Ebola Vaccine Approved for the First Time Ever by the European Union
On Monday, the European Union (EU) gave official permission for the "conditional marketing authorization" of the first-ever Ebola vaccine. A pharmaceutical company, Merck, is developing the vaccine known as 'Ervebo.'
Ervebo has been approved for "individuals aged 18 years and older" and has already been used in critical situations with emergency guidelines in the Democratic Republic of Congo (DRC).
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Merck, Ervebo and the EU
The vaccine 'Ervebo' was first developed by the Public Health Agency of Canada and the U.S. Army approximately ten years ago. It was in 2014 that Merck bought the rights to develop the vaccine, following the Ebola outbreak in West Africa.
Its a conditional approval.— PharmakonAsia (@PharmakonA) November 12, 2019
The #vaccine conditional marketing authorization for use in adults aged 18 years or older to protect against #Ebola virus disease caused by the Zaire species of the virus.https://t.co/jhTwcJ6vgW
The E.U.'s "conditional marketing authorization" is an approval exclusively for medicine that focuses on unmet medical needs, such as Ebola.
It permits the development of medicine to move forward with less comprehensive data than is usually required, only if the benefits outweigh the risks.
Ervebo has been 100% effective during its trials in Guinea, and Merck has already offered over 250,000 doses to the World Health Organization (WHO).
The plan for Ervebo
Even though this news is incredibly promising, patience is still required. Merck's plan is to start manufacturing the vaccine in Germany in 2020, at the start of the third quarter.
In the U.S., the Food and Drug Administration (FDA) still has the vaccine under "priority review," with an answer expected next year.
Merck's Ervebo, the world's first Ebola shot, wins inaugural approval in EU: https://t.co/Hf2YvfYtEO #pharma #regulatory— Pharma Regulatory (@EURegulatory) November 11, 2019
The decision by the E.U. is indeed a promising one, especially given the European Commission's records that state over 11,000 people have died in West Africa since the outbreak began in 2014.
The DRC has shown a 67% fatality rate once people contract the virus, and between August 2018 and October 2019, there were over 3,000 confirmed cases of the virus and 2,123 documented deaths.
The Ebola crisis is not over yet and is still considered an international public health emergency.
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