"Ebola"

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The Ebola outbreak centered in the eastern region of the Democratic Republic of Congo has come to an end

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Merck's response to Ebola outbreak

Along with international agencies and governments, Merck has played — and continues to play — a leadership role in responding to Ebola.

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ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification

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

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Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ERVEBO® (Ebola Zaire Vaccine, Live) (pronounced er-VEE-boh) 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 a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein. “Approval of this vaccine by the FDA represents another important milestone in the global response to Ebola Virus Disease and stands as a tremendous accomplishment by a unique global partnership,” said Dr. Roger M. Perlmutter president,

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Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

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

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Merck Receives EU CHMP Positive Opinion for Investigational V920 Ebola Zaire Vaccine for Protection Against Ebola Virus Disease

Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L1 (CPS ≥1) Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a conditional marketing authorization for V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live). If affirmed by the European Commission, the vaccine will be authorized under the brand name ERVEBO ® (pronounced UR-VEE-BOH) and indicated 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 CHMP’s recommendation, completed under accelerated assessment, will now be considered by the European Commission. If the European Commission affirms the CHMP

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FDA Accepts Merck’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Merck’s investigational Ebola vaccine (V920), under review for the prevention of disease caused by the Ebola Zaire virus. The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020 . In July 2016, the FDA granted Breakthrough Therapy Designation to V920. “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,” said Dr. Paula Annunziato, vice president, Merck Research Laboratories. “A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed supply

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Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that it has started the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for V920 (rVSV∆G-ZEBOV-GP, live attenuated), the company’s investigational vaccine for Ebola Zaire disease. This rolling submission is made pursuant to the FDA’s Breakthrough Therapy Designation for V920, which was announced by the company in July 2016. “By the FDA agreeing to accept our BLA on a rolling basis, we have together made another important step forward in accelerating the regulatory review process for V920,” said Paula Annunziato, M.D., vice president for clinical research, Merck Research Laboratories. “We are fully committed to the development of this important vaccine against Ebola. In the meantime, pre-licensure, investigational doses of V920 are available to support response to Ebola Zaire outbreaks on an emergency basis in coordination with global public

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Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME ( PRI ority ME dicines) status. The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. PRIME is an approach from the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. PRIME is intended to optimize development

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World Health Organization to Review Merck’s Investigational Ebola Vaccine for Emergency Use Assessment and Listing

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the application for Emergency Use Assessment and Listing (EUAL) for the company’s investigational Ebola Zaire vaccine, V920 (rVSV∆G-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization (WHO). According to the WHO, the EUAL process is designed to expedite the availability of vaccines needed for public health emergencies such as another outbreak of Ebola. The procedure is intended to assist United Nations’ procurement agencies and Member States on the acceptability of using a vaccine candidate in an emergency-use setting. EUAL designation is not prequalification by WHO, but rather is a special procedure implemented when there is an outbreak of a disease with high rates of morbidity and/or mortality and a lack of treatment and/or prevention options. In such instances, WHO may recommend making a vaccine available for a limited time, while further clinical trial

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In Interim Results from Phase 3 Study, Merck’s Investigational Ebola Vaccine Efficacious; Study is Continuing

Merck (known as MSD outside the US and Canada) said today that its investigational Ebola vaccine candidate, rVSV-ZEBOV, was found to have 100 percent efficacy in an analysis of interim data from a Phase 3 ring vaccination trial in Guinea. Preliminary conclusions from this study, which is continuing, were published on-line today in The Lancet . The authors report that vaccine efficacy was 100 percent (95% confidence interval: 74.7 - 100%; p=0.0036) following vaccination with a single dose of the rVSV-ZEBOV vaccine. It appeared that all vaccinated individuals were protected against Ebola virus infection within 6 to 10 days of vaccination. To date, more than 4,000 participants have received the vaccine in this innovative trial, called “Ebola ça suffit” or “Ebola, that’s enough.” The trial was conducted by a team that included researchers from the World Health Organization (WHO), the Norwegian Institute of Public Health, the Health Ministry of Guinea and Médecins sans Frontières, among

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Phase III Trial of the Merck and NewLink Genetics Investigational Ebola Vaccine Initiated in Sierra Leone

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ: NLNK), confirmed today that the third, late-stage, clinical trial of their Ebola vaccine candidate rVSV-ZEBOV-GP (V920) has been initiated in Sierra Leone. The vaccine candidate was originally developed by the Public Health Agency of Canada’s National Microbiology Laboratory and licensed to NewLink Genetics in 2010. On Nov. 24, 2014, Merck and NewLink Genetics announced an exclusive licensing and collaboration agreement for the investigational Ebola vaccine. The Phase II/ III safety and effectiveness study, called STRIVE (Sierra Leone Trial to Introduce a Vaccine against Ebola) taking place in Sierra Leone will involve 6,000 health and other frontline workers and is being led by the Sierra Leone College of Medicine and Allied Health Sciences, Sierra Leone Ministry of Health and Sanitation, and the U.S. Centers for Disease Control and Prevention (CDC). “Fighting Ebola remains

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Merck and NewLink Genetics Enter Into Licensing and Collaboration Agreement for Investigational Ebola Vaccine

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate. The vaccine candidate, originally developed by the Public Health Agency of Canada (PHAC), is currently being evaluated in Phase I clinical trials. Pending the results of ongoing Phase I trials the U.S. National Institutes of Health (NIH) has announced plans to initiate, in early 2015, a large randomized, controlled Phase III study to evaluate the safety and efficacy of the rVSVEBOV vaccine and another investigational Ebola vaccine co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline. “Effective Ebola vaccines will be a critical component of comprehensive prevention and control measures for people at risk of Ebola virus