Allergy concerns about COVID-19 vaccines
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Webinar Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH Speaker: Dr. Tang Min Moon, consultant dermatologist in Kuala Lumpur Hospital, Ministry of Health Malaysia.
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Allergy concerns about COVID-19 vaccines
- 2. Disclaimers •ThisslidewaspreparedfortheWebinarSeriesonCOVID-19 sessionon3rdMarch 2021,byDrTangMinMoon, DermatologistattheKualaLumpurHospital,Malaysia. •Thisisintendedtosharewithinhealthcareprofessionals,not forpublic. •Kindlyacknowledge“ClinicalUpdatesinCOVID-19 http://www.nih.gov.my/covid-19”shouldyouplantosharethe informationobtainedfromthisslidewithyourcolleagues. Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research, NIH
- 3. Content/Outline 1. TypesofCOVID-19vaccinesavailableinMalaysia 2. ThereactionsafterCOVID-19vaccination 3. The“allergenicculprit”ofCOVID-19vaccines 4. COVID-19vaccinationinthosewithallergies 5. Treatment&premedicationforreactionsfollowing vaccination 6. Iftheseconddoseiscontraindicated,what’snext? 7. Pharmacovigilence
- 6. COVID-19Vaccines OtherCountries US UK Pfizer-BioNTech Moderna J&JJanssen Oxford/AztraZeneca Pfizer-BioNTech Moderna HongKong Singapore CoronaVac(Sinovac) Pfizer-BioNTech Pfizer-BioNTech Moderna Thailand Indonesia Oxford/AztraZeneca CoronaVac(Sinovac) Oxford/AztraZeneca CoronaVac(Sinovac) Currently&Potentiallyavailable inMalaysia 1. Comirnaty® Pfizer-BioNTech (mRNA) 2. CoronaVac® (Sinovac)(inactivated) 3. Oxford/AstraZeneca(Replication deficientvector) 4. CanSino(Replication-defectiveAd5vectors) 5. SputnikV(Non-replicatingvector)
- 9. COVID-19 Tcellresponses COVID-19 Neutralisingantibody Whatisgoingtohappen? TheAIMofCOVID-19Vaccination… USVaccineAdverseEvent ReportingSystem(VAERS) 14/12/20-24/1/21 UKMedicinesandHealthcareproducts RegulatoryAgency(MHRA)reports 9/12/20-14/4/21 HongKongPharmacovigilence system 22/2/21-4/4/21 PfizerBioNTech& Moderna Pfizer/BioNTech AstraZeneca PfizerBioNTech Sinovac 1st dose 2nd dose 1st dose 2nd dose Doseadministered 21,843,033 11.2mil 6.2mil 21.2mil 2.3mil 152,000 404,100 TotalAEFIreports 9,096(0.04%) 50,022(0.28%) (2875/milliondose) 145,994(0.62%) (6212/milliondose) 376(0.25%) 981(0.24%) Total reaction/events NA 143,034 (8220/milliondose) 548,495 (23,340/million dose) NA NA Death 196 334(0.0019%) 627(0.0027%) 2 13 Sourceofdata https://www.cdc.gov/vaccines/acip/meetin gs/downloads/slides-2021-01/06-COVID-Sh imabukuro.pdf(accessedon21/4/21) https://www.gov.uk/government/publications/coronavirus-covid-1 9-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yell ow-card-reporting(accessedon23/4/21) https://www.drugoffice.gov.hk/eps/do/en/doc/Safety_Mo nitoring_of_COVID-19_Vaccines_in_Hong_Kong.pdf (accessedon23/4/21)
- 10. ISRR ISRR–Immunizationstress-related responses 1. Vasovagalreaction 2. Panicattack Pfizer/BioNTech AstraZeneca 1st dose 2nd dose 1st dose 2nd dose Administered(million) 11.2 6.2 21.2 2.3 Syncope 453 1609 Anxietysymptoms 339 1253 Panicattacks& disorders 50 197 Hyperventilation 18 60 UKMedicinesandHealthcareproductsRegulatory Agency(MHRA)reports(9/12/20-14/4/21) https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/co ronavirus-vaccine-summary-of-yellow-card-reporting (accessed on 23/4/21) COVID-19 Tcellresponses COVID-19 Neutralisingantibody Whatisgoingtohappen? TheAIMofCOVID-19Vaccination…
