COVID-19 Vaccines and Autoimmune Hematologic Disorders 2022 María Eva Mingot-Castellano.pdf

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Review
COVID-19VaccinesandAutoimmuneHematologicDisorders
MaríaEvaMingot-Castellano1,*,NoraButta2,MarianaCanaro3,MaríadelCarmenGómezdelCastilloSolano4,
BlancaSánchez-González5,ReyesJiménez-Bárcenas6,CristinaPascual-Izquierdo7,
GonzaloCaballero-Navarro8,LauraEntrenaUreña9,TomásJoséGonzález-López10andonbehalfoftheGEPTI11,†
1HematologyDepartment,HospitalUniversitarioVirgendelRocío,InstitutodeBiomedicinade
Sevilla(IBIS/CSIC),41013Sevilla,Spain
2HospitalUniversitarioLaPaz-IdiPAZ,28046Madrid,Spain;******@
3HematologyDepartment,HospitalUniversitarioSonEspases,07210Palma,Spain;******@
4HematologyDepartment,HospitalGeneraldelaCoruña,15006ACoruña,Spain;
.******@
5HematologyDepartment,HospitaldelMar,08003Barcelona,Spain;******@
6HematologyDepartment,HospitalSerraníadeRonda,29400Ronsa,Spain;******@
7SpainDepartmentofHematology,GregorioMarañónGeneralUniversityHospital(HGUGM)Madrid,
Insti-tutodeInvestigaciónGregorioMarañón,28009Madrid,Spain;******@
8HematologyDepartment,HospitalUniversitarioMiguelServet,50009Zaragoza,Spain;
******@
9HematologyDepartment,HospitalUniversitarioVirgendelasNieves,18014Granada,Spain;
laura_******@
10HematologyDepartment,HospitalUniversitariodeBurgos,09006Burgos,Spain;
******@
11GrupoEspañoldePTI,28040Madrid,Spain;******@
Citation:Mingot-Castellano,.;*Correspondence:.******@
Butta,N.;Canaro,M.;delCarmen†AlltheauthorsfromthisgroupareincludedinAcknowledgmentspart.
GómezdelCastilloSolano,M.;
Sánchez-González,B.;Abstract:WorldwidevaccinationagainstSARS-CoV-2hasallowedthedetectionofhematologic
Jiménez-Bárcenas,R.;(AEs)ofthisnaturehadbeenpreviouslyobservedin
Pascual-Izquierdo,C.;
,although
Caballero-Navarro,G.;Entrena
Ureña,L.;González-López,T.;-,al-
COVID-19VaccinesandthoughtheincidenceoftheseAEsisextremelylow,theirevolutionmayleadtolife-threatening

Vaccines2022,10,://withbothmRNAandadenoviralvector-basedSARS-CoV-
/vaccines10060961secondaryimmunethrombocytopenia,immunethromboticthrombocytopenicpurpura,autoimmune
hemolyticanemia,Evanssyndrome,andanewlydescribeddisorder,so-calledvaccine-induced
AcademicEditor:
immunethromboticthrombocytopenia(VITT).ThehallmarkofVITTisthepresenceofanti-platelet
Received:-
Accepted:
Published:16June2022ofhematologicautoimmuneAEsdoesnotdiffersigniflcantlyfromthatofthesedisordersinanon-
Publisher’sNote:MDPIstaysneutralvaccinecontext,thusaddressingautoantibodyproductionandbleeding/
withregardtojurisdictionalclaimsinmeansthatcliniciansmustbeawareoftheirdistinctivesignsinordertodiagnosethemandinitiate
publishedmapsandinstitutionalaffll-treatmentassoonaspossible.
iations.
Keywords:COVID-19;vaccines;ITP;VITT;TTP;AIHAandEvanssyndrome;antiphospholipid
syndrome;catastrophicantiphospholipidsyndrome
Copyright:©2022bytheauthors.
LicenseeMDPI,Basel,Switzerland.
Thisarticleisanopenaccessarticle

distributedunderthetermsand
conditionsoftheCreativeCommonsTheexceptionalscenarioconditionedbythesuddenoutbreakofSARS-CoV-2infection
Attribution(CCBY)license(https://allovertheworldpromptedthesearchforvaccinesthatareefflcientandeasytomanufac-

