COVID-19 Vaccine, mRNA

(Spikevax®)

Spikevax®

Drug updated on 10/24/2024

Dosage FormInjection (intramuscular; 0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 12 years of age and older.

Latest News

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Summary
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  • This summary is based on the review of 102 systematic review(s)/meta-analysis(es). 2. mRNA-1273 (Spikevax) in Immunocompromised (IC) Individuals: Reduced risk of SARS-CoV-2 infection (Risk Ratio (RR) 0.85 [95% Confidence Interval (CI): 0.75-0.97]) and severe disease (RR 0.85 [95% CI: 0.77-0.93]) compared to BNT162b2. Hospitalization risk also decreased (RR 0.88 [95% CI: 0.79-0.97]). [1-102]
  • Heterologous Booster for mRNA-1273: Showed high effectiveness against COVID-19 infection (89.19% [95% CI: 78.49-99.89]) and severe disease (69.99% [95% CI: 52.16-87.82]).
  • Seroconversion in Lung Transplant Recipients: Overall rate was 72%, with lower rates in the leukopenia group (59%) and higher rates in recipients >7 years post-transplant (83%).
  • Mortality in IC Populations: COVID-19-related mortality was significantly reduced with mRNA-1273 (RR 0.63 [95% CI: 0.44-0.90]).
  • Lung Transplant Recipients (LTR): Adverse events were reported in 18% of individuals, with the most common being pain at the injection site and fatigue. No severe adverse events were noted.
  • Patients with Plasma Cell Dyscrasia: There were no severe adverse events reported in this population, despite lower seroconversion rates linked to older age and active therapy.
  • Systemic Lupus Erythematosus (SLE) Patients: Adverse events, including lupus flares, were infrequent. Severe adverse events were rare.
  • Myocarditis and Pericarditis: These adverse events were more common in younger males, typically after the second dose of mRNA vaccines.
  • In immunocompromised populations, mRNA-1273 demonstrated improved clinical effectiveness compared to BNT162b2, while a higher incidence of adverse events was observed, particularly in those undergoing immunosuppressive treatments, with certain subgroups experiencing lower seroconversion rates (e.g., leukemia patients).
  • Lung transplant recipients showed significant variation in seroconversion rates influenced by factors such as BMI, leukopenia, post-transplant time, and type of immunosuppressants, with no major safety concerns beyond mild adverse events.

