Drug updated on 4/18/2024
| 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.
Summary
- COVID-19 Vaccine, mRNA (Spikevax) 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 12 and older.
- A total of 28 systematic reviews/meta-analyses provided insights into the safety and efficacy of Spikevax compared to other vaccines such as Pfizer-BioNTech's BNT162b2 and AstraZeneca's vaccine.
- Studies showed that Spikevax demonstrated high efficacy rates against unidentified SARS-CoV variants, including Beta and Gamma. Its effectiveness after two doses was found superior or comparable to those of AstraZeneca’s vaccine and Pfizer’s BNT162b2 across different variants respectively.
- Spikevax showed moderate effectiveness against Omicron infections in children aged between 5–11 years, indicating its potential use within this age group. In solid organ transplant recipients, higher seroconversion rates were observed with Spikevax than with Pfizer-BioNTech's BNT162b2.
- Rare cardiovascular complications have been reported post-vaccination with Spikevax; however, it has fewer associated events than the Pfizer-BioNTech vaccine. Rates of myocarditis and pericarditis were found higher particularly following the second dose, while localized swelling at dermal filler injection sites was a specific concern noted post-vaccination with this vaccine.
- The incidence rate for both anaphylactic and nonanaphylactic reactions post-COVID vaccination using Spikevax was low, but nonanaphylactic reactions occurred more frequently due to triggers like history of atopy or comorbidities such as asthma or allergic conditions.
- In a network meta-analysis study, among available vaccines studied, mRNA-based vaccines like Spikevax should be considered highly effective as it demonstrated the highest P-score and efficacy, closely followed by Pfizer-BioNTech and Gam-COVID-Vac vaccines.
- Subgroup considerations revealed that children aged 5–11 years showed a good safety profile with mRNA vaccines like Spikevax. Solid organ transplant recipients had better responses with this vaccine compared to Pfizer-BioNTech's BNT162b2. The study also indicated that pregnant women and their fetuses could safely receive mRNA-based vaccines for robust maternal and fetal antibody responses.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Spikevax (COVID-19 Vaccine, mRNA) prescribing information. | 2023 | Moderna US, Inc., Cambridge, MA |