FDA NewsPerspective

Merck’s Ebola vaccine, used widely in DRC outbreak, up for FDA approval

Today, Merck announced that the FDA has accepted a biologics license application and granted priority review for the company’s investigational Ebola vaccine, which has been widely used in the ongoing outbreak in the Democratic Republic of the Congo, or DRC.

The target action date is set for March 14, 2020. If approved, it would be the world’s first licensed Ebola vaccine.

The vaccine, V920, was developed to prevent disease caused by the Ebola Zaire virus. In July 2016, the FDA granted it breakthrough therapy designation.

In April, WHO reported that the vaccine has been more than 97% effective during a ring vaccination trial in the DRC. According to Merck, the company has shipped more than 245,000 donated 1.0 mL doses of the vaccine to WHO since 2018. More than 200,000 people have received the vaccine during the more than 1-year-long outbreak.

Photo of someone getting an Ebola vaccination 
Merck’s V920, used widely in the ongoing Congo outbreak, would become the world’s first licensed Ebola vaccine if approved by the FDA.
Source: World Bank/Vincent Tremeau. This work has not been changed and is licensed

“We continue to be proud and humbled to provide our investigational V920 Ebola vaccine as an additional tool in support of the comprehensive public health response efforts against the current Ebola outbreak,” Paula Annunziato, MD, vice president of Merck Research Laboratories, said in a news release. “Merck appreciates and continues to work closely with our collaborators and is inspired by the relentless determination of everyone involved, especially frontline responders, working to contain this unique and dangerous outbreak.”

Merck said it has remained committed to scaling up production of the investigational vaccine. In June 2019, the company implemented an “updated replenishment strategy” to address the vaccine supply. With consultations from HHS, WHO and Gavi, the Vaccine Alliance, the company expects to produce an additional estimated 650,000 1.0 mL doses, which will be phased in over the next 6 to 18 months.

“Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine. FDA’s priority review designation underscores our long-standing partnership with the U.S. government toward its development and licensure,” Annunziato said.

Today, Merck announced that the FDA has accepted a biologics license application and granted priority review for the company’s investigational Ebola vaccine, which has been widely used in the ongoing outbreak in the Democratic Republic of the Congo, or DRC.

The target action date is set for March 14, 2020. If approved, it would be the world’s first licensed Ebola vaccine.

The vaccine, V920, was developed to prevent disease caused by the Ebola Zaire virus. In July 2016, the FDA granted it breakthrough therapy designation.

In April, WHO reported that the vaccine has been more than 97% effective during a ring vaccination trial in the DRC. According to Merck, the company has shipped more than 245,000 donated 1.0 mL doses of the vaccine to WHO since 2018. More than 200,000 people have received the vaccine during the more than 1-year-long outbreak.

Photo of someone getting an Ebola vaccination 
Merck’s V920, used widely in the ongoing Congo outbreak, would become the world’s first licensed Ebola vaccine if approved by the FDA.
Source: World Bank/Vincent Tremeau. This work has not been changed and is licensed

“We continue to be proud and humbled to provide our investigational V920 Ebola vaccine as an additional tool in support of the comprehensive public health response efforts against the current Ebola outbreak,” Paula Annunziato, MD, vice president of Merck Research Laboratories, said in a news release. “Merck appreciates and continues to work closely with our collaborators and is inspired by the relentless determination of everyone involved, especially frontline responders, working to contain this unique and dangerous outbreak.”

Merck said it has remained committed to scaling up production of the investigational vaccine. In June 2019, the company implemented an “updated replenishment strategy” to address the vaccine supply. With consultations from HHS, WHO and Gavi, the Vaccine Alliance, the company expects to produce an additional estimated 650,000 1.0 mL doses, which will be phased in over the next 6 to 18 months.

“Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine. FDA’s priority review designation underscores our long-standing partnership with the U.S. government toward its development and licensure,” Annunziato said.

    Perspective
    Amesh A. Adalja

    Amesh A. Adalja

    The announcement that Merck’s Ebola vaccine, which has been instrumental in the current Ebola outbreak in the DRC, is on track for FDA priority review and likely approval is a major milestone in the fight against this disease. Without this vaccine — which has been shown to be highly effective — the current outbreak would likely be much larger. There are currently no FDA approved countermeasures against Ebola, and it is hoped that having a licensed vaccine will set a precedent for more medical countermeasures (antivirals, diagnostics, and other vaccines) against this disease.

    • Amesh A. Adalja, MD
    • Senior scholar
      Johns Hopkins Center for Health Security

    Disclosures: Adalja reports being a shareholder in, and serving on the speakers bureau and gram-negative advisory board for Merck.

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