Butantan will announce overall effectiveness tomorrow, says SP government



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The Butantan Institute will release tomorrow the general efficacy data of CoronaVac, a possible vaccine against covid-19 developed by the Chinese laboratory Sinovac and tested in Brazil by the São Paulo institute. The publication of new data from phase 3 of the immunization tests was confirmed by the Governor of São Paulo, João Doria, and by secretary State Health, Jean Gorinchteyn.

Last Thursday (7), João Doria, together with the president of Butantan, Dimas Covas, announced in an interview that the vaccine was 78% to 100% effective against coronavirus in secondary results and that the potential vaccine was 100 %. effective in preventing severe and moderate cases of Covid-19.

However, researchers and experts demanded more data from phase 3 of the tests, mainly the overall effectiveness of the immunizer, which consists of comparing the number of “events” (sick people) in the vaccinated and placebo groups. That is, in a vaccine with a 65% rate -as pointed out in the CoronaVac tests in Indonesia-, taking and counting a group of 100 people who received the immunizer, 65 were protected against the disease.

The WHO (World Health Organization) recommends a minimum effectiveness rate of 50%.

In an interview with Rádio CBN, João Doria said that an interview with the technical staff of the Butantan Institute, tomorrow at 12:45 pm (Brasilia time), will clarify the doubts raised after the initial disclosure.

“Butantan will make another specific presentation on the vaccine tomorrow, with complementary data, at 12:45 pm. Dimas and other scientists will discuss this issue. It is a matter of science, not of politics,” he said.

Jean Gorinchteyn, in turn, explained in an interview to GloboNews the importance of the result on the overall effectiveness. “These data that we call global effectiveness are in the possession of Butantan and Anvisa, and in this way we will all know tomorrow this information that is of fundamental importance for us to insert in the campaign proposals (vaccination), bringing out this quality of information”, said.

On Friday, Butantan joined the National Sanitary Surveillance Agency (Anvisa) with a request for emergency use of CoronaVac in the country.

Indonesia announces an effectiveness of 65.3%

Today, another country that tested CoronaVac, Indonesia, announced that the effectiveness of the immunizer was 65.3% as a preliminary result of phase 3, which included 1,620 volunteers. The country has published the emergency use of the vaccine.

In Turkey, preliminary results indicated a 91.25% effectiveness in preliminary test results with 7,371 volunteers.

According to Doria, the announcement from Indonesia is positive. “The approval of Indonesia is welcome, it is the first country that formally approves, by the health agency, CoronaVac. They are observing a sense of urgency to save the lives of its inhabitants. I hope that Anvisa understands that it also needs to save lives here “, said.

Sale of CoronaVac to the Ministry of Health

São Paulo Governor João Doria (PSDB) explained that the sale of CoronaVac doses to the Ministry of Health will not affect the application of vaccines in the state.

“There will be no lack of doses to start the vaccination. We have 11 million doses in Brazil. Of the 5 shipments that arrived at the airport, 4 I went to receive. We have a vaccine available for the initial phase. Either in São Paulo or in Brazil, this The initial phase gives priority to health professionals. This quantity of the Butantan vaccine is perfect for this population. And it is worth remembering that the only vaccine on Brazilian soil is Butantan, “said Doria, in an interview for CNN Brazil radio.

Recently, the Ministry of Health announced the purchase of 100 million doses of the CoronaVac vaccine. Still, Doria has maintained that he will only follow the federal government’s plan if vaccination begins on or before January 25.

At the moment CoronaVac has not received the approval of Anvisa (National Health Surveillance Agency) and therefore the Ministry of Health has not stipulated a date to start vaccination. Minister Eduardo Pazuello has been considering starting the vaccination, in the best case scenario, on January 20.

In addition to CoronaVac, there is also an expectation about the approval of the vaccine developed by the AstraZeneca laboratory, in partnership with the University of Oxford and Fiocruz. An order has been placed to purchase and authorize the emergency use of this immunizer, but for now there are no doses in Brazil.

Pandemic situation and concern about Carnival

Doria was asked about the situation of the pandemic in São Paulo. He criticized the population for having parties at the end of last year and said that therefore the trend is for the “2nd wave of covid-19” to worsen in the coming weeks. He also expressed concern about Carnival, which will be on February 16.

“During Carnival, if people are not aware that they should not participate in the crowds, it will get worse. I ask that the parents talk to the children so that they do not accept parties. The incidence in young people has grown alarmingly. Dr. Kalil told me ‘I’m scared, I’ve never seen anything like this. ‘He has 40 years of experience and he’s scared. This is in a private hospital. Obviously he grew up in a public hospital. We already had this terrible experience at the turn of the year and this is being repeated throughout Brazil, “concluded Doria.

Analysis in Anvisa

At the moment, the CoronaVac data is being evaluated by Anvisa (National Health Surveillance Agency) after an emergency use request made by the Butantan Institute.

On Saturday, Anvisa reported that it asked Butantan to send documents that were already planned and were not delivered. Yesterday, the institute began to send the pending documents.

The status of the report, updated at 8:16 p.m. yesterday, indicates that 48.36% of the records have yet to be completed. In analysis it is 8.1%. The total process of regularization of the order for emergency vaccines is 38.07% complete. According to Anvisa, 5.47% of the studies have not yet been presented by Butantan, which includes the report of immunogenicity, which is the ability of a substance to elicit an immune response.

* With information from Reuters.

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