SAO PAULO (Reuters) – The Brazilian production partner for a coronavirus vaccine developed by China’s Sinovac Biotech filed on Friday for emergency use authorization with health regulator Anvisa, the day after announcing results from a late-stage trial.
The Chinese vaccine is the first with an emergency use request filed in Brazil, where more than 200,000 have died of COVID-19 – the worst death toll outside the United States.
Anvisa will evaluate the request and reach a conclusion within in 10 days, the regulator said in a statement.
Butantan, which is funded by the Sao Paulo state government, has already begun filling and finishing doses of the vaccine known as CoronaVac with ingredients from China. The institute said separately that it had filed the request Friday morning.
Butantan officials announced on Thursday that the vaccine was 78% effective against mild COVID-19 infections and entirely prevented severe cases in a late-stage trial, however the lack of details left some demanding more transparency.
The filing submitted to Anvisa on Friday is expected to contain the detailed trial data for regulators to scrutinize Butantan’s findings.
Health Minister Eduardo Pazuello said on Thursday that the federal government would buy Butantan’s full output of CoronaVac this year, signing a deal for 100 million doses to supply a national immunization program starting this month.
(Reporting by Eduardo Simões and Lisandra Paraguassu; Writing by Ana Mano; Editing by Brad Haynes and David Gregorio)