US pharmaceutical major Moderna has revealed that its experimental coronavirus vaccine is 94.5 per cent effective against preventing the vaccine. The vaccine efficacy data was ascertained by an independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, Moderna's vaccine candidate against COVID-19.
As explained by Moderna, mRNA-1273 is a vaccine against COVID-19 encoding for a prefusion stabilised form of the Spike (S) protein, which was co-developed by the company and investigators from NIAID's Vaccine Research Center.
"This 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 (NIAID), 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 said in a statement on Monday.
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Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups, the company further stated. The interim analysis did not show any safety concerns with the vaccine candidate, Moderna added
In a separate statement, Moderna stated that its COVID-19 vaccine candidate remains stable for 30 days at 2-degree Celsius to 8-degree Celsius, the temperature of a standard home or medical refrigerator. The company said mRNA-1273 remains stable at -200 C (-40F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.
Based on the interim safety and efficacy data, Modena is planning "to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks". The EUA application will be supplemented with the final safety and efficacy data in coming days, it added. The company will also approach global regulatory agencies for authorisations.
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Moderna is working with the US Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the US government, as well as global stakeholders, to prepare for distribution of its COVID-19 vaccine candidate mRNA-1273. The company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the US by the end of 2020.
Moderna said that it is on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273. Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.
The announcement from Moderna comes on the back of a Pfizer-BioNTech combine announcing that their vaccine was found 90 per cent effective in preventing COVID-19. The vaccine candidate is currently in Phase 3 of clinical trials, similar to the one being developed by Moderna.
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