COVID-19 Vaccine, mRNA

(Spikevax (Moderna COVID-19 Vaccine)®)

Spikevax (Moderna COVID-19 Vaccine)®

Drug updated on 4/18/2024

Dosage FormInjection (intramuscular; 0.5mL)
Drug ClassVaccines
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.

Latest News

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Summary
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  • 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 TitleYearSource
Spikevax (COVID-19 Vaccine, mRNA) prescribing information.2023Moderna US, Inc., Cambridge, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Risks of cardiac arrhythmia associated with COVID-19 vaccination: a systematic review and meta-analysis.2023Vaccines
The efficacy and effectiveness of COVID-19 vaccines around the world: a mini-review and meta-analysis.2023Annals of Clinical Microbiology and Antimicrobials
Adverse events following COVID-19 mRNA vaccines: a systematic review of cardiovascular complication, thrombosis, and thrombocytopenia.2023Immunity, Inflammation and Disease
Vaccine efficacy against SARS-CoV-2 for Pfizer BioNTech, Moderna, and AstraZeneca vaccines: a systematic review. 2023Frontiers in Public Health
Safety and effectiveness of vaccines against COVID-19 in children aged 5-11 years: a systematic review and meta-analysis. 2023The Lancet. Child & Adolescent Health
Localised swelling at sites of dermal filler injections following administration of COVID-19 vaccines: a systematic review.2023Singapore medical journal
Comparing the efficacy and adverse events of available COVID-19 vaccines through randomized controlled trials: updated systematic review and network meta-analysis.2023Journal of Research in Health Sciences
Characteristics of sudden hearing loss after different COVID-19 vaccinations: a systematic review and meta-analysis.2023European Archives of Oto-Rhino-Laryngology
Detection of sars-cov-2-specific antibodies in human breast milk and their neutralizing capacity after COVID-19 vaccination: a systematic review.2023International Journal of Molecular Sciences
A systematic review and meta-analysis of the association between sars-cov-2 vaccination and myocarditis or pericarditis.2023American Journal of Preventive Medicine
Anti-SARS-CoV-2 spike IgG following injection of the third dose vaccine: a systematic review with meta-analysis of heterologous versus homologous vaccination.2023Frontiers in Public Health
COVID arm as a common cutaneous manifestation after mRNA-1273 vaccination: a systematic review.2023BMC Infectious Diseases
Efficacy and safety of COVID-19 vaccines.2022Cochrane Database of Systematic Reviews
Lymphadenopathy post-COVID-19 vaccination with increased FDG uptake may be falsely attributed to oncological disorders: a systematic review.2022Journal of Medical Virology
COVID-19 vaccine induced myocarditis in young males: a systematic review.2022European Journal of Clinical Investigation
Safety and adverse events related to covid-19 MRNA vaccines; a systematic review.2022Archives of Academic Emergency Medicine
The effectiveness of mRNA-1273 vaccine against COVID-19 caused by Delta variant: a systematic review and meta-analysis.2022Journal of Medical Virology
Efficacy of COVID-19 vaccines: a systematic review and network meta-analysis of phase 3 randomized controlled trials.2022Pharmacological Reports
Seroconversion rate after primary vaccination with two doses of BNT162b2 versus mRNA-1273 in solid organ transplant recipients: a systematic review and meta-analysis.2022Nephrology, Dialysis, Transplantation
Thyroid inconveniences with vaccination against sars-cov-2: the size of the matter. A systematic review.2022Frontiers in Endocrinology
Global reports of myocarditis following COVID-19 vaccination: a systematic review and meta-analysis.2022Diabetes & Metabolic Syndrome
Thrombotic thrombocytopenic purpura (TTP) after COVID-19 vaccination: a systematic review of reported cases.2022Thrombosis Research
Meta-analysis of risk of myocarditis after messenger RNA COVID-19 vaccine.2022American Journal of Cardiology
Potency of BNT162b2 and mRNA-1273 vaccine-induced neutralizing antibodies against severe acute respiratory syndrome-CoV-2 variants of concern: a systematic review of in vitro studies.2022Reviews in Medical Virology
Serologic response to coronavirus disease 2019 (COVID-19) vaccination in patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis.2022Gastroenterology
mRNA Covid-19 vaccines in pregnancy: a systematic review.2021PLoS One
Effectiveness of COVID-19 vaccines against delta (B.1.617.2) variant: a systematic review and meta-analysis of clinical studies.2021Vaccines
Evaluation of the safety profile of COVID-19 vaccines: a rapid review.2021BMC Medicine
Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis.2021Allergy, Asthma & Clinical Immunology