Brazil authorizes emergency vaccines against Oxford / AstraZeneca and Coronavac

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A few minutes later, Monica Calazans, a black nurse from downtown São Paulo, became the first Brazilian to be vaccinated. Calazans, who is at high risk for Covid-19 complications and works in an ICU that’s been 90% or higher since April, burst into tears before getting the Coronavac shot.

“You don’t understand what this means to me,” she said to João Doria, Governor of São Paulo State.

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 from coronavirus. While several of its neighbors have already approved vaccines for use, Brazil appears to be lagging behind despite its famous public health and vaccination track record.

Developed by the Chinese company Sinovac, Coronavac 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 has shown a low average efficacy of 50.4% – barely more than the 50% minimum set by the World Health Organization. The number, dropping well below the previously announced 78%, has raised questions about the veracity of the data and fueled skepticism about the apparent lack of transparency regarding Chinese vaccines.

ANVISA’s technical report greenlighting Coronavac stressed that the agency had also taken into account the urgency of Brazil’s sky-high Covid-19 cases and “the lack of therapeutic alternatives.”

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It also recommended further monitoring of the vaccine, as the Butantan Institute had not provided key data from its Phase III study, such as the duration of protection the vaccine provides and its effect on the elderly, those with co-morbidities and other patient groups.

Doria has pledged to make state-developed vaccines available to Brazil’s 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 said at a news conference after the vaccines were approved – one pointed to Health Minister Eduardo Pazuello’s reluctance to commit to a start date for nationwide vaccinations, which he previously said would begin “in the D day and in the hour H.”
The Oxford / AstraZeneca vaccine, which showed an average efficacy of 70.4% in preliminary phase III studies, has also been approved for the use of 2 million doses, provided by the Brazilian Oswaldo Cruz Foundation (Fiocruz) of the Indian Serum Institute will be imported.

Fiocruz signed an agreement in June to purchase and manufacture the vaccine with pharmaceutical giant AstraZeneca. After successive delays, the Brazilian government signed a contract for 256 million doses in October and announced that it would receive the first in December.

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

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

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