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The European Medicines Agency (EMA) human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine that provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged 1 year and older.
The recommendation to grant a marketing authorisation for the new vaccine follows the approval of the first Ebola vaccine in November 2019. The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster.
“Currently, there are no therapies approved for Ebola. EMA is working together with regulatory authorities around the world to support WHO and to advise on possible pathways for the development, evaluation and approval of medicines and vaccines to fight Ebola,” said the EMA in a statement.
“Zabdeno and Mvabea received a positive opinion for marketing authorisations under exceptional circumstances because the applicant was able to demonstrate that it is not possible to conduct a randomised controlled study that might generate comprehensive clinical data on the efficacy of the new Ebola vaccine even after authorisation. This was considered acceptable in light of the ongoing Ebola outbreak and high mortality rates in Democratic Republic of Congo (DRC).
“The opinion adopted by the CHMP is an intermediary step on Zabdeno and Mvabea’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.
“Once marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each member state taking into account the potential role/use of the new Ebola vaccine in the context of the national health system of that country.”