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Anvisa (National Health Surveillance Agency) meets today (17), at 10 am, to define if it authorizes the emergency use of the first vaccines against covid-19 in Brazil. The management of the organ will broadcast live the meeting in which the clinical studies of Butantan and the application requests of CoronaVac, developed with the Sinovac laboratory, and Fiocruz (Oswaldo Cruz Foundation), developed in partnership with Oxford / AstraZeneca, will be analyzed.
Anvisa’s approach is to certify that vaccines are safe and effective. If approved, the Health Ministry expects to start vaccination this week. The emergency use is intended for the immunization of risk groups, such as indigenous people, the elderly and health professionals.
The decision, if approved, takes effect from the moment of its publication in the Official Gazette of the Federation, which should still occur today.
The meeting is extraordinary and takes place on the penultimate day of the deadline that Anvisa itself established to present a decision.
In order for the laboratories to achieve mass vaccination and the common sale of vaccines, it is necessary to request registration from Anvisa. No laboratory has made this request to date. Fiocruz expects the order to be made until next Friday (22).
This type of order should take up to 60 days to be analyzed by Anvisa. There is a law approved last year that determines a 72-hour period for Anvisa to approve the registration of drugs (including vaccines) since they have been approved by reference regulatory agencies.
The law applies to vaccines that are registered (for mass use) with agencies in the United States, the European Union, Japan, or China. To date, no vaccine is approved for this condition by any of these agencies. Approval in these countries is emergency, until now.
How will the meeting be
Like the FDA (Food and Drug Administration), the US regulatory agency, when it authorized the use of emergency vaccines in the United States, Anvisa will broadcast the technical meeting online. It is a normal situation and foreseen in the internal regulations.
The meeting should last about two hours and be broadcast on official Anvisa channels, such as YouTube. During this period the laboratory studies will be presented. The opinions analyzed were made by dozens of technicians from three sectors: Registration of Medicines, Inspection and Pharmacovigilance (this one for monitoring the application of doses).
The meeting will serve for the analysis of quality, good manufacturing practices, monitoring and control strategies and the results of clinical trials.
It is necessary to have a simple majority, that is, three votes, to approve the emergency use.
The coordinators of the five technical councils of Anvisa participate:
1st board
- Antonio Barra Torres – CEO of Anvisa, is in charge of the portfolio on the recommendation of Jair Bolsonaro (without party) and approval of the Senate since last year. The mandate of the Rear Admiral of the Navy will last until December 2024.
2nd board
- Meiruze Sousas Freitas – Head of the group with operations in medicines, biological products and food. She is the rapporteur for the requests from Fiocruz and Butantan. The analysis of the technical staff of this board will be discussed at the meeting.
3rd board
- Cristiane Rose Jourdan Gomes – responsible for acting on regulatory practices of toxicology, tobacco products for smoking or non-smoking, technology for health and hygiene products, perfumes, cosmetics, disinfectant products.
4th board
- Romison Rodrigues Mota – coordinates matters related to sanitary infraction, public health, sanitary inspection, operation of companies and public health laboratories.
Fifth board
- Alex Machado Campos – deals with matters related to the monitoring of products subject to sanitary surveillance and port, airport, border and customs areas.
Distribution
In a meeting last week, the coordinator of the FNP (National Front of Mayors), Jonas Donizette (PSB), reported that Minister Eduardo Pazuello promised the start of vaccination for Thursday (21). The federal government is committed to distributing vaccines exclusively and simultaneously to all states.
On Friday (15), the National Forum of Governors asked the Minister of Health to define how many doses of vaccine against the new coronavirus will be distributed in each state and municipality.
The Ministry of Health expects to apply 8 million doses of vaccines in January, 2 million from Fiocruz, which must be imported from India, and 6 million from Butantan, which are already in São Paulo.
The Bolsonaro government bought all the vaccine production from Butantan. The institute estimates the production of 46 million CoronaVac at the end of March.
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