The Food and Drug Administration has approved a vaccine against Ebola, a first for the US agency, officials announced Thursday.
No cases of the deadly bleeding and fever disease have been reported in the US since 2014, despite the uphill battle against the outbreak radiating outward from Democratic Republic of the Congo that’s been ongoing since August 2018.
But the disease is highly infectious and often lethal.
Regulators at the European Commission approved the vaccine in November and two days later, the World Health Organization green lit its safety.
Now, the US has approved Erverbo, a shot given in a single dose, for anyone over 18, as part of its effort in the global initiative to stop the disease’s spread.
Ervebo, a vaccine against Ebola (pictured), has become the first to get US FDA approval to prevent the disease that’s killed more than 2,000 people in West Africa since 2018 (file)
‘Ebola virus disease is a rare but severe and often deadly disease that knows no borders. Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur,’ said Dr Peter Marks, of the FDA’s Center for Biologics Evaluation and Research.
‘The FDA’s approval of Ervebo is a major advance in helping to protect against the Zaire ebolavirus as well as advancing US government preparedness efforts.’
In October, a major Global Health Security Index report warned that, amid the ongoing Ebola outbreak, the US was one of 195 countries worldwide that were not prepared to handle a disease pandemic.
The deaths of 2,220 people have been linked to the current Ebola outbreak.
More than 3,000 people in Congo have tested positive for Ebola, which is about 50 percent fatal.
Although the outbreak has been largely confined to the country where it began, four deaths have been reported in neighboring Uganda.
The international community is not immune to the disease’s spread.
Ebola spreads through blood or bodily fluids – such as saliva, semen, urine or even sweat – are inhaled, consumed or come into contact with broken skin.
The disease’s symptoms become noticeable within 21 days of exposure, and it comes on fast.
Typically, its first symptoms are fever, headache, sore throat, joint and muscle weakness.
Shortly thereafter, diarrhea and vomiting and stomach pain set in.
Also called ‘hemorrhagic fever’ Ebola causes some patients to bleed excessively, internally or externally.
In the US, there’s no approved antiviral treatment for Ebola. Those with the disease are mostly cared for with supportive efforts, like IV fluids, oxygen, and managing the fever, blood pressure changes, vomiting and pain associated with the disease.
So far, this outbreak has not seen any cases spill over to the US.
But it’s happened before.
The outbreak of Ebola in West African countries between 2014 and 2016 killed more than 11,00 people and two Americans that contracted the disease there returned to the disease and subsequently died.
Health officials began testing Ervebo, which is made by Merck, in Congo last year.
In the close study conducted of the vaccine, it was found to be 100 percent effective in preventing Ebola ‘with symptom onset greater than 10 days after vaccination,’ the FDA said in its press release.
‘While the risk of Ebola virus disease in the US remains low, the US 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.
‘[Thursday’s] approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the US Department of Health and Human Services, as well as our international partners, such as the World Health Organization.
‘These efforts, including today’s landmark approval, reflect the FDA’s unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission.’