expresspharmaDecember 15, 2020
Tag: Moderna , singapore , COVID-19 vaccine , mRNA-1273
Moderna confirmed that it has concluded an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s vaccine candidate against COVID-19.
“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,” said Stéphane Bancel, CEO, Moderna.
The data from the Phase 3 COVE study involving 30,000 participants demonstrated efficacy of 94.1 per cent against COVID-19 and 100 per cent 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 US 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 seven 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.
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