{"content":[{"text":"Page 2 – ModernaTX, Inc.","bbox":{"left":0.117647,"top":0.046119,"width":0.20911799999999997,"height":0.016778999999999995}},{"text":"FDA reviewed safety and efficacy data from an ongoing phase 3 trial in approximately 30,000 \n participants randomized 1:1 to receive Moderna COVID‑19 Vaccine or saline control. The trial \n has enrolled participants 18 years of age and older.","bbox":{"left":0.117647,"top":0.091574,"width":0.7525059999999999,"height":0.05162699999999999}},{"text":"FDA’s review of the available safety data from 30,351 participants 18 years of age and older, \n who were followed for a median of 7 weeks after receiving the second dose, did not identify \n specific safety concerns that would preclude issuance of an EUA. Review of additional safety \n data from these participants with a median of 9 weeks of follow-up after receipt of the second \n dose did not change FDA’s assessment of safety of the vaccine.","bbox":{"left":0.117647,"top":0.161271,"width":0.74,"height":0.086476}},{"text":"FDA’s analysis of the efficacy data from 28,207 participants 18 years of age and older without \n evidence of SARS-CoV-2 infection prior to dose 1 confirms the vaccine was 94.1% effective \n (95% confidence interval (CI) 89.3, 96.8) in preventing COVID-19 occurring at least 14 days \n after the second dose (with 11 COVID-19 cases in the vaccine group compared to 185 COVID- \n 19 cases in the placebo group). In this final scheduled analysis participants had been followed for \n a median of 9 weeks following the second dose. This result is consistent with that obtained from \n an interim analysis of efficacy conducted after these participants had been followed for a median \n of 7 weeks after the second dose (vaccine efficacy 94.5%, 95% CI: 86.5, 97.8).","bbox":{"left":0.117647,"top":0.265816,"width":0.76349,"height":0.138749}},{"text":"Based on the safety and effectiveness data, and review of manufacturing information regarding \n product quality and consistency, it is reasonable to believe that Moderna COVID‑19 Vaccine \n may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific \n evidence available, that the known and potential benefits of Moderna COVID‑19 Vaccine \n outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in \n individuals 18 years of age and older. Finally, on December 17, 2020, the Vaccines and Related \n Biological Products Advisory Committee voted in agreement with this conclusion.","bbox":{"left":0.117647,"top":0.422634,"width":0.7580100000000001,"height":0.121249}},{"text":"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the \n Act are met, I am authorizing the emergency use of Moderna COVID-19 Vaccine for the \n prevention of COVID-19, as described in the Scope of Authorization section of this letter \n (Section II) and subject to the terms of this authorization.","bbox":{"left":0.117647,"top":0.561953,"width":0.7480170000000002,"height":0.06905099999999997}},{"text":"I.","bbox":{"left":0.117647,"top":0.649074,"width":0.012549000000000005,"height":0.01677899999999999}},{"text":"Criteria for Issuance of Authorization","bbox":{"left":0.17647,"top":0.649074,"width":0.318059,"height":0.01677899999999999}},{"text":"I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of \n COVID-19 when administered as described in the Scope of Authorization (Section II) meets the \n criteria for issuance of an authorization under Section 564(c) of the Act, because:","bbox":{"left":0.117647,"top":0.683922,"width":0.7541930000000001,"height":0.05162800000000001}},{"text":"1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including \n severe respiratory illness, to humans infected by this virus;","bbox":{"left":0.169118,"top":0.753619,"width":0.680686,"height":0.0342039999999999}},{"text":"2.","bbox":{"left":0.169118,"top":0.805892,"width":0.014705999999999997,"height":0.01677899999999999}},{"text":"Based on the totality of scientific evidence available to FDA, it is reasonable to believe \n that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19, and that, \n when used under the conditions described in this authorization, the known and \n potential benefits of Moderna COVID‑19 Vaccine when used to prevent COVID-19 \n outweigh its known and potential risks; and","bbox":{"left":0.193627,"top":0.805892,"width":0.683305,"height":0.08647599999999989}}],"images_bbox":[],"images_bbox_not_text_overlap":[]}