COVID-19 mRNA Vaccine (Pfizer-Biontech)

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 0.3 mL IM as a single dose each year If previously vaccinated with any earlier COVID-19 vaccine formulation, administer at least 2 months after last vaccine dose

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 Use vial with yellow cap and label (must dilute) Not previously vaccinated with a COVID-19 vaccine 3 dose primary series: 0.3 mL IM each Dose 1: Week 0 Dose 2: Week 3 Dose 3: >8 weeks after dose 2 Previously vaccinated with 1 dose of Pfizer COVID-19 mRNA vaccine 2 doses: 0.3 mL IM each Dose 1: 3 weeks after previous dose of Pfizer COVID-19 vaccine Dose 2: >8 weeks after dose 1 Previously vaccinated with 2-4 doses of Pfizer COVID-19 mRNA vaccine Single dose: 0.3 mL IM >8 weeks after last previous COVID-19 vaccine dose 5-11 years Use vial with blue cap and label (do not dilute) Single dose: 0.3 mL IM Administer >2 months after receipt of last previous COVID-19 vaccine 12-17 years 0.3 mL IM as a single dose each year If previously vaccinated with any earlier COVID-19 vaccine formulation, administer at least 2 months after last vaccine dose

CDC recommendations of 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 the vaccine.

Appropriate treatment used to manage immediate allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response May not protect all vaccine recipients Myocarditis and pericarditis May increase risks of myocarditis and pericarditis, particularly within 7 days following the second dose. Risk is higher among adolescent and adult males aged <40 years than among females and older males, and the observed risk is highest among males aged 12-17 years 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 CDC guidelines for vaccination of pregnant or lactating females 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

>10% Aged 12-15 years Dose 1 Pain at injection site, moderate (43.7%) Pain at injection site, mild (41.4%) Fatigue, moderate (34.1%) Headache, mild (32%) Fatigue, mild (24.7%) Headache, moderate (22.3%) Muscle pain, moderate (18%) Muscle pain, mild (13.9%) Chills, mild (17.3%) Fever >38C (10.1%) Dose 2 Pain at injection site, mild (42.5%) Pain at injection site, moderate (35.8%) Fatigue, moderate (42.7%) Headache, moderate (35%) Headache, mild (27.5%) Fatigue, mild (21.1%) Chills, mild (20.1%) Chills, moderate (19.5%) Fever >38C (19.6%) Muscle pain, moderate (12.9%) Muscle pain, mild (11.1%) Aged 18-55 years Dose 1 Pain at injection site, mild (51.1%) Pain at injection site, moderate (31%) Headache, mild (27.4%) Fatigue, moderate (26.1%) Fatigue, mild (19.9%) Headache, moderate (13.4%) Muscle pain, mild (11.2%) Dose 2 Pain at injection site, mild (49.5%) Fatigue, moderate (33.7%) Pain at injection site, moderate (27.1%) Headache, mild (25.6%) Headache, moderate (22.9%) Fatigue, mild (21.1%) Chills, mild (17.1%) Chills, moderate (15.9%) Fever >38ºC (15.8%) Muscle pain, mild (15.5%) Joint pain, moderate (11.2%) Aged >56 years Dose 1 Pain at injection site, mild (55.9%) Fatigue, mild (20.7%) Headache, mild (19.3%) Pain at injection site, moderate (15%) Fatigue, moderate (13.3%) Dose 2 Pain at injection site, mild (47%) Fatigue, moderate (26.6%) Headache, mild (25.4%) Fatigue, mild (21.1%) Pain at injection site, moderate (18%) Muscle pain, moderate (15.6%) Headache, moderate (13%) Muscle pain, mild (12.2%) Chills, mild (12%) Fever >38ºC (10.9%)

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