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Coronavírus

Anvisa cria comissão para avaliar registro e autorização de vacinas

Uma Comissão Provisória da Agência Nacional de Vigilância Sanitária (Anvisa) vai acompanhar, avaliar e atuar nos procedimentos de registro e autorização de uso emergencial de vacinas contra a covid-19.

Sob a coordenação técnica de um servidor especialista, a comissão vai alinhar as ações de diversas áreas da Anvisa para dar suporte técnico aos processos e garantir celeridade nas decisões e na avaliação completa dos aspectos de segurança, qualidade e eficácia dos imunobiológicos, com foco no processo de monitoramento, após aprovação pela Agência.

De acordo com a Portaria Conjunta 1/2020, publicada ontem (23) no Diário Oficial da União (DOU), a coordenação da comissão “poderá convidar, quando necessário, representantes de outras unidades organizacionais da Anvisa e também de outros órgãos e entidades, públicas e privadas, além de pesquisadores e especialistas ligados ou não a sociedades científicas ou médicas, para o cumprimento das competências da comissão, assegurando o interesse público”.

“Ressalta-se que a Comissão terá caráter consultivo quanto à proposição das autorizações temporárias de uso emergencial, sendo a deliberação final atribuída à Diretoria Colegiada (Dicol) da Anvisa”, explicou a Anvisa.

A comissão será extinta quando a Organização Mundial da Saúde (OMS) declarar o fim da atual emergência em saúde pública de importância internacional provocada pela covid-19.

“A Portaria Conjunta é mais uma medida que favorece a segurança dos pacientes, pré-requisito essencial, especialmente no que diz respeito ao monitoramento da autorização de vacinas a serem disponibilizadas aos brasileiros”, disse o diretor da Anvisa Alex Campos.

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