Product Monograph / Prescribing Information

Document TitleYearSource
Spikevax (COVID-19 Vaccine, mRNA) Prescribing Information.2024Moderna US, Inc., Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative effectiveness of mRNA-1273 and BNT162b2 COVID-19 vaccines in immunocompromised individuals: a systematic review and meta-analysis using the GRADE frameworkFrontiers in Immunology
Factors influencing immunogenicity and safety of SARS-CoV-2 vaccine in liver transplantation recipients: a systematic review and meta-analysisFrontiers in Immunology
COVID-19 vaccine immune response in patients with plasma cell dyscrasia: a systematic reviewTherapeutic Advances in Vaccines and Immunotherapy
Effectiveness of homologous or heterologous immunization regimens against SARS-CoV-2 after two doses of inactivated COVID-19 vaccine: A systematic review and meta-analysisHuman Vaccines & Immunotherapeutics
COVID-19 vaccination in systemic lupus erythematosus: a systematic review of its effectiveness, immunogenicity, flares and acceptanceRheumatology
COVID-19 vaccine immunogenicity among chronic liver disease patients and liver transplant recipients: A meta-analysisClinical and Molecular Hepatology
COVID-19 vaccine-associated vasculitis: A systematic reviewSAGE Open Medicine
Status epilepticus as a complication of SARS-CoV-2 vaccination: Two case reports and systematic review with individual patients' data analysisSeizure
The immunologic outcomes and adverse events of COVID-19 vaccine booster dose in immunosuppressed people: A systematic reviewPreventive Medicine Reports
Impact of COVID-19 Vaccination on In Vitro Fertilization Outcomes: A Systematic ReviewInternational Journal of Fertility & Sterility
Alopecia areata following COVID-19 vaccine: a systematic reviewEuropean Journal of Medical Research
An overview and single-arm meta-analysis of immune-mediated adverse events following COVID-19 vaccinationFrontiers in Pharmacology
Cardiac and Neurological Complications Post COVID-19 Vaccination: A Systematic Review of Case Reports and Case SeriesVaccines
Efficacy, Effectiveness, and Safety of COVID-19 Vaccine Compared to Placebo in Preventing COVID-19 Infection among 12-17 Years Old: A Systematic ReviewActa Medica Philippina
A Systematic Review of Perinuclear Antineutrophil Cytoplasmic Antibody-Associated Glomerulonephritis Following Coronavirus Disease 2019 Vaccination: A 2024 UpdateCureus
A Comparison of the Immunogenicity and Safety of an Additional Heterologous versus Homologous COVID-19 Vaccination among Non-Seroconverted Immunocompromised Patients after a Two-Dose Primary Series of mRNA Vaccination: A Systematic Review and Meta-AnalysisVaccines
New Onset and Exacerbation of Autoimmune Bullous Dermatosis Following COVID-19 Vaccination: A Systematic ReviewVaccines
Immunogenicity and Safety of the Three-Dose COVID-19 Vaccine Regimen in Patients Receiving Renal Replacement Therapy: A Systematic Review and Meta-AnalysisKidney Diseases
New-onset psychosis following COVID-19 vaccination: a systematic reviewFrontiers in Psychiatry
Rare COVID-19 vaccine side effects got lost in the shuffleFrontiers in Medicine
New-onset or flare-up of bullous pemphigoid associated with COVID-19 vaccines: a systematic review of case report and case series studiesFrontiers in Medicine
Parsonage-Turner Syndrome following COVID-19 Vaccination: A Systematic ReviewVaccines
Comparative Effectiveness of mRNA-1273 and BNT162b2 COVID-19 Vaccines Among Older Adults: Systematic Literature Review and Meta-Analysis Using the GRADE FrameworkInfectious Diseases and Therapy
Efficacy and Clinical Outcomes of mRNA COVID-19 Vaccine in Pregnancy: A Systematic Review and Meta-AnalysisIntervirology
Relative effectiveness of bivalent COVID-19 vaccine: a systematic review and meta-analysisFrontiers in Medicine
Reported effectiveness of COVID-19 monovalent booster vaccines and hybrid immunity against mild and severe Omicron disease in adults: A systematic review and meta-regression analysisVaccine
Comparing reactogenicity of COVID-19 vaccine boosters: a systematic review and meta-analysisExpert Review of Vaccines
Takotsubo syndrome and vaccines: a systematic reviewESC Heart Failure
Comparing the Efficacy and Adverse Events of Available COVID-19 Vaccines Through Randomized Controlled Trials: Updated Systematic Review and Network Meta-analysisJournal of Research in Health Sciences
Guillain-Barre syndrome and COVID-19 vaccination: a systematic review and meta-analysisJournal of Neurology
