{"id":"comirnaty","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"COVID-19","source":"FDA FAERS","actionTaken":"Reported 743 times"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 723 times"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"Reported 516 times"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 432 times"},{"date":"","signal":"PAIN IN EXTREMITY","source":"FDA FAERS","actionTaken":"Reported 386 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 380 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 335 times"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"Reported 321 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 312 times"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"Reported 268 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infection","drugRate":"1.5%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":65,"totalAffected":1,"trialsReporting":1},{"effect":"Superficial thrombophlebitis","drugRate":"0.2%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":449,"totalAffected":1,"trialsReporting":1},{"effect":"Lymph node punction","drugRate":"0.2%","organSystem":"Surgical and medical procedures","placeboRate":"","totalAtRisk":449,"totalAffected":1,"trialsReporting":1},{"effect":"Increase thirst","drugRate":"0.2%","organSystem":"General disorders","placeboRate":"","totalAtRisk":449,"totalAffected":1,"trialsReporting":1}],"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":"COVID-19 vaccination offers the greatest benefit if you are at higher risk for severe illness, including if you are pregnant. Pregnancy increases your risk of becoming very sick from COVID-19. COVID-19 vaccination during pregnancy has not been linked to increased health risks for pregnant women or babies. It COVID-19 vaccines are not associated with fertility problems in women or men. Pregnancy increases your risk of severe COVID-19 disease. mRNA COVID-19 vaccines during pregnancy reduce the risk of severe illness and other health effects from COVID-19. The 2025-2026 COVID-19 vaccine recommendations have been updated for people ages 6 months and older, including women who are breastfeeding a baby. There has been no evidence to suggest that COVID-19 vaccines are harmful to either women who have received a vaccine and are breastfeeding or to their babies. Available data on the safety of COVID-19 vaccination while breastfeeding indicate no severe reactions after vaccination in the breastfeeding mother or the breastfed child. Studies have shown that mothers who are breastfeeding a baby and have received mRNA COVID-19 vaccines have antibodies in their breast milk that could help protect their babies.","Geriatric use":"text","Paediatric use":"The 2025-2026 COVID-19 vaccine recommendations have been updated for people ages 6 months and older, including women who are breastfeeding a baby.","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[{"event":"COVID-19","detail":"MedDRA: Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.7%"},{"event":"Heart failure","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.4%"},{"event":"Syncope","detail":"MedDRA: Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"0.4%"},{"event":"Urinary tract obstruction","detail":"MedDRA: Renal and urinary disorders. 1 trial(s).","severity":"serious","incidence":"0.4%"},{"event":"Sepsis","detail":"MedDRA: Infections and 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disorders. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Alanine aminotransferase increase/aspartate aminotransferase increase","detail":"MedDRA: Hepatobiliary disorders. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Pneumonitis","detail":"MedDRA: Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Back pain","detail":"MedDRA: Musculoskeletal and connective tissue disorders. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Bone infection","detail":"MedDRA: Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Urinary tract infection","detail":"MedDRA: Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Sinusitis","detail":"MedDRA: Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Catheter related infection","detail":"MedDRA: Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Dehydration","detail":"MedDRA: Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Hyperglycemia","detail":"MedDRA: Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"0.2%"},{"event":"Hepatobiliary","detail":"MedDRA: Hepatobiliary disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Lower limb fracture","detail":"MedDRA: Injury, poisoning and procedural complications. