Anvisa autoriza estudos clínicos com 3ª dose de vacina da AstraZeneca e com a proxalutamida
A Agência Nacional de Vigilância Sanitária (Anvisa) autorizou hoje o estudo clínico para avaliar a segurança, a eficácia e a imunogenicidade de uma terceira dose da vacina da AstraZeneca — a AZD1222 - ChAdox1 nCoV-19. Participam do ensaio voluntários do estudo inicial que já haviam recebido as duas doses do imunizante, com intervalo de quatro semanas entre as aplicações. A terceira dose será aplicada entre 11 e 13 meses após a segunda dose, informa a autarquia em nota.
“Trata-se de um estudo de fase III, controlado, randomizado, simples-cego, ou seja, em que só o voluntário não saberá o que tomou: se uma dose da vacina ou de placebo”, detalha o comunicado.
Segundo a Anvisa, serão incluídos voluntários com idade entre 18 e 55 anos, que estejam altamente expostos à infecção com o novo coronavírus, como profissionais de saúde. Não participarão do estudo gestantes ou pessoas com comorbidades.
O estudo, patrocinado pela AstraZeneca, ocorrerá somente no Brasil. Inclui os Estados da Bahia (1.500 voluntários), Rio de Janeiro (1.500 voluntários), Rio Grande do Sul (3.000 voluntários), Rio Grande do Norte (1.500 voluntários) e São Paulo (2.500 voluntários).
“Após a quebra do cegamento da pesquisa (quando os voluntários ficam sabendo se receberam a vacina ou o placebo), todos os participantes do grupo placebo serão convidados a ser imunizados”, diz a nota.
Na quarta-feira da semana passada (14/7), a Anvisa tinha autorizado um estudo clínico com a vacina AstraZeneca AZD2816 — uma nova versão do produto atualmente disponível no Brasil...
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