![]() Severe Covid-19 occurred in 30 participants, with one fatality all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases COVE number, NCT04470427.).Ĭopyright © 2020 Massachusetts Medical Society.ĭr.Īside from transient local and systemic reactions, no safety concerns were identified. Baden reports being funded by the NIH to conduct clinical trials in collaboration with Crucell/Janssen and Moderna Dr. Rouphael, receiving grant support from Pfizer, Merck, Sanofi–Pasteur, Eli Lilly, and Quidel Dr. Creech, receiving grant support from Merck, consulting fees from Horizon Pharma and GSK, and fees for serving on a data and safety monitoring board from Astellas Dr. Neuzil, receiving grant support from Pfizer Dr. Graham, holding pending patent WO/2018/081318 on prefusion coronavirus spike proteins and their use and pending patent 62/972,886 on 2019-nCoV vaccine Dr. ![]() ![]() Bennett, being employed by and owning stock and stock options in Moderna Dr. Pajon, being employed by and owning stock in Moderna Dr. Knightly, being employed by and owning stock and stock options in Moderna Drs. Leav, Deng, and Zhou being employees of Moderna Dr. Han, being employed by and owning stock and stock options in Moderna Dr. Ivarsson, being employed by and owning share options in Moderna Dr. Miller, being employed by and owning stock and stock options in Moderna and Dr. Zaks, being employed by and owning stock options in Moderna. No other potential conflict of interest relevant to this article was reported. ![]() The data cutoff for the primary analysis occurred on November 25, 2020. #Karlson and mckenzie full#The full analysis population consisted of participants who underwent randomization and received at least one dose of mRNA-1273 or placebo the modified intention-to-treat population comprised participants in the full analysis population who had no immunologic or virologic evidence of Covid-19 on day 1, before the first dose and the per-protocol analysis population included participants in the modified intention-to-treat population who received two doses, with no major protocol deviations. The safety population included all participants who received at least one injection. Among participants who received an incorrect injection, three participants in the mRNA-1273 group received at least one dose of placebo and no dose of mRNA-1273 and were included in the placebo safety population, and three received one dose of placebo and one dose of mRNA-1273 and were included in the mRNA-1273 safety population in the placebo group all seven received mRNA-1273 and were included in the mRNA-1273 safety population. ![]()
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