- 12. ImmunologicallymediatedAEFIs TheGell&CoombsSystemofHypersensitivity Type Description Example I SpecificIgEantibodies 🡪Mastcellactivation Urticaria,angioedema, anaphylaxis II Cytotoxicreactionsmediatedbydrug-specificIgGorIgMantibodies 🡪Phagocytes,NKcells Haemolyticanemia Thrombocytopenia III IgG-solubleantigen🡪complementimmunecomplex Vasculitis,serumsickness IV Delayed-typehypersensitivityreactions cellularimmunemechanisms IVa IFN-γ,TNF-α(Th1)🡪activationofMonocytes Contactdermatitis IVb IL5,IL4,IL13(Th2)🡪activationofEosinophils MPE,DRESS IVc Perforin/GranzymeB(CTL)🡪activationofCD4+orCD8+T cells SJS,TEN,MPE,DRESS IVd IL8,GM-CSF🡪activationofNeutrophils AGEP PichlerWJ.Delayeddrughypersensitivityreactions.AnnInternMed2003:139:683-93 Bologniaetal.Dermatology4thEd2018;18:305 MPE-maculopapulareruption,DRESS–drugreactionseosinophiliawithsystemicsymptoms,SJS-StevensJohnsonSyndrome,TEN-Toxicepidermalnecrolysis,AGEP–acute generalizedexanthematouspustulosis
- 13. ImmunologicallymediatedAEFIs TheGell&CoombsSystemofHypersensitivity Type Description Example I SpecificIgEantibodies 🡪Mastcellactivation Urticaria,angioedema, anaphylaxis II Cytotoxicreactionsmediatedbydrug-specificIgGorIgMantibodies🡪 Phagocytes,NKcells Haemolyticanemia Thrombocytopenia III IgG-solubleantigen🡪complementimmunecomplex Vasculitis,serumsickness IV Delayed-typehypersensitivityreactions cellularimmunemechanisms IVa IFN-γ,TNF-α(Th1)🡪activationofMonocytes Contactdermatitis IVb IL5,IL4,IL13(Th2)🡪activationofEosinophils MPE,DRESS IVc Perforin/GranzymeB(CTL)🡪activationofCD4+orCD8+Tcells SJS,TEN,MPE,DRESS IVd IL8,GM-CSF🡪activationofNeutrophils AGEP PichlerWJ.Delayeddrughypersensitivityreactions.AnnInternMed2003:139:683-93 Bologniaetal.Dermatology4thEd2018;18:305 SzebeniJ.MolImmunol.2014;61(2):163-73. Stoneetal.BrJClinPharmacol.2019;85(12):2694-2706. CARPA–complementactivationrelatedpseudo-allergy
- 14. Immediatereactions--Urticaria Wheal - Transientsuperficialdermalswellingduetoplasmaleakage - Pruritic&pink/paleinthecenter - Individuallesionscome&gorapidlywithin24hours Angioedema - Deepswellingsoftheskinormucosa - Painful,lesswelldefined,tendtobenormalincolor - Lastfor2-3days
- 15. Immediatereactions duetoCOVID-19vaccines https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-a dverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting (accessedon23/4/21) MMWRMorbMortalWklyRep2021;70:46–51. USCDC14-23/12/2020 Non-anaphylaxisallergic reactions • 83casesof1,893,360doseof Pfizer-BioNTechCOVID-19vaccine(1st dose)=43.8casespermilliondoses • 87%nonserious • Pruritus,rash,itchy&scratchysensations inthethroat,mildrespiratorysymptoms Pfizer/BioNTech AstraZeneca 1st dose 2nd dose 1st dose 2nd dose Administered(million) 11.2 6.2 21.2 2.3 Urticaria 711(40.9/million) 1454(62/million) Angioedema 95(5.5/million) 210(8.9/million) Pruritus 2068(119/million) 5089(217/million) UKMedicinesandHealthcareproductsRegulatory Agency(MHRA)reports(9/12/20-14/4/21)
- 16. Anaphylaxis morethanjustAngioedema Allergic Reactions (16/12/20-12/2/21) USMassGeneralBrigham(MGB) employees Moderna n=38,971(%) PfizerBioNTech n=25,929(%) Self-reported 859(2.2%) 506(1.95%) Anaphylaxis 9(0.023%) 7(0.027%) Priorhistoryof anaphylaxisin thosewhodev anaphylaxisto C19vaccine 44% 14%
- 17. Anaphylaxis morethanjustAngioedema MedicinesandHealthcareproductsRegulatory Agency(MHRA)reports(9/12/20-14/4/21) Pfizer/BioNTech AstraZeneca 1st dose 2nd dose 1st dose 2nd dose Administered (million) 11.2 6.2 21.6 2.3 Anaphylaxisor anaphylactoid 268 (nodeath) 540 (1death) Rateof anaphylaxisor anaphylactoid 0.0015% 15.4cases/million 0.0023% 22.6cases/million
- 19. Reactogenicity–“nopain,nogain”? Reaction (selfreportedbyvaccinees) Pfizer-BioNTech Dose1(%) (n=1659724) Dose2(%) (n=949497) Injection site reaction Any 65.4 68.6 Pain 63.6 66.5 Redness 3.4 6.0 Swelling 6.6 10.3 Itching 3.8 6.3 Systemic reaction Any 48.0 64.2 Fatigue 29.1 47.8 Headache 24.7 40.4 Myalgia 17.0 36.8 Chills 7.0 22.7 Fever 7.0 21.5 Jointpain 7.4 19.9 Nausea 6.9 13.1 Vomiting 0.6 1.2 Diarrhea 5.0 6.2 Abdominalpain 2.8 5.0 Rashoutsidetheinjectionsite 1.1 1.4 Chapin-Bardalesetal.JAMA.2021Apr5.doi:10.1001/jama.2021.5374. HervéCetalNPJVaccines.2019;4:39.