/).thatsuccessfullypassedphaseIIItrialsand,thus,,
Vaccines2022,10,:///vaccines10060961:.
Vaccines2022,10,9612of23
theextendeduseinthereal-worldofdrugsthathavesuccessfullypassedthetestofclinical
trialsofteninvolvestheemergenceofadverseevents(AEs).Althoughtheseareinfrequent
andwillnottipthebalancetowardsproductwithdrawal,theycanbeseriousandtheir
,thisphenomenonoccurredwhenCOVID-19


oftheseepisodesaremildandtransient,seriousAEs(SAEs)areoccasionallydescribed
that,albeitrarely,
isnotunexpected,sincehumoralimmuneresponsetovaccinationinvolvestheproduction
ofantibodiesagainstforeignantigensthat,occasionally,couldmimicself-
oftenaffectedbyautoimmunedisordersincludeplatelets,,it
isnotsurprisingthathematologicautoimmunedisordersareassociatedwithSARS-CoV-2
vaccines,eitherthemRNAoradenoviralvector-basedones.
Whenahematologicautoimmunedisorderdevelopsfollowingvaccination,aprompt
andaccuratediagnosisisessentialtoinitiatetheappropriatetreatmentandavoidbleeding
orthromboemboliccomplicationsthatmaysometimesbelife-
autoimmunedisordersofahematologicnaturethathavebeenlinkedtoSARS-CoV-2
.
Wheresuggested,potentiallyinvolvedmechanismslinkingvaccinesandautoimmune
,guidelinestofollowinordertopromptlyrecognizeand
managethesecomplicationsareprovided.

Inordertoselecttheeligiblestudieswhoseresultswouldbeconsideredacompre-
hensiveupdateabouttheAEsofhematologicautoimmunenaturereportedinthecontext
ofCOVID-19infection,theauthorssearchedthePubMedregistryandtheregularup-
datesoftheEuropeanDatabaseofSuspectedAdverseDrugReaction(EudraVigilance),
UnitedKingdomMedicines&HealthcareProductsReleasedRegulatoryAgency(MHRA),
Health-InfobaseGovernmentofCanada,andtheVaccineAdverseEventsReportingSystem
(VAERS).ThesearchcriteriaconsistedofconsideringallreportsregardingphaseIIIclinical
trialsandthereal-worlduseofvaccines,statingthatanyhematologicAEhadoccurred.

enumeratingAEs,thescarcityofavailableliteraturepromptedustoconsiderallstatements
addressingtheoccurrenceofhematologicAEs,eveniftheinformationwasincomplete.
Thechosenkeywordsorwordcombinationstotracktheinformationofinterest
wereCOVID-19,vaccines,ITP,VITT,TTP,AIHA,AntiphospholipidandEvanssyndrome,
autoimmunedisorder,thrombocytopenia,andanemia.
-19Vaccines
Morethan100vaccineshavebeendevelopedagainstSARS-CoV-2,26ofwhichhave
beenevaluatedinphaseIIIclinicaltrialsaccordingtotheWorldHealthOrganization
(WHO)[1].Thesecanbestratifledintouptoflvedifferentcategoriesaccordingtohow

attenuatedvirus,althougheffective,-
vationmaynotbediscarded,andeverybatchneedstobechecked[2].Thedevelopmentof
antibodydiseaseenhancement(ADE)syndromeduetonon-neutralizingantibodiesmay
beariskwhich,intheCOVID-19scenario,canincreaselungpathology[3].Furthermore,
therewasaneedforquicklyavailable,-based
,their
lipidnanoparticle-basedplatformisrobustandefflcient,andcanberapidlyproducedat
,theyarebeingwidelyused,atleastinWesterncountries,
inspiteofthechallengeraisedbythepoorstabilityofmRNA-basedproductsthatlimits
storageperiodsandmaycompromiseinvivoactivity[4].:.
Vaccines2022,10,9613of23
Theaforementionedcategoriesareinactivated-virusvaccines,mRNAvaccines,DNA
vaccines,viralvectorvaccinesandprotein--virusvaccines

