J&J receives EU approval for Ebola vaccine
Though the ongoing COVID-19 pandemic has overshadowed the threat posed by the Ebola virus, parts of Africa are still grappling with the infectious disease.
The most serious outbreak began in 2014 and the number of cases caused sufficient alarm that pharmaceutical companies worked to rapidly develop vaccine programs against the virus.
Merck, known as MSD outside of the US and Canada, was the first to receive approval for its Ebola vaccine from the US Food and Drug Administration (FDA) and in Europe towards the end of last year – the approval representing a final step in the long timeline to develop a solution against the virus.
Johnson & Johnson has now received European Commission approval for Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) as a two-dose regimen for the prevention of Ebola virus disease.
According to J&J, the approval will allow for the ‘accelerated registration’ of the vaccine regimen in African countries.
Such efforts are still necessary, as there are ongoing outbreaks emerging, particularly in the Democratic Republic of Congo – where both Merck and J&J provided their vaccine prior to approval.
For J&J, the approval is a landmark one for the company, as the approved product represents the first vaccine to emerge from its pipeline, as well as being the first to use its ‘AdVac’ technology – the same technology utilized to develop the company’s leading COVID-19 vaccine candidates.
The two-dose regimen sees patients receive the first dose, which is based on Janssen’s viral vector technology, and then receive a second dose of Bavarian Nordic’s MVA-BN technology after eight weeks.
According to J&J, the company is still in discussions with the FDA over the required data to file for a US license for the vaccine.