- 20. Reactogenicity–“nopain,nogain”? Blumenthal.NEnglJMed.2021Apr1;384(13):1273-1277.. McMahonJAmAcadDermatol.2021Apr7:S0190-9622(21)00658-7. Baecketal.NEnglJMed.2021Apr21:10.1056/NEJMc2104751#sa1. Cutaneousreaction(assessedby dermatologistorotherhealthcare professionals) Pfizer-BioNTech Dose1(%) (n=34) Dose2(%) (n=40) Delayedlargelocalreaction 15 18 Localinjectionsitereaction 24 25 Urticariaafter24h 26 18 Angioedema 0 2.5 Morbiliform(maculopapular) 18 7.5 Erythomelalgia 2.9 5.0 Flareofexistingdermatologic condition* 24 7.5 Vesicular 8.8 5.0 Pernio/chilblains 8.8 5.0 *Herpessimplexvirus,atopicdermatitis,psoriasis,urticarialvasculitis,unspecified eczema US:12casesofdelayedlargelocal reactiontoModernamRNACOVID-19 vaccine Belgium: delayedlarge localrectiontoPfizer BioNTechmRNAC19 vaccine🡪negativeallergy test
- 21. Reactogenicity Immediate AllergicReactions ISRR Hervé C et al NPJ Vaccines. 2019;4:39. COVID-19 Tcellresponses COVID-19 Neutralisingantibody Whatisgoingtohappen? TheAIMofCOVID-19Vaccination… TypeIII&IV Hypersensitivity Reactions
- 22. Type Description Example I Drug-specificIgEantibodies 🡪Mastcellactivation Urticaria,angioedema, anaphylaxis II Cytotoxicreactionsmediatedbydrug-specificIgGorIgMantibodies🡪 Phagocytes,NKcells Haemolyticanemia Thrombocytopenia III IgG-solubleantigen🡪complementimmunecomplex Vasculitis,serumsickness IV Delayed-typehypersensitivityreactions cellularimmunemechanisms IVa IFN-γ,TNF-α(Th1)🡪activationofMonocytes Contactdermatitis IVb IL5,IL4,IL13(Th2)🡪activationofEosinophils MPE,DRESS IVc Perforin/GranzymeB(CTL)🡪activationofCD4+orCD8+Tcells SJS,TEN,MPE,DRESS IVd IL8,GM-CSF🡪activationofNeutrophils AGEP Chenetal..Cureus.2018;10(3):e2323. Abdallaetal.BMJCaseRep.2020;13(3):e234714. McMahonJAmAcadDermatol.2021Apr7:S0190-9622(21)00658-7. PichlerWJ.Delayeddrughypersensitivityreactions.AnnInternMed2003:139:683-93. Pneumovax23–3daysprior Influenzavaccine–2weeksprior Vasculitis(systemicorcutaneous)occurredafterCOVID-19vaccinations –US:3casesreported(2Moderna,1Pfizer/BioNTech) -UK(MHRA):37casesreportedinPfizer/BioNTech,77casesreportedinAstraZeneca ImmunologicallymediatedAEFIs TheGell&CoombsSystemofHypersensitivity
- 23. Type Description Example I SpecificIgEantibodies 🡪Mastcellactivation Urticaria,angioedema, anaphylaxis II Cytotoxicreactionsmediatedbydrug-specificIgGorIgM antibodies🡪Phagocytes,NKcells Haemolyticanemia Thrombocytopenia III IgG-solubleantigen🡪complementimmunecomplex Vasculitis,serumsickness IV Delayed-typehypersensitivityreactions cellularimmunemechanisms IVa IFN-γ,TNF-α(Th1)🡪activationofMonocytes Contactdermatitis IVb IL5,IL4,IL13(Th2)🡪activationofEosinophils MPE,DRESS IVc Perforin/GranzymeB(CTL)🡪activationofCD4+orCD8+T cells SJS,TEN,MPE,DRESS IVd IL8,GM-CSF🡪activationofNeutrophils AGEP PichlerWJ.Delayeddrughypersensitivityreactions.AnnInternMed2003:139:683-93 Suetal.Vaccine.2020Feb11;38(7):1746-1752. MPE-maculopapulareruption,DRESS–drugreactionseosinophiliawithsystemicsymptoms,SJS-StevensJohnsonSyndrome,TEN-Toxicepidermalnecrolysis,AGEP–acute generalizedexanthematouspustulosis ImmunologicallymediatedAEFIs TheGell&CoombsSystemofHypersensitivity