byformalin,
drawback,andadjuvantsand/[5]containthe
mRNAoftheantigenofinterest,whichenterscellsandistranslatedintothecorresponding

responseandtheyareeasiertostoreandtherouteofadministrationmaynotbeexclusively
intramuscular,
,
whichareoftenemployed,havealsobeenusedasnon-envelopeddoublestrandedDNA
(dsDNA)forgenetherapypurposes,becausetheencodedgenecanbedeliveredintohuman
cellswithoutintegratinginthehumangenome[6].Finally,protein-basedvaccinesare
,
fromwhichtheproteinispurifled,arecombinantprotein,virus-infectedcells,orvirus-like
,andaddinganadjuvantmightbe
needed[7].SupplementaryTableS1showswhichcategoryeachoneofthe26COVID-19

featuresofthemostwidelyusedones.
,mechanismofproduction,storage,efflcacy,andadverseeventsofvaccines
againstCOVID-19.
CompoundManufacturerMechanismDosesIntervalStorageEfflcacy
(TradeName)Needed(C)(%)
BNT162b2Pflzer/BioNTechmRNA221d7095
(Comirnaty)
mRNA-1273(Spikevax)
ChAdOx1nCoV-19(Vaxzevria)AstraZeneca/OxfordAdV-vectored24–12wk2–870
&JohnsonAdV-vectored1-2–
Gam-COVID-Vac(SputnikV)GamaleyaResearchInstituteAdV-vectored221d1892
Ad5-nCoVCanSinoAdV-vectored1-
(Convidecia)
NVX-
(Covovax)
EpiVacCoronaVectorInstituteProteinsubunit221d2–.
(Aurora-CoV)
BBIBP-CorV(Covilo)Sinopharm(Beijing)Inactivatedvirus221–28d2–879
WIBP-CorVSinopharm(Wuhan)Inactivatedvirus214–21d2–
Verocell(CoronaVac)SinovacBiotechInactivatedvirus228d2–850–
BBV152(Covaxin)BharatBiotechInactivatedvirus228d2–881
AdV,adenovirus;d,days;.,notavailable;wk,weeks.
Keyconcepts
Therearecurrentlymanydifferentwaysofproducingvaccines.
Obstaclesordisadvantagesmaybestorage,stability,orlowimmunogenicity.
-19Vaccines
COVID-,the
needforreadyavailabilitypromptedtheapprovalofvaccineswhosestudiesregarding
sideeffectsandefflcacyinvolvedshorterthandesirablefollow-
on,casesofmoderatetosevereadverseevents(AEs)associatedtoSARS-CoV-2vaccines

regularly,andreportsarebeingmadeavailableviadatabasesandagenciessuchasthe
EuropeanDatabaseofSuspectedAdverseDrugReaction(EudraVigilance),theUnited
KingdomMedicines&HealthcareProductsReleasedRegulatoryAgency(MHRA),the
Health-InfobaseGovernmentofCanada,ortheVaccineAdverseEventsReportingSystem
(VAERS).AEsarealwaysclassifledaccordingtotheCommonToxicityCriteria(CTC)cate-:.
Vaccines2022,10,9614of23
gories[8–11].BetweenDecember2020andMarch2022,1,114,386,127dosesoffourdifferent
COVID-19vaccines,twoofthemmRNA-basedandtheothertwousingadenovirusas
vectors,wereadministeredintheEuropeanUnion,UnitedKingdomandCanada.
Table2depictstheamountofdosesadministereduptoMarch2022,includingfre-
quencyandtypesofcommonAEsandseriousAEs(SAEs)correspondingtoeachtypeof
vaccine,accordingtotheinformationreleasedbytheaforementioneddatabasesandarticles
concerningclinicaltrials[8–15].Globalnumbersofc