“This is an important step towards relieving the burden of this deadly disease” said the European Medicines Agency’s (EMA) Executive Director.
The Committee for Medicinal Products for Human Use’s (CHMP) recommendation is the outcome of many years of joint global efforts to discover and develop new medicines and vaccines against Ebola.
The clinical development of the vaccine was a reaction to the 2014-2016 Ebola outbreak, in which 11000 people died in West Africa. The vaccine is a genetically engineered, replication-competent, attenuated live vaccine. It has been tested in approximately 16000 people, through clinical studies, which have proven its safety, efficacy and immunogenicity against the “Zaire” Ebola virus which caused the 2014-2016 outbreak. The vaccine has been supported through the EMA’s Priority Medicines (PRIME) scheme, which allows enhanced scientific and regulatory support to medicines that have a greater potential to answer patients’ unmet medical needs.
Early data suggests that it is also effective in the current outbreak in the Democratic Republic of Congo (DRC), which has infected more than 3000 people. In the DRC, the vaccine is currently being used under the Expanded Access Protocol to treat those at highest risk of infection, through which additional efficacy and safety data are being collected. An Expanded Access Protocol allows physicians and patients access to pre-approval, investigational drugs, which have shown great promise.
Due to the requirement for further information relating to the manufacturing process, the vaccine has only received a positive opinion for a conditional marketing authorisation. The opinion will now be sent to the European Commission (EC) for a decision on a European Union (EU)-wide marketing authorisation. Furthermore, the EMA is collaborating with regulatory authorities from around the world, including the World Health Organisation (WHO), to accelerate the distribution and access of this vaccine in the worst-affected countries. They are also involved in discussions regarding gathering evidence to support future investigational agents for the treatment of Ebola.
To see the EMA’s full statement regarding the regulatory challenges which have affected the Ebola vaccine, click here.