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BRASILIA – Hours after the governor of São Paulo, João Doria (PSDB), announces the start of vaccination in the state on January 25, a National Health Surveillance Agency (Anvisa) He reinforced, in a note, that he only discloses the use of the vaccine after analyzing several documents.
Among the roles required, Anvisa recalls, are the data from “phase 3” of the research for product development, which has not yet been presented by the Butantã Institute, a laboratory that participates in the development of Coronavac in partnership with the Chinese pharmaceutical company Sinovac.
“None of the four vaccines under development in Brazil has submitted a registration protocol. Therefore, none of the four is endorsed by Anvisa for wide use at this time. We do not have protocols to analyze,” said the president of the Agency National Health Surveillance (Anvisa), Antônio. Barra Torres, in a radio interview Young bread.
“We have tried to stay completely out of any unscientific discussion, especially out of political discussions,” Barra Torres said. “Now we are facing the allocation of deadlines. We stay out of this issue of setting deadlines. If you check my previous interviews, I have always said that I hope to have the vaccine in the first half of 2021, but I never set a month, much less a day”. . For those who do, I wish you good luck. In the meantime, we continue to work with the real world, which is the scientific world. ”
Between the lines, Anvisa’s note reflects the agency’s leadership position that Doria cannot run over the rite of freeing the use of vaccines and other drugs. The agency also reinforces that it needs to finalize the inspection report of the Sinovac factory, China. The survey was carried out last week, on site, by technicians from the Brazilian health authority, and the document should be published only between December 30 and January 11.
This report indicates whether or not the pharmaceutical company has “good manufacturing practices”. The same inspection is being carried out this week at the AstraZeneca plant, also in China, from which supplies will come for the manufacture of the immunizer that is the government’s commitment. Jair bolsonaro.
Anvisa managers and technicians received Doria’s plan with surprise. Privately, agency members say the governor’s plans ignore the agency’s role and may raise suspicions about the questions asked before launching or not using the vaccine.
The mistrust between the Anvisa summit and the São Paulo government is mutual. Members of the Doria government also see political biases in Anvisa’s decisions.
In private, a São Paulo health manager points out two reasons for closely monitoring the movements of the health authority: the closeness between President Jair Bolsonaro and the head of Anvisa, the doctor and Rear Admiral Antonio Barra Torres, in addition to the recent appointment of the lieutenant. Colonel Jorge Luiz Kormann in charge of director of the agency. “Number 3” in the administration of Minister Eduardo Pazuello, the military man echoes theses that are disapproved of by the same body that he can command.
As the Status, Kormann Liked Posts, in social networks, contrary to the World Health Organization (who) and also criticisms of Coronavac.
The dispute escalated in early November, when the Anvisa suspended Coronavac tests. The São Paulo government, at the time, said the decision was exaggerated. The agency said the suspension followed the protocols, but mistrust about the agency exploded when Bolsonaro celebrated the stop in the studios on social media.
In the end, the suspension lasted two days and the trials were resumed after Anvisa received an opinion from the international safety council accompanying the development of the vaccine.
The São Paulo government intends to request both the registration of the vaccine (which even allows commercialization to the private sector) and emergency use, which is valid only in the SUS and for restricted groups, such as health professionals and seniors.
OR Butantã Institute promises to deliver final data from the Coronavac studies on December 15. To grant the definitive registration, Anvisa has 20 days to analyze this last “block” of information. It is common for the agency to block the time to request information from developers.
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.
When evaluating emergency use, Anvisa does not give deadlines, but hopes to be faster. The agency must have at least preliminary data from phase 3 studies, showing greater than 50% effectiveness, and approving the target audience. Before submitting the request for emergency use, Instituto Butantã must attend a meeting at the agency.
“It is important to note that for the request for Authorization for Emergency Use, it is expected that the data described in the Guide on the minimum requirements for submitting a request for temporary authorization for emergency use, on an experimental basis, of Covid vaccines will be submitted. -19 ”, Anvisa says in a note.
Ministry and Coronavac
The possible purchase of Coronavac by the Health Ministry has also become the reason for a fight between Bolsonaro and Doria. In October, the president pushed Pazuello back and denied that he would invest in this immunizer.
However, under pressure, Bolsonaro has recognized that he must buy vaccines that receive Anvisa registration. This Monday 7, the president wrote on social networks that there should be no lack of resources to immunize the entire population. “If there is ANVISA certification (scientific guidelines and legal precepts), the Brazilian government will offer the vaccine to the entire population free of charge and not compulsory. According to the Ministry of Economy, there will be no lack of resources so that everyone can be cared for. Health and Hand Life economy, “Bolsonaro wrote.
– In case of certification by @anvisa_oficial (scientific guidelines and legal precepts) or @govbr will offer the vaccine to everyone, free and not mandatory.
– According to @MinEconomy There will be many resources for everyone to be served.
– Health and Economy hand in hand for life. pic.twitter.com/l1JmtnBkRI – Jair M. Bolsonaro (@jairbolsonaro) December 7, 2020
See Anvisa’s full note on Coronavac’s analysis:
“Clarifications on the analysis of the Sinovac vaccine studies.
1. To date, two sets of safety and efficacy study data have been submitted through the continuous submission procedure. The first one was sent on 10/02/2020 and its analysis has already been completed. The second was sent on 11/30/2020 and is under analysis.
2. No data have been submitted for phase III, which is the phase that confirms the safety and efficacy of the vaccine. This data is essential for evaluating both emergency use authorization requests and registration requests.
3. The inspection in Sinovac concluded on 04/12: Once the inspection is completed, the inspection team prepares a document (Annex III of POP-O-SNVS-001), which lists all the inspection findings (possible non-conformities ).
This document will be formally sent to the Butantan Institute within 3 business days after the inspection. The document must be formally answered by the Butantan Institute within 5 business days after receipt.
Based on the responses provided by the IB, the inspection team prepares the Inspection Report, which despite having a maximum processing period of 31 business days, was planned in this mission, thus taking a maximum of 10 business days. .
The Inspection Report is the conclusive document on the Certification, and its conclusions may lead to the approval or rejection of the certification.
Adding the days presented, it is concluded that the Inspection Report must be finalized between December 30 and January 11, 2020.
4. It is important to note that for the Emergency Use Authorization request, the data described in the Guide on minimum requirements for submitting a temporary authorization request for emergency use, on an experimental basis, of Covid vaccines is expected to be submitted. -19. “
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