Johnson & Johnson’s (J&J) Janssen Vaccines & Prevention has submitted its investigational preventive Ebola prime-boost vaccine regimen for review to the World Health Organisation (WHO) for Emergency Use Assessment and Listing (EUAL).
The EUAL procedure can be implemented at the time of an outbreak of a disease with high rates of morbidity or mortality and when there are no treatment or prevention options.
Johnson & Johnson chief scientific officer Paul Stoffels said: “Over the past four decades, we have seen 25 Ebola outbreaks, with the most recent in West Africa killing seven times more people than all previous outbreaks combined.
“If the WHO grants an emergency use listing, this will accelerate the availability of Janssen’s investigational vaccine regimen to the international community in the event another Ebola crisis occurs.”
UN Member States and procurement agencies will get support from the EUAL to determine the acceptability for use of a specific vaccine in a public health emergency.
Prior to granting the investigational preventative vaccine regimen, WHO will evaluate available data including quality, safety, and immunogenicity, as well as a risk / benefit analysis.
Janssen Pharmaceutical Companies infectious diseases and vaccines global therapeutic area head Johan Van Hoof said: “40 years after Ebola’s discovery, the potential availability of a durable prime-boost vaccine would be a tremendous achievement in global health.
“If listed for emergency use, the investigational Janssen vaccine regimen could be a vital prevention tool for rapid outbreak response, particularly for health workers and vulnerable communities on the frontlines.”
Prime-boost vaccination involves giving an initial dose to prime the immune system, followed by a booster dose later on to strengthen and optimise the duration of immunity.