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Brazil authorizes and rolls out COVID-19 vaccines

Brasilia 17th January 2021 – The Brazilian Regulatory Agency ANVISA authorized the emergency use of vaccines from Oxford-AstraZeneca and China’s Sinovac, doses of which will be distributed by local public partners, Fiocruz and Butantan, in all 27 states. Brazil has the world’s second-highest death toll from Covid-19 and cases are rising again across the country. More than 220,000 COVID-related deaths have been recorded in Brazil, a total figure only exceeded by the US. Over 9 million infections have been confirmed since the start of the pandemic – the third-highest tally in the world. The national vaccination programme in the country of 211 million people would begin in the coming days. About six million doses of the Sinovac-manufactured CoronaVac and up to an additional 40 million doses filled in Brazil by Butantan have been approved, while the government is waiting for shipments of the AstraZeneca vaccine from a laboratory in India. Two Brazilian companies have been given authorization to manufacture the vaccines locally.

CoronaVac vaccine had been found to be 50.4% effective in a Butantan sponsored clinical trial in Brazil with 78% protection form mild-to-severe cases requiring medical assistance, over the 50% needed for regulatory approval. The efficacy of the Oxford vaccine was reported to be 70.4%. An ANVISA rapporteur stated that the benefits of both vaccines outpace the eventual risks assessed, and both products satisfy the quality and safety criteria required for emergency use, conditional to the monitoring and periodic re-evaluation of the epidemiologic situation and immunogenicity data.

Importantly, the emergency use authorization includes no marketing authorization and thus cannot be commercialized, only distributed in the public health immunization programme. The emergency use can be withdrawn at any time by ANVISA.

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