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BRASIL & MUNDO

Anvisa aprova retomada de testes da vacina de Oxford contra a Covid-19

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A Agência Nacional de Vigilância Sanitária aprovou a retomada dos testes da vacina da Universidade de Oxford no Brasil. A decisão foi anunciada nesse sábado (12) após o órgão receber informações oficiais do laboratório AstraZeneca, responsável pelo desenvolvimento da vacina junto à instituição de ensino britânica. “Após avaliar os dados do evento adverso, sua causalidade e o conjunto de dados de segurança gerados no estudo, a Anvisa concluiu que a relação benefício/risco se mantém favorável e, por isso, o estudo poderá ser retomado”, disse a agência reguladora, segundo o G1 Bem Estar. Os testes haviam sido suspensos na terça-feira (8) pelo laboratório, depois que uma voluntária que tomou a vacina apresentou reação adversa (saiba mais aqui). De acordo com o G1, o jornal The New York Times informou que a paciente teve mielite transversa, uma síndrome inflamatória que afeta a medula espinhal. No Brasil, no entanto, não há relato de eventos adversos graves até o momento. Após análises, a Autoridade Reguladora da Saúde de Medicamentos (MHRA) indicou que era seguro retomar os testes e assim foi anunciado pela AstraZeneca na manhã de ontem (veja aqui). Vale ressaltar que a suspensão de ensaios clínicos é um procedimento padrão, que ocorre sempre que um participante desenvolve uma doença não explicada. A vacina de Oxford é objeto de um acordo firmado pelo laboratório com o governo brasileiro. Se ao final dos testes, o resultado mostrar êxito, o imunizante será distribuído no Brasil. Em agosto, o presidente Jair Bolsonaro (sem partido) assinou uma medida provisória (MP) que garante um acordo para a produção de 100 milhões de doses da vacina no país. (Bahia Notícias)

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