BRASILIA – Discussions to release testing of Pfizer and Janssen vaccines in adolescents in Brazil are in the final stages at the National Health Surveillance Agency (Anvisa). The statement was made by the agency’s general manager of medicines, Gustavo Mendes, in an interview with GloboNews on Sunday night
– We already have Pfizer and Janssen with strategies involving teenagers. We evaluated this information and saw that it is possible. We are in the final discussion for this approval, but we saw that the data does support these test approvals in this population – he declared.
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Mendes explained that, for this type of order, Anvisa assesses different aspects related to security. In the case of vaccines for children and adolescents, metabolic and physiological differences are taken into account, which require specific tests in this public.
– We believe that soon we will have these studies being conducted in Brazil, together with the new vaccine proposals that are coming – he said, recalling that in addition to the vaccines for adolescents from Pfizer and Janssen, there are new national and foreign vaccine initiatives that require tests in the country.
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As GLOBO has already shown, the seven vaccines against Covid-19 with contracts or negotiations with Brazil have already carried out clinical studies in children and adolescents in other countries. Pfizer, for example, has already published the final study of research with teenagers.
Janssen, which is a company of the Johnson & Johnson group, has tests abroad and has already requested authorization for research in the country.
Other vaccines in the crosshairs
When mentioning other vaccine initiatives that are on Anvisa’s radar, Mendes made reference to two immunizers that are being developed in Brazil and two other Chinese.
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According to the manager of Anvisa, the agency is monitoring the development of Butanvac, the national vaccine of the Butantan Institute, and Versamune, a partnership between the Faculty of Medicine of the University of São Paulo in Ribeirão Preto (FMRP-USP) and Farmacore Biotecnologia e PDS Biotechnology, from the United States.
According to Mendes, there are two other Chinese vaccines that intend to carry out phase 3 clinical studies in the country. Anvisa still analyzes these orders.
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