- 24. ReportsofTypeIVhypersensitivityto COVID-19vaccine Pfizer/BioNTech AstraZeneca 1st dose 2nd dose 1st dose 2nd dose Administered(million) 11.2 6.2 21.2 2.3 Erythemamultiforme 16 17 SJS/TEN 3(1SJS,2TEN) 6(5SJS,1TEN) Fixeddrugeruption 1 2 DRESS 0 10 ExfoliativeDermatitis 42 75 UKMedicinesandHealthcareproductsRegulatoryAgency(MHRA)reports (9/12/20-14/4/21) MPE-maculopapulareruption;SJS-StevensJohnsonSyndrome;TEN–toxicepidermalnecrolysis;DRESS-drugeruptioneosinophiliawithsystemic symptoms https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting(accessedon23/4/21)
- 27. WhatarethePOTENTIALALLERGENSin COVID-19Vaccines? Vaccine&manufacturer Comirnaty®(BNT162b2) (Pfizer-BioNTech) CoronaVac (Sinovac,China) Convidecia (CanSinoBiologics) ChAdOx1 (Oxford/ AstraZeneca) SputnikV (Gamaleya ResearchInst) JanssenCOVID-19 Vaccine (JanssenBiotechInc.) Activeimmunizing antigens/Vaccine Platform Nucleoside-modifiedmRNAencodingtheviral spikeglycoproteinofSARS-CoV-2 Inactivated vaccine (inactivated with β-propiolacto ne) Replication-defec tiveAd5vectors expressingthe full-lengthspike gen Replicationdeficient Viralvectorvaccine (adenovirusfrom chimpanzees) Non-replicating, two-component vector.Component1consists ofarecombinantadenovirus vectorbasedonthehuman adenovirustype26,containing theSARS-CoV-2Sproteingene. recombinant, replication-incomp etentadenovirus type26expressing theSARS-CoV-2 spikeprotein Culturemedia None Verocells ?Producercell line humanembryonickidney (HEK)293cells ?Producercellline ?Producercellline Additives(including antibiotics, preservatives, stabilizers, adjuvants,inactive residues) (4-hydroxybutyl) azanediyl)bis (hexane6,1-diyl)bis(2hexyldecanoate)] (ALC0315),2[(polyethylene glycol)-2000]-N,Nditetradecylacetamide (ALC-0159), 1,2-Distearoyl-snglycero-3phosphocholine cholesterol,potassiumchloride,potassium dihydrogenphosphate,sodiumchloride, disodiumhydrogenphosphatedehydrate, sucrose,waterforinjection Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride Notavailableyet L-Histidine,L-Histidine Hydrochloridemonohydrate, Magnesiumchloride hexahydrate, polysorbate80, Ethanol,Sucrose, Sodiumchloride, Disodiumedetate dihydrate,Waterfor Injection Tris(hydroxymethyl) aminomethane, sodiumchloride, sucrose,magnesium chloridehexahydrate, SodiumEDTA, polysorbate80, ethanol,waterfor injection citricacid monohydrate, trisodiumcitrate dihydrate,ethanol, 2-hydroxypropyl- β-cyclodextrin (HBCD), polysorbate-80, sodiumchloride. Turneretal.WorldAllergyOrganJ.2021Feb;14(2):100517.
