Gripe A – Porque será…

… que a EMEA (Agência Europeia do Medicamento) num documento intitulado “European Strategy for Influenza A/H1N1 Vaccine Benefit-Risk Monitoring” de Outubro escreve as seguintes recomendações e salvaguardas? (vide AQUI)

Safety

- Rapid detection, exchange and assessment of emerging signals of new or changing safety issues from spontaneous reporting systems, epidemiological studies, screening of electronic health records, clinical trials and other sources.
- Active surveillance of vulnerable populations, such as children, pregnant women and
immunocompromised subjects.
- Active data collection on rare and severe potential risks (such as Guillain-Barré syndrome and other neurological disorders).
- Prompt assessment of new safety information and evaluation of its impact on the benefit-risk balance.

Benefit-risk evaluation

- Prompt re-evaluation of the benefit-risk balance of vaccines whenever new safety issues arise or data on immunogenicity data are available.
- Collection of data on benefits and risks of the Influenza A/H1N1 vaccines at different time points.
- Based on this evaluation, accelerated decision-making regarding recommendations for the use of vaccines and conduct of vaccination campaigns.
- If necessary, communication to health care professionals and the public based on scientific evidence.

É bom que estejamos atentos, pois não é linear que este organismo bem como os nacionais estejam de facto somente interessados na saúde pública, falem com os vossos médicos, sobretudo dadas as notícias de ontem e hoje em Portugal, mães grávidas e futuras mães analisem bem todo o panorama, pois ao que parece e analisando o acima transcrito avançou-se na vacinação pese a mingua de testes prévios.

JPR