MPF questions the Ministry of Health and Anvisa on the choice of vaccines against Covid-19 | Saint Paul

Prosecutors from São Paulo, Rio Grande do Sul and Pernambuco question the federal government, which closed an agreement only for the purchase of vaccines produced by COVAX Facility, led by the World Health Organization (WHO) and developed by AstraZeneca / Oxford.

The opening of the procedure is due to the political dispute between Governor João Doria (PSDB) and President Jair Bolsonaro (no party) over CoronaVac. The purchase of the CoronaVac vaccine, developed by the Chinese laboratory Sinovac and the Butantan Institute, was announced but was suspended after statements by the president to the contrary.

Requests for clarification were sent to the Ministry of Health, the National Health Surveillance Agency (Anvisa), the Butantan Institute, and the São Paulo State Secretariat of Health. Prosecutors question the initial position of the Ministry of Health not to consider other immunizers that are in development.

The MPF also sent a letter to the Butantan Institute, due to the declaration of its director Dimas Covas that Anvisa was delaying the authorization to import raw material from the pharmaceutical company Sinovac. The agency asked the institution for information on the stages of the vaccine testing process. It was also questioned whether the delay in the release of imports of inputs for the production of vaccines was justified.

On Monday (23), Anvisa released the import of 6 million prepared doses of CoronaVac from China, but the agency has not yet imported supplies for the processing in Brazil of another 40 million of the vaccine in Brazil.

The Secretariat of Health of the State of São Paulo also received a request from the MPF to present the terms of the agreement signed with the Ministry of Health regarding the intention to purchase the 46 million doses of CoronaVac, announced by Minister Eduardo Pazuello by letter and also in a meeting with governors.

Although Bolsonaro has expressly stated that “Chinese vaccine” will not be purchased, the State Health Secretariat said it has not officially communicated about the withdrawal of the agreement.

All agencies have 15 days to respond to requests from the MPF.

Import release

The director of the Butantan Institute, Dimas Covas, said on Friday (23) that the schedule stipulated by the São Paulo government for the production of the CoronaVac vaccine in the country is maintained even with the delay of the National Sanitary Surveillance Agency (Anvisa) in allowing the importation of raw materials from China.

Butantan, which has a partnership with the Chinese laboratory Sinovac for the production of CoronaVac, said on Thursday (22) that it had been waiting more than a month for the launch of Anvisa to import inputs, and that this could “Impact” of starting vaccination on health professionals until the end of the year, if effectiveness is proven in the last phase of testing.

“The original program was to start production [envase] in the second half of October. Therefore, depending on this decision, we will have a delay of 10 to 15 days. And we will recover this delay, we will put our production line receiving the raw material to recover the schedule. This is what we want as long as this launch exists. “

On Friday (23), Anvisa declared that “there is no delay / delay / delay” by the agency. He also said that he dismembered the analysis of requests made by Butantan to streamline the process.

“In the same process as the supplies, an exceptional authorization is requested to import vaccine in the form of a full syringe and in the form of an intermediate product, not bottled. It is important to clarify that they are products in different sanitary conditions. […] To avoid wasting time, the process was divided and packaged vaccines will have their analysis within a maximum period of up to five business days, regardless of the analysis of the entry order, “he said in a note.

On the same day, the agency announced the release of importation of the 6 million prepared doses of the vaccine, but the request for supplies for the other 40 million is still under analysis.

The São Paulo government signed a contract with Sinovac for the acquisition of 46 million doses of CoronaVac. Of these, 6 million will come ready from China and the other 40 million will be packaged and labeled at the Butantan Institute. As the agreement also provides for the transfer of technology for the production of the vaccine, Butantan will start producing more doses on a large scale after a factory adaptation.

CoronaVac is in the third phase of testing among Brazilian health professionals. To be released for use in the population, its efficiency has not yet been tested.

The government of São Paulo also announced on Friday (23) the creation of six new CoronaVac test centers in volunteers. As a result, the total number of places where research is carried out in the country amounts to 22.

