State Health Secretaries ask the federal government to buy the first Covid-19 vaccine approved by Anvisa | Sao Paulo

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The National Council of Health Secretaries (Conass) sent a letter to the Minister of Health, Eduardo Pazuello, this Thursday (15), asking the federal government buy the first Covid-19 vaccine that is ready and is approved by the National Health Surveillance Agency (Anvisa).

The request comes after the State Secretary of Health of São Paulo, Jean Gorinchteyn, affirms to the G1, on Wednesday night (14), that the federal government did not release money for the purchase of the CoronaVac vaccine, developed by the Chinese company Sinovac in partnership with the Butantan Institute.

The João Doria management (PSDB) tries to negotiate so that CoronaVac receives federal funds to be distributed throughout the country by the Unified Health System (SUS), if its effectiveness is proven in the third phase of testing.

So far, the Ministry of Health has made agreements to guarantee the purchase of the vaccine from the company AstraZeneca, in partnership with the University of Oxford, and with the vaccine from Covax, a global consortium of vaccines against the coronavirus.

In a note, the ministry states that “the immunizer that gets ready first – which means meeting all the safety and efficacy criteria required by Anvisa – will be an option for purchase” (see the full note below).

The request of the state secretaries is for the government to commit to buying the first vaccine that is approved by Anvisa. Conass argues that CoronaVac may be ready before the Oxford vaccine and the vaccine obtained through Covax, which were the two fronts announced by the government.

In the letter, the council requests “the adoption of the necessary and immediate measures for incorporation into the national immunization program for vaccines for Covid-19 produced by the Butantan Institute, in partnership with the pharmaceutical company Sinovac”.

In an interview with G1, the SP secretary said that the purchase of additional doses, in addition to the 61 million already guaranteed by the state government, it will be “unviable” without these resources.

In a virtual meeting held this Wednesday afternoon, the Ministry of Health presented a schedule of vaccination of the population against the coronavirus for 2021.

According to Gorinchteyn, who participated in the meeting with other state secretaries, the federal government only considered purchasing the AstraZeneca vaccine, developed by the University of Oxford.

SP Health Secretary Jean Gorinchteyn, during a visit to the Ministry of Health at the end of August – Photo: Wallace Martins / Futura Press / Estadão Content

“Why is it that a vaccine such as CoronaVac, which is on the same foot as Oxford’s, is even more advanced, receiving a different treatment? That was a question that we ended up asking and all the secretaries understood. If I have vaccines that are at the same stage of discussion, why does Oxford’s receive a provisional measure with R $ 1.9 billion? We are not even asking for this amount, but we want a nod from the ministry in the acquisition of vaccines as well. democratic, “said the secretary to G1.

At an event this Thursday, Gorinchteyn spoke again on the topic and said that the absence of CoronaVac at the meeting of the Ministry of Health caused “embarrassment”.

“The meeting yesterday between the secretaries of health with the secretaries of the Ministry of Health brought some estimates of vaccines that would be available, and it is clear that we have the joint understanding, as secretaries and as doctors, that all available vaccines are worthy of the same attention, “he said.

“I say again that we are receiving a very intense attention from the minister, and the fact that we did not yesterday identify the Coronavac vaccine as a cause for embarrassment for everyone, to the point that today, Conass sent the request to the minister. We have no doubt that the ministry has this concern with vaccines and with that we will be inserting the Butantan vaccine into the national vaccination program “, he added.

In previously released estimates, the São Paulo government said it was negotiating with the Ministry of Health the same investment of around R $ 1.9 billion for CoronaVac.

As the secretary reaffirmed this Wednesday, R $ 85 million would go to the clinical study and another R $ 60 million to renovate the factory at the Butantan Institute. The remaining amount would enable the vaccine supply to reach 100 million doses by May 2021.

Of this total, the secretary affirms that the government “waved” R $ 92 million, but the funds have not yet been released.

“They were [seriam] R $ 85 million from the study, plus R $ 65 million from the expansion of the factory, totaling R $ 145 million. And then there was a R $ 80 million wave and then they were sent, a value of R $ 92 million is being evaluated by the technical chambers, “he said.

The São Paulo government signed a contract with the Chinese to receive 46 million doses of CoronaVac by December. The forecast is that the total will reach 60 million by February 2021 and the expectation was that, with the federal government’s money, the total could reach 100 million.

