EBOLA VACCINE BREAKTHROUGH: MERCK DEVELOPS FIRST REGULATORY APPROVED AND LICENSED EBOLA VACCINE "ERVEBO"
by John G. Baresky on 11/12/19
Another vaccine breakthrough by Merck
Merck ( NYSE: MRK ) has announced its Ebola vaccine, Ervebo, has been approved by European regulators.
The
product, which has already been deployed in its investigational format in the Democratic Republic of Congo ( DRC ), was cleared by Europe’s “Committee
For Medicinal Products for Human Use ( CHMP )" and will be manufactured in
Germany. Merck anticipates it will be
able to start shipping Ervebo product to customers by the 3rd
quarter of 2020.
Ervebo’s
journey from development to approval
The
development of Ervebo was a clinical research and product licensing journey. Canada’s
National Microbiology Laboratory was the original developer of the immunization
which it then licensed to NewLink Genetics of Ames, Iowa. When the 2014 Ebola outbreak was triggered, Merck licensed it and went to work on further developing the vaccine along
with other collaborators.
Genetically engineered
Ervebo is an advanced product that is the result of rigorous research and development efforts. It is genetically engineered to express a glycoprotein from the Zaire ebolavirus so as to provoke a neutralizing immune response to the Ebola virus. Merck was able to not only fully prove the efficacy of the immunization but also demonstrate its ability to mass produce it at premium quality levels to assure reliability and safety of the product.
Until full commercial production is underway, the prototype / investigational formulation of the vaccine will continue to be deployed in Congo which has a population of about 92 million people through oversight by the U.S. Federal Government, World Health Organization ( WHO ) and vaccine alliance GAVI. Ervebo requires the administration of only one injection for it to be effective; another investigational Ebola vaccine being distributed in Congo to counter the Ebola outbreak is produced by Johnson & Johnson and requires two injections.
The U.S. Food and Drug Administration expects to review the product for potential approval
to be used within the United States during the first half of 2020.
Ongoing Ebola outbreak threat
Why and how Ebola is such an enormous health threat
Ebola Virus Disease ( EVD ) is an uncommon and deadly disease in people and nonhuman primates. Viruses causing EVD are found primarily in sub-Saharan Africa. People can get EVD through direct contact with an infected animal (bat or nonhuman primate) or person; including the dead bodies of EVD victims.
Ebola virus has a harmful and often fatal impact on the ability for blood to clot. This condition is described as hemorrhagic fever virus as the clotting disruption it causes leads to internal bleeding from blood leaks in the small blood vessels of the body.
The Ebola virus creates further issues as it causes severe inflammation and tissue damage. Due to being so deadly as well as contagious, Ebola is a major challenge for the individuals it infects and furthermore is a ruthless danger for caregivers and medical professionals who not only care for the Ebola patients but must also take thorough precautions to protect themselves.
Ebola's Deadly History
The Ebola virus was initially discovered in 1976 near the Ebola River in DRC. Over the last 40 years, there have been several severe Ebola outbreaks. Previous to the current outbreak ( which is now ranked as the second worst to date) the West African Ebola epidemic resulted in about 30,000 EVD cases and more than 11,000 deaths between 2014 and 2016.
Merck is a global leader in vaccine / immunization development
The commercial development of Ervebo is another vaccine development victory for Merck who has had a long standing commitment to global vaccine development. Its HPV STD and Oncology vaccine, Gardasil, has saved millions of lives and generated considerable savings for consumers, medical professionals and payers.
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