{"id":"comirnaty-intramuscular-injection","safety":{"drugInteractions":[{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the effect of COMIRNATY"},{"drug":"Interferon-alpha","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Interferon-beta","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Interferon-gamma","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the effect of COMIRNATY"},{"drug":"Interferon-alpha","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Interferon-beta","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Interferon-gamma","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the effect of COMIRNATY"},{"drug":"Interferon-alpha","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Interferon-beta","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"},{"drug":"Interferon-gamma","action":"Monitor","effect":"May enhance the adverse/toxic effect of COMIRNATY"}],"commonSideEffects":[],"contraindications":["Known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY.","individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine."],"specialPopulations":{"Pregnancy":"8.1 Pregnancy\nRisk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects, miscarriage and pre-eclampsia in clinically recognized pregnancies is 2% to 4%, 15% to 20%, and 5% to 7%, respectively. There are no available data with COMIRNATY use in pregnant women before 24 weeks gestation to inform about risks for major birth defects and miscarriage. A developmental toxicity study has been performed in female rats administered the equivalent of a single  d. Among infants born to women in the COMIRNATY group, atrial septal defect (ASD) occurred in 1 infant with Trisomy 21, 1 infant   ...    central nervous system anomalies (see footnote f), 1 infant with a maternal history of congenital heart disease, and 1   ...    e. Among infants born to women in the COMIRNATY group, microcephaly occurred in 1 infant with Trisomy 21 and 1 infant   ...    27   ...    fertility, fetal development, or postnatal development were reported in the study.","Geriatric use":"8.5 Geriatric Use\n...    No overall difference in safety or effectiveness was observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"8.4 Pediatric Use\n...    The mean duration of pain at the injection site after Dose 2 was 2.3 days (range 1 to 37 days), for redness 2.0 days (range 1 to 10 days), and for swelling 2.2 days (range 1 to 16 days) for children in the COMIRNATY  were generally consistent with those reported in pediatric participants receiving COMIRNATY as part of the   ...    more likely to be hospitalized and have CMR, variability in diagnostic testing, and variability in follow-up1.","Renal impairment":"text","Hepatic impairment":"text","Immunocompromised Individuals":"8.6 Immunocompromised Individuals\n...    COMIRNATY may not be effective in individuals with severe or moderate immunocompromised states"}},"trials":["NCT05057169","NCT07280858","NCT05032976","NCT06821126","NCT06742281","NCT06672055","NCT06452654","NCT06130410","NCT06919796","NCT04894435","NCT04815031","NCT05993325","NCT04949490","NCT05515042","NCT04880447","NCT05977127","NCT05406908","NCT05084989","NCT05239975","NCT04805125","NCT05188677","NCT05516459","NCT05323461","NCT05542693","NCT05534048","NCT05029245","NCT05329051","NCT05239806","NCT05238441","NCT05238454","NCT04900467"],"company":"Pfizer","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=comirnaty-intramuscular-injection","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-05-16T02:04:06.476820+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:49:22.710316+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:49:16.676865+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=comirnaty-intramuscular-injection","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:49:22.907817+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108760/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:49:23.621542+00:00"}},"allNames":"comirnaty intramuscular injection","timeline":[],"aiSummary":"COMIRNATY is a COVID-19 vaccine developed by Pfizer Inc. It works by instructing cells in the body to produce a protein from the SARS-CoV-2 virus, which triggers an immune response. The vaccine is administered intramuscularly and is approved for individuals 6 months of age and older. It is particularly recommended for those with certain heart conditions or weakened immune systems. COMIRNATY has generated significant revenue, with $63.6 billion in sales. The vaccine's mechanism of action and broad indications have made it a crucial tool in the fight against COVID-19. Its commercial success has also driven further pipeline developments.","brandName":"COMIRNATY intramuscular injection","isGeneric":true,"mechanism":{"target":"SARS-CoV-2 spike protein","novelty":"first-in-class","modality":"mRNA","drugClass":"mRNA vaccine","explanation":"","oneSentence":"","technicalDetail":"COMIRNATY uses a lipid nanoparticle formulation to deliver the mRNA to cells, where it is translated into the SARS-CoV-2 spike protein. This protein is then recognized by the immune system, which mounts a response to protect against future infections. The vaccine has been shown to be safe and effective in numerous clinical trials."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"yoyGrowth":"7%","revenueYear":2025,"annualCostUS":"$80,000/yr","annualRevenue":4367,"genericStatus":"Generic — off-patent","revenueSource":"Pfizer 2026-02-26 (verified from SEC filing)","currentRevenue":"","revenueCurrency":"USD","peakSalesEstimate":"","revenueConfidence":"high"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=comirnaty-intramuscular-injection","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=comirnaty-intramuscular-injection","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency 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months of age and older with certain kinds of heart disease, such as heart failure, coronary artery disease, and hypertension","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 6 months of age and older with weakened immune systems, such as people with conditions or taking medications that weaken the immune system","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 6 months of age and older with lung disease, such as chronic obstructive pulmonary disease (COPD) and asthma","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 6 months of age and older with type 1 diabetes","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 6 months of age and older with obesity","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 6 months of age and older with neurologic conditions such as dementia","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 6 months of age and older with 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