Merck wins US regulatory approval for Ebola vaccine

FDA follows EMA with approval of Merck's Ebola vaccine

Ebola is arguably one of the most feared viruses and the Food and Drug Administration just approved a vaccine to prevent it for the first time ever in the United States.

Cases of EVD in the U.S. are very rare and have generally occurred when people already infected with the virus have traveled into the country or when health care workers have become infected treating those sickened by EVD.

"Whereas the danger of Ebola virus illness within the USA stays low, the US authorities stays deeply dedicated to combating devastating Ebola outbreaks in Africa, together with the present outbreak within the Democratic Republic of the Congo", Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, stated in a press launch.

The Zaire strain of the deadly virus has killed upwards of 2,000 people in the current outbreak in the Democratic Republic of the Congo. 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 comes shortly after another Ebola vaccine developed by Johnson & Johnson and Bavarian Nordic, known as Ad26.ZEBOV/MVA-BN-Filo, was filed for approval in Europe. Individuals who provide care for people with EVD, including health care workers who do not use correct infection control precautions, are at the highest risk for infection.

FDA approval was based on the outcomes of a study conducted during 2014-2016 outbreaks in Guinea in the individuals of 18 years or above. Scientists said that the virus is always present in infected wild animals at low levels. The appearance of symptoms of EVD is sudden and may include fever, muscle pain, fatigue and headache which is followed by vomiting, diarrhea, impaired liver and kidney function and in some severe cases external or internal bleeding.

The approval was granted to Merck & Co., Inc.

Studies involving participants in Liberia, Sierra Leone, Canada, Spain, and the USA showed they had similar immune response, and it was found to be safe in further work in Africa, Europe, and North America.

The Erverbo approval by the FDA is a major step to protect the Zaire ebolavirus.

Azar said the government will continue to support the DRC and other governments in the region as well as the World Health Organization "until the Ebola outbreak is brought to an end, and we will continue working with governments around the world to prepare for and prevent such infectious disease outbreaks in the future".

The FDA granted the vaccine priority review and a tropical disease priority review voucher.

"The research approach used to study the effectiveness and safety of this vaccine was precedent-setting during a public health emergency and may help create a model for future studies under similar circumstances". Vaccination is essential to preventing and stopping Ebola outbreaks, he added.



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