FDA geeft zijn eerste goedkeuring voor een ebolavaccinjanuari 4, 2020
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A month ago the European Union issued marketing authorization for a vaccine to prevent the Ebola virus in adults, and now the FDA has approved it. While noting that Ebola cases in the US have been very rare, director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said in a statement that “Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur.”
Studies supporting its approval included one with 900 subjects in Canada, Spain and the U.S., where antibody responses matched with those seen elsewhere. Side effects included “pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue.” An ongoing outbreak of Ebola in the Congo has killed more than 2,000 people, and more than 200,000 people have received the vaccine. A study during an outbreak in Guinea ” determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination.”
The EU marketing approval precedes increased manufacturing of the dose, called V920, in Germany later in 2020.