Sao Paulo, Brazil (Bioreports)Amid a devastating resurgence of the coronavirus in parts of Brazil, federal health officials have finally voted to authorize two vaccines for emergency use. Sunday, Brazilian regulatory agency Anvisa approved both the Oxford/AstraZeneca vaccine and the Coronavac vaccine.
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 has been at 90% capacity or above since April, exploded into tears before receiving the Coronavac shot.
“You don’t understand what this means to me,” she told São Paulo state governor João Doria.
Brazil is the country hit hardest 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 has seemed to lag despite its renowned public health and vaccination track record.
Coronavac, developed by Chinese company Sinovac, is now authorized for use of 6 million imported doses. It has a history in Sao Paulo state, 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%— barely above the 50% minimum established by the World Health Organization. The number, which falls far below the 78% previously announced, has raised questions about the veracity of the data and fueled skepticism over the apparent lack of transparency regarding Chinese vaccines.
The technical report from ANVISA greenlighting Coronavac stressed that the agency had also taken into account the urgency of Brazil’s skyrocketing Covid-19 cases and “the absence of therapeutic alternatives.”
It also recommended that the vaccine be monitored further, noting the Butantan Institute had not provided 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 other patient groups.
Doria has promised to make vaccines developed in the state available to Brazil’s federal health ministry for national distribution.
“Today is V day. It is the day of the vaccine, it is the day of truth, it is the day of victory, it is the day of life,” he said at a news conference after the vaccines were approved — a pointed jab at 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 70.4% average efficacy in preliminary Phase III trials, has also been approved for use of 2 million doses, which will be imported from India’s Serum Institute by Brazil’s Oswaldo Cruz Foundation (Fiocruz).
Fiocruz signed a deal to purchase and produce the vaccine with pharmaceutical giant AstraZeneca in June. After successive delays, the Brazilian government signed in October a contract for 256 million doses and announced that it would receive the first ones in December.
After another series of delays, Fiocruz expects to receive the first shipment by the end of January.
Bioreports’s Rodrigo Pedroso reported from São Paulo and Caitlin Hu reported from New York.
