Transcription of Administration
1 :ALLUNDERSECRETARIESANDASSISTANTSECRETAR IES;DIRECTORSOFBUREAUS,SERVICESANDCENTER SFORHEALTHDEVELOPMENT;MINISTEROFHEALTH BANGSAMOROAUTONOMOUSREGIONINMUSLIMMINDAN AO;EXECUTIVEDIRECTORSOFSPECIALTYHOSPITAL SANDNATIONALNUTRITIONCOUNCIL; ,SANITARIAANDINSTITUTES;PRIVATESECTORPAR TNERS;ANDOTHERSCONCERNEDSUBJECT:InterimG uidelinesontheAdministrationandManagemen tofCOVID-19 VaccineBooster/AdditionalDosestoPriority GroupA2:SeniorCitizensages60vearsoldand aboveandPriorityGroupA3 ,2021,thePhilippineFoodandDrugAdministra tion(FDA)issuedanamendmentintheEmergency UseAuthorization(EUA)toallowadministrati onofadditional/ ; ; (DM) :EssentialWorkersinFrontlineHealthServic es( ).Followingtheobjectivesofthe NationalCOVID-19 VaccineDeploymentandVaccinationProgramin ensuringreductionofmortalityfromCOVID-19 andpreservationofhealthsystemcapacity,th e DOHissuestheseinterimguidelinesfor theadministrationofCOVID-19additionaland boosterdosestothePriorityGroupsA2: SeniorCitizensand A3:Building1,SanLazaroCompound,RizalAven ue, ,1003 Manila TrunkLine651-7800local1108,1111,1112,111 3 DirectLine:711-9502.
2 711-9503 Fax:743-1829 theEUAissuedbythe ,immunocompromisedindividualsoftenfailto mountaprotectiveimmuneresponseafterastan dardprimaryseries, ,when,withtime,vaccineeffectivenesshasfa llenbelowaratedeemedsufficientinthatpopu lation, , theapprovedEUAissuedbythePhilippineFDA(R efertoAnnexAforthecopyoftheEUA) (Pfizer-BioNTech) (Moderna) (Sinovac) (AstraZeneca) ,dosingandschedule, Administration ,contra indications,warnings,adversereactions,an dusewithothervaccinesshallfollowtheprodu ct-specificEUAprovidedbythe themanagementofAdverseEffectsFollowingIm munization(AEFIs)andAdverseEventsofSpeci alInterest(AESIs)shallfollowtheprovision softheapprovedCOVID-19vaccineEUAoftheFDA ,succeedingguidelinesfromtheFDA,andother recognizedprofessionalorganizationsandre gulatorybodies, (AEFI) ,screening,counselling,vaccinerecipientr eporting,andAEFI monitoringandreferralshallfollowDepartme ntMemorandum2021-0099or InterimOmnibusGuidelinesfortheImplementa tionoftheNationalVaccineDeploymentPlanfo rCOVID-19",DM2021-0175or FurtherClarificationoftheNationalDeploym entandVaccinationPlanforCOVID-19 VaccinesandAdditionalGuidelinesforSinova cVaccineImplementation ,DM2021-0218or FurtherClarificationontheNationalVaccina tionDeploymentPlanonHealthScreeningandMa nagementofAdverseEventsFollowingImmuniza tion ,DM2021-0220or InterimGuidelinesonAdverseEventsFollowin gImmunization(AEFI)CommunityManagementan dCrisisCommunicationsRelatedtoCOVID-19 Vaccines , :SeniorCitizensages60yearsand such, DM ImplementingGuidelinesforPriorityGroupA3 and FurtherClarificationoftheNationalDeploym entandVaccinationPlan forCOVID-19 Vaccines onPriorityGroupA3eligibilityisclarifiedt oincludeimmunocompromisedconditionsident ifiedbytheWHO-SAGE.
