Testes de fase 3 serão realizados pelo Instituto Albert Einstein
Por Ludmilla Souza – Repórter da Agência Brasil
O Instituto Israelita de Ensino e Pesquisa do Hospital Albert Einstein deve começar em março, por um período de 45 a 90 dias, o teste da fase 3 da vacina Covaxin, com previsão para o resultado em maio. Serão em torno de 3 mil voluntários testados em cinco centros de referência. A vacina é desenvolvida na Índia pelo laboratório Bharat Biotech.
De acordo com a imunologista e pesquisadora do instituto Glaucia Vespa, a Coxavin é uma vacina de vírus inteiro inativado e apresenta efeitos colaterais comuns. “Os efeitos colaterais serão determinados no estudo clínico de fase 3. Os dados observados até agora indicam que a vacina é bem tolerada e segura, apresentando apenas efeitos colaterais comuns às vacinas inativadas utilizadas rotineiramente”.
Os locais em que a vacina será testada ainda não foram determinados. “Estamos em processo de finalização de contrato com cinco centros de referência pelo Brasil. Serão 3 mil voluntários, com inclusão competitiva. Ou seja, vai depender da seletividade no processo de recrutamento e inclusão dos centros”, disse.
Os voluntários não precisam ser profissionais de saúde, apenas maiores de 18 anos de idade, sem histórico da covid-19. Serão aplicadas duas doses da vacina, com intervalo de 28 dias.
Mesmo com a decisão de ontem (3) da Agência Nacional de Vigilância Sanitária (Anvisa) de não exigir estudos da fase 3 em andamento no Brasil para autorização emergencial no país, a pesquisadora Glaucia Vespa disse que o objetivo do instituto é consolidar o país como referência no segmento, além de aumentar o acesso às vacinas.
“O Einstein acredita que a realização de estudos clínicos com vacinas candidatas confere maior expertise aos centros de pesquisas clínicas brasileiros, consolidando o país como referência no segmento, e apresenta vantagens aos participantes, que receberão a vacina imediatamente após a conclusão pela sua eficácia. Além de aumentar o acesso à vacinas nesse momento pandêmico tão crítico para a população”, disse a pesquisadora.
Edição: Fernando Fraga.
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