Cambridge, Mass. - December 14, 2020
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Company concluded an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support ongoing efforts to secure access to a safe and effective COVID-19 vaccine for the people of Singapore.
“We appreciate the confidence the Ministry of Health of Singapore has demonstrated in our mRNA vaccine platform by including mRNA-1273 in their portfolio of vaccines. We recognize that addressing this global pandemic will require a number of vaccines and therapeutic options, and we are proud of the role Moderna has been able to play in this global effort,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We continue to advance the clinical development of mRNA-1273 and the recent positive primary efficacy analysis from our Phase 3 COVE study is an encouraging step forward as we work together to address this global health emergency by delivering a vaccine to the people of Singapore and around the world.”
The data from the Phase 3 COVE study involving 30,000 participants demonstrated efficacy of 94.1% against COVID-19 and 100% against severe COVID-19. Efficacy was consistent across age, race and ethnicity, and gender demographics in the 196 observed cases of COVID-19. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose. The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna plans to submit data from the Phase 3 COVE study to a peer-reviewed publication.
Moderna recently announced data showing that mRNA-1273 remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours. Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.
Over the past nine years, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. The investments in this proprietary platform have enabled Moderna to expeditiously create, manufacture and clinically develop mRNA-1273 to potentially address the current COVID-19 pandemic.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.