WebEuropean Medicines Agency WebJan 1, 2024 · Thaw between 2°C to 8°C (36°F to 46°F) for 3 hours. Let each vial stand at room temperature for 15 minutes before administering. Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 1 hour and 30 minutes. 3 DOSAGE FORMS AND STRENGTHS. SPIKEVAX is a suspension for injection. A single dose is 0.5 mL.
Overview of BLA for Use of Moderna’s COVID-19 - Centers for …
WebFeb 17, 2024 · FDA has determined that SPIKEVAX (COVID-19 Vaccine, mRNA), meets the criteria for a material threat MCM priority review voucher. SPIKEVAX is indicated for active immunization to prevent coronavirus disease 2024 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age … WebVaccin SPIKEVAX (Moderna) : La stabilité physicochimique en cours d’utilisation a été démontrée pendant 19 heures entre +2° et +25 °C après première utilisation. D’un point de vue microbiologique, le produit doit être utilisé le plus rapidement possible. Les durées et conditions de conservation du vaccin blob field arcgis
Overview of BLA for Use of Moderna’s COVID-19 - CDC
WebFeb 4, 2024 · Primary series administration of SPIKEVAX to individuals ≥18 years of age Median months of follow-up: • Blinded phase - 5.3 months • Blinded + open label phases - 7.6 months BLA does not include: • Indication for use of 100 µg 3 rd dose in immunocompromised (EUA approved Aug 13, 2024) WebJan 11, 2024 · Health Canada has authorized a shelf-life extension, from 7 months to 9 months, for SPIKEVAX / COVID-19 Vaccine Moderna 5 mL vials. This 2-month extension may be retroactively applied to vials that are currently on the market with printed expiry dates between February 2024 and August 2024 (see Products affected section), as long … WebSPIKEVAX is a suspension for injection. A single dose is 0.5 mL. 4 CONTRAINDICATIONS Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX [see Description (11)]. 5 WARNINGS AND PRECAUTIONS 5.1 Management of Acute Allergic Reactions free baby samples for doctors offices