Drug updated on 3/28/2024
| Dosage Form | Injection (intramuscular; 0.3mL) |
| Drug Class | Vaccines |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
Summary
- COVID-19 Vaccine, mRNA (Comirnaty) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 16 years and older.
- The vaccine has shown high efficacy rates against SARS-CoV-2 infection with a median vaccine efficacy of 64.5% after one dose and an increased rate of up to 89% after two doses, according to the systematic review data.
- In comparison with other vaccines such as AstraZeneca and Moderna, Comirnaty showed higher median vaccine efficacies for asymptomatic, symptomatic, and severe infections against unidentified variants at respective rates of 85.5%, 93.2%, and 92 .2% respectively post second dose administration.
- Eight Systematic Reviews / Meta-Analyses were reviewed which reported on various aspects including safety profile comparisons across different platforms like RNA vaccines versus non-replicating vector vaccines where the former had significantly lower local reactions but higher systemic reactions than latter ones.
- Some adverse events have been noted post-vaccination including lymphadenopathy that mimics metastases in oncologic patients; however these are benign reactive lymphadenopathies secondary to vaccination rather than malignancies requiring unnecessary biopsies or interventions if properly identified by radiologists or oncologists.
- The effectiveness of this drug was found not only consistent among all age groups but also remained relatively stable over time even though there was some decrease observed approximately six months following full vaccination especially against infection and symptomatic diseases while remaining high against severe diseases.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Comirnaty (For dilution) (COVID-19 Vaccine, mRNA) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
| Comirnaty (Not for dilution) (COVID-19 Vaccine, mRNA) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |