The world came a big step closer to having a fully licensed Ebola vaccine on Friday, with a panel of the European Medicines Agency recommending conditional marketing authorization for Merck’s experimental Ebola vaccine.
Meanwhile, the company announced the brand name for the vaccine; it will be sold as Ervebo. The vaccine protects against the most common strain of Ebola viruses to cause outbreaks, the Zaire ebolavirus.
“This positive opinion … represents important progress towards licensure of a vaccine to provide protection from Ebola virus disease to people in areas affected by the Ebola Zaire virus,” Dr. Roger Perlmutter, president of Merck Research Laboratories, said in a statement.
The conditional authorization, for people 18 years and older, must receive European Commission approval before the vaccine will become licensed in the 28 EU countries and the countries of the European Economic Area — Iceland, Liechtenstein, and Norway.
The Food and Drug Administration is also reviewing a licensure application for Ervebo. A decision is expected by March 14, 2020.
The vaccine has been used for the past year and a half in the Democratic Republic of the Congo to battle first a small outbreak in the west of the country in the spring of 2018 and, since August 2018, the second-largest Ebola outbreak on record in the northeast of the country, in the provinces of North Kivu and Ituri.
Nearly 240,000 doses of the vaccine have been administered in the ongoing outbreak, which has infected more than 3,200 people and killed more than 2,150.
Because the vaccine is unlicensed, it is being used there under a research protocol sponsored by the World Health Organization. The WHO also sponsored the Phase 3 clinical trial conducted in Guinea near the end of the 2014-2016 West African Ebola outbreak that showed the vaccine is protective against the virus.
WHO Director-General Tedros Adhanom Ghebreyesus called the EMA news “a triumph for public health,” saying development of this vaccine is the result of an “unprecedented collaboration between scores of experts worldwide.”
“This vaccine has already saved many lives in the current Ebola outbreak, and the decision by the European regulator will help it to eventually save many more,” Tedros, as he is known, said in a statement.
The vaccine was developed by scientists at Canada’s National Microbiology Laboratory, with funding from the U.S. government’s Biomedical Advanced Research and Development Authority.
Using an unlicensed vaccine in an outbreak is cumbersome, requiring more paperwork and mandating discussions with recipients about the status of the vaccine to ensure they give informed consent to be vaccinated. Once the vaccine is licensed, it will be quicker and easier to use.
The recommendation of a conditional marketing authorization will not ease those restrictions on its use in DRC, the WHO said, noting that the first licensed doses will only be available in mid-2020.
The North Kivu-Ituri outbreak, which is in its 15th month, appears to be slowing. But the end of an Ebola outbreak can be messy and protracted; while the WHO and its partners in the effort to stop this outbreak are expressing cautious optimism, they are also unwilling to make predictions when it might be over.