Brazil may approve Oxford / AstraZeneca and Coronavac vaccines for emergency use

Minutes later, Monica Calazans, a black nurse from downtown São Paulo, becomes the first Brazilian to be vaccinated. Calazans, who are at high risk for Covid-19 complications and work in an ICU that has been 90% or higher since April, burst into tears before getting the Coronavac shot.

“You do not understand what this means for me,” she told São Paulo governor João Doria.

Brazil is the country hardest hit by Covid-19 in Latin America. It has recorded more than 8 million cases and more than 200,000 deaths due to coronavirus. Although several of its neighbors have already approved vaccines for use, Brazil appears to be lagging behind despite its well-known public health and vaccination record.

Coronavac, developed by the Chinese company Sinovac, is now authorized to use 6 million imported doses. It has a history in the state of Sao Paulo, where the local Butantan Institute conducted Phase III clinical trials of the vaccine. Butantan will also produce future doses.

However, Coronavac showed a low average efficacy rate of 50.4% – barely above the 50% minimum set by the World Health Organization. The number, which falls well below the 78% previously announced, has raised questions about the truth of the data and sparked skepticism about the apparent lack of transparency regarding Chinese vaccinations.

The technical report of ANVISA, which alleviates Coronavac, stressed that the agency also took into account the urgency of the dazzling Covid-19 cases in Brazil and ‘the absence of therapeutic alternatives’.

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It is also recommended that the vaccine be further monitored, pointing out that the Butantan Institute has not provided important data from its Phase III study, such as the term of protection provided by the vaccine and its effect on the elderly, those with comorbidity and others. patient groups.

Doria has promised to make vaccines developed in the state available to the Brazilian Federal Ministry of Health for national distribution.
“Today is V-day. It’s the day of the vaccine, it’s the day of truth, it’s the day of victory, it’s the day of life,” he told a news conference after the vaccinations were approved is – a sign of Health Minister Eduardo Pazuello’s unwillingness to commit to a start-up date for nationwide vaccinations, which he said would start earlier ‘in the D-day and in the hour H.’
The Oxford / AstraZeneca vaccine, which has shown an average efficacy of 70.4% in preliminary phase III trials, has also been approved for the use of 2 million doses, by the Brazilian Oswaldo Cruz Foundation (Fiocruz) from India. Serum Institute will be introduced.

Fiocruz entered into an agreement in June to buy and manufacture the vaccine with pharmaceutical giant AstraZeneca. Following successive delays, the Brazilian government signed a 256 million dose contract in October, announcing that it would receive the first one in December.

After another series of delays, Fiocruz expects to receive the first shipment by the end of January.

CNN’s Rodrigo Pedroso reports from São Paulo and Caitlin Hu reports from New York.

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