EMA – First vaccine to protect against Ebola (updated) :: WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries :: Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

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EMA – First vaccine to protect against Ebola (updated)
CHMP, Last updated: 14/11/2019
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus.

“This is an important step towards relieving the burden of this deadly disease,” said Guido Rasi, EMA’s Executive Director. “The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola. Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives.”…

Ervebo is a genetically engineered, replication-competent, attenuated live vaccine. Data from clinical trials and compassionate use programs have shown that Ervebo protects against Ebola virus disease in humans following a single dose administration.

The clinical development of Ervebo was initiated in response to the 2014-2016 Ebola outbreak in cooperation with public health stakeholders, including national institutes of health, ministries of health in countries such as Guinea and DRC, WHO, the US Centers for Disease Control and Prevention, the Public Health Agency of Canada, Médecins Sans Frontières and others. In the ongoing Ebola outbreak in DRC, the vaccine is being used under an Expanded Access Protocol or ‘compassionate use’ to protect people at highest risk of infection such as healthcare workers, or people who have come into contact with infected patients or contacts of contacts according to a ring vaccination strategy.

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 (i.e. able to make the immune system respond to the virus) and effective against the Zaire Ebola virus that circulated in West Africa in 2014-2016. Preliminary data suggest that it is effective in the current outbreak in DRC. Additional efficacy and safety data are being collected through the Expanded Access Protocol and should be included in post-marketing safety reports, which are continuously reviewed by EMA.

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 immunisation against Ebola…

 

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WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries
12 November 2019 News release
The World Health Organization (WHO) today prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks. This is the fastest vaccine prequalification process ever conducted by WHO.
Prequalification means that the vaccine meets WHO standards for quality, safety and efficacy. United Nations agencies and Gavi, the Vaccine Alliance, can procure the vaccine for at-risk countries based on this WHO recommendation.

“This is a historic step towards ensuring the people who most need it are able to access this life-saving vaccine,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”

The injectable Ebola vaccine, Ervebo, is manufactured by Merck (known as MSD outside the US and Canada). It has been shown to be effective in protecting people from the Ebola Zaire virus and is recommended by the WHO Strategic Advisory Group of Experts (SAGE) for vaccines as part of a broader set of Ebola response tools. The decision is a step towards greater availability of the vaccine in the future, though licensed doses will only be available mid-2020.

This announcement comes less than 48 hours after the European Commission decision to grant a conditional marketing authorization for the vaccine, following the recommendation from the European Medicines Agency (EMA)...

 

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Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union
:: Authorization Represents Significant Advancement in the Global Response to Ebola
:: Merck Remains Committed to Working with International Health Partners in Ebola Outbreak Response
November 11, 2019
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has granted a conditional marketing authorization to ERVEBO for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. The use of ERVEBO should be in accordance with official recommendations. The approval is based on data submitted to the European Medicines Agency for accelerated assessment in March 2019. With this approval, the European Commission will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. ERVEBO is currently under Priority Review with the U.S. Food and Drug Administration (FDA) with a target action date of March 14, 2020.

“The European Commission’s marketing authorization of ERVEBO is the result of an unprecedented collaboration for which the entire world should be proud. It is a historic milestone and a testament to the power of science, innovation and public-private partnership,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “After recognizing the need and urgency for an Ebola Zaire vaccine, many came together across sectors to answer the global call for outbreak preparedness. We at Merck are honored to play a part in Ebola outbreak response efforts and we remain committed to our partners and the people we serve. We also look forward to continuing to work with the FDA and the African countries on their regulatory reviews over the coming months and with the World Health Organization on vaccine prequalification, which will help broaden access to this important vaccine for those who need it most.”

Given the unique manufacturing requirements for ERVEBO, this approval allows Merck to initiate manufacturing of licensed doses in Germany, which are expected to start becoming available in the third quarter of 2020. Merck is also working closely with the World Health Organization (WHO), the United States Government, and Gavi, the Vaccine Alliance, to ensure uninterrupted access of its investigational Ebola Zaire vaccine (V920) in support of ongoing international response efforts in the DRC. As previously announced, Merck has committed to manufacture additional doses of investigational V920 over the coming year.

As part of its clinical development, and in response to requests from the WHO, Merck has, to date, donated more than 250,000 1.0mL doses of V920 to the WHO for use in outbreak response efforts occurring in the DRC since May 2018.

Merck has made a submission to the WHO seeking prequalification status for the vaccine, as well as submissions to selected African country National Regulatory Authorities in collaboration with the African Vaccine Regulatory Forum (AVAREF), which, if approved, will allow the vaccine to be registered in several African countries….