The first human vaccine against the often-fatal viral disease Ebola is now an official reality. On Monday, the European Union approved a vaccine developed by the pharmaceutical company Merck, called Ervebo.
The stage for Ervebo’s approval was set this October, when a committee assembled by the European Medicines Agency (EMA) recommended a conditional marketing authorization for the vaccine by the EU. Conditional marketing authorizations are given to new drugs or therapies that address an “unmet medical need” for patients. These drugs are approved on a quicker schedule than the typical new drug and require less clinical trial data to be collected and analyzed for approval.
In Ervebo’s case, though, the data so far seems to be overwhelmingly positive. In April, the World Health Organization revealed the preliminary results of its “ring vaccination” trials with Ervebo during the current Ebola outbreak in the Democratic Republic of Congo. Out of the nearly 100,000 people vaccinated up until that time, less than 3 percent went on to develop Ebola. These results, coupled with earlier trials dating back to the historic 2014-2015 outbreak of Ebola that killed over 10,000 people, secured Ervebo’s approval by the committee.
“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,” Vytenis Andriukaitis, commissioner in charge of Health and Food Safety at the EU’s European Commission, said in a statement announcing the approval. “Today’s decision is therefore a major step forward in saving lives in Africa and beyond.”
Although the marketing rights for Ervebo are held by Merck, it was originally developed by researchers from the Public Health Agency of Canada, which still maintains non-commercial rights.
The vaccine’s approval, significant as it is, won’t tangibly change things on the ground anytime soon. In October, the WHO said that licensed doses of Ervebo will not be available to the world until the middle of 2020. In the meantime, people in vulnerable areas will still have access to the vaccine through the current experimental program. Although Merck has also submitted Ervebo for approval by the Food and Drug Administration in the U.S., the agency’s final decision isn’t expected until next year as well.
Source: In a World First, the EU Has Approved an Ebola Vaccine
Robin Edgar
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