Brazil to Allow Vaccine Makers to Seek Emergency Authorization

A volunteer received a vaccine shot in August in Porto Alegre, Brazil.

Photo: silvio avila/Agence France-Presse/Getty Images

SÃO PAULO—Brazil’s health authority Anvisa said Thursday it would allow producers of Covid-19 vaccines to request emergency authorization in the country, raising hopes that the hard-hit nation can begin its immunization rollout as early as this month.

Anvisa has come under intense pressure during recent weeks as state governments scramble to secure vaccines for their own cities, clashing with the federal government and President , who has dismissed the disease as nothing more than a “little flu.”

At least one state governor has filed a lawsuit at the Supreme Court for permission to bypass Anvisa and buy vaccines that have already been approved by regulators in other countries.

“Anvisa has found itself in dire straits,” said Carlos Fortaleza, an epidemiologist at São Paulo State University, adding that it normally takes two or three months to approve a vaccine in Brazil. Under the newly announced rules, it could take two or three days, he said.

Covid-19 has killed about 180,000 people in Brazil so far, second only to the U.S. The average daily death toll peaked at more than 1,000 people in July and had steadily been in decline, but a sharp rise over the past few weeks has raised concerns about a possible second surge in the country.

As states and hospitals in the U.S. race to roll out the first vaccines, WSJ’s Daniela Hernandez hears from a hospital administrator and immunization expert about the logistical challenges involved in this first phase of the vaccination process. Photo: Victoria Jones/PA Wire/Zuma Press

Frustrated with Mr. Bolsonaro and what they say is inaction by the federal government, many state governors have taken it upon themselves to deal with the pandemic locally, enforcing their own lockdowns and trying to secure vaccines themselves.

Tensions have flared in São Paulo, where Mr. Bolsonaro’s political rival, Gov. João Doria, has been one of the president’s most vocal critics. The state has joined with China’s Sinovac to develop CoronaVac, one of the most advanced vaccines in Brazil, and began to produce the vaccine locally this week.

However, Brazil’s states still need permission from the federal regulator, Anvisa, to administer the vaccine, raising fears that Mr. Bolsonaro could try to delay CoronaVac’s approval.

In an episode that sent alarm through Brazil’s medical community last month, Anvisa suspended development of CoronaVac, citing a “severe adverse event.” It later emerged that one of the volunteers had died by suicide—a tragedy that the vaccine’s researchers said had nothing to do with the trials. Anvisa later allowed the trials to continue.

“How sad that Brazil has a president who doesn’t have any compassion for Brazilians, a president who abandoned Brazil,” said Mr. Doria, who is expected to try to wrest the presidency from Mr. Bolsonaro in the 2022 elections. “We will save Brazilians,” he said.

A fierce critic of China as well as Mr. Doria, Mr. Bolsonaro has refused to buy CoronaVac, betting instead on the vaccine being developed by the University of Oxford and AstraZeneca PLC.

Anvisa said Thursday that it has not yet received any request to authorize a vaccine. While the new rules could help accelerate the approval of CoronaVac, they would also allow emergency use of other vaccines such as those being developed by AstraZeneca, Pfizer Inc., and Johnson & Johnson.

Write to Samantha Pearson at and Luciana Magalhaes at

Read original article here.