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The São Paulo government and the Butantan Institute announced today that the CoronaVac vaccine against covid-19, produced in association with the SinoVac laboratory, was safe and effective enough to request registration for emergency use.
However, the rate of effectiveness was not disclosed, according to the authorities, at the request of the Chinese laboratory, which will review the data before sending it to Anvisa (National Health Surveillance Agency). The agency should only receive the documentation within 15 days, when it will analyze the information and decide whether to approve the use of the immunizer in national territory.
Dimas Covas, director of the Butantan Institute, said that the delay in the dissemination of the results of the phase 3 tests will not interfere with the approval period of the vaccine.. The goal, he said, is for the data to be compared with research results in other countries, preventing the immunizer from having different advertised efficacy rates.
This request from Sinovac is supported by the contract and we can only disclose this number together. And we will do so in due time. We hope it will be as soon as possible
Dimas Covas, director of the Butantan Institute
Despite not revealing the figures, the Secretary of State for Health, Jean Gorinchteyn, said that the vaccine reached “the superiority of efficacy” required “by both Anvisa and the WHO”, that is, above 50% in clinical trials.
When asked if the lack of data reflects disappointment in the results, Gorinchteyn denied this, saying the goal has always been for effectiveness to exceed the 50% rate. “If for us it was 51% it was already important, especially at a time when we are experiencing a health crisis,” he said.
Regarding the adverse reactions of the vaccine, Covas affirmed that the immunizer registered mild manifestations, the main one being “pain at the injection site”.
From a security point of view, the data is available. Show that this [vacina] It is the safest in Brazil without a doubt
Dimas Covas, director of the Butantan Institute
The Butantan director said he had spoken to Anvisa about the matter. The negotiations were with Gustavo Mendes, director of the study area, who asked him: “To let me know in advance when these data are made available to Anvisa, so that he can prepare to carry out the analysis as soon as possible.”
Start of vaccination
The government of São Paulo marked the start of vaccination for January 25, a date that was maintained despite today’s delay.
“All vaccination planning remains the same,” said the secretary. “We have a 50% superiority, which gives us the peace of mind of being able to dedicate it to the State Program.
Dosage production is happening here at the Butantan factory and we will begin our state immunization program on January 25th.
Jean Gorinchteyn, Secretary of State for Health
Will the federal government buy?
After many public controversies over CoronaVac, the federal government has been negotiating with Butantan to buy doses of the vaccine. A practically closed contract foresees 46 million doses delivered 3 times: 9 million doses in January, 15 million in February and 22 million in March. Another negotiation estimates the purchase of more than 100 million doses, which would be delivered at the end of the first half of 2021.
The Ministry of Health did not provide a date for the start of vaccination. But according to the PNI (National Vaccination Program), the distribution of immunizers will occur in a maximum of 5 days after Anvisa delivers the guarantee of any vaccine.
Discussions and controversies
CoronaVac was negotiated and bought directly by the governor of São Paulo, João Doria (PSDB), which generated friction with President Jair Bolsonaro (without a party), who sees the toucan as a possible opponent in the 2022 presidential elections.
The peak of the confrontation occurred in October, when Health Minister Eduardo Pazuello expressed interest in buying CoronaVac. The next day, Bolsonaro dismissed Pazuello saying that he would cancel the letter signed by the minister and that he would not buy the vaccine because it was of Chinese origin.
After interrupting phase 3 of the tests due to the death of a volunteer (not related to the vaccine), Bolsonaro even celebrated the suspension, writing on social media that it was a victory against Doria.
Days later, Bolsonaro said he would buy any vaccine approved by Anvisa. Despite this, there has been a campaign so that the immunizer is not mandatory and also warned about the serious consequences of vaccination.
Dose production
By the end of this month, Butantan will have 10.8 million doses of the vaccine on Brazilian soil. Tomorrow, a shipment with supplies for 5.5 million doses will land at the Viracopos International Airport in Campinas.
Three previous shipments secured 3.12 million doses to Butantan. The new load consists of 2.1 million doses ready for application and another 2.1 thousand liters of supplies, corresponding to 3.4 million doses. Final shipments for 2020 are scheduled for the 28th, with 400,000 doses, and the 30th, with 1.6 million additional doses.
Vaccination around the world
For now, other countries have started vaccinating their populations. Saudi Arabia, Canada, the United States, China, Russia and the United Kingdom have already begun applying vaccines against the coronavirus in their population.
Switzerland was the first country to authorize a vaccine in a standard form, not for emergency use. The Pfizer vaccine will begin in the next few days.
The 27 countries of the European Union should start vaccinating the population together on December 27. The United Kingdom, which left the bloc, began vaccinating before neighboring countries.
In Turkey, the announcement of the results of the CoronaVac clinical study is expected.
“We are looking forward to it,” wrote to UOL Professor Murat Akova, coordinator of vaccine research in the country, member of the Department of Infectious Diseases at Hacettepe University and member of ESCMID (acronym for European Society for Clinical Microbiology and Infectious Diseases ). .
According to Akova, the Turkish government plans to start vaccination in mid-January if the results of phase 3 of the Sinovac and Butantan Institute study are positive.
