COVID-19 mRNA Vaccine (Moderna)

COVID-19 disease prevention

Injection COVID-19 Disease Prevention Indicated for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged ?12 years Spikevax 0.5 mL IM as a single dose each year If previously vaccinated with any earlier COVID-19 vaccine formulation, administer at least 2 months after the last vaccine dose mNexspike 0.2 mL IM >3 months after the last dose of the COVID-19 vaccine Approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and are >65 years 12-64 years with >1 underlying condition that puts them at high risk for severe outcomes from COVID-19 CDC recommendations for additional doses for certain individuals People aged >65 years or those who are moderately or severely immunocompromised may receive a second dose 6 months after their first dose each year This also allows for flexibility for additional doses (ie, >3) for those who are moderately or severely immunocompromised

COVID-19 Disease Prevention September 2023: EUA issued for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 6 months through 11 years <6 months Safety and efficacy not established 6 months through 4 years Not previously vaccinated with a COVID-19 vaccine 2 doses primary series: 0.25 mL IM x 2 doses 1 month apart Individuals turning from 4 years to 5 years of age during the vaccination series should receive both doses with Moderna COVID-19 vaccine (2023-2024 formula) Previously vaccinated with 1 dose of Moderna COVID-19 mRNA vaccine Single dose: 0.25 mL IM 1 month after previous dose of Moderna COVID-19 vaccine Previously vaccinated with ?2 dose of Moderna COVID-19 mRNA vaccine Single dose: 0.25 mL IM 2 months after previous dose of Moderna COVID-19 vaccine 5-11 years Single dose: 0.25 mL IM Administer >2 months after receipt of last previous COVID-19 vaccine 12-17 years Spikevax 0.5 mL IM as a single dose each year If previously vaccinated with any earlier COVID-19 vaccine formulation, administer at least 2 months after the last vaccine dose mNexspike 0.2 mL IM >3 months after the last dose of the COVID-19 vaccine Approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and are 12-64 years with >1 underlying condition that puts them at high risk for severe outcomes from COVID-19 CDC recommendations for additional doses for certain individuals

>65 years 12-64 years with >1 underlying condition that puts them at high risk for severe outcomes from COVID-19 CDC recommendations for additional doses for certain individuals People aged >65 years or those who are moderately or severely immunocompromised may receive a second dose 6 months after their first dose each year This also allows for flexibility for additional doses (ie, >3) for those who are moderately or severely immunocompromised

IM Administration For IM injection only

Known history of a severe allergic reaction (eg, anaphylaxis) to any component in vaccine.

Appropriate treatment used to manage immediate allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to vaccine Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting Vaccine may not protect all vaccine recipients Myocarditis and pericarditis Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose Risk is higher among adolescent and adult males aged <40 yr than among females and older males; risk is highest among males aged 18-24 yr Based health insurance claims from inpatient and outpatient settings, estimated unadjusted incidence of myocarditis and/or pericarditis within 7 days following administration of 2023-2024 mRNA COVID-19 vaccine formulation was ~8 cases/million doses in patients aged 6 months through 64 years and ~27 cases/million doses in males aged 12-24 years Some cases required intensive care support, although available data from short-term follow-up suggest most individuals had symptom resolution with conservative management

Not Classi Pregnancy A growing body of evidence on the safety and effectiveness of COVID-19 vaccination indicates that the benefits of vaccination outweigh any known or potential risks of COVID-19 vaccination during pregnancy Recent studies have also shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination of people who are pregnant reduces the risk of COVID-19 hospitalization in infants younger than 6 months Animal data Vaccine administered IM to female rats 28 and 14 days prior to mating, and on gestation days 1 and 13 No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported Clinical considerations Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with nonpregnant individuals Lactation Unknown whether vaccine is excreted in human milk Data are unavailable to assess the effects on breastfed infants or milk production/excretion For preventive vaccines, underlying maternal condition is susceptibility to disease prevented by the vaccine

Data are not available to assess concomitant administration with other vaccines

>10% Aged 18-64 years Injection site pain (93.3%) Fatigue (71.9%) Headache (68.7%) Myalgia (64.8%) Arthralgia (48.6%) Nausea/vomiting (25.7%) Axillary swelling/tenderness (22.2%) Fever (17.3%) Injection site swelling (15.4%) Injection site erythema (10.5%) Aged >65 years Injection site pain (88.3%) Fatigue (64.8%) Headache (53.3%) Myalgia (51.8%) Arthralgia (40.2%) Chills (32.7%) Nausea/vomiting (15%) Injection site swelling (13%) Axillary Swelling/tenderness (12.7%) Dose 2 Injection site pain (89.9%) Fatigue (67.6%) Headache (62.8%) Myalgia (61.6%) Chills (48.6%) Arthralgia (45.5%) Nausea/vomiting (21.4%) Fever (17.4%) Axillary swelling/tenderness (16.2%) Injection site swelling ≥25mm (12.6%) Myalgia, grade 3 (10.1%) Fatigue, grade 3 (10.7%) Aged >65 years Dose 1 Injection site pain (74%) Fatigue (33.3%) Headache (24.5%) Myalgia (19.7%) Arthralgia (16.4%) Dose 2 Injection site pain (83.2%) Fatigue (58.3%) Myalgia (47.1%) Headache (46.2%) Arthralgia (35%) Chills (30.9%) Nausea/vomiting (11.8%) Injection site swelling >25mm (10.8%)

Nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; formulated in lipid particles, which enable delivery of RNA into host cells to allow expression of the SARS-CoV-2 S antigen Elicits an immune response to the S antigen, which protects against COVID-19