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The general director of Medicines and Biological Products of Anvisa (National Surveillance Agency Sanitary), Gustavo Mendes, said this morning that the CoronaVac vaccine, produced by the Butantan Institute with the Chinese laboratory Sinovac, had data from immunogenicity considered inappropriate, but, in view of the Brazilian need, recommended immunizer approval.
At the meeting that began at 10 am today, Anvisa’s technical board will evaluate the technical recommendations to release or not the emergency use in Brazil of vaccines against covid-19 Coronavac and AstraZeneca, developed by the University of Oxford with Fiocruz. The meeting is expected to last between 5 and 7 hours.
Gustavo Mendes said: “The data provided on the immunogenicity of Coronavac are not quantitative, they are qualitative and, therefore, they were not considered adequate by Anvisa. It is an information package that must be sent, this data is essential.”
Mendes has no voting power. Five directors of Anvisa will decide: Antonio Barra Torres, who is the general director of Anvisa, the rapporteur of the requests, Meiruze Sousa Freitas and the other directors Cristiane Rose Jourdan Gomes, Romison Rodrigues Mota and Alex Machado Campos.
According to a presentation prepared by the Anvisa team, in relation to CoronaVac, “the results of the immunogenicity evaluation were not presented in time for this study, as expected and defined in the protocol” and that “the only result presented it was not considered suitable for evaluation and conclusion “.
Anvisa stated that, through the secondary efficacy outcome, the predicted neutralizing antibody evaluations did not have the expected results, as well as the predicted binding antibodies and predicted seroconversion and cellular immunity.
Despite this, Gustavo Mendes stated that he recommends CoronaVac approval to the directors. The recommendation, as a technical area, is that, given the pandemic scenario, the increase in cases and the absence of therapeutic alternatives, the management recommends the approval of the emergency use of CoronaVac, with monitoring of the uncertainties that we still have and reevaluation. periodic “.
Anvisa meeting
Anvisa says that the decision on both vaccines will be based on opinions from technical areas and that, if approved, they will be used preferably in public health programs.
Anvisa’s focus at the meeting is to analyze the efficacy and safety of vaccines, according to the regulatory agency itself, for emergency use, that is, for use in the immunization of risk groups, such as indigenous people, the elderly and health professionals . .
If Anvisa supports the emergency use of vaccines, Brazil could already, in theory, apply immunizers. The measure, however, will be valid from the moment the decision is published in the Official Gazette (DOU), which can still happen this Sunday.
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. In São Paulo, the Secretary of Health, Jean Gorinchteyn, said yesterday that the state could start immediately.
The Butantan Institute claims to have 10.8 million doses of the Coronavac vaccine available on Brazilian soil. At the end of March, the total number 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.
For immunization, both vaccines need a double dose.
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