Moderna remains on track to be able to start delivery of its COVID-19 vaccine candidate to help protect Swiss citizens following regulatory approval by Swiss health authorities.
Moderna could ship its COVID-19 vaccine as soon as December if regulatory approval is granted this month.
The company has already initiated the rolling review process with Swissmedic and intends to seek Prequalification and/or Emergency Use Listing with the World Health Organization.
Swiss vaccine supply will be sourced from Moderna's European production capacity with its strategic manufacturing partner Lonza of Switzerland, and ROVI of Spain for fill-finish services.
This updated agreement comes as the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis, indicating a vaccine efficacy of 94.1% against COVID-19 and 100% efficacy against severe disease.
Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board.
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 US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant secretary for Preparedness and Response at the US Department of Health and Human Services.
Recently released interim Phase 1 further indicates that 90 days following the second vaccination, trial participants retained high levels of neutralizing antibodies, suggesting that mRNA-1273 can generate durable neutralizing antibodies across all age groups including in older and elderly adults.
Moderna is advancing messenger RNA 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 with 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 and Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense, and BARDA.
Moderna has been named a top biopharmaceutical employer by Science for the past six years.
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