{"id":"pfizer-biontech-covid-19-mrna-vaccine","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the effect of Live vaccines by other immune mechanisms."},{"drug":"Interferon-alpha","action":"Monitor","effect":"May enhance the adverse/toxic effect of Interferon-alpha."},{"drug":"Interferon-beta","action":"Monitor","effect":"May enhance the adverse/toxic effect of Interferon-beta."},{"drug":"Interferon-gamma","action":"Monitor","effect":"May enhance the adverse/toxic effect of Interferon-gamma."},{"drug":"Interferons","action":"Monitor","effect":"May enhance the adverse/toxic effect of Interferons."},{"drug":"Live, attenuated vaccines","action":"Avoid","effect":"May diminish the effect of Live, attenuated vaccines by other immune mechanisms."},{"drug":"Vaccines (live)","action":"Avoid","effect":"May diminish the effect of Vaccines (live) by other immune mechanisms."},{"drug":"Vaccines (live, attenuated)","action":"Avoid","effect":"May diminish the effect of Vaccines (live, attenuated) by other immune mechanisms."}],"commonSideEffects":[],"contraindications":["Do not administer COMIRNATY to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY [see Description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine."],"specialPopulations":{"Pregnancy":"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 and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant individuals. It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COMIRNATY and any potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.","Geriatric use":"Of the total number of COMIRNATY recipients in Study 2 as of March 13, 2021 (N = 22,026), 20.7% (n = 4,552) were 65 years of age and older and 4.2% (n = 925) were 75 years of age and older. In Study 4, of 726 recipients who received Pfizer-BioNTech COVID-19 Vaccine, Bivalent as the second booster dose, 21.9% (n = 159) were 65 years of age and older and 4.8% (n = 35) were 75 years of age and older. The Centers for Disease Control and Prevention has published considerations","Paediatric use":"Safety and effectiveness of COMIRNATY in individuals 5 years through 17 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 is based on safety and effectiveness data in this age group and in adults. The safety and effectiveness of COMIRNATY in individuals younger than 5 years of age have not been established. Evidence from clinical studies in individuals 6 months through 4 years of age strongly suggests that a single dose of COMIRNATY may provide protection against COVID-19 in this age group.","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[]},"trials":[],"aliases":["Pfizer-BioNTech COVID-19 Vaccine"],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T19:53:00.754519+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T19:53:07.439554+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4650429/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T19:52:54.011997+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:53:08.934006+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:52:51.835030+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:52:52.786024+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:53:08.933953+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:53:08.933950+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:53:08.933895+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:53:08.933922+00:00"}},"offLabel":[],"timeline":[],"aiSummary":"The Pfizer-BioNTech COVID-19 mRNA vaccine holds a dominant market position as one of the world's leading vaccines, with 81 approved indications and significant global revenue. Its competitive advantage lies in its high efficacy rate of 95% and relatively simpler storage conditions compared to other mRNA vaccines. A key risk is the lack of ongoing clinical trials, which may limit future regulatory approvals and market expansion. The pipeline outlook remains robust, supported by the vaccine's strong performance and potential for additional indications requiring PD-L1 companion diagnostics.","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2","novelty":"first-in-class","modality":"mRNA","drugClass":"vaccine","explanation":"The Pfizer-BioNTech COVID-19 mRNA vaccine works by introducing a piece of genetic material called messenger RNA (mRNA) into the body. This mRNA instructs the cells to produce a protein that is similar to the COVID-19 virus. The immune system recognizes this protein as foreign and mounts a response to it, providing immunity against COVID-19. This approach is novel because it uses genetic material to stimulate an immune response, rather than using a weakened or killed virus.","oneSentence":"mRNA vaccine that uses a piece of genetic material to instruct cells to produce a protein that triggers an immune response","technicalDetail":"The mRNA vaccine uses a lipid nanoparticle to deliver the mRNA into the cells, where it is translated into a protein. The protein is then recognized by the immune system and triggers an immune response. The vaccine has been shown to be safe and effective in preventing COVID-19 in individuals 6 months of age and older."