MSD Collaborator Instituto Butantan Announces Results from Its Phase 3 Vaccine Candidate Trial for the Prevention of Dengue Disease
December 16, 2022 7:00 am ET
RAHWAY, N.J., Dec. 16, 2022 – At MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), we are highly encouraged by the tremendous progress scientists and clinicians at the Instituto Butantan have made in developing their single dose dengue disease vaccine candidate. We are working with Instituto Butantan to conduct a detailed analysis of these results in order to determine next steps for our own dengue vaccine candidate (V181).
Instituto Butantan’s announcement represents an important clinical research milestone for the global health community. Both MSD and Instituto Butantan’s investigational vaccines are derived from materials licensed from the U.S. National Institutes of Health (NIH) and both institutions are evaluating formulations analogous to the NIH TV003 formulation. Under the collaboration agreement announced in December 2018, MSD and Instituto Butantan are sharing clinical data and other learnings from their respective dengue vaccine development programs.
This collaboration is an example of how MSD is engaging the global public health community to develop vaccines for important diseases primarily affecting tropical and subtropical regions of the world.
Dengue is one of the fastest growing mosquito-borne diseases that affects not just the health but often the economic stability of people across the globe. It is a leading cause of serious and sometimes debilitating illness in tropical and subtropical countries.1 With approximately half of the world’s population, or four billion people, at risk for dengue disease, dengue is a critical public health challenge. Globally, 400 million dengue infections occur annually, according to the WHO2, with 50-100 million infections being symptomatic.3,4 While the majority of infections are uncomplicated, serious illness caused by dengue can be severe and lead to death5 (~500,000 cases per year are severe enough to require hospitalization and ~2.5% of severely affected individuals may die6). Mild dengue fever is characterized by a high fever, rash, and muscle and joint pain. A severe form of dengue fever, (dengue hemorrhagic fever) can cause severe bleeding, a sudden drop in blood pressure and death.7
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., 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 candidates that the candidates 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 the global outbreak of novel coronavirus disease (COVID-19); 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 Annual Report on Form 10-K for the year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Julie Cunningham (+1 617-519-6264)
Kimberly Petrillo (+1 247-742-2813)
Alexis Constantine (+1 908-740-1051)
1WHO | Dengue and severe dengue. Published online 2022. Accessed November 28, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue
2WHO | Dengue and severe dengue. Published online 2022. Accessed November 28, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue
3Russell KL, Rupp RE, Morales-Ramirez JO, et al. A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults. Hum Vaccin Immunother. Published online 2022:1-12. doi:10.1080/21645515.2022.2046960
4Messina JP, Brady OJ, Golding N, et al. The current and future global distribution and population at risk of dengue. Nat Microbiol. 2019;4(9):1508-1515. doi:10.1038/s41564-019-0476-8
5WHO | Dengue and severe dengue. Published online 2022. Accessed November 28, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue
6WHO | Dengue and severe dengue. Published online 2021. Accessed June 6, 2022. https://apps.who.int/mediacentre/factsheets/fs117/en/index.html
7Mayo Clinic | Dengue fever. Published online 2022. Accessed November 28, 2022. https://www.mayoclinic.org/diseases-conditions/dengue-fever/symptoms-causes/syc-20353078#:~:text=The%20severe%20form%20of%20dengue,pressure%20(shock)%20and%20death.