- 28. Polyethyleneglycols(PEG)allergy? Caballeroetal.JAllergyClinImmunolPract.2021:S2213-2198(21)00302-0. WenandeEetal.ClinExpAllergy.2016Jul;46(7):907-22. Turneretal.WorldAllergyOrganJ.2021Feb;14(2):100517. Personwhohashypersensitivityreactions(HSR) 1. PEG-containingbowelpreparations 2. RepeatedHSRstounrelateddrugsand products(labelledas“Idiopathic anaphylaxis”) 3. Certainbrandnamesordosesofthesame drug 4. HSRstoPEGylateddrugs/productswhere hypersensitivitytotheactivedrug/ingredient isexcluded 5. HSRsfollowinginvasiveproceduresor perioperativeHSR 6. PEGderivatives
- 32. Canapatientwithahistoryofanallergic reactionreceiveaCOVID-19Vaccine? USCDC UKCOVID-19: TheGreenbookChapter14a Allergicreactions(includingsevereallergicreactions)notrelatedto vaccines(COVID-19orothervaccines)orinjectabletherapies,suchas allergicreactionsrelatedtofood,pet,venom,orenvironmentalallergies, orallergiestooralmedications(includingtheoralequivalentsof injectablemedications),arenotacontraindicationorprecautionto COVID-19vaccination.ThevialstoppersofCOVID-19vaccinesarenot madewithnaturalrubberlatex,andthereisnocontraindicationor precautiontovaccinationforpeoplewithalatexallergy.Inaddition, becausetheCOVID-19vaccinesdonotcontaineggsorgelatin,peoplewith allergiestothesesubstancesdonothaveacontraindicationorprecaution tovaccination. ProceedwithVaccination ∙ previousallergicreaction (including anaphylaxis)to afood,insectstingandmost medicines(wheretriggerhasbeenidentified) ∙ familyhistoryofallergies ∙ previousnon-systemicreactiontoavaccine ∙ hypersensitivitytonon-steroidal anti-inflammatorydrugse.g.aspirin, ibuprofen ∙ mastocytosis https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=htt ps%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fpfizer%2Fclinical-considera tions.html https://assets.publishing.service.gov.uk/government/uploads/system /uploads/attachment_data/file/961287/Greenbook_chapter_14a_v7 _12Feb2021.pdf
- 33. WhataretheCONTRAINDICATIONS fortheCOVID-19Vaccine? USCDC UKCOVID-19: TheGreenbookChapter14a ∙ Severeallergicreaction(e.g.,anaphylaxis)afteraprevious doseortoacomponentoftheCOVID-19vaccine. ∙ Immediateallergicreactionofanyseveritytoapreviousdose orknown(diagnosed)allergytoacomponentofthevaccine ∙ priorsystemicallergicreactiontotheCOVID-19vaccine ∙ foranmRNA-basedCOVID19vaccine,priorallergic reactiontoanothermRNAvaccine ∙ priorallergicreactiontoacomponentofthevaccine, includingPEG https://www.cdc.gov/vaccines/covid-19/info-by-product/clinicalconsiderations.html?CD C_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-produc t%2Fpfizer%2Fclinical-considerations.html https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attach ment_data/file/961287/Greenbook_chapter_14a_v7_12Feb2021.pdf
- 34. WhataretheSPECIAL PRECAUTIONS(NotContraindication) fortheCOVID-19Vaccine? USCDC UKCOVID-19: TheGreenbookChapter14a ∙ Historyofanimmediateallergicreactiontoanyothervaccine orinjectabletherapy(i.e.,intramuscular,intravenous,or subcutaneousvaccinesortherapies[excludingsubcutaneous immunotherapyforallergies,i.e.,“allergyshots”]) ∙ historyofimmediateanaphylaxistomultiple,different drugclasses,withthetriggerunidentified(thismay indicatePEGallergy) ∙ historyofanaphylaxistoavaccine,injectedantibody preparationoramedicinelikelytocontainPEG(e.g.depot steroidinjection,laxative) ∙ historyofidiopathicAnaphylaxis https://www.cdc.gov/vaccines/covid-19/info-by-product/clinicalconsiderations.html?CDC_ AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2 Fpfizer%2Fclinical-considerations.html https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attach ment_data/file/961287/Greenbook_chapter_14a_v7_12Feb2021.pdf
