Today’s announcement by EMA, the European agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies, is a key step before the European Commission decision on licensing. In parallel, WHO will move towards prequalification of the vaccine.
“The conditional authorization of the world’s first Ebola vaccine is a triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “My deepest gratitude is to the studies’ volunteers, researchers, health workers in Guinea, other countries and the Democratic Republic of the Congo who have put themselves at risk to ensure people are protected with this vaccine.”
In the past five years, WHO has convened experts to review the evidence on various Ebola vaccine candidates, informed policy recommendations, and mobilized a multilateral coalition to accelerate clinical evaluations. The EMA review was unique in that WHO and African regulators actively participated through an innovative cooperative arrangement put in place by WHO, which will help accelerate registration for the countries most at risk.
A randomized trial for the vaccine began during the West Africa Ebola outbreak in 2015. When no other organization was positioned to run a trial in Guinea during the complex emergency, the government of Guinea and WHO took the unusual step to lead the trial.
A global coalition of funders and researchers provided the critical support required. Funders included the Canadian Government (through the Public Health Agency of Canada, Canadian Institutes of Health Research, International Development Research Centre, Global Affairs Canada); the Norwegian Ministry of Foreign Affairs (through the Research Council of Norway's GLOBVAC programme); the Wellcome Trust; the UK government through the Department for International Development, READ.http://https://www.who.int/news-room/detail/18-10-2019-major-milestone-for-who-supported-ebola-vaccine
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