A Systematic Review of COVID-19 Vaccine-Induced Takotsubo Cardiomyopathy: A 2023 UpdateCureus
COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literatureInternational Journal of Cardiology. Heart & Vasculature
Neuromuscular diseases associated with COVID-19 vaccines: a systematic review and pooled analysis of 258 patientsBMC Neurology
Distinctions between survivors and non-survivors with SARS-CoV-2 vaccine-induced thrombotic thrombocytopenia: A systematic review and meta-analysisVaccine: X
Review of short-term and long-term adverse effects of covid-19 vaccination during pregnancyTravel Medicine and Infectious Disease
Immunogenicity and effectiveness of COVID-19 booster vaccination among people living with HIV: a systematic review and meta-analysisFrontiers in Medicine
An analysis of reported cases of hemophagocytic lymphohistiocytosis (HLH) after COVID-19 vaccinationHuman Vaccines & Immunotherapeutics
Efficacy, Immunogenicity, and Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases: A Systematic Review and Meta-AnalysisVaccines
Antibody titers of individuals vaccinated for COVID-19: A systematic reviewJournal of Biosciences
Herpesviruses reactivation following COVID-19 vaccination: a systematic review and meta-analysisEuropean Journal of Medical Research
Systematic review of the oral manifestations produced by the SARS-CoV-2 vaccineJournal of Clinical and Experimental Dentistry
Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysisBMJ Open
Efficacy and safety of mRNA and AstraZeneca COVID-19 vaccines in patients with autoimmune rheumatic diseases: A systematic reviewVaccine
ANCA Associated Glomerulonephritis Following SARS-CoV-2 Vaccination: A Case Series and Systematic ReviewVaccines
Myocarditis Following COVID-19 Vaccination: A Systematic ReviewCureus
Acquired hemophilia A (AHA) due to anti-SARS-CoV-2 vaccination: A systematic reviewEJHaem
Humoral response after a fourth dose of SARS-CoV-2 vaccine in immunocompromised patientsFrontiers in Public Health
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysisVaccine
New-Onset Arthritis Following COVID-19 Vaccination: A Systematic Review of Case ReportsVaccines
Associations of COVID-19 vaccination during pregnancy with adverse neonatal and maternal outcomes: A systematic review and meta-analysisFrontiers in Public Health
Detection of SARS-CoV-2-Specific Antibodies in Human Breast Milk and Their Neutralizing Capacity after COVID-19 Vaccination: A Systematic ReviewInternational Journal of Molecular Sciences
Anti-SARS-CoV-2 spike IgG following injection of the third dose vaccine: A systematic review with meta-analysis of heterologous versus homologous vaccinationFrontiers in Public Health
Safety, Efficacy, and Immunogenicity of Varying Types of COVID-19 Vaccines in Children Younger Than 18 Years: An Update of Systematic Review and Meta-AnalysisVaccines
Development of myocarditis and pericarditis after COVID-19 vaccination in children and adolescents: A systematic reviewClinical Cardiology
COVID-19 vaccine induced myocarditis in young males: A systematic reviewEuropean Journal of Clinical Investigation
Immune thrombocytopenic purpura secondary to COVID-19 vaccination: A systematic reviewEuropean Journal of Haematology
Immunogenicity of SARS-CoV-2 vaccines in patients with multiple myeloma: a systematic review and meta-analysisBlood Advances
CNS inflammatory demyelinating events after COVID-19 vaccines: A case series and systematic reviewFrontiers in Neurology
The effect of COVID-19 vaccines on sperm parameters: a systematic review and meta-analysisAsian Journal of Andrology
Myopericarditis After COVID-19 mRNA Vaccination Among Adolescents and Young Adults: A Systematic Review and Meta-analysisJAMA Pediatrics
Risk factors affecting COVID-19 vaccine effectiveness identified from 290 cross-country observational studies until February 2022: a meta-analysis and meta-regressionBMC Medicine
Cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysisExpert Review of Vaccines
Myocardial infarction following COVID-19 vaccine administration; a systematic reviewHeliyon
Diagnostic accuracy of vaccine and vaccine excipient testing in the setting of allergic reactions to COVID-19 vaccines: A systematic review and meta-analysisAllergy
Comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with different covid-19 vaccines: international network cohort study from five European countries and the USBMJ
Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysisBMC medicine
A Systematic Review and Meta-analysis of the Association Between SARS-CoV-2 Vaccination and Myocarditis or PericarditisAmerican Journal of Preventive Medicine
Saliva is suitable for SARS-CoV-2 antibodies detection after vaccination: A rapid systematic reviewFrontiers in Immunology
A Systematic Review of Reported Cases of Immune Thrombocytopenia after COVID-19 VaccinationVaccines
Immunogenicity of COVID-19 vaccines in patients with diabetes mellitus: A systematic review Frontiers in Immunology
New Onset and Exacerbations of Psoriasis Following COVID-19 Vaccines: A Systematic ReviewAmerican Journal of Clinical Dermatology
Vaccines and Bell's palsy: A narrative reviewTherapie
A Systematic Review and Meta-Analysis of Serologic Response following Coronavirus Disease 2019 (COVID-19) Vaccination in Solid Organ Transplant RecipientsViruses
Rare Heterogeneous Adverse Events Associated with mRNA-Based COVID-19 Vaccines: A Systematic ReviewMedicines
Global reports of takotsubo (stress) cardiomyopathy following COVID-19 vaccination: A systematic review and meta-analysisInternational Journal of Cardiology. Heart & Vasculature
Seroconversion following the first, second, and third dose of SARS-CoV-2 vaccines in immunocompromised population: a systematic review and meta-analysisVirology Journal
Humoral and cellular response of COVID-19 vaccine among solid organ transplant recipients: A systematic review and meta-analysisTransplant Infectious Disease
Thyroid Inconveniences With Vaccination Against SARS-CoV-2: The Size of the MatterFrontiers in Endocrinology
Comparing reactogenicity of COVID-19 vaccines: a systematic review and meta-analysisExpert Review of Vaccines
Watch out for neuromyelitis optica spectrum disorder onset or clinical relapse after COVID-19 vaccination: What neurologists need to know?Multiple Sclerosis and Related Disorders
Global reports of myocarditis following COVID-19 vaccination: A systematic review and meta-analysisDiabetes & metabolic Syndrome
Efficacy of COVID-19 vaccines by race and ethnicityPublic Health
Myocarditis after COVID-19 mRNA vaccination: A systematic review of case reports and case seriesClinical Cardiology
Effectiveness of heterologous and homologous covid-19 vaccine regimens: living systematic review with network meta-analysisBMJ
Immunogenicity and Safety of Homologous and Heterologous Prime-Boost Immunization with COVID-19 Vaccine: Systematic Review and Meta-AnalysisVaccines
Thrombotic thrombocytopenic purpura (TTP) after COVID-19 vaccination: A systematic review of reported casesThrombosis Research
Immunogenicity and Safety of the COVID-19 Vaccines Compared With Control in Healthy Adults: A Qualitative and Systematic ReviewValue in Health
Safety, Immunogenicity, and Efficacy of COVID-19 Vaccines in Adolescents, Children, and Infants: A Systematic Review and Meta-AnalysisFrontiers in Public Health
The Effects of COVID-19 Vaccination on Lactating Women: A Systematic Review of the LiteratureFrontiers in Immunology
Immunogenicity and Safety of COVID-19 Vaccines in Patients Receiving Renal Replacement Therapy: A Systematic Review and Meta-AnalysisFrontiers in Medicine
Myocarditis Following COVID-19 Vaccination: A Systematic Review (October 2020-October 2021)Heart, Lung & Circulation
Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regressionLancet
Effectiveness and Durability of COVID-19 Vaccination in 9447 Patients With IBD: A Systematic Review and Meta-AnalysisClinical Gastroenterology and Hepatology
Myocarditis following mRNA Covid-19 vaccination: A pooled analysis Vaccine
A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and IssuesVaccines
COVID-19 Vaccine-Related Thrombosis: A Systematic Review and Exploratory AnalysisFrontiers in Immunology
Clinical characteristics and prognostic factors of myocarditis associated with the mRNA COVID-19 vaccineJournal of Medical Virology
Comparing the clinical efficacy of COVID-19 vaccines: a systematic review and network meta-analysisScientific Reports
Can SARS-CoV-2 vaccine increase the risk of reactivation of Varicella zoster? A systematic reviewJournal of Cosmetic Dermatology
COVID-19 Vaccine-Associated Thrombosis With Thrombocytopenia Syndrome (TTS): A Systematic Review and Post Hoc AnalysisClinical and Applied Thrombosis/Hemostasis
Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trialsInfectious Diseases of Poverty
Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical TrialsVaccines