- 36. Whatisourrecommendation? 2)theOrange&(3)theRed SpecialPrecautions Vaccinationcontraindicated 1. Historyofanaphylaxistopreviousvaccine 2. Historyofanaphylaxistoinjectablemedicinesor substancespossiblycontainingpolyethylene glycol(PEG)orpolysorbate¶ . 3. Historyofanaphylaxistomultipledifferentdrug classes 4. Historyofidiopathicanaphylaxis 1.Severe allergic reaction (e.g. anaphylaxis, SCARs) after a previous dose or to any ingredient§ oftheCOVID-19vaccine 2. Allergic reaction of any severity within 72 hours after a previous dose or any known (diagnosed) allergy to any ingredient§ of the COVID-19vaccine. 5. Allergictowardsanyvaccine Forpoints1-4: DonotadministerComirnaty® (Pfizer-BioNTechvaccine);chooseaCOVID-19 vaccinewithoutPEGorpolysorbate Forpoint5: DonotadministerCoronaVac® (Sinovac) ∙ RefertoHospitalvaccinationcentre ∙ Donotvaccinatewiththesamevaccinein question ∙ ChooseadifferentCOVID-19vaccinethatis notcontraindicatedifavailable ∙ Considerreferraltoallergists/immunologists ifnoothervaccineavailable Patient Characteristics Actions
- 38. Areantipyretics allowedforvaccination? TheimpactofNSAIDsonreactogenicityandimmunogenicityofvaccine Saleh et al. Hum Vaccin Immunother 2016;12:2391–2402 Gross et al. Clin Diagn Lab Immunol 1994; 1:134–138 Doedee et al. PLoS ONE 2014; 9:e98175 Falup-Pecurariuet al. Hum. Vaccin. Immunother 2017;13:649–660 Karambinet al. Int J Prev Med 2015;6:124 Antipyretic Impactonreactogenicity Impactonimmunogenicity Administeredprophylactically (atthetimeofvaccinationand withinthefollowing24h) ↓tenderness,↓fever,↓swelling, ↓pain ↓Antibodyresponsein5of13 pneumococcalserotypes,hepatitis, diphtheria,tetanus.Impactwaslowerafter seconddose Administeredtherapeutically ↓pain,↓fever,↓swelling Noimpact Administeredprophylactically (atthetimeofvaccinationand withinthefollowing24h) Limitedimpact ↓antibodyresponseinpertussistoxin, tetanus.Noimpactaftertheseconddose. Administeredtherapeutically ↓pain,↓fever Noimpact Paracetamol Ibuprofen
- 39. Areantihistamines allowedforvaccination? UsedasTreatment√ • Continuepatient’sregularantihistaminesforthe underlyingallergicconditionssuchasAllergicrhinitis andChronicspontaneousurticaria • Touseforthetreatmentofpost-vaccinationlocalor systemicsymptoms UsedasPre-medications? • CDC:Routineprophylacticadministrationofthese medicationsforthepurposeofpreventing post-vaccinationsymptomsisnotcurrently recommended https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/961287/Greenbook_chapter_14a_v7_12Feb2021.pdf Kounisetal.Vaccines(Basel).2021Mar5;9(3):221.
- 41. Ifyouare contraindicatedforseconddose… 1. Leaveitasonedoseofvaccine 2. Toreceiveadi erenttypeofvaccine a) RestartthedoubledoseofadifferentvaccineegSinovac b) Touseasingle-dosevaccineegCanSino,J&JJanssen
- 45. MalaysiaCOVID-19vaccine AdverseEventReport(25/2/21-13/4/21) DatafromtheMOHMalaysia preparedbyNationalPharmaceuticalRegulatoryAgency(NPRA) Country Anaphylaxis Comirnaty® (case/milliondoses) USCDC 5 USMGB employees 270 UK 15.4 Malaysia 17.1 Japan 45.6
- 47. Takehomemessage 1. Peoplewithunderlyinghistoryofallergiescanbevaccinatedwith COVID-19vaccines,observefor30minutespostvaccination • Watchoutforthecontraindicationsandprecautions 2. Vaccineallergyincludinganaphylaxishasbeenobservedfollowing COVID-19vaccination,butRARE • Watchoutforthosewithpossiblepolyethyleneglycol(PEG)&polysorbateallergy • Donotgivetheseconddoseinthosewhohaveallergytothefirstdose • Useantipyreticsandantihistamineswhenmedicallyneeded 3. AEFIreportingisimportantforlocalvaccinedatabase&policy implementation
- 48. Thankyou WHO