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Pharmaceutical Decides To Ask Anvisa For Authorization For Phase 3 Tests Of Indian Vaccine

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Precis Medicamentos, representative of the Indian Bharat Biotch in Brazil, which develops the vaccine against Covid-19 Covaxin, will request authorization from the National Health Surveillance Agency (Anvisa) to begin phase 3 clinical tests in Brazil. It will be up to a hospital to coordinate the tests with the volunteers. Last week, the Brazilian Association of Vaccine Clinics (ABCVAC) signed a contract with Precis Medicamentos to broker its associates to acquire 5 million doses of Covaxin. With this, approximately 300 clinics associated with ABCVAC will be able to sign individual agreements with the Bharat Biotech representative in Brazil for the purchase of doses.

To obtain Anvisa’s approval for emergency use of any vaccine, the laboratory must have carried out phase 3 tests in Brazil – as was the case with CoronaVac, developed by the Chinese laboratory Sinovac in partnership with the Butantan Institute, and with the ChAdOx1 vaccine, from the University of Oxford with the AstraZeneca laboratory (I, who, here, have a partnership with Fiocruz). Emergency vaccine use, understand Anvisa’s requirements Covaxin is produced in India by Bharat Biotech and on January 3, it was approved for emergency use. On the same day, ABCVAC informed that it started negotiating with the Indian laboratory the purchase of 5 million doses for private clinics linked to the association.

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The first clinical studies with Covaxin in India also approved on day 3, showed that the immunizer does not generate serious side effects and produces antibodies to Covid-19. The approval for emergency use in the country occurred, however, before the completion of phase 3 testing. On January 12, Precis stated that Bharat Biotech produces separate quantities of vaccines for the public and private sectors. This means, according to the company, that the destination of part of the production for private sales would not affect the availability of the public sector. In a broadcast on a social network, referring to the Oxford vaccine, President Jair Bolsonaro said the federal government did not will “create a problem” for private clinics to buy doses of vaccines against Covid-19.

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