{"id":"bnt162b2-b-1-351","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fever"}]},"_chembl":{"chemblId":"CHEMBL3980047","moleculeType":"Small molecule","molecularWeight":"471.62"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This vaccine delivers lipid nanoparticle-formulated mRNA that encodes an optimized spike protein antigen from the B.1.351 variant. Upon intramuscular injection, the mRNA is translated by host cells to produce the spike protein, which triggers both CD8+ T-cell and antibody-mediated immune responses. This variant-specific formulation was developed to address potential immune escape by the Beta variant.","oneSentence":"BNT162b2.B.1.351 is an mRNA vaccine encoding a modified spike protein from the B.1.351 (Beta) variant of SARS-CoV-2, designed to elicit immune responses against this variant.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:47:20.604Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"COVID-19 prevention (variant-specific booster or primary series against B.1.351 variant)"}]},"trialDetails":[{"nctId":"NCT05289037","phase":"PHASE2","title":"COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2022-03-30","conditions":"COVID-19","enrollment":1270},{"nctId":"NCT05000216","phase":"PHASE2","title":"COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-08-13","conditions":"Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris","enrollment":258},{"nctId":"NCT04889209","phase":"PHASE1, PHASE2","title":"Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-05-28","conditions":"COVID-19","enrollment":867},{"nctId":"NCT05405283","phase":"PHASE3","title":"Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-06-08","conditions":"COVID-19 Vaccines","enrollment":189},{"nctId":"NCT04713553","phase":"PHASE3","title":"A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants","status":"COMPLETED","sponsor":"BioNTech SE","startDate":"2021-02-15","conditions":"SARS-CoV-2 Infection, COVID-19","enrollment":1574},{"nctId":"NCT05124171","phase":"PHASE3","title":"Immunogenicity and Reactogenicity Following a Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-12-08","conditions":"COVID-19, Vaccine Reaction","enrollment":247}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"BNT162b2.B.1.351","genericName":"BNT162b2.B.1.351","companyName":"BioNTech SE","companyId":"biontech-se","modality":"Biologic","firstApprovalDate":"","aiSummary":"BNT162b2.B.1.351 is a COVID-19 booster vaccine being studied in a clinical trial for its effects on individuals with autoimmune diseases who did not respond to initial vaccinations. The conditions being studied in this trial include Rheumatoid Arthritis, Systemic Lupus Erythematosus, Pemphigus Vulgaris, Multiple Sclerosis, and Systemic Sclerosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}