Anvisa divulga regras para autorização emergencial de vacina contra Covid-19

 

Exigências serão menores, mas segurança é garantida, diz agência

A Agência Nacional de Vigilância Sanitária (Anvisa) divulgou hoje (2) critérios para uma modalidade especial de autorização emergencial de vacinas contra a covid-19 em caráter experimental. Esse modo simplificado terá menos exigências do que os registros de outros medicamentos e tratamentos, mas a agência declarou que serão garantidos requisitos de segurança.

A permissão especial poderá ser fornecida para vacinas que estejam em estudo no Brasil na chamada Fase 3, em que a eficácia e a segurança são analisadas. Nesse caso, as vacinas serão destinadas a programas de governo, não podendo ser comercializadas pelas empresas que obtiveram a permissão.

A autorização será temporária e abarcará apenas públicos específicos, não podendo ser disponibilizadas para o público em geral. A autorização emergencial só ficará como alternativa enquanto durar o que a Anvisa chamou de “situação de emergência bem estabelecida”.

“Existiam autorizações de importações excepcionais, mas a autorização de uso emergencial foi criada com base na questão especifica da pandemia da covid-19. Essa discussão está alinhada com as melhores práticas internacionais. A Organização Mundial da Saúde publicou regras específicas para essa modalidade”, afirmou o gerente geral de Medicamentos e Produtos Biológicos da Anvisa, Gustavo Mendes.

Critérios

Apenas as empresas que estão desenvolvendo as vacinas poderão solicitar a autorização na Anvisa. Deve ser comprovada a capacidade de fabricar ou de importar a substância.

As companhias interessadas em tal alternativa deverão fazer antes uma reunião com a equipe da Anvisa, que é chamada de “pré-submissão”, e demandará do requerente informações que servirão como forma de auxiliar na análise.

Será preciso também já ter aprovado na Anvisa um dossiê de desenvolvimento clínico. Isso ocorre no caso de vacinas em teste no Brasil, que já tiveram os estudos liberados, o que implica o envio de informações que demonstram perfil de segurança adequado e abordam o compromisso com a continuidade dos ensaios clínicos.

Avaliação

Até o momento, nenhuma farmacêutica ou centro de pesquisa deu entrada com pedido de registro ou da autorização emergencial de vacinas contra a covid-19. No caso dos requerimentos que poderão ser feitos, a equipe da Anvisa vai avaliar uma série de aspectos.

Como a autorização será limitada a um público específico, a Anvisa analisará a relação entre riscos e benefícios da vacina para esse grupo populacional, o que inclui a taxa de eficácia e os efeitos adversos. “Como são medicamentos que vão gerar dados complementares, pode ser que o risco benefício seja alterado. A possibilidade de ser revogada precisa estar muito clara”, disse Gustavo Mendes.

Um dos aspectos avaliados envolve os níveis de eficácia e segurança. O coordenador responsável pela área na agência ressaltou que o debate internacional vem considerando patamares por volta dos 50%.

Também serão considerados na análise as tecnologias empregadas, os procedimentos de fabricação, o prazo de validade, as condições de armazenamento e o tempo em que a vacina funcionará após descongelada.

O coordenador geral da área de vacinas da Anvisa acrescentou que a avaliação também levará em conta o que chamou de “boas práticas de fabricação”, onde as doses serão fabricadas e quais são os procedimentos de treinamento de pessoal para que cumpra com os parâmetros de qualidade.

Também faz parte dos aspectos analisados o que a agência denomina “farmacovigilância”, o acompanhamento do desenvolvimento da vacina, a duração da imunidade e a complementação dos dados para que a empresa possa, eventualmente, pleitear um registro.

Obrigações

Uma vez obtida a autorização emergencial, as empresas são suscetíveis a um conjunto de obrigações. A responsabilidade pela qualidade da vacina enquanto armazenada é da fabricante e deve ser respeitada.

Elas devem colocar no rótulo, de forma clara, que se trata de uma substância experimental. Outra exigência é o monitoramento de eventuais episódios adversos. E a farmacêutica pode ter a autorização revogada a qualquer momento.

Ag. Brasil

Por favor deixe seu like ou compartilhe:

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