Merck’s Ebola Zaire Vaccine Approved in Europe
The European Commission announced the granting of marketing authorization to Merck Sharp & Dohme B.V. for its Ebola Zaire vaccine.
The Ervebo vaccine has been in development since the Ebola outbreak in West Africa in 2014.
Formally known as v920 (rVSVΔG-ZEBOV-GP), it is a recombinant, replication-competent Ebola vaccine, consisting of a vesicular stomatitis virus (VSV), which has been genetically engineered to express a glycoprotein from the Zaire ebolavirus, so as to provoke a neutralizing immune response to the Ebola virus.
This announcement on November 11, 2019, follows the recommendation from the European Medicines Agency (EMA), which has assessed the benefits and risks of the vaccine.
It also follows the recent announcement of a clinical trial for a 2nd Ebola vaccine regimen from Janssen Pharmaceuticals (Ad26.ZEBOV, MVA-BN-Filo) that is now underway in the Democratic Republic of Congo (DRC).
This outbreak was declared a public health emergency of international concern by the World Health Organization (WHO) in July and then extended in October 2019.
A total of 3,286 Ebola Zaire virus cases and 2,191 related fatalities have been reported in the DRC, as of November 9, 2019.
The current DRC outbreak is caused by Ebola Zaire, which has shown case fatality rates of approximately 67 percent.
Vytenis Andriukaitis, Commissioner in charge of Health and Food Safety, said in a press release, “Finding a vaccine as soon as possible against this terrible virus has been a priority for the international community ever since Ebola hit West Africa 5 years ago.”
“Today's decision is, therefore, a major step forward in saving lives in Africa and beyond.”
Recently, the U.S. Agency for International Development (USAID) announced it is providing nearly $56 million dollars in additional humanitarian assistance to combat the ongoing Ebola Zaire virus outbreak in the DRC.
Announced in a press release on November 8, 2019, this USAID additional funding increases the USA’s total to more than $266 million since the beginning of the outbreak in the DRC during August 2018.
The clinical development of Ervebo vaccine was made possible through cooperation with public health stakeholders, which include national institutes of health, ministries of health in Africa (notably in Sierra Leone, Liberia, and Guinea), as well as the WHO, the Norwegian Institute of Public Health, and Médecins Sans Frontières.
The development of the vaccine was supported by 2 projects from the Innovative Medicines Initiative (IMI) funded by the EU's research and innovation program Horizon 2020:
- VSV-EBOVAC (March 2015-Feb. 2019), led by Academisch Ziekenhuis Leiden (NL) with €3.9 million EU contribution,
- VSV-EBOPLUS (April 2016-March 2021), led by Merck, with €8.5 million EU contribution.
Previously, the US Centers for Disease Control and Prevention (CDC) updated the existing Level 2 Travel Alert regarding the Ebola Zaire outbreak in the DRC.
This Travel Alert says ‘travelers to this area could be infected with Ebola if they come into contact with an infected person’s blood or other body fluids. It is also spread by contact with contaminated objects or infected animals.’
‘The risk of Ebola infection for most travelers to DRC is low.’
But, the CDC says ‘travelers to the DRC should seek medical care immediately if they develop fever, muscle pain, sore throat, diarrhea, weakness, vomiting, stomach pain, or unexplained bleeding or bruising during or after travel.’
Ebola news published by Vax-Before-Travel