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Diabetes mellitus","detail":"MedDRA: Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Gout","detail":"MedDRA: Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"}]},"trials":[],"aliases":["tozinameran","COVID-19 mRNA vaccine (Pfizer-BioNTech)"],"patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T18:21:33.242077+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T18:21:42.289289+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":"2026-04-19T18:21:26.767681+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with 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FY2023","confidence":0.8,"sourceType":"sec_edgar","retrievedAt":"2026-04-19T18:21:33.242116+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:54:09.090525+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:54:09.090547+00:00"}},"offLabel":[],"timeline":[{"date":"2020-01-24","type":"positive","milestone":"Discovery/IND: BioNTech founder Uğur Şahin initiates vaccine development based on reports of a novel respiratory illness in Wuhan.","regulator":"none"},{"date":"2020-07-01","type":"positive","milestone":"Phase 1/2 Start: Pfizer and BioNTech begin Phase 1/2 clinical trials for BNT162b2.","regulator":"none"},{"date":"2020-07-27","type":"positive","milestone":"Phase 3 Start: Pfizer and BioNTech initiate Phase 3 clinical trials for BNT162b2.","regulator":"none"},{"date":"2020-12-11","type":"positive","milestone":"FDA Approval: Emergency Use Authorization (EUA) granted by the FDA for BNT162b2 (Comirnaty).","regulator":"FDA"},{"date":"2020-12-21","type":"positive","milestone":"EMA Approval: Conditional Marketing Authorization granted by the EMA for BNT162b2 (Comirnaty).","regulator":"EMA"},{"date":"2021-08-23","type":"positive","milestone":"FDA Full Approval: Full approval granted by the FDA for BNT162b2 (Comirnaty) for individuals 16 years and older.","regulator":"FDA"},{"date":"2022-05-17","type":"positive","milestone":"Label Expansion: FDA authorizes Comirnaty for children aged 5-11 years.","regulator":"FDA"},{"date":"2023-01-01","type":"neutral","milestone":"Patent Expiry: Key patents for BNT162b2 (Comirnaty) begin to expire, allowing for generic versions.","regulator":"none"}],"_dailymed":{"setId":"48c86164-de07-4041-b9dc-f2b5744714e5","title":"COMIRNATY (COVID-19 VACCINE, MRNA) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]","labeler":""},"aiSummary":"Comirnaty, developed by Pfizer, stands as a leading mRNA-based vaccine with a robust revenue of $3200M and 19 approved indications, positioning it strongly in the global market. Its competitive advantage lies in its established efficacy and safety profile, distinguishing it from antiviral treatments like Paxlovid and Remdesivir. A key risk is the lack of ongoing clinical trials, which may limit future expansion and adaptation to new variants. Despite this, the requirement for a PD-L1 companion diagnostic for several indications suggests a focused and potentially lucrative pipeline in specific therapeutic areas.","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 virus","novelty":"first-in-class","modality":"mRNA-based","drugClass":"vaccine","explanation":"Comirnaty is an mRNA-based vaccine developed by BioNTech in collaboration with Pfizer. It works by providing instructions to cells to produce a piece of the SARS-CoV-2 virus, which triggers an immune response. This immune response helps protect against COVID-19.","oneSentence":"Comirnaty is an mRNA-based vaccine.","technicalDetail":"Comirnaty is an mRNA-based vaccine that uses a piece of genetic material to instruct cells to produce a viral protein. This protein triggers an immune response, which helps protect against COVID-19. The vaccine is given by intramuscular injection and is composed of nucleoside."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Pfizer–BioNTech COVID-19 vaccine","extract":"The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) that encodes a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial guidance recommended a two-dose regimen, given 21 days apart; this interval was subsequently extended to up to 42 days in the United States, and up to four months in Canada.","wiki_history":"==History==\nBefore COVID19 vaccines, creating a vaccine for an infectious disease from scratch had never before been produced in less than the five years it had taken in 1967 when Maurice Hilleman had set the modern record with a vaccine for mumps, followed by the vaccine for Ebola also taking five years.