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Credit, Reuters
For now, the closest vaccines to application in Brazil are Sinovac (above) and AstraZeneca
The start (or not) of vaccination against the coronavirus in Brazil has a decisive chapter this Sunday (1/17), when Anvisa holds an extraordinary meeting to decide whether to authorize two vaccines with a request for emergency use: CoronaVac from Sinovac and Instituto Butantan and Oxford-AstraZeneca, produced by Fiocruz.
If the authorization of the Sanitary Surveillance Agency is granted, the vaccines can, in theory, begin to be applied in Brazil as soon as the decision is officially informed to the laboratories.
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Broadcast live on official government channels, the meeting is led by five members of Anvisa’s collegiate board, all appointed by President Jair Bolsonaro, who has declared more than once that he does not intend to be vaccinated.
Antônio Barra Torres He was confirmed as CEO of Anvisa in December and is a Rear Admiral of the Navy. In the Armed Forces, he directed the Center for Medical Specialization and the Center for Medical Assistance. A personal friend of the president, the military man has a degree in medicine and was diagnosed with coronavirus weeks after appearing without a mask among protesters with Bolsonaro.
Cristiane Rose Jourdan Gomes He is an endocrinologist, worked as a health plan manager at Amil for 13 years and directed the Federal Hospital of Bonsucesso, in Rio de Janeiro, between August 2019 and August 2020. He has already publicly defended hydroxychloroquine, a drug whose use in the Coronavirus treatment is not recommended by international authorities such as the World Health Organization.
Alex Machado Campos Graduated in Law and built his career in technical positions in the Chamber of Deputies. The main position before the appointment of Jair Bolsonaro to the Anvisa board was that of chief of staff of the former Minister of Health Luiz Henrique Mandetta. He was appointed to the position by the center, an informal group of parliamentarians who generally seek proximity to the government in exchange for positions and other benefits.
Romison Rodrigues Mota He has a degree in Economics and a specialist in Health Surveillance. He joined Anvisa through public competition in 2005, where he was Budget and Finance Manager for five years. He became General Director of Administrative and Financial Management in 2015 and was appointed, last year, Alternate Director of the entity.
Meiruze Sousa Freitas Graduated in Pharmacy and incorporated to Anvisa through public tender in 2007, as a specialist in Health Regulation and Surveillance in General Drug Management. She held various positions, serving as deputy director, general director of Toxicology and director of the area of medicines, until she was confirmed as director in November 2020.
The federal government has not set an official date for the start of vaccination in Brazil, but the Minister of Health, Eduardo Pazuello, has said that the forecast is to start immunization on Wednesday (1/20), simultaneously throughout the country – a project questioned by immunization experts.
In São Paulo, Governor João Doria had planned to start vaccination in the state on January 25, but said he could anticipate the immunization campaign depending on Anvisa’s approval.
The decision is broadcast on national channels through official government channels at a time of high infections and deaths from covid-19 in Brazil and chaos in the health system in cities like Manaus.
How does the meeting work?
The decision to launch the vaccines or not will be made by a simple majority. Therefore, 3 votes will be enough to block or allow immunizers.
Director Meiruze Freitas is the rapporteur for the two requests for emergency use and will open the meeting, followed by presentations on technical analysis of the vaccines.
According to Anvisa, the presentations will be in charge of the medicine area, which evaluates clinical studies and efficacy and safety; the Good Manufacturing Practices certification area, which verifies that vaccine manufacturing sites have the appropriate conditions; and the adverse event monitoring area, which monitors and investigates after vaccination whether people have had a reaction to the vaccine.
Freitas will be the first to read your vote, followed by the other four directors.
Antônio Barra Torres, president of Anvisa, is in charge of announcing the final result.
The decision of the Anvisa Collegiate Council refers to vaccines for which there was a formal request for emergency use: CoronaVac, produced by China Sinovac in partnership with the Butantan Institute, and Oxford-AstraZeneca, whose request was made by Fiocruz.
This Saturday, Anvisa rejected an order for the emergency use of the Russian Sputnik V vaccine, produced by the União Química laboratory. According to the agency, “the order was returned to the company for not meeting the minimum criteria, especially due to the lack of authorization to conduct phase 3 clinical trials, ongoing conduct in the country and issues related to good manufacturing practices. “,
Anvisa points out that, at the moment, what is being evaluated is the emergency use of vaccines that are still considered experimental, so that the immunizers, once approved, would continue to be used “temporarily, until the vaccine receives the definitive registration in the country “. “.
An attempt to bring in 2 million doses of the Indian-made AstraZeneca vaccine failed on Friday. With a chartered plane ready to bring the immunizer, the Brazilian government faced a refusal from the Indian government and is now awaiting a decision on the purchase.
The federal government says it has 6 million doses of CoronaVac, which will be delivered by the Butantan Institute. On Friday, the federal government demanded “immediate delivery” of doses.
In total, Butantan says it already has 10.8 million doses of CoronaVac on Brazilian soil. “As of the end of March, the total load of immunizers made available by the institute is estimated at 46 million doses,” the agency says.
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