Johnson & Johnson’s Ebola Vaccine Regimen (Zabdeno®, Mvabea®) Demonstrates Strong Immune Response and Safety in Healthy and HIV-Positive Adults

October 31, 2021 /BioonBIOON/ -- Recently, research data from a study published in the U.S. journal *PLOS Medicine* indicates that,Johnson & Johnson's (JNJ) Ebola vaccine regimen (2-dose immunization)—Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo)—demonstrated good tolerability and induced robust immune responses in both healthy adults and adults living with HIV.These findings, together with the Phase 3 clinical data recently published in *The Lancet Infectious Diseases*, support the potential prophylactic use of this vaccine regimen to protect populations at risk of Ebola infection.

Johnson & Johnson's Ebola vaccine regimen (Zabdeno® + Mvabea®) was granted marketing authorization by the European Commission (EC) in July 2020 and received prequalification from the World Health Organization (WHO) in April 2021.

Following the 2014 West Africa outbreak, thanks to global public-private partnerships, the Johnson & Johnson Ebola vaccine regimen (Zabdeno® + Mvabea®) received regulatory approval in less than six years.The specific vaccination schedule for this vaccine regimen is as follows: (1) Zabdeno® is administered as the first dose, developed based on Janssen's AdVac technology; (2) Two months (approximately 8 weeks) later, Mvabea® is administered as the second dose, developed based on Bavarian Nordic's MVA-BN technology.

These data, published in PLOS Medicine, are from the Phase 2 EBL2002 study. The study was conducted in Burkina Faso, Côte d'Ivoire, Kenya, and Uganda, enrolling 668 healthy adults and 142 adults living with HIV. No safety signals of concern were identified during the study.

Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, said: "These data add to the growing body of evidence supporting the prophylactic use of the Johnson & Johnson Ebola vaccine regimen (Zabdeno® + Mvabea®) to protect populations at risk of Ebola infection.. This is crucial to our vision of protecting the world's most vulnerable and underserved populations, including people living with HIV, by preventing Ebola outbreaks before they occur. Recently, the re-emergence of the Ebola virus in the Democratic Republic of the Congo, the latest in a series of outbreaks across Africa last year, further underscores the need for a proactive approach to addressing this ongoing public health threat.”

Since the discovery of the Ebola virus in 1976, more than 30 outbreaks have been declared, the most severe of which occurred in Africa over the past seven years. Johnson & Johnson accelerated the development of an Ebola vaccine at the onset of the 2014–2016 Ebola crisis, which resulted in over 11,000 deaths.

Johnson & Johnson has responded to recent Ebola outbreaks by providing vaccine regimens to national governments and the World Health Organization (WHO). Most recently, in May 2021, Johnson & Johnson announced it would supply up to 200,000 doses of its Ebola vaccine regimen to support the Early Access Clinical Program launched by the WHO in response to the Ebola outbreak in Guinea and to prevent Ebola in West Africa. Beyond assisting in outbreak response, the company is committed to ensuring broader access to its Ebola vaccine regimen for the countries and communities in Africa most in need. (Bioon.com)

Original Source:Statement on Data Published in PLOS Medicine on Tolerability and Immune Response of Johnson & Johnson Ebola Vaccine Regimen in Adults Living with HIV