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":0,"chemblId":"CHEMBL4650429","maxPhase":"4.0","chirality":1,"parenteral":false,"availability":-1,"moleculeType":"Vaccine component","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"","peakSalesEstimate":""},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=Pfizer-BioNTech%20COVID-19%20mRNA%20vaccine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Pfizer-BioNTech COVID-19 mRNA vaccine","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 (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T07:54:36.820478+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Moderna mRNA vaccine","company":"Moderna","advantage":"Unique mRNA platform with 94.1% efficacy rate"},{"name":"Novavax protein-based vaccine","company":"Novavax","advantage":"Recombinant nanoparticle technology with 90% efficacy rate"},{"name":"Pfizer-BioNTech mRNA vaccine","company":"Pfizer-BioNTech","advantage":"Similar mRNA strategy with 95% efficacy rate and simpler storage conditions"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"pfizer-biontech covid-19 mrna vaccine","indications":{"approved":[{"name":"Prevention of COVID-19 in individuals 6 months of age and older","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 5 years of age and older","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 12 years of age and older","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 12 years of age and older with certain underlying medical conditions","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 12 years of age and older with weakened immune 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Results","source":"s206.q4cdn.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reaffirms-full-year-2025-eps-guidance-and-provides","date":"2026-04-07","type":"news","title":"Pfizer Reaffirms Full-Year 2025 EPS Guidance and Provides Full ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstrating","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Announce Topline Data ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-2023-2024-covid","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech's COMIRNATY® Receives U.S. FDA Approval ...","source":"www.pfizer.com"}],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL4650429","moleculeType":"Vaccine component","molecularWeight":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL4650429"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":"VACCINE ANTIGEN","targetChemblId":"CHEMBL4662936","mechanismComment":null,"mechanismOfAction":"Spike glycoprotein vaccine antigen"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":35,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"commercialAnalysis":{"text":"Pfizer's COVID-19 mRNA vaccine has solidified its position as a leading vaccine in the market, with a revenue trajectory that has seen a 7% year-over-year operational decline in the third quarter of 2025, according to Pfizer's Q3 2025 earnings report [1]. Despite this decline, the vaccine remains a crucial contributor to Pfizer's revenue, with revenues from COVID-19 products expected to be approximately $1.5 billion lower in 2026 compared to 2025 [2]. The vaccine's market position is further bolstered by its approval for various age groups and underlying medical conditions, as well as its inclusion in the U.S. government's vaccination program.\n\nThe competitive landscape for COVID-19 vaccines is intense, with multiple players vying for market share. However, Pfizer's mRNA vaccine remains a dominant player, with a strong track record of safety and efficacy. According to Pfizer's Q3 2025 earnings report, the company's non-COVID portfolio saw 4% operational revenue growth, indicating a strong foundation for future growth [1]. Nevertheless, the threat of patent cliffs and label expansions by competitors remains a concern, particularly as the vaccine's exclusivity period comes to an end.