Indications for: COMIRNATY
Active immunization to prevent COVID-19 in individuals ≥12yrs of age.
Efficacy in Participants 16 Years of Age and Older
The ongoing, multicenter, multinational, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate–selection, and efficacy study (Study 2) evaluated Comirnaty in approximately 44,000 participants 12 years of age and older.
Patients were stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older. The study excluded patients who were immunocompromised and those who had previous diagnosis of COVID-19. The study included patients with preexisting stable disease. Patients were randomly assigned to receive 2 doses of Comirnaty or placebo.
Efficacy Against COVID-19
36,621 participants 12 years of age and older who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose were evaluable for analysis.
Vaccine efficacy against confirmed COVID-19 occurring at least 7 days after the second dose was 95.0% (95% credible interval: 90.3, 97.6), which met the pre-specified success criterion.
Efficacy Against Severe COVID-19
Vaccine efficacy against first severe COVID-19 occurrence was 95.3% (95% CI, 70.9, 99.9).
Vaccine efficacy against first severe COVID-19 occurrence based on CDC definition was 100% (95% CI, 87.6, 100.0).
Efficacy in Adolescents 12 Through 15 Years of Age
Among 2260 adolescents 12 to 15 years of age, Study 2 evaluated the efficacy of Comirnaty against confirmed COVID-19 cases up to a data cutoff date of September 2, 2021.
Vaccine efficacy against first COVID-19 occurrence from 7 days after dose 2 without evidence of prior SARS-CoV-2 infection was 100% (95% CI, 86.6, 100.0).
Immunogenicity in Adolescents 12 Through 15 Years of Age
Study 2 evaluated SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants which demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2.
Adults and Children:
<12yrs: not established. Give by IM inj only. ≥12yrs: 0.3mL given as a 2-dose series 3 weeks apart.
Have epinephrine inj available. Increased risks of myocarditis and pericarditis (esp. within 7 days after the second dose); higher risk among males <40yrs of age, and highest among males 12–17yrs of age. Syncope. Immunocompromised. Pregnancy. Nursing mothers.
Immunosuppressants: may get suboptimal response.
Inj site reactions (eg, pain, swelling, redness), fatigue, headache, muscle pain, chills, joint pain, fever.
Generic Drug Availability:
Multiple-dose vials—25, 195 (w. diluent; shipped separately)