Merck nears approval of experimental Ebola vaccine

Merck has started the submission of a rolling Biologics License Application to the U.S. Food and Drug Administration for an investigational vaccine to combat the Zaire strain of the Ebola virus, the company recently announced.

The V920 vaccine, scientifically known as rVSV-ZEBOV, falls under the FDA’s Breakthrough Therapy Designation. It is intended to expedite the development of a candidate that can treat a serious or life-threatening condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies, according to a written statement from Merck.

“By the FDA agreeing to accept our BLA on a rolling basis, we have together made another important step forward in accelerating the regulatory review process for V920,” said Paula Annunziato, M.D., vice president for clinical research at Merck Research Laboratories. “We are fully committed to the development of this important vaccine against Ebola. In the meantime, pre-licensure, investigational doses of V920 are available to support response to Ebola Zaire outbreaks on an emergency basis in coordination with global public health authorities.”

Merck expects the rolling submission of the BLA to be completed in 2019.

Although not commercially licensed, the vaccine is being administered to individuals at highest risk of the virus under “compassionate use” in the ongoing Ebola outbreak in North Kivu in the eastern Democratic Republic of the Congo. By using the “ring vaccination” strategy, health officials capture the high-risk social network of patients, identifying people they live and work with who likely encountered the individuals while they were symptomatic. It’s projected that each ring may be composed of an average of 150 persons, say World Health Organization (WHO) officials.

To date, approximately 27,000 doses of the vaccine have been administered in North Kivu during the outbreak.

There are other experimental vaccines available, but Merck’s is the furthest along in the development process, reported STAT News, “having been shown to be protective in a clinical trial in Guinea at the tail end of the devastating West African outbreak of 2014-2016.”

In 2015, Merck’s vaccine was given to more than 16,000 volunteers involved in several studies in Africa, Europe and the United States where it was determined to be safe and protective against the Ebola virus, according to the WHO.