Ebola Vaccine Recommended For Marketing Authorization in Europe
The European Medicines Agency (EMA) human medicines committee (CHMP) has recommended granting a conditional marketing authorization in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunization of individuals aged 18 years and older at risk of infection with the Ebola virus.
Ervebo (v920) is a genetically engineered, replication-competent, attenuated live vaccine.
The EMA opinion adopted by the CHMP is an intermediary step on Ervebo’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization.
This EMA vaccine recommendation announced on October 18, 2019, is important since the current outbreak in the Democratic Republic of Congo (DRC), which is caused by Ebola Zaire, has shown case fatality rates of approximately 67 percent.
Ervebo has been tested in approximately 16,000 individuals involved in several clinical studies in Africa, Europe, and the United States, where it has been proven to be safe, immunogenic, and effective against the Zaire Ebola virus that circulated in West Africa in 2014-2016.
Data from clinical trials and compassionate use programs have shown that Ervebo protects against Ebola virus disease in humans following a single-dose administration.
Ervebo was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. Ervebo was granted eligibility to PRIME in June 2016 for active immunization against Ebola.
“EMA’s positive opinion for the first vaccine against Ebola virus disease demonstrates the scientific expertise in the EU that can be mobilized to reduce the impact of deadly diseases like Ebola,” said Harald Enzmann, Chair of the CHMP.
Currently, there are no therapies approved for the Ebola disease, which is a rare but severe illness caused by the Ebola virus.
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.
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.
Ebola News published by Vax-Before-Travel