FDA Approves Ebola Vaccine

Merck’s vaccine, Ervebo, was also approved by the European Commission in November, as STAT reported.

The vaccine was used widely by the World Health Organization and the Democratic Republic of Congo to help reduce the spread of the Ebola virus in a few West African countries from 2014 to 2016, according to Reuters. Ebola Zaire is the strain of the virus responsible for the ongoing outbreak in the Democratic Republic of the Congo, according to STAT.

The Ebola virus is extremely rare in the U.S. The only cases that have ever existed are from people infected in other countries who traveled to the U.S. or from healthcare workers who treated people infected with the virus, according to ABC News.

“Ebola virus disease is a rare but severe and often deadly disease that knows no borders,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement reported by STAT. “Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur.”

Secretary of Health and Human Services Alex Azar touted the vaccine, which is a single-dose injection that works within 10 days of injection, as “a triumph of American global health leadership,” according to CNN.

The Ebola Zaire virus has claimed thousands of life in West Africa and set off widespread panic during an outbreak in 2014. The current outbreak has claimed 2,000 lives in the Democratic Republic of Congo, while the outbreak in 2014 led to more than 11,000 deaths in West Africa, according to CNN.

The Ebola virus causes hemorrhagic fever, which can quickly shut down bodily functions. It spreads when a person makes direct contact with the bodily fluids of an infected person, as ABC News reported.

The vaccine is approved for patients 18 and older. It will make up a large portion of the vaccine stockpile held by the Gavi, the Vaccine Alliance, to have readily available at the next sign of an outbreak, according to STAT. Gavi recently said it planned to stockpile half a million doses of the vaccine. Ervebo is attractive to Gavi for its simplicity since it is just a single-dose and has a fairly quick immune response time of just 10 days, as STAT reported.

“While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, FDA deputy commissioner for policy, legislation and international affairs, in a statement Thursday, as ABC News reported. “Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization.”

The vaccine has been in the works for decades, starting in the 90s. However, the dearth of commercial interest in an Ebola vaccine kept large pharmaceutical companies from partnering in the research and development of the drug. The outbreak in 2014 triggered a change in attitude and the drug was rapidly developed.

It underwent extensive testing, culminating in a clinical trail in Guinea, which was effected by the outbreak. Ervebo proved effective in stopping the spread of the virus, as STAT reported.

More than 258,000 people have been vaccinated in the current outbreak, according to STAT.