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Covaxin receives approval for trial of booster shot

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eMediNexus    04 April 2021

The indigenous COVID-19 vaccine – Covaxin - will now be evaluated for a booster dose, which can be given six months following the second dose.

The subject expert committee (SEC) that advises the Drugs Controller General of India (DCGI), has given approval for this and has recommended that Bharat Biotech must carry out the booster dose study only on Phase II trial participants after they have been given 6mcg of Covaxin. The participants have to be followed up for at least six months after the administration of the third dose. The approval for the booster dose study has come after Bharat Biotech requested amendments in the approved Phase II trial protocol, to permit administration of a booster dose 6 months after the second dose of the vaccine… (ET Healthworld – TNN, April 3, 2021)

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