Drug updated on 9/5/2024
Dosage Form | Injection (intramuscular; 0.5mL) |
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 12 years of age and older.
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Summary
- Spikevax (COVID-19 vaccine, mRNA) 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 12 years of age and older.
- This summary is based on the review of 28 systematic review(s)/meta-analysis(es). [1-29]
- The Moderna COVID-19 vaccine demonstrated 74% effectiveness (95% CI: 0.65, 0.83) after the first dose and 93% effectiveness (95% CI: 0.89, 0.97) after the second dose in preventing COVID-19 infections. 4. mRNA vaccines (Pfizer and Moderna) showed vaccine efficacy (VE) ranging from 64.5% after one dose to 89% after two doses against PCR-positive infections, with median VE for two doses at 93.2% for symptomatic infection and 92.2% for severe infection.
- Moderna vaccine exhibited higher effectiveness compared to AstraZeneca, Pfizer, and Bharat vaccines, with second-dose efficacy for Pfizer at 93% (95% CI: 0.85, 1.00), AstraZeneca at 67% (95% CI: 0.54, 0.80), and Bharat at 71% (95% CI: 0.61, 0.82).
- High effectiveness against variants was observed for Moderna, including 96% effectiveness (95% CI: 0.96, 0.96) against the Beta variant and 91% effectiveness (95% CI: 84%-95%) against the Delta variant after the second dose.
- The Moderna COVID-19 vaccine was commonly associated with side effects such as fatigue, pain, fever, and, in rare instances, hearing loss. Severe adverse events primarily involved cardiac complications, including myocarditis and pericarditis, with an incidence of serious adverse events similar between treatment and placebo groups (RR: 0.92, 95% CI: 0.78 to 1.08).
- The risk of myocarditis or pericarditis was significantly higher after the second dose of mRNA vaccines, with Moderna (mRNA-1273) showing an increased relative risk (RR: 4.15, 95% CI: 1.87, 9.22) compared to other vaccines. This risk was notably higher in males aged 12-24 years.
- The incidence of cardiac arrhythmia following Moderna vaccination was reported at 0.76% (95% CI: 0.04% to 12.08%). Additionally, while Moderna showed fewer cardiovascular events compared to Pfizer, it was associated with a higher incidence of stroke in some studies.
- For children aged 5-11 years, mRNA-1273 (Moderna) exhibited moderate effectiveness against infections and hospitalizations. Higher seroconversion rates were observed in Solid Organ Transplant (SOT) recipients vaccinated with mRNA-1273 compared to BNT162b2 (Pfizer), with a relative seroconversion rate of 0.795 (95% CI: 0.732-0.864) favoring mRNA-1273. Additionally, a higher incidence of myocarditis was noted among younger males (12-24 years) after the second dose of mRNA vaccines, while mRNA vaccines, including Moderna, showed no clear harm in pregnancy.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Spikevax (COVID-19 Vaccine, mRNA) prescribing information. | 2023 | Moderna US, Inc., Cambridge, MA |