São Paulo Governor Floats Using Sinovac Vaccine without ANVISA Approval

RIO DE JANEIRO, BRAZIL – São Paulo could roll out a COVID-19 vaccine developed by China’s Sinovac without approval from the national health regulator, Governor João Doria said in an interview on Thursday, November 26th, pressuring Brasilia to greenlight the vaccine.

Health experts said Doria’s comments were an empty threat, as no drugs or vaccines can be used legally in Brazil without clearance from health regulator ANVISA, which pushed back against the comments. Still, his statements reveal growing tensions over the vaccine rollout in Latin America’s biggest country, with the world’s second-highest COVID-19 death toll.

Critics of President Jair Bolsonaro argue he is threatening the independence of ANVISA with political appointees to gain leverage over governors and other rivals.

In a video interview on the news website Metropoles, Doria said São Paulo could use the vaccine from Sinovac Biotech Ltd based on approval from regulators in other countries.

“Today, there is suspicion that ANVISA could suffer political interference from the presidency and could fail to be an independent agency as it should be, as it must be,” he said.

He added the state would consider the vaccine appropriate for use if approved by authorities “in the United States, in Europe and, above all, in Asia.”

In a statement, ANVISA said that was impossible.

“It is important to clarify that the tacit approval of vaccines by other agencies … is not foreseen in the law,” the regulator said. “Even after it is approved in another country, Anvisa’s approval is necessary.”

Doria, a staunch opponent of Bolsonaro, has already ordered the construction of facilities to produce the Sinovac vaccine, which is currently undergoing late-stage trials in São Paulo and elsewhere in Brazil.

Bolsonaro, a strident China critic, has frequently dismissed the Sinovac vaccine, known as Coronavac, saying he is concerned about its “origin.”

So far, the federal government’s principal bet has been on a vaccine being developed by AstraZeneca, though federal health officials have also held discussions with other vaccine developers, such as Johnson & Johnson and Pfizer Ltd.