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Worldwide, the EU has approved the Ebola vaccine



T he first vaccine against humans against the common fatal viral disease Ebola is now now an official reality. On Monday, the European Union approved a vaccine developed by Merck, a pharmaceutical company called Ervebo.

The approval stage for Ervebo was set in October, when a committee assembled by the European Medicines Agency (EMA) recommended a conditional marketing authorization for the EU vaccine. Conditional marketing authorizations are granted to new drugs or therapies that address an "unmet medical need" for patients. These drugs are approved faster than the typical new drug and require less data to be collected from clinical trials and analyzed for approval.

However, in the case of Hervebo, the data so far appear to be overwhelmingly positive . In April, the World Health Organization revealed the preliminary results of its "ring vaccination" efforts with Hervebo during the current Ebola epidemic in the Democratic Republic of the Congo. Of the nearly 100,000 people vaccinated so far, less than 3 percent continue to develop Ebola. These results, combined with earlier attempts dating back to the historic Ebola outbreak in 2014-2015, killing more than 10,000 people, have secured Hervebo's approval by the committee.

"Finding a vaccine as soon as possible against this terrible virus has been a priority for the international community since Ebola struck West Africa five years ago," Vitenis Andryukitis, Commissioner for Health and Food Safety at the European Commission of the EU, said in a state document ent declaring approval . "Therefore, today's decision is an important step forward in saving lives in Africa and beyond."

Although Ervebo's marketing rights are held by Merck, it was originally developed by researchers at the Public Health Agency of Canada , which still maintains non-commercial rights.

The approval of the vaccine, significant as it is will not change things significantly on the ground soon. In October, WHO stated that licensed doses of Ervebo would not be available worldwide until mid-2020 . In the meantime, people in vulnerable areas will still have access to the vaccine through this experimental program. Although Merck also submitted Ervebo for approval by the US Food and Drug Administration, the agency's final decision is not expected until next year.

And while Ervebo may be a highly effective vaccine, the biggest obstacles to the current Ebola epidemic are structural. Public health officials struggle to treat and vaccinate vulnerable communities in the country's armed wars and have sometimes been the target of violence . The vaccine is also approved only for people over 18 years of age to protect against Ebola Zaire, the most common subtype of the virus dangerous to humans.

From August 2018 to this October, there were more than 3114 confirmed cases and 2 213 deaths documented and the Ebola crisis remains an international emergency in public health.


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