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)

3 ,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.

4 (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).

5 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( ). ( )arerecommendedtobeboostedwithadifferent vaccineplatform,duetothetheoreticalpossi bilityofpre-existingimmunityattenuatingo rweakeningthe immuneresponseonthesecondorthirddose.

6 Vaccinerecipientswithaprevioushistoryofa dversereactionsafteradministrationofCOVI D-19vaccineandpopulationswithhigherriskf oradversereactions(suchastheelderly,peop lewithcomorbidities,peoplepronetobloodcl ots,myocarditis,andanaphylaxis)shallcons ulttheirattendingphysicianfor ,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.

7 :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.

8 ,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.]

9 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.

10 , ,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).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.}