COVID-19 Vaccine, mRNA

(Comirnaty (Pfizer-BioNTech COVID-19 Vaccine)®)

Comirnaty (Pfizer-BioNTech COVID-19 Vaccine)®

Drug updated on 6/25/2024

Dosage FormInjection (intramuscular; 0.3mL)
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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  • The COVID-19 Vaccine, mRNA (Comirnaty - Pfizer-BioNTech COVID-19 Vaccine) 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 years and older.
  • A total of 82 systematic reviews/meta-analyses were reviewed to gather information about the safety, effectiveness, and subgroup considerations regarding the Comirnaty vaccine.
  • The Comirnaty vaccine has shown a higher incidence of local and systemic reactions compared to other vaccines, like inactivated or protein subunit vaccines. However, serious adverse events were extremely rare across all types.
  • Concerns specific to the Comirnaty vaccine include myocarditis among young males after the second dose. Despite these reports, most cases had a mild clinical course, with symptom resolution achieved quickly.
  • Lymphadenopathy post-vaccination has been observed, particularly on the same side as the injection site, which can help avoid unnecessary interventions in oncology settings if recognized early enough.
  • The effectiveness of the Comirnaty vaccine varies by dose but significantly enhances protection following two doses against symptomatic COVID–19 infection, along with hospitalization and death due to it.
  • The Comirnaty vaccine's efficacy remains substantial even against variants such as Delta, especially after completion of the two-dose regimen.
  • Pregnant women vaccinated with mRNA vaccines, including Comirnaty, displayed no clear harm from vaccination, suggesting protective benefits for both mother and fetus through strong maternal-fetal antibody responses elicited by vaccination.
  • In cancer patients receiving immune checkpoint inhibitors (ICIs), there was no increase in the incidence of immune-related adverse events (irAEs). This suggests that mRNA vaccinations are safe for individuals undergoing cancer immunotherapy.
  • Vaccine demonstrated notable effectiveness amongst adolescents and children, preventing them from getting infected while maintaining a reasonable safety profile; mild to moderate side effects are common, but serious ones are infrequent. Immunocompromised individuals showed variably reduced antibody responses to vaccination, highlighting the need for tailored vaccination and booster strategies.

