Covaxin will now be tested for a booster dose, to be given six months after the second jab.

Bharat Biotech has received the approval of the subject expert committee (SEC) for this. The SEC, which advises the Drugs Controller General of India (DCGI), has recommended that Bharat Biotech conduct the booster dose study only on Phase II trial participants after they have taken 6mcg of Covaxin.

The committee has also directed the company to follow up the subjects for at least for six months after the third dose is administered.

The SEC’s nod for the booster dose study came after Bharat Biotech requested amendments in the approved Phase II trial protocol to allow for administration of a booster dose six months after the second dose.

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