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U.S. FDA staff raises no new concerns with Moderna's coronavirus vaccine

Published: 12/15/2020 13:56 GMT
Moderna Inc (MRNA) - U.S. FDA Staff Publishes Briefing Documents on Moderna Covid-19 Vaccine Ahead of Advisory Committee Meeting on Thursday.
U.S. FDA Docs Says Safety Data Supported a Favorable Safety Profile, With No Specific Safety Concerns Identified That Would Preclude Issuance of Eua.
U.S. FDA Docs Says Meeting Being Convened to Provide Recommendations on Whether Benefits of Moderna Covid-19 Vaccine Outweigh Risks for Use in Individuals 18 Years of Age and Older.
U.S. FDA Docs Says Proposed Use of Moderna Vaccine Under an Eua is for Prevention of Covid-19 in Adults 18 Years of Age and Older.
FDA Reviewed Chemistry Manufacturing & Control Data Submitted for Moderna's Vaccine & Determined That Information is Consistent With Eua Recommendations.
U.S. FDA Docs Says 2-dose Moderna Vaccination Regimen Was Highly Effective in Preventing Covid-19 Occurring at Least 14 Days After Receipt of Second Dose.
FDA Asks for Post Authorization Safety and Effectiveness Studies on Moderna Vaccines As Well As Immune Markers of Protection - FDA Docs.
U.S. FDA Docs Says Moderna Reported Bell's Palsy in 3 Vaccine Recipients and 1 Placebo Recipient, 3 of Which Resolved Themselves.
Safety Profile of Mrna-1273 Was Generally Similar Across Age Groups, Genders, Ethnic & Racial Groups, Participants With/without Comorbidities - FDA Docs.
Vaccine Efficacy in Participants After One Dose of Moderna's Vaccine Was 80.2% at Time of Interim Analysis - FDA Docs.