OMS: consulta sobre critérios para listar vacinas de COVID-19 em seus programas
Esta notícia está disponível somente em inglês:
The World Health Organization has published the consultation on criteria for listing of COVID-19 vaccines at https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/WHO_evaluation_covid_vaccine/en/
This document provides advice to manufacturers on both the process and the criteria that will be used by the WHO to evaluate COVID-19 vaccines that are submitted either for prequalification (PQ) or for Emergency Use Listing (EUL). The current status of development of a candidate Covid-19 vaccine, the extent of the available quality, safety and efficacy data and regulatory approvals by relevant NRAs will guide WHO’s decision on which pathway (PQ or EUL) to follow for each vaccine.
Comments are due by 8th October by email at the following address WHOEUL@who.int