The U.S. Food and Drug Administration has announced the approval of the vaccine, Ervebo, that is inoculated in the people for the prevention of Ebola virus disease (EVD). “Zaire ebolavirus” is a causative agent for this disease and usually occurs in individuals who are 18 years old and older.
The cases of this disease are not very common in the U.S. rather disease comes from the other countries through the infected individuals when they traveled to the U.S. While treating the patients with EVD, health care workers got the infection.
EVD, a contagious disease that is transmitted through direct contact with body fluids, blood and tissues of wild animals and people who are infected with this virus. Also spread by though surfaces and materials that are contaminated with Ebola viruses such as clothing and bedding.
The onset symptoms of the EVD are sudden including fatigue, fever, muscle pain, sore throat, and headache. In severe cases, vomiting, rash, diarrhea, impaired liver, and kidney function and internal or external bleeding are seen. The incubation period for the Ebola virus is 2 to 21 days. The health care workers who do not use infection control precautions while treating the EVD patients are at high risk of getting an infection.
According to Anna Abram, who is Deputy Commissioner for Policy, Legislation, and International Affairs at FDA that the risk of Ebola virus in the U.S. is very low. these Ebola devastating outbreak are common in the African countries (current outbreak in the Democratic Republic of Congo) and the U.S. government is committed to combat these outbreaks through the development of the vaccines against it.
The approval vaccine is an important step that shows the effort of FDA partners that work with the U.S. Department of Health and Human Services and the World Health Organization. This reveals the FDA’s expertise dedication and devotion to developing safe and effective medical products against the various infection to protect the public health and to fulfill their medicinal needs.
Since the 1970s the confirmed outbreaks of EVD have been reported and documented that occurred mainly in the areas of Sub-Saharan Africa. Scientist believed that virus is present in the infected wild animal at a low level. When people came in contact with infected wild animals, they got the disease and from here outbreaks resulted.
From 2014 to 2016, the Ebola outbreak was recorded in three West African countries Guinea, Sierra Leone and Liberia, CDC reports. More than 28000 cases were reported and more 11,000 death occurred due to the Zaire ebolavirus.
The outbreak in the Democratic Republic of the Congo is 2nd largest outbreak of the world. To help mitigate the outbreak the World Health Organization and DRC developed Ervebo and use against the Ebola virus in the patients as an investigational vaccine under an expanded program in 2018. The vaccination is a vital step to control and prevent the infection outbreak in the people.
Peter Marks, who is the director of the FDA’s Center for Biologics Evaluation and Research said that Ebola virus disease is a rare disease but sometimes it proves severe and deadly. Through vaccination, it is easy to control and prevent the spread of disease and it ultimately reduces the outbreaks in different regions. Today approval by FDA for the ERVEBO vaccine is an important step that helps prevent the infection due to ZAIRE EBOLAVIRUS proving the commitment of the U.S. government. To study the effectiveness and safety of the vaccine in the people’s research approach is used.
The safety level of the Ervebo vaccine was checked in nearly 15,000 individuals in Africa, North America, and Europe. The common side effected reported were swelling, pain mad redness at the site of injection. Moreover, headache, joint and muscle aches, fever and fatigue were reported.
Ervebo is an alive and attenuated vaccine. It has been genetically engineered for protein from the Zaire ebolavirus. The single-dose injection is administrated in the patients.
This application was granted Priority Review and Tropical Disease Priority Review Voucher by the FDA. This is done under the program that encourages the development of new drugs and biologics for preventing and treating certain tropical diseases. Breakthrough Therapy designation for Ervebo was granted by the FDA to facilitate the development and evaluation of the vaccine. The evaluation of the safety and effectiveness of the Ervebo is completed in less than six months.