So far, 15,000 vaccines have been given to 9,000 volunteers. Each volunteer receives two doses. With the opening of the new centers, the objective is to expand the survey for a total of 13,000 volunteers.

In this final phase of the research, half of the participants are inoculated with the vaccine and the other half receive a placebo. To determine the effectiveness of CoronaVac, at least 61 participants must be infected with the coronavirus.

If the immunizing agent reaches the necessary levels of efficacy and safety, it can be sent to Anvisa (National Health Surveillance Agency) for registration and subsequent use in the population.

To streamline the process for testing potential coronavirus immunizers, Anvisa reduced the initial documentation requirement and simplified the registration process so that study data is submitted during work, and not just at the end. Since early October, the state government has been sharing data on CoronaVac with the agency.

So far, the state government has only submitted partial data on the safety of the vaccine, but these have not yet been sent to the agency or published in scientific journals.

According to Dimas Covas, now, with the mark of 15 thousand vaccinations in volunteers, it will be possible to send safety data.

“Yesterday we reached 15 thousand vaccinations and that is why we reached the first milestone in relation to the FDA itself, which is ‘Anvisa americana’. ‘Anvisa americana’ requires that at least 3 thousand vaccinations of a candidate vaccine do not follow serious adverse effects. We reached that figure and we are preparing a report to be sent to our Anvisa, thus closing the security issue there, ”he said on Friday.

According to the director of Butantan, the opening of new research centers will also accelerate the process of demonstrating the effectiveness of the vaccine to Anvisa.

“With the opening of these centers, we will gain speed so that the demonstration of effectiveness can appear as soon as possible. We expect this to happen in November, mid-December,” said the director of Butantan.

Withdrawal from the federal government

Last Tuesday (20), the Minister of Health, Eduardo Pazuello, announced his intention to buy 46 million doses of CoronaVac and its inclusion in the National Immunization Plan (PNI), after it was announced by Anvisa. With this, the federal government would issue a new Provisional Measure to make R $ 2.6 billion available to CoronaVac.

However, on Wednesday (21), President Jair Bolsonaro (no party) disapproved of the minister saying he would “not buy vaccines from China” and said he ordered the deal to be canceled. After the repercussions of the disapproval, Pazuello said in a live broadcast with the president on Thursday that “it is that simple: one commands and the other obeys.”

On Thursday (23), the Secretary of Health of the State of São Paulo, Jean Gorinchteyn, said that he has not yet been officially notified by the Ministry of Health about the suspension of the purchase. In a note sent to the press on Wednesday (21), the São Paulo State Health Secretariat declared that it expects the ministry to fulfill “a commitment that it has made publicly” to negotiate the purchase of CoronaVac.

The secretariat cited an official letter on Monday (19), in which the Ministry expressed its intention to purchase, in addition to the minister’s own speech during the meeting with the governors on Tuesday, in which he stated that “The Butantan vaccine will be the Vaccine Brazilian “.

The government of São Paulo closed on September 30 the contract with the Chinese laboratory for the acquisition of these 46 million doses of CoronaVac with state financing. But the direction of João Doria (PSDB) seeks to negotiate with the federal government so that they are financed and distributed through the Unified Health System (SUS).

Despite this, the governor has already said that, in the absence of an agreement with the Ministry of Health, the state government would guarantee the vaccination of “Brazilians from São Paulo.”

The deal to buy 46 million doses cost $ 90 million. The signing was done by Doria during a press conference in late September. According to Dimas Covas, director of the Butantan institute, the vaccine would begin to be packaged in Brazil from September.

The state government also announced the forecast to acquire 15 million additional doses by February 2021, reaching a total of 61 million with its own funds. The expectation was that, with money from the federal government, another 40 million would be acquired, reaching 100 million in May 2021.

However, the agreement canceled by the federal government did not include the 55 million additional doses that the SP state government announced until May 2021, only the 46 million doses that were already guaranteed.

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