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[e-drug] Four countries in the African region license vaccine for Ebola prevention

E-DRUG: Four countries in the African region license vaccine for Ebola 
prevention
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14 February 2020 News release  Brazzaville/Geneva
https://www.who.int/news-room/detail/14-02-2020-four-countries-in-the-african-region-license-vaccine-in-milestone-for-ebola-prevention

The Democratic Republic of the Congo (DRC), Burundi, Ghana and Zambia have 
licensed an Ebola vaccine, just 90 days after World Health Organization (WHO) 
prequalification. Registration of the vaccine is expected in additional 
countries in the coming weeks.

The licensing of the vaccine means that the manufacturer can stockpile and 
widely distribute this vaccine to African countries at risk of Ebola virus 
disease outbreaks. Once licensed doses are available, use of the vaccine will 
not require clinical trial or other research protocols.

"The approval of the Ebola vaccine by these countries is another milestone in 
the fight against this unforgiving disease," said WHO Director-General Dr 
Tedros Adhanom Ghebreyesus. “Africa has rallied to cement hard-fought progress 
to keep its people safe from Ebola." 

WHO accelerated the licensing and roll-out of the Ebola vaccine by certifying 
that it met the organization’s standards for quality, safety and efficacy in 
its fastest vaccine prequalification process ever, announced in November 2019. 

The speed with which this has been achieved has been made possible by a 
different approach, where national licensing procedures were done in parallel 
based on one single scientific review process. Usually, these process are done 
one by one, which can take years. The process was led by WHO with the 
participation of the African Vaccine Regulatory Forum (an African network of 
national regulatory authorities and ethics committees), the European Medicines 
Agency, and Merck. 

“The rapid approval of the Ebola vaccine by countries in the Africa Region 
helps ensure this critical prevention tool will be available when and where it 
is needed most,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. 
“This kind of collaboration and innovation is a model for other health 
priorities.”

The injectable Ebola vaccine, Ervebo, is manufactured by Merck (known as MSD 
outside the US and Canada). Preliminary study results have shown a 97.5% 
vaccine efficacy. Data also suggests that vaccinating people who are already 
infected reduces their chances of dying. 

In response to the ongoing Ebola outbreak in the DRC, over 290 000 people have 
been vaccinated under compassionate use protocols. Once licensed doses are 
available, use of the vaccine in DRC will no longer require these protocols.

Carinne Bruneton E-Med
<carinne.bruneton@hotmail.fr>

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