‘We will immunize Brazilians in São Paulo in January’, says Doria about vaccine against Covid-19 | Saint Paul

The vaccine is still in the third phase of testing, in which its effectiveness must be tested before being launched by the National Health Surveillance Agency (Anvisa). The state government says the final report must be sent to the agency in December and that it should not be necessary to request emergency use of the vaccine.

“In São Paulo, responsibly, following the law, next January, following the protocol with Anvisa and obeying the principles of protection of life, we will begin to immunize Brazilians in São Paulo. We will not wait for March,” said Doria.

The governor criticized the federal government’s announcement that the national vaccination schedule should begin in March 2021. CoronaVac has not yet been included in the Health Ministry’s plan.

According to Doria, vaccination in São Paulo will be carried out even without investment from the federal government. “On Monday (7) we are going to present the complete state vaccination program, with a schedule, with priority sectors, vaccine volume, logistics. All processes will be presented ”.

The director of the Butantan Institute, Dimas Covas, also said on Thursday (3) that CoronaVac, a vaccine produced by the Chinese laboratory Sinovac in association with the Butantan Institute, should be available to be applied to the population in January next year.

“The vaccine will be available and registration with Anvisa, I think, will also be available. So, we can start a vaccination program in january i think. And wait [que] with the support of the Ministry [da Saúde], despite all these statements they do not mention the Butantan vaccine by name. Our expectation is that the vaccine will be incorporated, even taking into account what the minister himself says, without mentioning the vaccine, that the vaccine that is available and registered will be incorporated, “he said.

On Tuesday (1), the federal government released the “preliminary” strategy to vaccinate Brazilians. In the calendar presented, CoronaVac is not mentioned by the Ministry of Health.

The vaccine is in the final phase of testing and is expected to be distributed in Brazil. The São Paulo government signed an agreement to purchase 46 million doses and transfer technology to the Butantan Institute.

In October, the Minister of Health, Eduardo Pazuello, even announced in a virtual meeting with more than 23 governors, the purchase of the immunizer, but, less than 24 hours later, the acquisition was unauthorized by President Jair Bolsonaro.

In an interview with GloboNews this morning, Dimas Covas also stated that the vaccine is very close to obtaining registration with the National Health Surveillance Agency (Anvisa) and ruled out the need to request emergency use.

In September, Dimas Covas even said that he would ask for a release for emergency use if the vaccine showed at least 50% effectiveness in preliminary analysis.

“We are very close to applying for registration. We will not have the need to request this emergency record.Now we will request the vaccination record. We are very close to that happening. Registration and vaccination are available, we have to start the vaccination. That’s all we want ”, defended Dimas Covas.

This Wednesday (2), Anvisa said that it will accept that companies that develop vaccines against Covid-19 request “emergency use” in Brazil and announced the requirements for the application.

“Emergency use” is different from “health registration,” which is full approval for the use of an immunizer. Final registration is dependent on more data and the completion of all vaccine testing steps.

Also according to the director of the Institute, the government of São Paulo is working with alternative plans to vaccinate the population, in case the vaccine is not incorporated into the National Immunization Program.

“Every day without a vaccine counts. If the vaccine is to be used, we have to start the vaccination. And that, for a simple reason: the vaccine can save the lives of thousands of people. of the responsibility to delay the use of a vaccine available and ready, already registered in Anvisa. We will work together with the states, if applicable, together with the municipalities, to make this happen“said the director.

Previously, Dimas Covas was at the Guarulhos airport, together with Governor João Doria (PSDB) and the Secretary of State Health, Jean Gorinchteyn, to accompany the arrival of the batch with 600 liters of raw material for the Coronavac vaccine to São Paulo .

“We came here to receive another batch of the CoronaVac vaccine, the Butantan vaccine, the vaccine that will save the lives of millions of Brazilians. Today we receive supplies for 1 million doses of the vaccine. In addition to the 20 thousand that we have already received, now we have 1 million and 120 thousand doses of the vaccine, ”said João Doria.

Also according to the governor, until the beginning of next year, the government should receive the more than 46 million doses planned.

“By the end of this month of December we will be receiving six million doses of the vaccine at the Guarulhos airport, totaling 7 million 120 thousand doses of the vaccine. And next January, until January 15, another 40 million. dose of the vaccine. The Butantan vaccine, the vaccine that saves lives “.

The shipment of supplies, which can deliver up to 1 million doses of vaccines against Covid-19, arrived at 5:27 am at Guarulhos airport.

This is the second shipment of orders from the state government of the Chinese laboratory. The first was with 120,000 doses of vaccines ready, on November 19.

The batch will be transported to Butantan, in a vehicle that will have a special escort.

The inputs are the “ingredients” necessary for the completion of the vaccine in the country. Butantan will be in charge of completing the final manufacturing stage.

In total, according to the agreement, Butantan will receive 6 million ready-to-use doses from the Chinese laboratory and will formulate and fill another 40 million doses.

Minimum number of infected

In late November, CoronaVac’s phase 3 study reached the minimum number of people infected with Covid-19 needed to begin the final testing phase.

The step allows the opening of the study and the intermediate analysis of the immunizer results. The expectation is that the data will be published by the São Paulo government in the coming weeks.

Immune response and safety

A study of 743 patients found that CoronaVac showed safety and a satisfactory immune response during phases 1 and 2 of the tests.

Phase 2 of testing a vaccine verifies the safety and ability to elicit a defense system response. It is usually done with hundreds of volunteers. Phase 1, on the other hand, is carried out by dozens of people and phase 3 by thousands. It is in phase 3, the current one, where the effectiveness of the vaccine is measured.