ERVEBO® [Ebola Zaire Vaccine] Awarded Prequalification Status by the World Health Organization (WHO)
WHO prequalification means that ERVEBO has met the WHO’s standards of quality, efficacy and tolerability
JOHANNESBURG, South Africa, November 14, 2019/ — Merck (NYSE: MRK), known as MSD (www.MSD.com) outside the United States and Canada, today announced that ERVEBO [Ebola Zaire Vaccine (rVSVΔ-ZEBOV-GP live)] has been awarded prequalification status by the World Health Organization (WHO). ERVEBO is the first vaccine to be prequalified by the WHO for the prevention of Ebola Virus Disease. WHO prequalification follows the European Commission’s grant of a conditional marketing authorization to ERVEBO on November 11, 2019. ERVEBO is currently under Priority Review with the U.S. Food and Drug Administration (FDA) with a target action date of March 14, 2020.
WHO prequalification means that ERVEBO has met the WHO’s standards of quality, efficacy and tolerability, which, in conjunction with other criteria, offers guidance to the United Nations (UN) and other global health entities in making relevant vaccine decisions. Importantly, prequalification status allows a vaccine to be procured and purchased by the UN, now allowing ERVEBO to be considered as a vaccine to be included in a global Ebola vaccines stockpile being planned by the WHO, UNICEF, Gavi (the Vaccines Alliance), and others.
In addition to the submission to the FDA, MSD has also made submissions to selected African country National Regulatory Authorities in collaboration with WHO-AFRO and the African Vaccine Regulatory Forum (AVAREF), which, if approved, will allow the vaccine to be registered in those countries.
MSD’s Commitment to Infectious Diseases
For more than 100 years, MSD has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, MSD has multiple programs that span discovery through late-stage development. To learn more about MSD’s infectious diseases pipeline, visit www.MSD.com.
For more than a century, MSD, a leading global biopharmaceutical company 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. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.MSD.com and connect with us on Twitter (https://bit.ly/2CGExWv) , Facebook (https://bit.ly/2QlopBY), Instagram (https://bit.ly/350ebuJ), YouTube (https://bit.ly/33O9owv) and LinkedIn (https://bit.ly/2Oein3k).
Forward-Looking Statement of MSD:
This news release of MSD (known as Merck & Co., Inc., Kenilworth, N.J. in the USA (the “company”)) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2018 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).