Virus World

The US Food and Drug administration has approved for the first time in the United States a vaccine for the prevention of the deadly Ebola virus, the agency announced Thursday.  The vaccine, Ervebo, was developed by Merck and protects against Ebola virus disease (EVD) caused by Zaire ebolavirus in people 18 and older, the FDA said in a statement. Cases of EVD in the US 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.

"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," Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, said in a press release. Secretary of Health and Human Services, Alex Azar, called the new vaccine "a triumph of American global health leadership." The Zaire strain of the Ebola virus has caused more than 2,000 deaths in the current outbreak in the eastern DRC, and more than 11,000 deaths during an outbreak in 2014 in West Africa. Ebola virus is highly contagious and transmitted through direct contact with blood, body fluids and the tissue of infected wild animals or people. It's also transmitted through surfaces and materials that have come into contact with an infected person or animal.

FDA Press Release (December 19, 2019):

https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-ebola-virus-disease-marking-critical-milestone-public-health

The European Union authorised the marketing of a vaccine against Ebola on Monday, permitting the first wider commercial use of a protection that has helped stem an outbreak in DR Congo.  The European Commission announced that, after a trial by the European Medicines Agency (EMA), it would allow US pharmaceutical giant Merck to bring the drug to market in the bloc as "Ervebo".

Previously, the UN's World Health Organization had welcomed the advice of the EMA in favour of Ervebo as a "major milestone"—and more vaccines from other manufacturers are to be tested soon.

"Finding a vaccine as soon as possible against this terrible virus has been a priority for the international community ever since Ebola hit West Africa five years ago," said EU health commissioner Vytenis Andriukaitis.  "Today's decision is therefore a major step forward in saving lives in Africa and beyond." Since the start of the latest outbreak in the Democratic Republic of Congo, which has claimed some 2,150 lives since August 2018, more than 236,000 people have received the vaccine, known in the lab as rVSV-ZEBOV-GP. They included more than 60,000 health workers. Merck's vaccine was being administered under an exceptional procedure, granting permission to use non-licensed drugs in emergency cases. It was tested in about 16,000 people in clinical studies in Africa, Europe and the United States, and proved to be effective. Additional data is being collected.

Earlier this month, DR Congo medical officials said a second vaccine, Ad26-ZEBOV-GP produced by Johnson & Johnson, will also be introduced from November. And eight vaccines are undergoing clinical evaluation. This is the eighth epidemic of the deadly haemorrhagic fever on Congolese soil since the disease was first identified in the country, then called Zaire, in 1976. It is the second most deadly outbreak since around 11,000 people died in Guinea, Liberia and Sierra Leone between 2013 and 2016.