3 (RefertoAnnexBforthedefinitionofimmunoco mpromisedpersonsfromtheWHO-SAGE InterimRecommendationsforanextendedprima ryserieswithanadditionalvaccinedoseforCO VID-19vaccinationinimmunocompromisedpers onsasofOctober ) :IndividualswithComorbiditiesinimmunocom petentstate( ) A3 : PriorityGroupA2 : :IndividualswithComorbiditiesinimmunocom petentstate(othercomorbidities). and A3shallbegiventheoptiontochoosewhetherhe /sheshallreceiveahomologousoraheterologo usboosterdose, doserequirementsperbrandbasedonthecomput ednumberofPriorityGroupA2andA3duetorecei vetheboosterandadditionaldoses, ,atleastsix(6)monthsaftercompletionofthe primarydoseseriesofthefollowingvaccines: Pfizer-BioNTech,Moderna,Sinovac,Gamaleya ,andAstraZenecaCOVID-19vaccines;andatlea stthree(3) (Janssen) (halfoftheregulardose) .SinovacCOVID-19 A3maychoosetoreceivethesamebrandastheirp rimaryseries(homologousbooster)oranother brand(heterologousbooster).(RefertoAnnex CfortheSummaryTableonRecommendedBoosterD oseCombinationforPriorityGroupsA2andA3) ,withspecialprecautionsasstatedinthe SinovacCOVID-19primarydoseseriesmaybegiv enwithAstraZeneca,Pfizer,oraModernaCOVID -19 ,oraModernaCOVID-19 ,Pfizer,oraModernaCOVID-19 (Janssen)COVID-19primarydoseseriesmaybeg ivenwithAstraZeneca,Pfizer,oraModernaCOV ID-19 ( )arenotrecommendedtobeboostedwitholdvacc ineplatforms( ).
4 ( )arerecommendedtobeboostedwithadifferent vaccineplatform,duetothetheoreticalpossi bilityofpre-existingimmunityattenuatingo rweakeningthe immuneresponseonthesecondorthirddose..Va ccinerecipientswithaprevioushistoryofadv ersereactionsafteradministrationofCOVID- 19vaccineandpopulationswithhigherriskfor adversereactions(suchastheelderly,people withcomorbidities,peoplepronetobloodclot s,myocarditis,andanaphylaxis)shallconsul ttheirattendingphysicianfor ,entitled InterimOmnibusGuidelinesfortheImplementa tionoftheNationalVaccineDeploymentPlanfo rCOVID-19". (Janssen) .MedicalCertificateforPriorityGroupA3 ,risks, (RefertoAnnexDforthetemplate). (RefertoAnnexEforthetemplate).Inthehealt hassessmentarea, Thevaccinationteamshallprovideanothervac cinationcardfor (RefertoAnnexFforthetemplate).Vaccinatio nsites .UsedifferentvaccinecarriersforCOVID-19 ,includingthequickcountnumbersonthedoses administeredandtheinventoryandthecomplet edlinelist,totheLGUwherethevaccinationis located, ,the ( ) Likewise,thelinelistshallbeupdatedtoincl udeanewcolumnwithheader Booster/Additionaldose.
5 :Response,includingclinicalmanagement,na vigationandreferral, ,musthaveanestablishedreferralsystemforp romptmanagementofAEFI,includingbutnotlim itedtoanaphylaxis,myocarditisand/orperic arditisandothercardiovasculareventsandrh ythmdisorders,thromboticthrombocytopenia syndromeor vaccine-inducedthrombosis~~withthrombocy topenia,immunethrombocytopenicpurpura,se izuredisorders,Guillain-Barr Syndrome,Bell'spalsy,erythemamultiforme, transversemyelitis,capillaryleaksyndrome ,thromboembolicevents,asepticencephaliti s,acutedisseminatedencephalomyelitis,acu tekidneyinjury,acuteliverinjury,acutepan creatitis,rhabdomyolysis, ,the latestversionoftheAEFICaseInvestigationF orm(CIF)shallbeusedinallAEFI casesofCOVID-19vaccines, versions,togetherwiththetrainingmaterial s,maybeaccessedanddownloadedthroughtheli nk, ,underthefolder AEFICaseInvestigationForm . ,Local,andRegionalESUs, approvingauthority ,investigation, ,orremarksaredeemedincompleteorinadequat efromthetransmittedreportsordocumentsPre viouslypublishedguidelinesrelevanttoAEFI shallremainineffectforallrecipientsofvac cinesundertheCOVID-19 VaccinationProgram,regardlessofagegroup, vaccinebrand, AEFI surveillance, :Gettingadditional/boostershotsisstillvo luntarybutrecommendedtopeoplewhoareatahi gherriskforsevereCOVID-19orwithhigherexp osuretothedisease:Al,A2, (a)consistentwiththe EUAandthe DOHguidelines,and(b) ,itisstillimportanttoensureenoughcoverag efor theprimaryseriesand :MARIAROSARIOS/VERGEIRE,MD,MPH,CESO11 UndersecretaryofHealthPublicHealthServic e Team10 ANNEXA: COVID-19 VaccinesEUAforAdditional/BoosterDosesRep ublicofthe PhilippinesDepartmentofHealthFOODANDDRUG Administration [ , , ,ManilaSubject.]
