24 May 2019
Posted in Pharma
With approval of Merck’s V920 still months away, J&J’s Ebola vaccine finds elevated role in DRC outbreak
Following the recent news that Congolese Health Minister Oly Ilunga Kalenga is pushing for licensure and exclusive use of Merck’s Ebola vaccine in the current DRC outbreak, Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective:
“Successful delivery of vaccines to an outbreak depends on local capacity, transmission chain surveillance, and coordination of national resources, but these factors become highly unpredictable in conflict zones such as the DRC. Licensure of Merck’s V920 vaccine could accelerate immunization efforts by cutting red tape, including the requirement for informed consent from volunteer recipients. Merck is currently in the process of a rolling submission to the FDA for V920, and is not expected to receive a decision until late 2019 at the earliest.
“In the meantime, J&J’s investigational prime-boost Ebola vaccine is the best candidate to fill the gaps in coverage, particularly as concerns rise about the supply of V920. There are over 30 investigational products in development for Ebola virus disease, but less than 40% of the pipeline has entered clinical-stage testing and only three are in Phase III, including J&J’s vaccine.
“Timing has become a critical factor as the DRC outbreak continues to worsen by the week, spurred by persistent violence towards healthcare response workers. Despite the desire from Congolese officials for a single-vaccine approach, the rollout of a second vaccine for compassionate use could not only curb the spread of the current outbreak, but also provide valuable data in the event of a future epidemic.”