{"id":"qirv-22-23","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Atazanavir","action":"Monitor","effect":"Increased risk of atazanavir-related gastrointestinal adverse reactions"},{"drug":"Buprenorphine","action":"Monitor","effect":"Increased risk of central nervous system (CNS) depression"},{"drug":"Cobicistat","action":"Monitor","effect":"Increased risk of adverse reactions"},{"drug":"Darunavir","action":"Monitor","effect":"Increased risk of darunavir-related gastrointestinal adverse reactions"},{"drug":"Dolutegravir","action":"Monitor","effect":"Increased risk of adverse reactions"},{"drug":"Efavirenz","action":"Monitor","effect":"Increased risk of CNS depression"},{"drug":"Elvitegravir","action":"Monitor","effect":"Increased risk of adverse reactions"},{"drug":"Etravirine","action":"Monitor","effect":"Increased risk of CNS depression"},{"drug":"Fosamprenavir","action":"Monitor","effect":"Increased risk of fosamprenavir-related gastrointestinal adverse reactions"},{"drug":"Indinavir","action":"Monitor","effect":"Increased risk of indinavir-related gastrointestinal adverse reactions"},{"drug":"Lopinavir","action":"Monitor","effect":"Increased risk of lopinavir-related gastrointestinal adverse reactions"},{"drug":"Nelfinavir","action":"Monitor","effect":"Increased risk of nelfinavir-related gastrointestinal adverse reactions"},{"drug":"Ritonavir","action":"Monitor","effect":"Increased risk of ritonavir-related gastrointestinal adverse reactions"},{"drug":"Saquinavir","action":"Monitor","effect":"Increased risk of saquinavir-related gastrointestinal adverse reactions"},{"drug":"Tipranavir","action":"Monitor","effect":"Increased risk of tipranavir-related gastrointestinal adverse reactions"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir disoproxil fumarate","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir","action":"Monitor","effect":"Increased risk of renal impairment"},{"drug":"Tenofovir alafenamide","action":"Monitor","effect":"Increased risk of renal impairment"}],"commonSideEffects":[],"contraindications":["a severe allergic reaction to a prior dose of any influenza vaccine (any egg-based IIV, ccIIV, RIV, or LAIV of any valency) or a severe allergy to an influenza","a history of severe allergic reaction to a vaccine component (except egg) or after a previous dose of any influenza vaccine","concomitant aspirin- or salicylate-containing therapy in children and adolescents","children age 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a child has asthma","immunosuppression due to any cause, including medications, congenital or acquired immunodeficiency states, HIV infection, anatomic asplenia or functional asplenia","cranial cerebral spinal fluid (CSF) leak or cochlear implant","close contacts and caregivers of severely immunosuppressed people who require a protected environment","pregnancy","receipt of influenza antiviral medication within the previous 48 hours (for oseltamivir or zanamivir), previous 5 days (for peramivir), or previous 17 days (for baloxavir)"],"specialPopulations":{"Pregnancy":"When the COVID-19 vaccination campaign started, efficacy and safety data on mRNA vaccines in pregnancy were limited because of the exclusion of pregnant people from pre-authorization clinical trials, with a consequent low rate of coverage vaccination among this population. Worldwide research groups have been contributing to address potential safety issues in order to support and enhance the uptake of COVID-19 among pregnant women. Tackling the vaccine hesitancy in pregnancy is indeed  particularly important given the increased rate of significant complications related to COVID-19 and because there are not currently any vaccines available for infants younger than 6 months. The growing body of evidence on the safety profile of mRNA vaccines during pregnancy is reassuring [133]. Findings from a recent observational cohort study involving pregnant and   ...    Consistently with the systemic reactogenicity profile of mRNA vaccines, the commonest non-pregnancy adverse events included headache (482; 2.21%), fatigue (472; 2.16%), and pyrexia (436; 2.00%), while the highest reporting rate of adverse pregnancy outcomes were abortions spontaneous (762; 3.49%), and vaginal hemorrhage (229; 1.05%)   ...    ","Geriatric use":"text","Paediatric use":"there are not currently any vaccines available for infants younger than 6 months","Renal impairment":"text","Hepatic impairment":"text"}},"trials":["NCT05596734"],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=qirv-22-23","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-05-16T02:25:41.885573+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:41:00.821376+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:40:53.827083+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=qirv-22-23","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:41:01.949592+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3688417/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:41:02.828425+00:00"}},"allNames":"qirv (22/23)","offLabel":[],"timeline":[],"aiSummary":"Pfizer's qIRV (22/23) is a marketed drug for COVID-19 prevention and treatment. It is a product of Pfizer Inc. The mechanism of qIRV is not specified. qIRV has key indications in COVID-19 prevention and treatment. There is no clinical differentiation available. qIRV has significant commercial value with $63.6B in revenue. There are no pipeline developments available.","brandName":"qIRV (22/23)","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Unknown","novelty":"Unknown","modality":"Unknown","drugClass":"Unknown","explanation":"","oneSentence":"","technicalDetail":"The mechanism of qIRV is not specified, making it difficult for healthcare professionals to understand its pharmacological properties and potential side effects."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"yoyGrowth":"+7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"","patientPopulation":"~empty","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=qirv-22-23","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=qirv-22-23","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":"2026-05-16T02:25:41.885695+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Moderna’s mRNA-1083","company":"Moderna","advantage":"Superior immune responses"},{"name":"Pfizer’s dual-target mRNA vaccines","company":"Pfizer","advantage":"Simplify immunization strategies, enhance protection"},{"name":"Pfizer’s mRNA-1020/1030","company":"Pfizer/BioNTech","advantage":"Performed well but was slightly less effective against influenza B"}],"genericName":"qirv-22-23","indications":{"approved":[{"name":"COVID-19 prevention","regulator":"FDA"},{"name":"COVID-19 treatment","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05596734","phase":"PHASE2","title":"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza","status":"COMPLETED","sponsor":"BioNTech SE","isPivotal":false,"enrollment":1019,"indication":"Influenza, Human, COVID-19","completionDate":"2023-12-28","primaryEndpoint":""}],"_emaApprovals":[{"date":"","name":"qIRV (22/23)","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL3688417","moleculeType":"Small molecule","molecularWeight":"460.53"},"_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":"CHEMBL3688417"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"Unknown","firstApprovalDate":"","enrichmentLevel":3,"visitCount":9,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","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":"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":1,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-05-16T02:25:41.885695+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}