6 COVID-19 Vaccines(Additional/BoosterDoses)DearUnd erecretaryVergeire,Thisreferstoyourreque stdatedOctober22,2021askingthe FoodandDrugAdministration(FDA)toreviewan damendtheEmergencyUseAuthorization 1ssued COVID-19 Vaccinestoallowthe ,therecommendationoftheDepartmentofScien ceandTechnologyVaccineExpertPanel(DOST-V EP),andtherecognitionandrelianceaccorded toemergencyuseauthorizationsgivenbymatur eand establishedNationalRegulatoryAuthorities (NRA)suchasthe UnitedStatesofAmerica, ,theDepartmentofHealth(DOH)isgivenauthor izationfor theemergencyuseofCOVID19vaccineadditiona l/boosterdoseaslistedinANNEXAT hescopeof workers18yearsofageorolderwithfrequentin stitutionaloroccupationalexposuretoSARS- CoV-2:2:0swhomayfailtomountanadequateres ponse10aprimaryseriesofichasseniorcitize nsandpatients18yearsofageorolderwhoareno sedwithimmunocompromisedconditions; , ,therecommendationand ,thebenefitsofvaccinationstilloutweighth erisksCivicDrive,FilinvestCity,Alabang17 81 Muntinlupa,PhilippinesTrunkLine 6328371900 Fan+63180 Website:www{dagovtEmail:nfa@idaAssenten2 se Todate,thefollowingEUAholdershaveapplied for variationforhomologousand/orheterologous useofboosters:Pfizer,Inc,AstraZenecaPhar maceuticals(Phils).}
7 IPBiotech, (PAITC).Heterologouscombinationswerealso reviewedbasedonthe listrecommendedbytheHealthTechnologyAsse ssmentCouncil(HTAC)Theforegomgconsidered ,DOHshallassumeprimaryresponsibilityfort heuseofCOVID-19 VaccinesasboosterdosesunderEUA, , ,Intheinterestofachievingtheoptimaleffec tsofvaccinationin thepopulation,FDAmaintainsthatitisimport anttocompletetherecommendeddosesofthepri maryregimenin themajorityofthepublic,andthe administrationofCOVID-19boostersshouldbe recommendationsandprecautionsfromthe DOST-VEP(ANNEXB)foryourguidanceSincerely , :ADDITIONAL/BOOSTERCOMBINATIONSP rimaryVaccine|"Proposedadditionaldose| ,Pfizer Modema | |L5. |11 Sinovac_|SpumikLight~~| | aJ| | Atleast2-3 * | | |24. ModernaSputnikLightaDAtleast 6 months[725 SpumikvPfizer|Component|&Component?|Astr azenecaELModerna ll|| !| | 'For2deme*$fugvacemedoseas3dosehocsterfo rMadamiii"us6 ANNEXB:RECOMMENDATIONSANDPRECAUTIONSFROM THEDOST-VEPN ewvaccineplatforms( )arenotrecommendedtobe haostedwitholdvacemeplatforms( inactivated)Therecommendationfortheboost ercombinationisbasedontheavailablethird( 3) ( ,HumanAd26)attenuatingtheimmuneresponseo n2*or3% ,AstrazenecausingaChimpanzeeAdenovirusve ctorisrecommendedtobe boostedwithHumanAdeno26vector-basedvacci nessuchasSputnikLightandJanssen,orviceve rsa,Higheradversereactionsareexpectedamo ngheterologousboostingespeciallywithmRNA vaccinesthusshouldbeconsideredespecially forpopulationswithhigherriskforadversere actions(reelderly,peoplewithcomorbidines ,peoplepronetobloodclots,myocarditis,and anaphylaxis,etc)Itis notedthatno vaccinefor3"boostershot issuperiortootherCOVID-19vaccinesbasedon thecurrentavailableevidenceastherecommen dationisonlybasedonimmunogenicitydata andthere1sstil!]
