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The São Paulo government announced on Wednesday (23) that CoronaVac is effective, but again postponed the publication of the effectiveness results of the vaccine developed by the Butantan Institute in association with the Chinese pharmaceutical company Sinovac.
According to the director of the institute, Dimas Covas, in addition to demonstrating that the vaccine against Covid-19 is safe, which had already been demonstrated in previous phases, the phase 3 study demonstrated that the vaccine is effective. THE effectiveness rate not announced but, according to the Secretary of Health of the State of São Paulo, Jean Gorinchteyn, it was higher than the minimum value recommended by the World Health Organization (WHO), which is 50%.
“We have reached the threshold of effectiveness, which allows the emergency use application process, either here in Brazil or in China,” said Dimas Covas during a press conference on Wednesday (23).
The initial forecast, to announce the effectiveness of the immunization on December 15, was postponed until this Wednesday (23) and, then, the announcement was postponed again. as well It was planned for this Wednesday to send the efficacy data to the National Health Surveillance Agency (Anvisa). According to Dimas Covas, sending the results to Anvisa will occur only after Sinovac analyzes the results sent by Butantan this Wednesday (23).
CoronaVac reaches the threshold of effectiveness, says Dimas Covas, director of Butantan
“That database [de resultados da fase 3] was transferred this morning so [Sinovac] We can carry out this analysis as soon as possible and then present the data, not only to NMPA, but so that we can also present this data to our Anvisa, ”said the director of Butantan.
According to Dimas Covas, the disclosure of data was postponed due to a clause in the contract signed with Sinovac and the Butantan Institute.
“We have a contract with Sinovac that specifies that the announcement of this number must be done together, at the same time. So yesterday we presented these numbers to our association, which, however, requested that the number not be disclosed for the reason that They need to analyze each case in order to apply these cases to the NMPA agency, which is Anvisa of China ”, he added.
CoronaVac vaccine packaging, developed by Sinovac in partnership with Butantan – Photo: Instituto Butantan
Different effectiveness data
The Secretary of Health of the State of São Paulo, Jean Gorinchteyn, said that the effectiveness of CoronaVac calculated by the Butantan study was different from the effectiveness verified in other countries where the vaccine is used. According to government spokesmen, this discrepancy in the data from different countries led to the postponement of the final disclosure.
“They [Sinovac] I understood that the fact that we were more effective than that [que é recomendado pela OMS], but unlike other countries where this vaccine is used, it deserves a re-evaluation, ”Gorinchteyn said.
Jean Gorinchteyn: ‘CoronaVac’s effectiveness in Brazil is different than in other countries’
“It cannot be effective here, there and there ‘there’. That is what the company itself understood. He wants isonomy. He wants all the results to be equal, without disparities, “he added.
Gorinchteyn also said that the effectiveness of the vaccine is higher than that recommended by the WHO, which is at least 50%, and that “this is the time to celebrate.”
“If it were 51%, it was already important to us, especially at the time when we are going through a health crisis, a crisis that has affected the entire world and was no different in our country. Therefore, a vaccine that already represents this minimal superiority, for us, it is time to celebrate, ”said the secretary.
Secretary of State for Health, Jean Gorinchteyn – Photo: Playback / TV Globo
Gorinchteyn also said that the data obtained would already be sufficient to request authorization to use the immunizer, but that the government would respect “red tape.”
“Based on the data we have, we can already register with our National Health Surveillance Agency, but we are respecting these bureaucratic procedures that are part of commercial deals so that later, together, we can have this equal and isonomic result between the different countries. So we have this data and we could start our regulatory agency immediately if we wanted to, “Gorinchteyn said.
The secretary also said that despite the delay, Vaccination in the state will begin on January 25. The start of the state vaccination campaign, however, depends on the approval of the vaccine by the regulatory agency.
“All the vaccine planning continues. The doses of the vaccine are being produced here at the Butantan Institute factory and we will start our state immunization program for the state of São Paulo now on January 25th. Despite this non-disclosure of specific efficacy data, we have their superiority, which gives us peace of mind, ”said Gorinchteyn.
CoronaVac is in the third phase of testing, a stage in which efficacy must be tested prior to launch. In order for the vaccine to begin to be distributed, it is necessary for the Butantan Institute to send the report to Anvisa and for the agency to approve the use of the immunizer.
If approved, CoronaVac could become the first vaccine against the new coronavirus available in Brazil. According to the São Paulo government’s schedule, vaccination in the state should begin on January 25.
The agreement between the Chinese laboratory and the Butantan Institute was announced by the São Paulo government in June and provides, in addition to sending ready doses, the supplies and technology so that the vaccine can be produced and commercialized by Butantan.
In Brazil, the vaccine was tested in 16 research centers, in seven states and in the Federal District. 12,500 Brazilian volunteers participated in the tests.
By the end of December, the São Paulo government should have 10.8 million doses ready for application. The largest batch of supplies will arrive in São Paulo this Thursday (24).
On December 9, the Butantan Institute began the process of filling the vaccine with raw material imported from China. Production is carried out at the Butantan factory, which occupies 1,880 square meters, and will have 120 new professionals, in addition to the 245 who usually work at the institute.
Factory certification
On Monday (21), Anvisa published the Good Manufacturing Practices certification for the CoronaVac vaccine factory.
Anvisa inspection team and Butantan observers on the left and Sinovac senior management on the right – Photo: Pearson / Anvisa
The conclusion was made by the Anvisa team that traveled to China to inspect the vaccine production of the Sinovac pharmaceutical company.
The group was in the country between November 30 and December 4 to carry out inspections and meetings with company executives.
According to the note published in the Official Gazette, the Butantan Institute sent the action plan to Anvisa on Wednesday (16). The conclusion of the technical team was completed last Sunday (20).
The authorization was published 10 days before the initial forecast established by the agency.
The certificate is valid for two years and is one of the prerequisites for both the vaccination registration process in Brazil and for an eventual request for authorization for emergency use.
