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Bringing a prophylactic Ebola vaccine to licensure

Periodic Reporting for period 2 - EBOVAC3 (Bringing a prophylactic Ebola vaccine to licensure)

Reporting period: 2019-06-01 to 2020-05-31

EBOVAC3 is one of the Innovative Medicines Initiative (IMI)’s Ebola+ Program projects, focused on supporting the development of a two-dose preventive vaccine regimen against Ebola Virus Disease (EVD) from Janssen Vaccines & Prevention B.V. part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and its partner Bavarian Nordic A/S. Other Ebola+ projects include EBOVAC1, EBOVAC2, EBODAC and EBOMAN.

Tremendous progress has been made in the development of this vaccine regimen, in large part due to the contributions made through the above-named IMI-funded projects. Recently, on 1st July 2020, the European Commission granted marketing authorisation to the Janssen Ebola vaccine regime, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo). Data from the EBOVAC 1, 2 and 3 projects were used in the vaccine’s approval process. This authorisation will allow Janssen to collaborate with the World Health Organization (WHO) on potential vaccine pre-qualification, which would aim to accelerate registration of the vaccine in African countries and facilitate broader access to communities at risk for Ebola Virus Disease (EVD). The authorisation was granted in just one month, following a positive opinion adopted by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP), demonstrating the importance of this preventative tool to the Commission and its public health agenda.

EBOVAC3 aims to further support the vaccine regimen licensure pathway, providing information on long-term safety and antibody persistence following vaccination and on the safety and immunogenicity of the vaccine regimen in infants and health care workers. The project is also preparing for future Ebola outbreaks through activities including mathematical modelling and social science research.
During the first two years, the EBOVAC3 project was focused on set-up activities and implementation of the clinical trials.

Now, during the third year, EBOVAC3 is continuing the implementation of three clinical trials of the two-dose Ebola vaccine regimen:

• EBL2005: Safety and immunogenicity study of the two-dose heterologous vaccine in healthy infants in Guinea and Sierra Leone.
• EBL2007: Open-label safety and immunogenicity study of the two-dose heterologous vaccine regimen in health care providers in the Democratic Republic of Congo.
• EBL3005: Long-term safety and immunogenicity study of the two-dose heterologous vaccine regimen in Sierra Leone.

For all three trials, study documents including protocols and informed consent forms were developed and submitted to the relevant ethics and regulatory authorities. Study sites in Guinea, Sierra Leone and the Democratic Republic of Congo were identified and site logistical preparations such as staff recruitment and training were carried out. All three trials started in 2019 and have reached target recruitment in the second year of the project.

EBOVAC3’s outbreak preparedness activities were set-up in the first year of the project. Research protocols were developed for social science research in Guinea and Sierra Leone into community understanding, expectations and acceptance of various Ebola vaccine strategies and data collection started in 2019. A research protocol was drafted for a study on regulatory authorities’ experiences of Ebola vaccine studies during the Ebola epidemic. This protocol was approved by the ethics committee in Sierra Leone. A study protocol to identify gaps in preparedness for a future Ebola outbreak in Guinea, Sierra Leone and the Democratic Republic of Congo is under preparation. Staff have been recruited to lead these research activities.

The mathematical modelling work progressed the joint analysis of EBOVAC1 and 2 trial data to study immune responses to the vaccine. Modelling work was conducted to evaluate the effect of different vaccination approaches (e.g. mass, ring and targeted) to inform the design of efficient Ebola vaccination strategies. Work was also conducted to improve the design of studies to evaluate the effect of vaccination.

The EBOVAC3 project is now progressing the implementation phase in the third project year.
The second-largest outbreak of Ebola on record affected the eastern North Kivu and Ituri provinces of the Democratic Republic of Congo (DRC) from August 2018 to June 2020, throughout the first and second years of the EBOVAC3 project. In May 2019, WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization recommended that the Janssen Ebola vaccine be used to help contain the geographic spread of the outbreak, in a deployment that was coordinated with and complementary to that of Merck’s Ebola vaccine. In June 2020, just as the outbreak in the eastern DRC was successfully brought to an end with the help of these vaccines, a new outbreak was declared in Équateur Province in western DRC, underscoring the ongoing need for preventive immunization in vulnerable communities.

The work of the EBOVAC family of projects is therefore as important as ever to the global fight against Ebola and supported the licensure in July 2020 of the two-dose Ebola vaccine regimen for prophylactic use in adults and children ≥ 1 year old in the European Union. This in turn enables the process of WHO prequalification to move forward in support of global use of the vaccine.

The data gathered from the clinical trials implemented by the EBOVAC3 project could further contribute to the licensure pathway of the 2-dose vaccine regimen, providing additional data on the long-term safety and persistence of immune response associated with the vaccine, as well as the safety and immunogenicity of the vaccine in infants and healthcare workers specifically. This will inform the clinical use of the vaccine regimen and facilitate real world vaccination efforts to combat or prevent future outbreaks of Ebola.

The preparedness activities will inform understanding of how best to deploy the vaccine to fight Ebola in ways that are tailored to communities, and meet the expectations and capacities of governments and regulatory authorities.

The economic and social costs of combatting an Ebola epidemic are significant for both affected countries and international responders, including countries in the European Union who mobilise and provide humanitarian aid. One estimate of the total economic and social burden from the 2014-2016 West Africa Ebola outbreak was a staggering $53 billion . An effective vaccine which offers long-lasting protection against Ebola could therefore have a significant impact in countries at risk of the virus, but also for the people of Europe.