8 Theadditionaldose3 dose/boosterisbasedonimmunogenicitydatag eneratedfromtheimmunocompromisedandelder lywhichis2-3monthspost-2 dose,whileatleast6monthsforthegeneralpop ulation(18yearsold andabove).Definitionofimmunocompromisedp atientswillfollowthe definitionset ( ) ( )shouldcontinuetobeimplementedEvolvingda tawillbe monitoredtoassessifcurrentrecommendation sstill standorifanyamendment'swill Oct26,2021( ) ,onlymoderatelytoseverslyimmunocompromiz adpersonswill be (322 Annex|forLiteranurereviewmethods) ,asincludedintheserecommendationsGroupDe tailsActivecancer ActiveimmuncsuppressiveTeatmentfor selidumoewrorkasmarolezicalmaliznancy(mc hidineleukaemia, mveloma),orwithir12menthsofendinzsuchtre atmentTransplantrecipients| Receiptofsolidorzanmansplantardfakingimm unosuppressivethermpy Receiotofstamcellwansplant( )Immunodeficiency Seversprimaryimmunodeficiency ChronicdialyssHIV HIV withacurrent{D4cellcountof<200cells' , (1. advancedHIVdisease)Immunosuppressives ,antimetabolites,wmansplant-relatedimmun osuppressivedrugscancerchemotherapeutica gents,fumour-pecresisfacter(TNF)blockers ,orotherhighlyimmunosuppressivedrugs+Imm unosuppressivechemotherapyorradiotherapy withinthepast6 monthsvANNEXC:RecommendedBoosterDoseComb inationforPriorityGroupsA2andA3 PrimaryIntervalfor Booster|HomologousBooster|HeterologousBo osterVaccinationSinovacAtleast6monthsSin ovacAstrazenecaPfizerModernaAstrazenecaA tleast6monthsAstraZeneca*PfizerModernaPf izerAt least6monthsPfizerAstrazenecaModernaMode rnaAtleast6monthsModernaAstrazenecaPfize rGamaleyaSputnikAt least6months-AstrazenecaPfizerModernaJan ssenAtleast3months-AstrazenecaPfizerMode rna*Precautionincludedin the BoosterDosesof COVID-19 Vaccine( )Name:Address:Occupation:Healthfacility. }
9 INFORMEDCONSENT1confirmthat|havebeenprov idedwithandhavereadtheCOVID-19 VaccineModerna/Pfizer-BioNTech/AstraZene ca/SinovacEmergencyUseAuthorization(EVA) InformationSheetandthesamehas theseCOVID-19 |havebeenscreenedfor benefitsandrisksofreceivingaadditional/b oosterdoseoftheCOVID-19vaccineand|unders tandthepossiblerisksif1amnotvaccinatedwi thanadditional/boosterdose.|wasprovideda nopportunitytoaskquestions,allofwhichwer eadequatelyandclearlyanswered.|,therefor e,voluntarilyreleasethe GovernmentofthePhilippines,the vaccinemanufacturer,theiragentsandemploy ees,aswellasthehospital,the medicaldoctorsandvaccinators,fromallclai msrelatingtothe resultsoftheuseand administrationof, effectsareminorandresolveontheirown,ther eisasmallriskofsevereadversereactions,su chas,butnotlimitedtoallergiesandbloodclo tsassociatedwithlowplateletcounts(vaccin e-inducedthromboticthrombocytopenia),hea rtconditions( )and thatshouldpromptmedicalattentionbeneeded ,referraltothenearesthospitalshallbeprov idedimmediatelybytheGovernmentofthePhili ppines.
10 |havebeengivencontactinformationforfollo wupforanysymptomswhichImayexperienceafte rvaccination.|understandthatby signingthisForm,|havearighttohealthbenef itpackagesunderthePhilippineHealthInsura nceCorporation(PhilHealth),incase|suffer asevereand/orseriousadverseevent,whichis foundtobeassociatedwiththeseCOVID-19vacc ineoritsadministration.|understandthat therighttoclaimcompensationissubjecttoth eguidelinesof thePhilHealthNINFORMEDCONSENTFORMFORADDI TIONAL/BOOSTERDOSESOFCOVID-19 VACCINEof thePhilippineNationalCOVID-19 VaccineDeploymentandVaccinationProgramas ofNovember19,2021 Birthdate:Sex:ContactNumber:PrimaryCOVID -19 VaccineSeries:1authorizereleasingallinfo rmationneededforpublichealthpurposesincl udingreportingtoapplicablenationalvaccin eregistries, theCOVID-19 VaccineModerna/Pfizer-BioNTech/Sinovac/A straZenecaSignatureoverDatePrintedNameIn caseeligibleindividualisunabletosign:Iha vewitnessedtheaccuratereadingoftheconsen tformandliabilitywaivertotheeligibleindi vidual;sufficientinformationwasgivenandq ueriesraisedwereadequatelyanswered.
