FDA approves Ebola vaccine

FDA approves Ebola vaccine

FDA approves Ebola vaccine

The vaccine, Ervebo, was approved by the U.S. Food and Drug Administration on Thursday, a month after Europe gave its nod to the vaccine, a move that has been hailed by the World Health Organization. While noting that Ebola cases in the United States have been very rare, director of the FDA's Center for Biologics Evaluation and Research Peter Marks said in a statement that "Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur".

Although cases of the deadly disease are extremely rare in the USA, infections have been acquired by those travelling to the country from affected areas, and health care workers who have fallen ill after treating people with Ebola.

Originally developed by NewLink Genetics, Ervebo - which was previously known as V920 or rVSVΔG-ZEBOV-GP - has been approved by the FDA to prevent disease caused by the Zaire strain of the Ebola virus in adults. It is characterized by fever, fatigue, muscle pain, headache and sore throat, followed by vomiting, diarrhea, and a rash. Healthcare professionals providing care to EVD patients are at a higher risk for not using proper precautions. Scientists said that the virus is always present in infected wild animals at low levels. It is also transmitted by way of surfaces and supplies which have come into contact with a contaminated particular person or animal.

The FDA approval of Ervebo was based on a study conducted in Guinea, West Africa during the 2014-2016 outbreak - the largest outbreak of Ebola to date. It was a randomized vaccination study.

So far, Merck has shipped 275,000 doses of the vaccine, and 258,225 people have been vaccinated in the DRC's latest outbreak. "The FDA's approval of Ervebo is a major advance in helping to protect against the Zaire ebolavirus as well as advancing USA government preparedness efforts". It is evidence of the advancing U.S government efforts.

In August DR Congo's health minister said the Congolese population were being used as guinea pigs when a second vaccine, by Johnson & Johnson, was introduced. This research approach was precedent-setting in the course of a public health emergency. The company is in discussion with the FDA for USA approval.

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.

The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine.

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