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Therefore, observational data on vaccine safety for prenatally exposed newborns are critical to inform recommendations on maternal immunization.","Geriatric use":"text","Paediatric use":"This large, nationally representative study examined various congenital outcomes and detected no increased risk for early infant morbidity or mortality among live-born infants prenatally exposed to BNT162b2 vaccination as compared with unexposed infants.","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[{"event":"Normocytic anaemia","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Small bowel obstruction","detail":"MedDRA: Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Right upper lobe pneumonia","detail":"MedDRA: Infections and infestations. 1 trial(s).","severity":"serious","incidence":"1.0%"},{"event":"Intracranial hemorrhage","detail":"MedDRA: Nervous 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trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Anaemia macrocytic","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Blood loss anaemia","detail":"MedDRA: Blood and lymphatic system disorders. 2 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Febrile neutropenia","detail":"MedDRA: Blood and lymphatic system disorders. 2 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Lymphadenitis","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Lymphadenopathy","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Microcytic anaemia","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Neutropenia","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Pancytopenia","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Splenic vein thrombosis","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Thrombocytopenia","detail":"MedDRA: Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Accelerated idioventricular rhythm","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Acute coronary syndrome","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Acute left ventricular failure","detail":"MedDRA: Cardiac disorders. 2 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Angina pectoris","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Angina unstable","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Aortic valve incompetence","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Arteriosclerosis coronary artery","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Arteriospasm coronary","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Atrial flutter","detail":"MedDRA: Cardiac disorders. 2 trial(s).","severity":"serious","incidence":"0.0%"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=bnt162b2","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:30:27.193951+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Bnt162B2","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:30:35.188944+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:30:43.722390+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:30:33.831671+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:30:27.269149+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bnt162b2","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:30:34.014209+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:55:44.881153+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Spike glycoprotein vaccine antigen","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:30:35.188911+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4650429/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:30:34.835170+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (6 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:55:44.880989+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (6 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:55:44.881010+00:00"}},"offLabel":[],"timeline":[{"date":"1967-01-01","type":"neutral","_source":"Wikipedia","milestone":"Maurice Hilleman sets modern record for vaccine development","regulator":"none"},{"date":"2019-01-01","type":"neutral","_source":"Wikipedia","milestone":"No vaccine existed for preventing a coronavirus infection in humans","regulator":"none"},{"date":"2019-12-01","type":"neutral","_source":"Wikipedia","milestone":"SARS-CoV-2 virus detected","regulator":"none"},{"date":"2020-01-24","type":"neutral","_source":"Wikipedia","milestone":"Uğur Şahin discovers novel respiratory illness in Wuhan","regulator":"none"},{"date":"2020-07-01","type":"neutral","_source":"Wikipedia","milestone":"Operation Warp Speed places advance order with Pfizer","regulator":"none"},{"date":"2020-12-15","type":"neutral","_source":"Wikipedia","milestone":"Pfizer agreements to supply 300million doses to the European Union","regulator":"none"},{"date":"2021-01-01","type":"neutral","_source":"Wikipedia","milestone":"10million doses of vaccine supplied to Thailand","regulator":"none"},{"date":"2022-06-26","type":"positive","_source":"Wikipedia","milestone":"649million doses of vaccine administered in the EU/EEA","regulator":"none"}],"aiSummary":"BNT162b2, marketed by Pfizer, is an mRNA-based vaccine for COVID-19 prevention, currently generating significant revenue as a leading product in the global vaccine market. Its key strength lies in its robust mechanism of action, which has been validated through widespread use and efficacy in preventing COVID-19. The primary risk is the competitive landscape, particularly from ChAdOx1 nCoV-19 by Oxford–AstraZeneca, which induces higher levels of specific T cells, and mRNA-1273 by Moderna, known for inducing higher antibody titers.","brandName":"BNT162b2","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 virus","novelty":"first-in-class","modality":"mRNA-based","drugClass":"vaccine","explanation":"","oneSentence":"","technicalDetail":"The vaccine uses a lipid nanoparticle to deliver the mRNA to the cells, where it is translated into a protein that is recognized by the immune system. The immune response is then triggered, providing protection against COVID-19. The vaccine has been shown to be safe and effective in clinical trials."},"_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\". Shots worth €4 billio"},"commercial":{"annualCostUS":"","genericStatus":"Generic — off-patent","currentRevenue":"","patientPopulation":"","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=bnt162b2","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bnt162b2","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://en.wikipedia.org/wiki/bnt162b2","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":6,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":7,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines 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