Brazil authorizes Oxford / AstraZeneca and Coronavac vaccines for emergency use

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A few minutes later, Monica Calazans, a black nurse in downtown São Paulo, became the first Brazilian to be vaccinated. Calazanas, who are at high risk for Covid-19 complications and work in an intensive care unit that has a capacity of 90% or more since April, burst into tears before receiving the Coronavac shot.

“You don’t understand what that means to me,” she told São Paulo Governor João Doria.

Brazil is the country most affected by Covid-19 in Latin America. It has recorded over 8 million cases and over 200,000 deaths caused by coronavirus. While several of its neighbors have already approved vaccines for use, Brazil seems to lag behind, despite its famous history of public health and vaccination.

Coronavac, developed by 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 has shown a low average efficacy rate of 50.4% – just above the minimum level of 50% set by the World Health Organization. The number, which falls well below the previously announced 78%, has raised questions about the veracity of the data and fueled skepticism about the apparent lack of transparency about Chinese vaccines.

The technical report from ANVISA Greenlighting Coronavac highlighted that the agency also took into account the urgency of the growing cases of Covid-19 in Brazil and the “absence of therapeutic alternatives”.

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He also recommended that the vaccine be monitored further, noting that the Butantan Institute did not provide important data from its phase III study, such as the duration of protection provided by the vaccine and its effect on the elderly, those with comorbidities and of other 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 the fifth 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 vaccines were approved – a blow to Health Minister Eduardo Pazuello’s reluctance to was committed to a national vaccination start date, which he previously said would begin “on D-Day and H-Day.”
The Oxford / AstraZeneca vaccine, which has shown an average efficacy of 70.4% in preliminary phase III studies, has also been approved for the use of 2 million doses, which will be imported from the Indian Serum Institute by the Foundation. Brazilian Oswaldo Cruz (Fiocruz).

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

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

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

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