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BRASILIA, Feb 4 ― Brazilian health regulator Anvisa said yesterday it would alter the requirements around emergency use authorisations of Covid-19 vaccines to allow for the approval of vaccines tested outside the country.
In a news conference, Anvisa officials said a separate process would be created for vaccine developers that only conducted mass clinical trials outside Brazil. Previously, only vaccines that did Phase III testing in Brazil were eligible for emergency use authorisation.
The regulator said the move should help to increase the supply of vaccines in the country. At present, only the shots developed by AstraZeneca Plc and China's Sinovac Biotech Ltd are approved for emergency use in Brazil.
Anvisa also said the timeline for approvals would differ, with a decision for vaccines tested in Brazil made within 10 days compared to 30 days for those tested abroad.
The regulator has been widely criticised for being slow to approve vaccines, as the start of inoculations in Brazil lagged neighbours.
Earlier yesterday, a source with knowledge of the matter told Reuters that Anvisa was set to loosen the requirements around emergency use approvals. ― Reuters
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