A computer generated image of the Ebola virus
… Great Progress In The Fight Against The Deadly Ebola Virus …

MERCK DEVELOPS FIRST REGULATORY APPROVED AND LICENSED EBOLA VACCINE: ERVEBO

John G. Baresky

  • FDA and CHMP approves Merck’s Ebola vaccine “Ervebo”
  • The FDA had Ervebo’s review slated for review in the first quarter of 2020 and then re-prioritized it so it’s approval was completed in mid- December 2019
  • The Merck Ebola vaccine is administered via a single injection
  • Ervebo is genetically engineered to express a glycoprotein from the Zaire Ebola virus so as to provoke a neutralizing immune response
  • Johnson & Johnson has an Ebola vaccine currently deployed in Africa as a government authorized emergency measure prior to its approval by 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 )” as well as the FDA in the United States. It will be manufactured in Germany. Merck anticipates it will be able to start shipping Ervebo product to customers by the 3rd quarter of 2020.

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.

According to the World Health Organization, there are approximately 15 Ebola immunizations ( including the Merck product ) currently in development in North America, China, Europe and Russia. GlaxoSmithKline ( GSK ), Johnson & Johnson are among the big pharma players besides Merck seeking an Ebola immunization solution.

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 the 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.

As the Food and Drug Administration expedited its review and approval of the product in December 2019, production and allocation plans can be expedited and larger volumes of Ervebo can be made available sooner.

Since it first started in August 2018, the present Ebola outbreak underway has killed more than 2,100 people. It is in the northeastern portion of the country, in North Kivu and Ituri provinces. Over 3,000 cases have been reported; Ebola has demonstrated its contagious abilities with 1,000 cases in the first month, then in a 90-day period ( April through June 2019 ) another 1,000 cases surfaced.

Through the rest of the Summer between 75 and 100 new cases presented themselves weekly then dropped down to about to per week since August. With the number of cases has surpassed 3,000, it is now by far the country’s largest-ever Ebola outbreak and the second-largest Ebola epidemic ever recorded, behind the West Africa outbreak of 2014–2016.

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, a member of the filvirus family, has a harmful and often fatal impact on the ability of blood to clot. There are 6 species of Ebola virus, 4 of which have caused illness in humans:

· Bundibugyo ebolavirus (BDBV)

· Sudan ebolavirus (SUDV)

· Tai Forest (TAFV) (formerly referred to as Ebola Ivory Coast)

· Zaïre ebolavirus (EBOV)

Described as “hemorrhagic fever virus”, the clotting disruption it causes leads to internal bleeding from blood leaks in the small blood vessels of the body. With symptoms including acute onset of fever, headache and myalgia underway, it rapidly progresses to multi-organ failure due to blood loss.

The Ebola virus creates further issues as it causes severe inflammation and tissue damage for survivors to contend with through recovery. Ebola is persistent as it has been detected in patients several months after their recovery.

Ebola outbreaks, small or large, were dealt with in a methodical process centered on containment and control. Identify infected cases, isolate them, then separately find those in closest contact to the infected individuals and monitor or isolate them as well. Carefully care for those infected and take all precautions necessary when handling the corpses of victims as they are still contagious. Control the number of persons traveling into locales where outbreaks are present and assess those leaving those locales to be certain they have not been exposed to Ebola.

It has been long believed fruit bats are the primary hosts of the Ebola virus although diligent research continues that includes the potential of insects ( which bats consume ), rodents and small mammals as hosts or widespread carriers of the virus.

Ebola literally emerges from a trap door in nature, unleashes its deadly effect on animals and humans, then disappears as victims either recover or die and surrounding populations are kept safely away. Presumably, Ebola runs its course in select animal populations until it runs its course of carriers and victims.

There are instances where clusters of dead primates ( monkeys, gorillas, etc. ), jungle antelopes and other mammals are discovered prior to or in conjunction with Ebola outbreaks in geographic proximity to human populations. When these carcasses have been examined, more than one strain of the Ebola virus has been present.

The Ebola virus was initially discovered in 1976 near the Ebola River in DRC. Over the last 40 years, there have been roughly 10 severe Ebola outbreaks and several less severe, isolated incidences. Previous to the current outbreak ( which is now ranked as the second-worst to date) the West African Ebola epidemic was so severe that it resulted in about 30,000 EVD cases and more than 11,000 deaths between 2014 and 2016.

The commercial development of Ervebo is another clinical and commercial vaccine product 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.

Additional options from other vaccine manufacturers and research organizations are necessary in order to stockpile product in the event Merck is unable to produce their product as well as to embark on a large scale immunization initiative to thwart Ebola outbreaks prior to their occurrence.

There has been concern about the potential for Ebola to be weaponized and this is all the more reason to have more than one producer of Ebola vaccine prepared to increase immunization production if necessary. Insights developed and applied in Ebola vaccine development can be readily applied to other vaccine and biotech initiatives.

Thank you for reading this story

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