Product Monograph / Prescribing Information

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy and safety of COVID-19 vaccines in phase III trials: a network meta-analysis.2024BMC Infectious Diseases
Comparing reactogenicity of COVID-19 vaccine boosters: a systematic review and meta-analysis.2024Expert Review of Vaccines
Serological response and immune-related adverse events following COVID-19 vaccination in cancer patients treated with immune checkpoint inhibitors: a systematic review and meta-analysis.2024Reviews in Medical Virology
Evaluation of vaccine effectiveness of mRNA COVID-19 vaccines in children: a systematic review and meta-analysis.2024European Review for Medical and Pharmacological Sciences
Evidence synthesis and pooled analysis of vaccine effectiveness for COVID-19 mRNA vaccine BNT162b2 as a heterologous booster after inactivated SARS-CoV-2 virus vaccine.2023Human Vaccines & Immunotherapeutics
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
Comparative effectiveness of mRNA-1273 and BNT162b2 COVID-19 vaccines in immunocompromised individuals: a systematic review and meta-analysis using the GRADE framework.2023Frontiers in Immunology
Herpesviruses reactivation following COVID-19 vaccination: a systematic review and meta-analysis.2023European Journal of Medical Research
Antibody response against severe acute respiratory syndrome coronavirus 2 messenger ribonucleic acid vaccines in infected individuals: a systematic review.2023The Malaysian Journal of Medical Sciences: MJMS
Immune response to anti-SARS-CoV-2 prime-vaccination in patients with cancer: a systematic review and meta-analysis.2023Journal of Cancer Research and Clinical Oncology
Incidence of myopericarditis after mRNA COVID-19 vaccination: a meta-analysis with focus on adolescents aged 12-17 years.2023Vaccine
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
Idiopathic inflammatory myopathies linked to vaccination against SARS-CoV-2: a systematic review.2023Reumatismo
Safety and immunogenicity of heterologous ChAdOx1-nCoV19 and BNT162b2 vaccination: a meta-analysis of the heterologous COVID-19 vaccination outcomes.2023Vaccine
Long-term effectiveness of COVID-19 vaccines against infections, hospitalisations, and mortality in adults: findings from a rapid living systematic evidence synthesis and meta-analysis up to December, 2022.2023The Lancet. Respiratory Medicine
Adverse events following COVID-19 mRNA vaccines: a systematic review of cardiovascular complication, thrombosis, and thrombocytopenia.2023Immunity, Inflammation and Disease
Effectiveness of mRNA and viral-vector vaccines in epidemic period led by different SARS-CoV-2 variants: a systematic review and meta-analysis.2023Journal of Medical Virology
New-onset inflammatory arthritis after COVID-19 vaccination: a systematic review.2023International Journal of Rheumatic Diseases
A systematic review and meta-analysis of the association between SARS-CoV-2 vaccination and myocarditis or pericarditis.2023American Journal of Preventive Medicine
Immunogenicity and reactogenicity of heterologous immunization schedules with COVID-19 vaccines: a systematic review and network meta-analysis.2023Chinese Medical Journal
Long-term persistence of IgG antibodies in recovered COVID-19 individuals at 18 months post-infection and the impact of two-dose BNT162b2 (Pfizer-BioNTech) mRNA vaccination on the antibody response: analysis using fixed-effects linear regression model.2023Virology
Humoral response after a fourth dose of SARS-CoV-2 vaccine in immunocompromised patients. Results of a systematic review.2023Frontiers in Public Health
COVID-19 vaccine induced myocarditis in young males: a systematic review.2023European Journal of Clinical Investigation
Vaccine efficacy against SARS-CoV-2 for Pfizer BioNTech, Moderna, and AstraZeneca vaccines: a systematic review.2023Frontiers in Public Health
Herpesviruses reactivation following COVID-19 vaccination: a systematic review and meta-analysis.2023European Journal of Medical Research
Effectiveness of COVID-19 Pfizer-BioNTech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: a systematic review and meta-analysis.2023Human Vaccines & Immunotherapeutics
Effectiveness of COVID-19 Pfizer-BioNTech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: a systematic review and meta-analysis.2023Human Vaccines & Immunotherapeutics
Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression.2022The Lancet
Vaccine-induced subacute thyroiditis (De Quervain’s) after mRNA vaccine against SARS-CoV-2: a case report and systematic review.2022Infectious Disease Reports
Lymphadenopathy post-COVID-19 vaccination with increased FDG uptake may be falsely attributed to oncological disorders: a systematic review.2022Journal of Medical Virology
Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: a systematic review and meta-analysis.2022Human Vaccines & Immunotherapeutics
Inflammatory myopathy following coronavirus disease 2019 vaccination: a systematic review.2022Frontiers in Public Health
The impact of COVID-19 vaccines on fertility-A systematic review and meta-analysis.2022Vaccine
A systematic review and meta-analysis of immune response against first and second doses of SARS-CoV-2 vaccines in adult patients with hematological malignancies.2022International Immunopharmacology
