São Paulo Governor Expects ANVISA Approval of Coronavac by January 15th

RIO DE JANEIRO, BRAZIL – The Butantan Institute will forward the third phase of vaccine trials results to the agency on December 15th. This is the last stage before the immunizer is approved.

“It will be officially approved by ANVISA, I have no doubts about a vaccine that has already proven to be safe and effective in Europe and Asia and the results of 13,500 people, doctors and paramedics who have been tested here will be formally submitted on Tuesday, December 15th to ANVISA. I have absolute confidence that ANVISA will issue its opinion and authorize the Butantan vaccine, the CoronaVac, by January 15th,” explained Doria, after attending the inauguration of the Registro Penitentiary, in Vale do Ribeira.

On Monday, ANVISA stated in a note that the document determining the approval of the vaccine, called inspection report, should be ready between December 30th, 2020 and January 11th, 2021, if all procedural steps are completed.

One day later, during a meeting with governors, Minister of Health General Eduardo Pazuello explained that ANVISA’s approval of any vaccine should take 60 days. At the same meeting, Doria asked him why President Jair Bolsonaro’s government had not invested resources in the CoronaVac.

Doria raises the question as to why the federal government has already spent approximately R$2 billion on immunization manufacturers who have neither registration nor a ready-made vaccine and has not invested “a single real in the Butantan’s Coronavac”.

“Will your Ministry buy the CoronaVac, once approved by ANVISA, yes or no, Minister?” Doria challenged.

When answering, Pazuello said he would like to maintain his “polite and gentle” approach, but ultimately reprimanded Bolsonaro’s political opponent.

“I already answered that, to all governors, when the Butantan vaccine, which is not from the state of São Paulo, is it governor? It’s from the Butantan, I don’t know why you refer so much to it as if it were from the state,” said the Minister of Health.

During a press conference at the Bandeirantes Palace last Monday, December 7th, Doria announced the PEI (State Immunization Plan), which will start immunizing healthcare professionals and the elderly over 70 from January 25th.

“In the state of São Paulo, immunization is scheduled to begin on January 25th. Phase 1 will be intended to healthcare professionals and people over 60 years of age. The selection of the target public considered the incidence of deaths, a total of 77% of deaths by Covid was concentrated in people over 60 years of age,” explained the governor.

The São Paulo executive has already signed an agreement to secure 46 million doses of the immunizer – which is enough to vaccinate 23 million people, since two doses are required. The first vaccination stage should comprise 18 million doses (that is, for nine million people).

The estimated time between the first and second doses is 21 days.