Brazilian regulator to scrap clinical trial requirement for vaccine approval

The Brazilian health regulatory agency Anvisa is set to revoke its requirement for late-stage clinical trials to be held in the country before emergency approval may be granted for Covid-19 vaccines, local media reports.  

The decision is of huge importance to laboratory União Química, as it had its request to produce the Russian-made Sputnik V vaccine denied earlier this year due to the lack of phase-three trials ongoing in the country. Indian laboratory Bharat Biotech, which produced the Covaxin vaccine, could also benefit from the new requirements. 

Anvisa is set to make an official announcement of the measure by 6 pm local time.

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