Merck gets European nod for Ebola vaccine Ervebo

The European Medicines Agency (EMA) said 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.

New Delhi: Merck & Co's vaccine for the Ebola virus received a recommendation of approval from a panel of the European drug regulator on Friday, taking it a step closer to becoming the first vaccine to be officially sanctioned for the rare and deadly disease.

The European Medicines Agency (EMA) said 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.

Read Also: JnJ Ebola vaccine to arrive in Congo in November: Health Authorities

"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.

Read Also: Merck Ebola Vaccine V920 up for USFDA review