{"id":"bretovameran","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"SYRINGE ISSUE","source":"FDA FAERS","actionTaken":"Reported 15 times"},{"date":"","signal":"DEVICE BREAKAGE","source":"FDA FAERS","actionTaken":"Reported 9 times"},{"date":"","signal":"DEVICE MATERIAL ISSUE","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"DEVICE ISSUE","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"DEVICE LEAKAGE","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 3 times"},{"date":"","signal":"BELL^S PALSY","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"BLOOD PRESSURE INCREASED","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"CARDIAC DISORDER","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"DEVICE CONNECTION ISSUE","source":"FDA FAERS","actionTaken":"Reported 2 times"}],"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Benzodiazepines","action":"Monitor","effect":"Enhanced sedative effects"},{"drug":"Opioids","action":"Monitor","effect":"Enhanced sedative effects"},{"drug":"CYP3A4 inhibitors","action":"Avoid","effect":"Increased bretovameran levels"},{"drug":"CYP3A4 inducers","action":"Avoid","effect":"Decreased bretovameran levels"}],"commonSideEffects":[],"contraindications":["Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.","Events of anaphylaxis have been reported.","No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty.","Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty.","Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as","Immunocompromised individuals The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals"],"specialPopulations":{"Pregnancy":"Administration of Comirnaty JN.1 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. There are clinical study data from the use of Comirnaty (tozinameran) in 173 pregnant women and no safety concerns were identified in the mother or their infant that were attributable to maternal vaccination.","Geriatric use":"Clinical studies of Comirnaty (tozinameran) include participants 65 years of age and older and In individuals 60 years of age and older, Comirnaty may be administered concomitantly with","Paediatric use":"The safety and efficacy of the vaccine in infants aged less than 6 months have not yet been established. Comirnaty JN.1 (Maroon or Yellow cap) should be used only for infants and children 6 months to 4 years of age. Individuals may not be fully protected until 7 days after their primary course of 3 doses of Comirnaty.","Renal impairment":"text","Hepatic impairment":"text"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=bretovameran","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:38:26.689252+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Bretovameran","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:38:41.477001+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:38:40.200883+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:38:26.711836+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bretovameran","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:38:40.926124+00:00"}},"offLabel":[],"timeline":[{"date":"1967-01-01","type":"neutral","_source":"Wikipedia","milestone":"Maurice Hilleman sets modern record with a vaccine for mumps","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":"The SARS-CoV-2 virus was detected","regulator":"none"},{"date":"2020-01-24","type":"neutral","_source":"Wikipedia","milestone":"Uğur Şahin noted a report in the science section of Der Spiegel website","regulator":"none"},{"date":"2020-07-01","type":"neutral","_source":"Wikipedia","milestone":"Operation Warp Speed placed an advance order with Pfizer","regulator":"none"},{"date":"2020-12-15","type":"neutral","_source":"Wikipedia","milestone":"Pfizer had agreements to supply 300million doses to the European Union","regulator":"none"},{"date":"2021-01-01","type":"neutral","_source":"Wikipedia","milestone":"10million doses were supplied to a country (not specified)","regulator":"none"},{"date":"2022-06-26","type":"positive","_source":"Wikipedia","milestone":"About 649million doses of the Pfizer–BioNTech COVID-19 vaccine were administered in the EU/EEA","regulator":"none"},{"date":"2023-01-01","type":"neutral","_source":"Wikipedia","milestone":"$11.220 billion in revenue","regulator":"none"}],"aiSummary":"Bretovameran is a research compound developed by Pfizer Inc. It is not approved by the FDA. The mechanism of action is not specified. It is a generic drug with multiple manufacturers. There is no clinical differentiation or commercial significance. There are no pipeline developments.","brandName":"Bretovameran","ecosystem":[],"isGeneric":true,"mechanism":{"explanation":"","oneSentence":"","technicalDetail":"The mechanism of action of Bretovameran is not specified, making it difficult to understand its potential therapeutic benefits or risks."},"_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":"Generic — multiple manufacturers","genericStatus":"Generic — off-patent","currentRevenue":"Generic — multiple manufacturers","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":"Generic — multiple manufacturers"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=bretovameran","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bretovameran","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/bretovameran","fields":["history","overview"],"source":"Wikipedia"},{"id":4,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":5,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":6,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:34:11.941582+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Comirnaty JN.1 10 micrograms/dose dispersion for injection","company":"BioNTech - Pfizer","advantage":"Alternative dosage form"},{"name":"Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection","company":"BioNTech - Pfizer","advantage":"Different dosage strength"},{"name":"Comirnaty JN.1 30 micrograms/dose dispersion for injection","company":"BioNTech - Pfizer","advantage":"Alternative packaging"},{"name":"Comirnaty JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe","company":"BioNTech - Pfizer","advantage":"Different administration method"}],"genericName":"bretovameran","indications":{"approved":[{"name":"Bretovameran is not approved by the FDA. It is a research compound."}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06613984","phase":"","title":"Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2024-10-11","conditions":"COVID-19 Vaccination","enrollment":660}],"_emaApprovals":[{"date":"","name":"Bretovameran","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_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":{"pubchemSID":"507432911"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"notes":"","period":"2019-present","_source":"Wikipedia","companyName":"BioNTech","relationship":"Originator"},{"notes":"Collaborated with BioNTech for clinical trials, logistics, and manufacturing","period":"2019-present","_source":"Wikipedia","companyName":"Pfizer","relationship":"Acquirer|Licensee"}],"publicationCount":0,"therapeuticAreas":["Other"],"biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:34:11.941582+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}