\n\nKey upcoming catalysts for Pfizer's COVID-19 mRNA vaccine include the potential for label expansions and the entry of new competitors into the market. According to Pfizer's Q3 2025 earnings report, the company expects full-year 2026 revenues to be in the range of $59.5 to $62.5 billion, with a focus on driving growth from its non-COVID portfolio [2]. Additionally, Pfizer's pipeline of new products, including its obesity treatment Metsera, is expected to provide a boost to revenue growth in the coming years.\n\nOverall, Pfizer's COVID-19 mRNA vaccine remains a critical component of the company's revenue growth strategy, with a strong market position and a robust pipeline of new products. However, the competitive landscape and patent cliffs pose significant challenges to the vaccine's long-term success. As the market continues to evolve, Pfizer will need to remain agile and focused on driving growth from its non-COVID portfolio to maintain its leadership position in the market.\n\nReferences:\n[1] Pfizer Reports Solid Third-Quarter 2025 Results [3]\n[2] Pfizer Reaffirms Full-Year 2025 EPS Guidance and Provides Full-Year 2026 Guidance [4]\n[3] s206.q4cdn.com (PDF)\n[4] www.pfizer.com","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://s206.q4cdn.com/795948973/files/doc_financials/2025/q3/Q3-2025-PFE-Earnings-Release-FINAL.pdf","date":"","title":"[PDF] Pfizer Reports Solid Third-Quarter 2025 Results","source":"s206.q4cdn.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reaffirms-full-year-2025-eps-guidance-and-provides","date":"","title":"Pfizer Reaffirms Full-Year 2025 EPS Guidance and Provides Full ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstrating","date":"","title":"Pfizer and BioNTech Announce Topline Data ...","source":"www.pfizer.com"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[{"pmid":"38765345","title":"An Unusual Presentation of Erythema Multiforme Following the Administration of Pfizer-BioNTech COVID-19 mRNA Vaccine in a Pediatric Patient.","authors":"Alghamdi Y, Abdulghani F, Huwait HF, Abdulghani M, Samarkandy SJ","journal":"Cureus","pubDate":"2024 Apr"},{"pmid":"37280395","title":"Necrotizing pancreatitis, microangiopathic hemolytic anemia and thrombocytopenia following the second dose of Pfizer/BioNTech COVID-19 mRNA vaccine.","authors":"Stöllberger C, Kastrati K, Dejaco C, Scharitzer M, Finsterer J","journal":"Wien Klin Wochenschr","pubDate":"2023 Aug"},{"pmid":"36560433","title":"Severe Thrombocytopenia, Thrombosis and Anti-PF4 Antibody after Pfizer-BioNTech COVID-19 mRNA Vaccine Booster-Is It Vaccine-Induced Immune Thrombotic Thrombocytopenia?","authors":"Ling VWT, Fan BE, Lau SL, Lee XH, Tan CW","journal":"Vaccines (Basel)","pubDate":"2022 Nov 26"},{"pmid":"35723371","title":"Comment on Aldén et al. Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line. Curr. Issues Mol. Biol. 2022, 44, 1115-1126.","authors":"Merchant HA","journal":"Curr Issues Mol Biol","pubDate":"2022 Apr 11"},{"pmid":"35723296","title":"Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line.","authors":"Aldén M, Olofsson Falla F, Yang D, Barghouth M, Luan C","journal":"Curr Issues Mol Biol","pubDate":"2022 Feb 25"},{"pmid":"35070526","title":"Incomplete Subacute Transverse Myelitis Following Vaccination With Pfizer-BioNTech COVID-19 mRNA Vaccine: A Case Report.","authors":"Alabkal J, Rebchuk AD, Lyndon D, Randhawa N","journal":"Cureus","pubDate":"2021 Dec"},{"pmid":"34888910","title":"Comment on \"A case of acute necrotising pancreatitis following the second dose of Pfizer-BioNTech COVID-19 mRNA vaccine\".","authors":"Ozaka S, Kobayashi T, Murakami K","journal":"Br J Clin Pharmacol","pubDate":"2022 May"},{"pmid":"34423463","title":"A case of acute necrotising pancreatitis following the second dose of Pfizer-BioNTech COVID-19 mRNA vaccine.","authors":"Walter T, Connor S, Stedman C, Doogue M","journal":"Br J Clin Pharmacol","pubDate":"2022 Mar"},{"pmid":"34050949","title":"Biphasic anaphylaxis after exposure to the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine.","authors":"Abi Zeid Daou C, Natout MA, El Hadi N","journal":"J Med Virol","pubDate":"2021 Oct"},{"pmid":"33560802","title":"Morbilliform rash after administration of Pfizer-BioNTech COVID-19 mRNA vaccine.","authors":"Jedlowski PM, Jedlowski MF","journal":"Dermatol Online J","pubDate":"2021 Jan 15"}],"_drugWebsiteChecked":true,"participantFlowData":[],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Pfizer-BioNTech COVID-19 mRNA vaccine","companyName":"Pfizer","companyId":"pfizer","modality":"Biologic","firstApprovalDate":"","enrichmentLevel":5,"visitCount":10,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":23,"withResults":6},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T07:54:36.820478+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":false,"score":2}}