The governor of SP, João Doria, the director of the Butantan Institute, Dimas Covas, and representative of the Sinovac laboratory during the signing of an agreement at the Palácio dos Bandeirantes – Photo: Reproduction / TV Globo

The secretary said that the government is still negotiating for the money to be released and that Doria should go to Brasília to talk directly with the Minister of Health, Eduardo Pazuello.

“We will receive these 60 million, there will be 61 million doses by the end of February, with the possibility of having another 40 million by May. These 61 million doses are guaranteed. The rest, to reach 100 million, is that the acquisition by Butantan became unviable, due to an economic issue “, he explained.

Asked what the state intends to do if the federal government maintains its position not to buy doses of CoronaVac, Gorinchteyn said there is a plan for immunization to be done at the state level.

“We have an immunization plan for the state, if that happens. But I reinforce, this is not what we want. We want the vaccine to be from Brazil, not São Paulo. We would like to extend this vaccine to Brazilians and we would like to put it through the Unified Health System to be distributed in the national immunization program “, he said.

The agreement for the purchase of 46 million doses was signed by Doria and Weining Meng, director of the Sinovac laboratory, during a press conference at Palácio dos Bandeirantes. At the same event, the governor announced that vaccination of health professionals should start on December 15.

The Coronavac vaccine is still being tested among Brazilian health professionals. Yet, 7 thousand volunteers have already participated in the research, according to the director of the Butantan Institute, Dimas Covas. The goal is to involve 13 thousand people in the research.

Regarding the amount paid by the state of SP to Sinovac, Doria said that the signed contract is for 90 million dollars. By December, the pharmaceutical company will send 6 million doses of the vaccine ready, while another 40 million will be filled in São Paulo, according to the government.

Government of SP signs contract for the purchase of 46 million doses of Chinese vaccine

However, the governor did not clarify whether this figure relates only to the purchase of the 46 million doses that should arrive in 2020, or if it also includes doses that should be delivered only in 2021. Doria also did not say whether the value of 90 million dollars adds to the R $ 85 million that, in June, the state government declared that it had paid for the agreement.

Vaccine for all Brazilians

The governor of São Paulo has already promised that the entire population of the state will receive the vaccine against Covid-19 until February 2021. He said that there is an “alternative plan” for the state of SP, in case there is no agreement with the federal government. for national distribution.

“To Brazilians from São Paulo, yes, I guarantee that we will have the vaccine, CoronaVac, to serve the entire population of São Paulo, already at the end of this year and throughout the first two months of 2021, and we will immunize them”, said Doria on September 21.

The state of São Paulo has about 44 million inhabitants, according to the IBGE. CoronaVac tests on volunteers, however, are done with two doses of the vaccine per person.

Release with 50% effectiveness

Dimas Covas has already stated that the São Paulo government will ask Anvisa to release Coronavac for emergency use if the vaccine shows at least 50% effectiveness in preliminary analysis.

A 50% effectiveness is not necessarily the ultimate goal of the vaccine, but a minimum value to be obtained in an interim analysis that should occur by November. This analysis compares how many volunteers had coronavirus among those who took the vaccine and those who took placebo.

The phase 3 study divides the volunteers into two equal groups: half of the participants get the vaccine and the other half, a placebo. Participants do not know which group they belong to. In order for Coronavac’s interim analysis to be carried out, it is necessary that at least 61 cases of Covid-19 occur among 13,000 volunteers, whether they are members of the vaccine group or the so-called control group.

The study should also have a second analysis, called a primary analysis, which is done when the number of confirmed cases of Covid-19 among the 13,000 volunteers reaches 154 cases.

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See the full note from the Ministry of Health:

The Ministry of Health has already signed two partnerships – with AstraZeneca and Covax Facility – that add up to the acquisition of 140 million doses for the Brazilian population. The portfolio also accompanies more than 200 studies that seek to identify a vaccine against Covid-19, with the aim of finding an effective and safe cure for the disease. The intention is to make available to Brazilians, as soon as possible, an effective vaccine, in quantity and quality to serve the population.

In this context, the Ministry is constantly evaluating new possibilities and remains in contact with Butantan and other national institutes that seek partnerships with foreign laboratories. The immunizer that gets ready first – which means meeting all the safety and efficacy criteria required by Anvisa – will be an option for purchase.

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