Ervebo’s U.S. approval is based on results from a study conducted between 2014-2016 during an Ebola outbreak in Guinea. These study results showed that the vaccine was nearly 100% effective in preventing patients from contracting Ebola with symptom onset greater than 10 days after vaccination. In addition, the vaccine was tested in Liberia, Sierra Leone, Canada, Spain and the U.S., with similar results. The approval was granted to Merck & Co., Inc.
The vaccine is administered as a single-dose injection that contains a protein from the virus. The most commonly reported side effects were pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue.
“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,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, in an FDA statement. “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.”
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