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The National Sanitary Surveillance Agency (Anvisa) met on Monday (4) with the Precis Farmacêutica laboratory, representative of the Indian company Bharat Biotech in Brazil. During the meeting, according to the note released by the regulator, some points were clarified and the pharmaceutical company said that “the strategy for Brazil is still to be defined.”
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Bharat Biotech is the developer of the vaccine. Covaxin, which had an approved emergency use in India this Sunday (3). That same day, the Brazilian Association of Vaccine Clinics (ABCVAC) reported that it is negotiating with the Indian laboratory purchase of five million doses of Covid-19 immunizer for private clinics.
Brazilian private clinics negotiate the purchase of 5 million Indian vaccines
The vaccine is in phase 3 testing in India, a stage in which the efficacy is verified. The first clinical studies showed that the immunizer does not cause serious side effects and produces antibodies against Covid-19. According to the president of ABCVAC, Geraldo Barbosa, the expectation is that the result of the last phase of the tests will come out in January.
Anvisa said Monday’s meeting was aimed at clarifying information on emergency use and definitive registration. The Brazilian agency explained that the company has not yet made any of the orders and the emergency cannot be requested because the Covaxin not being tested in Brazil, one of the prerequisites.
“No authorization for emergency use or registration has been requested for your vaccine. The emergency use rule states that the vaccine is being tested in the country to be licensed, which is not the case at this time for the Bharat Biotech vaccine. For companies that have not developed research in Brazil, the regularization of the vaccine must be done through the definitive registry, ”Anvisa reported.
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See the Anvisa note in its entirety:
This Monday (4), Anvisa participated in a meeting with the Precis Farmacêutica Ltda laboratory, which represents the Bharat Biotech company in Brazil. The meeting was scheduled to clarify the procedure for authorization of emergency use and registration of vaccines.
During the meeting, the company clarified that it will still define the strategy for Brazil, which will allow conducting phase III clinical studies or requesting a definitive registration directly.
No emergency authorization or registration was requested for your vaccine. The rule for emergency use states that the vaccine is being tested in the country to be authorized, which is not the case at this time for the Bharat Biotech vaccine.
For companies that have not developed research in Brazil, the vaccine must be regularized through definitive registration.
As a reference, Anvisa made itself available for other meetings as soon as the company defines the strategy.
The complexity of a vaccine requires strict monitoring, as well as compliance with health responsibilities by the company by making a biological product available to the Brazilian population.
Continuous shipment: it is the early presentation, in packages, of the information already ready. It must be carried out by the company that develops the Covid-19 vaccine, which must have a Commercial Operation Authorization (AFE) issued by Anvisa with the activity of manufacturing or importing medicines. The vaccine must have a phase 3 study, authorized and ongoing in Brazil.
Emergency use: it is a specific and temporary authorization for the vaccine to be used in a specific audience. It depends on the request of the laboratory that must have an ongoing study in Brazil.
