Merck Confirms Agreement with UNICEF to Establish the World’s First Global Ebola Vaccine Stockpile with ERVEBO® (Ebola Zaire Vaccine, Live)
January 13, 2021 6:45 am EST
Milestone represents another landmark moment in the global fight against Ebola virus disease thanks to science, innovation and global collaboration
KENILWORTH, N.J. January 13,2021 — Merck (NYSE:MRK), known as MSD outside the United States and Canada, today confirmed an agreement with UNICEF to establish the world’s first global Ebola vaccine stockpile with ERVEBO® (Ebola Zaire Vaccine, Live). This agreement represents another landmark milestone in the fight against Ebola and is the result of breakthrough innovation and collaboration across Africa and the world. ERVEBO is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The duration of protection conferred by ERVEBO is unknown. ERVEBO does not protect against other species of Ebolavirus or Marburgvirus. Effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown. Do not administer ERVEBO to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein.
The global stockpile will offer a critical, rapid-response tool to help combat future outbreaks of this highly contagious, hemorrhagic illness that is endemic in parts of Central and West Africa. The stockpile inventory will be built over time and maintained by Merck. To ensure equitable and public health risk-based use of the vaccine, the stockpile will be governed by the International Coordinating Group (ICG) on Vaccine Provision in accordance with guidance from the Strategic Advisory Group of Experts (SAGE) on immunization. Any country in the world will be eligible to request vaccine from ICG should it face an imminent risk or relevant need. ICG members include the World Health Organization (WHO), UNICEF, Médecins Sans Frontières (MSF), and the International Federation of Red Cross and Red Crescent Societies (IFRC). Gavi, the Vaccine Alliance, as a key collaborator of the ICG, is financing the stockpile and funding the deployment of vaccines for Gavi eligible countries.
John Markels, PhD, President of Merck Vaccines, said, “For Merck, bringing forward medicines and vaccines to fight infectious diseases is fundamental to our mission to save and improve lives around the world. It has been our honor to collaborate with WHO, Gavi, UNICEF, the United States government and many others in getting to this point. While there remains important work ahead, the stockpile is a new and powerful tool in supporting future outbreak preparedness and response efforts. This historic milestone demonstrates what’s possible when partners come together to pursue a common purpose.”
Merck’s agreement with UNICEF represents the company’s commitment to global, equitable, and sustainable access to all our medicines and vaccines. Given the unique nature of Ebola virus disease and what is relatively low demand for ERVEBO compared to routine vaccines, we are only seeking to recover manufacturing and operational costs associated with the program and charging what it costs to make and manage the vaccine.
Merck believes that the recent Ebola outbreaks in the Democratic Republic of the Congo present an urgent call to action for the world. Sustained attention and investment in health security, including a robust market for innovation and continued collaboration are essential to be better prepared to address future infectious disease threats.
More Information on ERVEBO
ERVEBO was initially engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and the technology was subsequently licensed by a subsidiary of NewLink Genetics Corporation now known as Lumos Pharma, Inc. ERVEBO was conditionally approved by the European Medicines Agency on November 11, 2019, obtained pre-qualification from the World Health Organization on November 12, 2019, was then approved by the U.S. Food and Drug Administration on December 20, 2019 and is now registered for use in 8 African countries. Since the outbreak began in the Democratic Republic of the Congo in 2018, Merck has donated more than 305,0001.0 mL investigational doses of the vaccine to the response efforts under the auspices of an Expanded Access protocol.
Selected Safety Information for ERVEBO
WARNINGS AND PRECAUTIONS
Management of Acute Allergic Reactions
Among 15,399 subjects vaccinated with ERVEBO, there were two reports of anaphylaxis. Monitor individuals for signs and symptoms of hypersensitivity reactions following vaccination with ERVEBO. Appropriate medical treatment and supervision must be available in case of an anaphylactic event following the administration of ERVEBO.
Limitations of Vaccine Effectiveness
Vaccination with ERVEBO may not protect all individuals. Vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission.
The safety and effectiveness of ERVEBO have not been assessed in immunocompromised individuals. The effectiveness of ERVEBO in immunocompromised individuals may be diminished. The risk of vaccination with ERVEBO, a live virus vaccine, in immunocompromised individuals should be weighed against the risk of disease due to Zaire ebolavirus.
Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults. Transmission of vaccine virus is a theoretical possibility.
The most common injection-site adverse reactions reported by subjects taking ERVEBO in Study 1 (N=500) were injection-site pain (34.0%) and redness/swelling (2%). The most common systemic adverse reactions reported following vaccination with ERVEBO in Study 1 (N=498) were headache (37%), feverishness (34%), muscle pain (33%), fatigue (19%), nausea (8%), joint pain/tenderness (7%), rash (4%), and abnormal sweating (3%). Study 1 was conducted in Liberia (N=1,000). Subjects were randomized 1:1 to receive ERVEBO or saline placebo and were assessed at Week 1 and Month 1 postvaccination for solicited local and systemic reactions. In a subset of subjects (n=201), joint symptoms and signs were also solicited during a Week 2 visit.
The most common injection-site adverse reactions reported by subjects taking ERVEBO in Study 2 (N=1051) were injection-site pain (70.0%), swelling (17%), and redness (12%). The most common systemic adverse reactions reported following vaccination with ERVEBO in Study 2 (N=1051) were joint pain (18%), arthritis (5%), rash (4%), and vesicular lesions (2%). Study 2 was conducted in the United States, Canada, and Spain (N=1,197). Subjects were randomized to receive ERVEBO (n=1,061) or saline placebo (n=133). Subjects recorded solicited local reactions from Days 1 to 5 postvaccination, and daily temperature measurements and solicited joint and skin events from Days 1 to 42 postvaccination.
Interference with Laboratory Tests
Following vaccination with ERVEBO, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens. GP-based testing may have limited diagnostic value during the period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine.
USE IN SPECIFIC POPULATIONS
There are no adequate and well-controlled studies of ERVEBO in pregnant women, and human data available from clinical trials with ERVEBO are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy.
Human data are not available to assess the impact of ERVEBO on milk production, its presence in breast milk, or its effects on the breastfed child.
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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Before administering ERVEBO® (Ebola Zaire Vaccine, Live), please read the Prescribing Information at https://www.merck.com/product/usa/pi_circulars/e/ervebo/ervebo_pi.pdf The Patient Information is also available at https://www.merck.com/product/usa/pi_circulars/e/ervebo/ervebo_ppi.pdf
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