[ad_1]
Anvisa (National Health Surveillance Agency) approved today the requests for emergency use in Brazil of the CoronaVac vaccines, produced by the Butantan Institute with the Chinese laboratory Sinovac, and AstraZeneca, developed by the University of Oxford with Fiocruz. The two immunizers are the first approved in the country to combat covid-19.
The vaccines will be used preferably for use in public health programs and, initially, intended for the immunization of people in risk groups such as indigenous people, the elderly and health professionals. Anvisa’s board of directors decided on the emergency statement during a meeting that is still taking place this Sunday.
During the morning and early afternoon, both vaccines were recommended, with weight, by Anvisa’s technical direction. Then Anvisa director and application reporter Meiruze Sousa Freitas voted to approve AstraZeneca and, with reservations, CoronaVac.
Following, the directors Romison rodrigues Speck, Alex Machado Campos, Cristiane Rose Jourdan Gomes and Antonio Barra Torres, who is the general director of the agency, followed the rapporteur, thus unanimously releasing the use of immunizers against covid-19.
With the endorsement of the emergency use of vaccines, Brazil can now, in theory, apply immunizers. The measure is valid from the moment the decision is published in the Official Gazette of the Federation, which should happen this Sunday. Butantan already has 10.8 million doses available for application, while Fiocruz awaits the arrival of the immunizer from India, which is not yet scheduled.
The initiation of immunization will, however, depend on the organization of the campaign and the logistics of distribution of the doses. The Health Ministry expects to start vaccination this week. The São Paulo government wants to start vaccination today.
The decision to approve emergency use, according to Anvisa, was based on opinions from technical areas. The agency says it will post on its site parameters approved for each vaccine.
Vaccine dose
Last Friday (15), the Ministry of Health requested “immediate urgency” to deliver the 6 million doses contracted with Butantan. Doria said today that it will ship immediately as soon as it is approved.
With the approval of Anvisa, the government of São Paulo must send the doses ready for application to the Guarulhos Distribution and Logistics Center as soon as possible.
Butantan has 10.8 million doses of the vaccine available on Brazilian soil. At the end of March, the total load of immunizers made available by the institute is estimated at 46 million doses.
Fiocruz, for its part, expects the arrival of 2 million doses of the AstraZeneca / Oxford vaccine imported from India. Last Friday, the Indian government frustrated Planalto’s expectations after stating that it is now unable to meet Brazilian demand.
The federal government has committed to distributing vaccines exclusively and simultaneously to all states and municipalities, who, in turn, will be responsible for the logistics of distribution and application of the immunizers.
For immunization, both vaccines need a double dose.
The Butantan vaccine
The governor of São Paulo, João Doria (PSDB), holds a CoronaVac box with the secretary of state health, Jean Gorinchteyn, and the director of the Butantan Institute, Dimas Covas
Image: Disclosure
The Butantan vaccine against covid-19 was 50.38% effective in a study conducted in Brazil. The amount between 50% and 60% was anticipated by Twitter. The percentage is above the 50% effectiveness required by the WHO (World Health Organization).
The results of the survey were also sent to an independent international committee.
The Butantan study involved 16 scientific research centers in seven states and the Federal District. They were 6 months of work in partnership with Sinovac.
During the analyzes, 12,500 health professionals were divided into two groups, one received a placebo (a neutral substance) and the other a vaccine.
The vaccine is developed with the inactivated virus. The goal is for the patient to receive the dose with a small amount of inactive virus to stimulate the body to produce antibodies and prevent contamination, or in case of infection, the symptoms will be mild.
This type of technology is the most used by Butantan in other vaccines, such as influenza.
The Fiocruz vaccine
Azul’s plane travels to India to bring the first doses of the Oxford vaccine to Brazil
Image: Playback / Twitter
The Fiocruz vaccine was developed by the University of Oxford, England, in partnership with the UK laboratory, AstraZeneca. The effectiveness of the vaccine is 70.4%. And it takes two doses for immunization.
The vaccine is produced from biomolecules containing small protein parts of the Sars-CoV-2 virus (covid-19 virus). It is the production based on genetically manipulated adenovirus, whose objective is to stimulate the body to produce antibodies.
In this process, the chimpanzee adenovirus is genetically engineered and receives the gene for the Sars-CoV-2 “Spike” protein (“S” protein).
In Brazil, around 10,000 volunteers participated in the application of doses. The research started in June 2020 and tests were carried out on healthcare professionals.
Mass vaccination
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 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 the vaccine) 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.
[ad_2]
