Overview

• Approval covers adults 65 and older plus individuals aged 12 to 64 with at least one underlying risk factor who have received prior COVID-19 vaccination.
• Phase 3 data showed 9.3% higher relative efficacy in participants 12 and older and 13.5% higher efficacy in adults 65 and older compared with Moderna’s original vaccine.
• mNEXSPIKE uses one-fifth of the dose of Spikevax and demonstrated comparable systemic safety with fewer local reactions in clinical trials.
• The limited authorization follows a similar FDA approval of Novavax’s vaccine under a policy shift to focus booster recommendations on vulnerable groups.
• Despite Health Secretary Robert F. Kennedy Jr.’s efforts to narrow immunization guidelines, the CDC has kept COVID-19 vaccines on the schedule for healthy children aged six months and older.