- The European Medicines Agency's human drugs panel Friday supported Merck & Co.'s experimental Ebola virus vaccine, clearing the way for the European Commission to give its OK within about two months.
- The vaccine is already available to people in the outbreak in the Democratic Republic of Congo under a compassionate use program that targets healthcare workers and people who have been in contact with infected patients.
- More than 3,000 people have been infected with the virus in this outbreak, and the fatality rate is estimated at 67%.
Ervebo, formerly known as V920, has already been tested in 16,000 people in clinical trials in the U.S., Europe and Africa, according to the EMA. It is a single-dose, live attenuated vaccine that is intended for people age 18 and older.
Under compassionate use in Africa, health authorities have applied a "ring" vaccination strategy that focuses on those most at risk, including healthcare workers, people who have been in contact with infected patients, and third-parties of those close to patients. So far that expanded access program has vaccinated at least 273,956 people, according to the World Health Organization.
The clinical trials showed that it stimulates an immune response and is effective against the Zaire Ebola virus that killed 11,000 in an outbreak in 2014-2016. That same virus is circulating now, and "preliminary data suggest that it is effective" in the current outbreak, EMA said.
The WHO reported Oct. 15 that 3,220 people have been infected so far in the current outbreak, and 2,150 have died. In the week preceding that report, only 15 new cases had been seen.
"While it is encouraging to see another week of relatively low numbers of newly confirmed cases, these are occurring in a concentrated area where limited access and insecurity pose challenges for the response," the report said.
To get Ervebo this far, Merck has relied on grants from the U.S. government, having received a total of $176 million to manufacture it. Last month, the New Jersey-based big pharma said it has shipped 245,000 doses to the WHO and plans to produce 650,000 over the next six to 18 months.
The vote by the EMA's human drugs panel sets up Ervebo for final approval by the European Commission within 67 days, giving it marketing authorization for the 28 countries in the European Union.
It is also being reviewed by U.S. regulators. The Food and Drug Administration has granted it priority review, and an approval decision is due by March 14, 2020.