EMA Advisory Committee Issues Positive Opinion for J&J’s Ebola VaccineBy
Johnson & Johnson’s (J&J) Janssen has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen. The vaccine uses the company’s proprietary viral vector technology, AdVac, which is the same technology being applied to the company’s development of a COVID-19 vaccine and is the basis of the company’s investigational HIV, respiratory syncytial virus (RSV), and Zika vaccine candidates. Janssen’s AdVac vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.
The CHMP’s opinion was for a vaccine for the prevention of the Ebola virus disease caused by the Zaire ebolavirus species. Two marketing authorization applications were submitted to the EMA in support of the vaccines in a two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo).
The regimen includes Ad26.ZEBOV as the first dose, based on Janssen’s proprietary AdVac viral vector technology and MVA-BN-Filo as the second dose, based on Bavarian Nordic’s MVA-BN technology, administered approximately eight weeks later. The company says the goal of this two-dose approach is to induce long-term immunity against Ebola virus disease.
The Janssen investigational preventive Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) uses a viral vector strategy in which the viruses, adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA), are genetically modified so that they cannot replicate in human cells. In addition, these vectors are modified to safely carry the genetic code of an Ebola virus protein in order to trigger an immune response. The AdVac technology, alongside the company’s PER.C6 production cell line, is also being used to develop the COVID-19 vaccine and is the basis of the company’s investigational HIV, RSV, and Zika vaccine candidates.
Janssen’s investigational Ebola vaccine regimen is designed to support preventive vaccination in countries that are at risk of Ebola outbreaks, as well as for other at-risk groups such as healthcare workers, Biosafety Level 4 lab workers, military deployed from other countries, and airport staff and visitors to high-risk countries. Janssen is collaborating with the World Health Organization on vaccine pre-qualification to broaden access of its investigational Ebola vaccine regimen to those most in need and enable registration in African countries. The company says European Commission approval of this regimen may help accelerate this process.
Discussions with the US Food and Drug Administration are ongoing to define the required data set for filing Janssen’s Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway, which allows the use of animal data to provide evidence of efficacy for biological products, including vaccines.
Source: Johnson & Johnson