Merck (NYSE: MRK), known as MSD outside the United States and Canada, today confirmed that four African countries, including the Democratic Republic of the Congo (DRC), have approved ERVEBO (pronounced er-VEE-boh).

ERVEBO was granted a conditional marketing authorization by the European Commission on November 11, 2019 and approved by the U.S. Food and Drug Administration (FDA) on Dec. 20, 2019. In the United States, ERVEBO is 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.

Approvals by these African countries signify continued, groundbreaking progress in advancing the future of global public health preparedness against Zaire ebolavirus disease, made possible by the unprecedented collaboration between the World Health Organization (WHO), the African Vaccines Regulatory Forum (AVAREF), African governments, the European Medicines Agency (EMA), and Merck. These approvals were the result of the successful implementation of the WHO's Roadmap for introduction and rollout of Merck rVSV-ZEBOV Ebola virus disease vaccine in African countries. The roadmap, designed to coordinate actions and contributions toward the licensing and roll-out of ERVEBO, helped facilitate near-parallel regulatory reviews and led to the approvals of the vaccine in several at-risk countries within 90 days of WHO prequalification.

'We are grateful for WHO's leadership in establishing a path forward for expediting the prequalification and licensing of this vaccine in countries at greatest risk,' said Kenneth C. Frazier, chairman and chief executive officer, Merck. 'This important milestone is one more example of the partnership that has formed in response to the outbreaks. While we are far from finished in the Ebola fight, this milestone shows what can be done when we work together to address the most challenging diseases that threaten people and communities.'

ERVEBO has now been registered by National Health Authorities in the following countries in Africa - DRC, Burundi, Ghana, and Zambia. Approvals in additional countries in Africa are anticipated in the near future.

As previously announced, Merck is working to initiate manufacturing of licensed doses and expects these doses to start becoming available in approximately the third quarter of 2020. Merck is working closely with the United States government, WHO, UNICEF, and Gavi (the Vaccine Alliance) to plan for how eventual, licensed doses will support future public health preparedness and response efforts against Zaire ebolavirus disease. In the meantime, Merck continues to work urgently with WHO and partners to make investigational Ebola Zaire vaccine (V920) doses available in support of international outbreak response efforts in the DRC and neighboring countries.

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.

Immunocompromised Individuals

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.

Transmission

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.

ADVERSE REACTIONS

The clinical development program for ERVEBO included clinical studies conducted in North America, Europe and Africa, in which a total of 15,399 adults received a dose of ERVEBO. The total number of subjects vaccinated with ERVEBO in double-blind, placebo-controlled trials was 1,712 and in open label trials was 13,687.

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 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 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%). 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%).

Arthralgia was reported to occur in 7% to 40% of vaccine recipients in blinded, placebo-controlled studies. Severe arthralgia, defined as preventing daily activity, was reported in up to 3% of subjects.

Arthritis (including events of arthritis, joint effusion, joint swelling, osteoarthritis, monoarthritis or polyarthritis) was reported to occur in 0% to 24% of subjects in blinded, placebo-controlled studies in which subjects received ERVEBO or a lower dose formulation, with all but one study reporting arthritis in

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