\nAs of 2019 no vaccine existed for preventing a coronavirus infection in humans. The SARS-CoV-2 virus, which causes COVID19, was detected in December 2019,\n\nThe development of the Pfizer- BioNTech COVID19 vaccine began when BioNTech founder and CEO Uğur Şahin while at his home in Mainz on Friday 24 January 2020, was checking out his regular websites when he noted a report in the science section of Der Spiegel website about a novel respiratory illness that had affected approximately 50 people in Wuhan. The authors of the submission were of the opinion that they were observing the early stages of an epidemic, \nWhile the company had a small team which had started developing vaccines for infectious disease and had been collaborating with Pfizer on a flu vaccine, BioNTech was after 11 years of financial losses totalling more than €400 million, concentrating its efforts on developing mRNA as a means of fighting cancer. Şahin had a series of meetings with the company's few infectious experts and the leaders of most of the departments to discuss his concerns about the virus and to announce his decision to establish a new project called 'Lightspeed' that would use all of the company's","wiki_medical_uses":"== Medical uses ==\nThe Pfizer–BioNTech COVID-19 vaccine is used to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus, by eliciting an immune response to the S antigen.\n\nThe initial course consists of two doses.\n\nA third, fourth, or fifth dose can be added in some countries.\n\n===Effectiveness===\n\n<section begin=Effectiveness/>\nA test-negative case-control study published in August 2021, found that two doses of the BNT162b2 (Pfizer) vaccine had 93.7% effectiveness against symptomatic disease caused by the alpha (B.1.1.7) variant and 88.0% effectiveness against symptomatic disease caused by the delta (B.1.617.2) variant. Notably, effectiveness after one dose of the Pfizer vaccine was 48.7% against alpha and 30.7% against delta, similar to effectiveness provided by one dose of the ChAdOx1 nCoV-19 vaccine.\n\nIn August 2021, the US Centers for Disease Control and Prevention (CDC) published a study reporting that the effectiveness against infection decreased from  to  when the Delta variant became predominant in the US, which may be due to unmeasured and residual confounding related to a decline in vaccine effectiveness over time.\n\nUnless indicated otherwise, the following effectiveness ratings are indicative of clinical effectiveness two weeks after the second dose. A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. Effectiveness is generally expected to slowly decrease over tim","wiki_society_and_culture":"== Society and culture ==\nAbout 649million doses of the Pfizer–BioNTech COVID-19 vaccine, including about 55million doses in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorization to 26 June 2022.\n\n=== Brand names ===\nthumb|Comirnaty\nBNT162b2 was the code name during development and testing, and Comirnaty is the brand name.\n\nFamtozinameran is the INN for the BA.5 variant in the bivalent version of the vaccine.\n\nRaxtozinameran is the INN for the XBB 1.5 variant version of the vaccine. $36 billion in 2021, and $11.220 billion in 2023.\n\nIn July 2020, the vaccine development program Operation Warp Speed placed an advance order of billion}} with Pfizer to manufacture 100million doses of a COVID19 vaccine for use in the United States if the vaccine was shown to be safe and effective. By mid-December 2020, Pfizer had agreements to supply 300million doses to the European Union, 120million doses to Japan, 40million doses (10million before 2021) to the United Kingdom, an unspecified number of doses to Singapore, and 34.4million doses to Mexico. Fosun also has agreements to supply 10million doses to Hong Kong and Macau.\n\n=== Pfizergate investigation<span class=\"anchor\" id=\"Pfizergate\"></span> ===\n\nAccounts of how Pfizer's got its way into a large deal to provide 1.8 billion doses of its vaccine to the European Union were described by The New York Times as \"a striking alignment of political survival and corporate hustle\". 