CoronaVac study reaches the minimum number of volunteers infected by Covid-19 and enters the final approval phase | Saint Paul

‘The good news, and the reason why we are here at the Butantan Institute is that the Butantan Institute details the final phase for the approval of coronavac having reached the minimum number of infected and that is the possibility of allowing the opening of the clinical study and the analysis of these results, “said State Health Secretary Jean Gorinchteyn.

The phase 3 study divides the volunteers into two equal groups: half of the participants receive the vaccine and the other half, a placebo. Participants do not know which group they belong to.

For the CoronaVac interim analysis to be performed, it was necessary for at least 61 cases of Covid-19 to occur among the 13 thousand volunteers, whether they are members of the vaccine group or the so-called control group. Total, 74 infected.

The group of infected people makes it possible to carry out the so-called intermediate analysis, the first analysis of the effectiveness of the vaccine. If there is still any doubt, the study should have a second analysis, called a primary analysis, which is performed when the number of confirmed Covid-19 cases among the 13,000 volunteers reaches 154 cases.

The director of the Butantan Institute, Dimas Covas, said that the forecast is that the result of the first analysis will come out in the first half of December and will soon be sent to the International Committee that controls the study. Still, according to Covas, once the results are published, the data will be sent to the National Surveillance Agency (Anvisa) and the agency that certifies vaccines in China.

“Quickly, in the first week of December we will have the results of these analyzes that will be sent to the International Committee that controls the study, which must validate these results and produce the report that will be sent to our Anvisa and, at the same time, Anvisa de China, ”said the director of Butantan.

“From that moment we are waiting, this must happen in the first half of December. From that moment on, we are waiting for the Anvisa demonstration. In fact, both Anvisas and, eventually, it may happen that one Anvisa is more agile than the other, faster in its evaluation and we will be able to have the approval of China or Brazil there in December ”, he added.

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.

The São Paulo state government received on Thursday morning (19) the first 120,000 doses of CoronaVac, a vaccine against Covid-19. The material was imported from China and developed by the Chinese Sinovac laboratory, in association with the Butantan Institute.

Governor João Doria (PSDB), the director of the Butantan Institute, Dimas Covas, and the Secretary of State Health, Jean Gorinchtey, accompanied the arrival of the batch, which was brought on a flight from China that landed at the International Airport of Guarulhos, in Greater Sao Paulo.

6 million doses by the end of the year

The 120,000 doses are part of a 6 million batch scheduled to arrive in late December. They will be stored in a place that was not disclosed by the São Paulo government for security reasons..

In addition to the vaccines, which will be ready, the Butantan Institute should receive part of the raw material this year to manufacture another 40 million doses, also according to the state government.

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In total, the São Paulo government signed a contract with the Chinese company Sinovac to purchase 46 million doses of CoronaVac. These first 6 million will come ready from China, and the other 40 million will be packaged and labeled at the Butantan Institute with material that will be imported.

Import and political dispute

At the end of October, the National Sanitary Surveillance Agency (Anvisa) authorized the importation of 6 million of the immunizer.

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CoronaVac is the subject of a political dispute involving the Ministry of Health, President Jair Bolsonaro and the Governor of São Paulo, João Doria.

At the end of October, the Minister of Health, Eduardo Pazuello, announced the negotiation to acquire the 46 million doses from the federal government. Annoyed, President Jair Bolsonaro ordered the cancellation of the purchase. The ministry later said “there is no intention to buy” and replaced the statement on the website.

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