Merck gets EU panel nod for Ebola vaccine
(Reuters) - Merck & Co's vaccine for the Ebola virus received recommendation of approval from a panel of the European drugs regulator on Friday, taking it a step closer in becoming the first vaccine to be officially sanctioned for the rare and deadly disease.
The European Medicines Agency (EMA) said bit.ly/2MrRw4c its human medicines committee (CHMP) has recommended granting conditional marketing authorization in the European Union for the vaccine to be branded as Ervebo for individuals 18 and older and at risk of contacting the Zaire Ebola virus.
Final approval depends on the European Commission, which generally follows recommendations from the CHMP.
The World Health Organisation (WHO) welcomed the decision, saying it will move towards prequalification of the vaccine. WHO's prequalification programme is a service that helps provide access to medicines for severe diseases such as HIV/AIDS and malaria.
"The conditional authorization of the world's first Ebola vaccine is a triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide," Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said in a statement.
The hemorrhagic fever, first discovered in Congo in 1976, spreads through direct contact with body fluids and typically kills roughly half of those it infects.
There are currently no therapies approved for Ebola and data from trials and compassionate use programs have shown Ervebo to be effective in protecting against the virus following a single dose, the EMA said.
The vaccine has been tested in about 16,000 people and is currently under review for approval in the United States.
A current Ebola outbreak in the Democratic Republic of Congo has infected more than 3,000 people.
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