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The governor João Doria (PSDB) announced on Thursday 10 the start of the national production of the vaccine Coronavac, developed in collaboration between Butantã Institute and the Chinese pharmaceutical Sinovac. According to him, 11 states have already signed the purchase of the immunizer and the institute began to produce it on the night of Wednesday 9. The results of effectiveness have not yet been presented to the Anvisa, and the government maintained the forecast that they will be completed on the 15th.
The states that signed a Coronavac purchase are Acre, by, Maranhao, Roraima, Piauí, South Mato Grosso, Holy Spirit, Rio Grande do Norte, Paraíba, Ceara me Rio Grande do Sul. In total, 276 municipalities have also formalized their interest in acquiring the immunizer and, according to Dimas Covas, president of Butantã, another 912 have also expressed their intention, which “should be formalized in the next few days.” 120 technicians were hired to assist in the production of the vaccine, which will take place “24 hours a day, 7 days a week,” increasing its daily production capacity to 1 million doses.
“No other alternative makes sense,” Covas said. “Just call me and I will make vaccines available to Ministry of Health“.” Why start vaccination in March, as the ministry announced, if we can start in January, safely and efficiently? “Doria added, referring to the vaccination schedule presented the week before.
The governor said that he had not yet received any formal communication from the ministry about a possible federal government interest in buying doses of the Butantã vaccine, although the Minister of Health, Eduardo Pazuello, said that it can be incorporated if there is a record of National Health Surveillance Agency (Anvisa). “We want a clear, written statement that Coronavac will be part of the National Immunization Program,” Doria said.
Covas said that Butantã will try, together with Anvisa, the two possible ways to register Coronavac. “Soon we will have the results of phase 3 (efficacy). We will present them for both the normal rite and for emergency use.” He did not rule out the possibility of asking exceptional launch from the approval of the immunizer in other regulatory bodies based on federal law 13,979, which authorizes the importation of products and supplies without registration in the country, as long as they have a license United States, Europe, Japan or China.
“In parallel (to the presentation to Anvisa), the results will be presented to the Chinese agency. It may come out very quickly, even this year. This refers us to another law. This being the case, Anvisa has to manifest itself within 72 hours. This is The alternative route. Ideally, it would be through normal rite or emergency use, “he explained. Covas also said that he had offered 100 million doses of Coronavac to the Ministry of Health to be delivered in May, in addition to 40 million to other countries. He said that had already received expressions of interest from several Latin American countries, such as Argentina, Peru me Uruguay.
In the second, Doria had already stated that the State intends to start the vaccination plan on January 25. Hours after Doria’s announcement last Monday, Anvisa said in a statement that it only released the use of the vaccine after analyzing documents, such as data from the “phase 3” survey. “None of the four vaccines under development in Brazil has submitted a registration protocol. Therefore, none of the four is endorsed for wide use at this time,” said the president. Antônio Barra Torresin an interview with Young bread.
After passing through Anvisa, the vaccine still needs to receive a price, which is defined by the Chamber for the Regulation of the Drug Market (CMED). The analysis of this organ takes up to 90 days, in normal cases, but the expectation is to shorten the analysis of vaccines against COVID-19.
On Tuesday, João Doria and the health minister disagreed during a meeting after the governor demanded a position from the portfolio in relation to the purchase of Coronavac. In parallel, the experts heard by Estadão affirm that it is possible to distribute the vaccine, as long as it is approved by at least one of the four international regulatory agencies, thanks to a federal law approved at the beginning of the pandemic.
In November, a study published in the journal Infectious Diseases Lancet He had already witnessed that Coronavac produced antibodies in 97% of the volunteers, 28 days after its application. In Brazil, the vaccine is tested on 13,000 volunteers spread over 16 research centers in São Paulo, Rio de Janeiro, Minas Gerais, Rio Grande do Sul, Paraná, Mato Grosso, Mato Grosso do Sul and the Federal District.
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