Immune-mediated liver injury following COVID-19 vaccination: A: a systematic review.2022Hepatology Communications
The effectiveness of COVID-19 vaccines in reducing the incidence, hospitalization, and mortality from COVID-19: a systematic review and meta-analysis.2022Frontiers in Public Health
Myocarditis or Pericarditis Following the COVID-19 Vaccination in Adolescents: a Systematic Review.2022Vaccines
Immunologic response, efficacy, and safety of vaccines against COVID-19 Infection in healthy and immunosuppressed children and adolescents aged 2 - 21 years old: a systematic review and meta-analysis.2022Journal of Clinical Virology : The Official Publication of The Pan American Society for Clinical Virology
Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review.2022BMJ (Clinical Research ed.)
Allergic reactions to COVID-19 vaccines: Risk factors, frequency, mechanisms and management.2022BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Efficacy of COVID-19 vaccines by race and ethnicity.2022Public Health
Characterization of the significant decline in humoral immune response six months post-SARS-CoV-2 mRNA vaccination: a systematic review.2022Journal of Medical Virology
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
Myocarditis following covid-19 vaccination: a systematic Review (October 2020-October 2021)2022Heart, Lung & Circulation
Safety and adverse events related to COVID-19 MRNA vaccines; A systematic review.2022Archives of Academic Emergency Medicine
Myocarditis after RNA-based vaccines for coronavirus.2022International Journal of Cardiology
Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis.2022The Journal of Headache and Pain
Myocarditis following mRNA Covid-19 vaccination: a pooled analysis.2022Vaccine
Meta-analysis of risk of myocarditis after messenger RNA COVID-19 vaccine.2022The American Journal of Cardiology
Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression.2022Lancet (London, England)
Vaccine-induced subacute thyroiditis (de quervain's) after mrna vaccine against SARS-CoV-2: a case report and systematic review.2022Infectious Disease Reports
The effectiveness of BNT162b2 mRNA vaccine against COVID-19 caused by Delta variant of SARS-CoV-2: a systematic review and meta-analysis.2022Inflammopharmacology
COVID-19 Vaccine-related thrombosis: a systematic review and exploratory analysis.2022Frontiers in Immunology
Real-world effectiveness of BNT162b2 mRNA vaccine: a meta-analysis of large observational studies.2022Inflammopharmacology
Effectiveness of Pfizer-BioNTech COVID-19 vaccine as evidence for policy action: a rapid systematic review and meta-analysis of non-randomized studies.2022PloS One
Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression.2022The Lancet
Vaccine-induced subacute thyroiditis (De Quervain’s) after mRNA vaccine against SARS-CoV-2: a case report and systematic review.2022Infectious Disease Reports
Lymphadenopathy post-COVID-19 vaccination with increased FDG uptake may be falsely attributed to oncological disorders: a systematic review.2022Journal of Medical Virology
Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression.2022The Lancet
Vaccine-induced subacute thyroiditis (De Quervain’s) after mRNA vaccine against SARS-CoV-2: a case report and systematic review.2022Infectious Disease Reports
Lymphadenopathy post-COVID-19 vaccination with increased FDG uptake may be falsely attributed to oncological disorders: a systematic review.2022Journal of Medical Virology
Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression.2022The Lancet
Vaccine-induced subacute thyroiditis (De Quervain’s) after mRNA vaccine against SARS-CoV-2: a case report and systematic review.2022Infectious Disease Reports
Lymphadenopathy post-COVID-19 vaccination with increased FDG uptake may be falsely attributed to oncological disorders: a systematic review.2022Journal of Medical Virology
A systematic review of effectiveness of BNT162b2 mRNA and ChAdOx1 adenoviral vector COVID-19 vaccines in the general population.2021Bulletin of the National Research Centre
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
Effectiveness of COVID-19 vaccines against delta (B.1.617.2) variant: a systematic review and meta-analysis of clinical studies.2021Vaccines
mRNA Covid-19 vaccines in pregnancy: a systematic review.2021PLoS One
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
Effectiveness of COVID-19 vaccines against delta (B.1.617.2) variant: a systematic review and meta-analysis of clinical studies.2021Vaccines
mRNA Covid-19 vaccines in pregnancy: a systematic review.2021PLoS One
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
Effectiveness of COVID-19 vaccines against delta (B.1.617.2) variant: a systematic review and meta-analysis of clinical studies.2021Vaccines
mRNA Covid-19 vaccines in pregnancy: a systematic review.2021PLoS One
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
Effectiveness of COVID-19 vaccines against delta (B.1.617.2) variant: a systematic review and meta-analysis of clinical studies.2021Vaccines
mRNA Covid-19 vaccines in pregnancy: a systematic review.2021PLoS One

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