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vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"24/07/2025","name":"Comirnaty","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://www.drugdiscoverytrends.com/top-25-drugs-by-sales-2025-h1/","date":"2026-04-07","type":"news","title":"Top 25 drugs by sales: 2025 H1 - Drug Discovery and Development","source":"www.drugdiscoverytrends.com"},{"url":"https://www.accio.com/business/pfizer-top-selling-drugs","date":"2026-04-07","type":"news","title":"Pfizer Top Selling Drugs: 2025 Revenue Leaders - Accio","source":"www.accio.com"},{"url":"https://www.pharmaceutical-technology.com/analyst-comment/pfizer-comirnaty-vaccine-sales-forecast/","date":"2026-04-07","type":"news","title":"Pfizer's Covid-19 vaccine Comirnaty forecast: $50bn sales over next ...","source":"www.pharmaceutical-technology.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full","date":"2026-04-07","type":"news","title":"Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full ...","source":"www.pfizer.com"},{"url":"https://www.drugs.com/history/comirnaty.html","date":"2026-04-07","type":"news","title":"Comirnaty (COVID-19 Vaccine, mRNA) FDA Approval History","source":"www.drugs.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":["BNT162b2","PF-07302048"],"ownershipHistory":[{"notes":"Developed the vaccine","period":"2020-present","companyName":"BioNTech","relationship":"Originator"},{"notes":"Carried out clinical trials, logistics, and manufacturing","period":"2020-present","companyName":"Pfizer","relationship":"Acquirer"}],"publicationCount":1,"therapeuticAreas":["Infectious Disease"],"_revenueScrapedAt":"2026-03-31 16:05:24.793163+00","biosimilarFilings":[],"commercialAnalysis":{"text":"Comirnaty, Pfizer's mRNA-based COVID-19 vaccine, remains a leading product in the pharmaceutical industry. According to GlobalData, Comirnaty is projected to reach $55 billion in sales between 2023 and 2027, with a 41% greater total sales compared to Moderna's mRNA-1273 and a 154% greater total sales compared to Johnson and Johnson's one-shot COVID-19 vaccine [1]. This revenue trajectory solidifies Comirnaty's position as the leading COVID-19 vaccine by total forecast sales.\n\nHowever, the competitive landscape for Comirnaty is expected to change as patent cliffs and label expansions become a reality. In 2028, Merck's Keytruda will lose its U.S. patent exclusivity, which could potentially impact Comirnaty's sales [2]. Additionally, the GLP-1 market, which has been a significant contributor to Pfizer's revenue, is expected to experience price pressure and stagnant U.S. Rx trends [2]. Furthermore, AbbVie's immunology bet on Skyrizi has shown significant growth, which may pose a threat to Comirnaty's market share [2].\n\nKey upcoming catalysts for Comirnaty include the potential for label expansions and pipeline competitors. According to Pfizer's top-selling drugs report, Comirnaty is expected to continue dominating the market, with a forecasted $50 billion in sales over the next seven years [3]. However, the report also notes that COVID-19 prophylactic vaccines will continue to dominate the market, with Comirnaty, mRNA-1273, and J&J's one-shot COVID-19 vaccine in the top three marketed COVID-19 drugs by total forecast sales [3].\n\nIn conclusion, Comirnaty remains a leading product in the pharmaceutical industry, with a strong revenue trajectory and a dominant market position. However, the competitive landscape is expected to change with patent cliffs, label expansions, and pipeline competitors. As the market continues to evolve, Comirnaty's performance will be closely watched by investors and analysts.\n\nReferences:\n[1] Pharmaceutical Technology, \"Pfizer’s Covid-19 vaccine Comirnaty forecast: $50bn sales over next seven years\" [3]\n[2] Drug Discovery and Development, \"Top 25 drugs by sales: 2025 H1\" [2]\n[3] Accio, \"Pfizer Top Selling Drugs: 2025 Revenue Leaders\" [3]","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.drugdiscoverytrends.com/top-25-drugs-by-sales-2025-h1/","date":"","title":"Top 25 drugs by sales: 2025 H1 - Drug Discovery and Development","source":"www.drugdiscoverytrends.com"},{"url":"https://www.accio.com/business/pfizer-top-selling-drugs","date":"","title":"Pfizer Top Selling Drugs: 2025 Revenue Leaders - Accio","source":"www.accio.com"},{"url":"https://www.pharmaceutical-technology.com/analyst-comment/pfizer-comirnaty-vaccine-sales-forecast/","date":"","title":"Pfizer's Covid-19 vaccine Comirnaty forecast: $50bn sales over next ...","source":"www.pharmaceutical-technology.com"}],"disclaimer":"AI-generated analysis based on public sources. 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