December 19, 2019
December 19, 2019 – The U.S. FDA has approved Ervebo® (Ebola Zaire Vaccine, Live) manufactured by Merck. It is the first vaccine in the world approved to prevent disease caused by Zaire ebolavirus, one of the organisms responsible for causing Ebola virus disease (EVD). The vaccine is indicated for use in individuals 18 years of age and older.
Rarely seen in the United States, EVD is caused by infection with one of multiple disease-causing viruses belonging to the Ebolavirus genus. These viruses are also a type of hemorrhagic fever virus, a group of organisms that damage blood vessels, interfere with the body’s ability to regulate itself, and have the capability to affect multiple organs. EVD is spread through contact with the bodily fluids of infected people or animals as well as contact with contaminated materials. The disease is most often seen in sub-Saharan Africa, where the first documented Ebola outbreaks occurred in 1976. On average, it has a case fatality rate of 50%.
Ervebo protects only against Zaire ebolavirus, and should not be used to prevent infection with other species of Ebolavirus or Marburgvirus, another genus of hemorrhagic fever virus. The FDA based Ervebo’s approval on multiple studies of safety, efficacy, and ability to provoke an antibody response, including one study that took place during an Ebola outbreak in Guinea. Recommended dosing is a single 1mL dose administered via intramuscular injection. At this time, the duration of protection conveyed by the vaccine is not known. Its effectiveness when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions has not been determined.
According to the manufacturer, licensed doses of the product should be available by the third quarter of 2020. Merck is working with several entities, including the U.S. government, to determine how best to support public health preparedness and response efforts when the licensed vaccines become available. In the meantime, the company will continue to make investigational vaccines available to address ongoing Ebola outbreaks in the Democratic Republic of the Congo and neighboring countries.
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.