Ebola vaccine moves closer to market licence: European regulator
The European Medicines Agency (EMA) said in a statement its human medicines committee “has recommended granting a conditional marketing authorisation in the European Union for Ervebo”, the only Ebola vaccine in circulation.
“This is an important step towards relieving the burden of this deadly disease,” said EMA executive director Guido Rasi.
The EMA’s recommendation will be forwarded to the European Commission for a decision on EU-wide marketing authorisation.
The UN’s World Health Organization welcomed the news as a “major milestone”.
“The conditional authorisation 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,” the WHO’s director-general Tedros Adhanom Ghebreyesus said.
Since the start of the latest outbreak in the Democratic Republic of Congo, which has claimed some 2,150 lives since August 2018, more than 236,000 people have received the vaccine known in the lab as rVSV-ZEBOV-GP, the WHO said.
They included more than 60,000 health workers.
Manufactured by the American pharma giant Merck, the vaccine is being administered under an exceptional procedure, granting permission to use non-licensed drugs in emergency cases.
It was tested in about 16,000 people in clinical studies in Africa, Europe and the United States, and proved to be safe and effective. Additional data is being collected.
Earlier this month, DR Congo medical officials said a second vaccine, Ad26-ZEBOV-GP produced by Johnson & Johnson, will also be introduced from November.
The J&J vaccine had been rejected by the country’s former health minister Oly Ilunga, who cited the risks of introducing a new and unlicensed product in communities where mistrust of Ebola responders is already high.
Ilunga resigned in July and was subsequently charged with embezzling funds intended for the fight against Ebola.
Eight vaccines are undergoing a clinical evaluation, the WHO said.
This is the eighth epidemic of the deadly haemorrhagic fever on Congolese soil since the disease was first identified in the country, then called Zaire, in 1976.
It is the second most deadly outbreak since about 11,000 people died in Guinea, Liberia and Sierra Leone between 2013 and 2016.
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