Ervebo: FDA approves Ebola vaccine for first time


The vaccine, Ervebo, was developed by Merck and protects against Ebola virus disease (EVD) caused by Zaire ebolavirus in people 18 and older, the FDA said in a statement.

The US Food and Drug Administration (FDA) has approved pharmaceutical company Merck's Ebola vaccine, which is being used to fight the deadly virus in the Democratic Republic of Congo. Ervebo was determined to be 100% effective in preventing cases of Ebola, with symptom onset greater than ten days after vaccination. The Ebola vaccine, which was used by the World Health Organisation and Democratic Republic of the Congo to decrease the extreme outbreak of Ebola disease on patients in West Africa between 2014/16, is the first-ever Ebola vaccine in the entire history, to be approved by the FDA and will only be provided to adults in a single dose.

Secretary of Health and Human Services, Alex Azar, referred to as the brand new vaccine "a triumph of American world health management".

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The Ebola outbreak in Congo has so far infected more than 3,300 people and killed more than 2,200 since the middle of past year, making it the second-worst on record.

Ebola virus is extremely contagious and transmitted by means of direct contact with blood, physique fluids, and the tissue of contaminated, wild animals or individuals. Documented since the 1970s, Ebola outbreaks can come from animals or other infected people. The stockpiling will start with Merck's Ervebo vaccine.

Ervebo, which the European Commission licensed in a landmark moment in November, is given as a live vaccine which contains a protein from the Zaire strain.

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Published on December 16, 2019, this Health Advisory (#432) says 'healthcare providers caring for a patient with possible Ebola virus infection should first contact their local or state public health authorities before any testing is performed'.

In additional studies, antibody responses to Ervebo were assessed in 477 individuals in Liberia, approximately 500 individuals in Sierra Leone and approximately 900 individuals in Canada, Spain and the U.S. The antibody responses among those in the study conducted in Canada, Spain and the U.S. were similar to those among individuals in the studies conducted in Liberia and Sierra Leone.

The company said it was working closely with the US government, WHO, UNICEF, and GAVI to prepare against the disease.

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The FDA granted a Tropical Disease Priority Review Voucher and Priority Review under a program intended for the development of new therapeutic drugs and biologics for the treatment and prevention of certain diseases.