Eric J. Holcomb Governor - Indiana

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Eric J. HolcombGovernorKristina M. Box, MD, FACOGState Health CommissionerStatewide Protocol for the Administration of Vaccines by Other ProvidersA.IntroductionThis protocol is pursuant to Indiana Code 16-19-4-11 which authorizes the state healthcommissioner or a designated public health authority who is a licensed prescriber to issue astatewide protocol allowing individuals who are licensed, certified, or registered by a board(as defined in IC 25-1-9-1), and if within the individual's scope of practice, to administer ordispense an immunization that is recommended by the federal Centers for Disease Controland Prevention Advisory Committee on Immunization Practices (ACIP) for individuals who arenot less than eleven (11) years of age. This includes any FDA authorized COVID-19 vaccine.The protocol outlined below is designed to reduce the morbidity and mortality of vaccinepreventable disease by creating a statewide vaccination protocol to allow providers to accessthe need for, educate patients on, administer, monitor for, and manage adverse effectsrelated to, and document the administration of vaccines.B.AuthorizationSubject to the requirements of this Protocol, eligible providers meeting the qualificationsspecified in Section C below and applicable law and regulation may:– determine the immunization needs in accordance with recommendations by the ACIPof the CDC;– screen all patients for contraindications and precautions for vaccine(s) needed usingan appropriate screening questionnaire (see Appendix A-C as examples) and vaccine‐specific screening as set forth in other Appendices as stipulated in this protocol;– administer vaccines according to directions provided in section K of this protocol; and– administer epinephrine and/or diphenhydramine in response to an adverse reactionfollowing vaccination as delineated in this protocol.C.–D.–QualificationsAn eligible provider seeking authorization to administer vaccines pursuant to thisprotocol shall be licensed, certified, or registered by a board (as defined in IC 25-1-91) and able to administer immunizations within their scope of practice.Limitations on ImmunizationAny vaccine authorized pursuant to this protocol shall not be administered to anypersons under the age of eleven (11) years.To promote, protect, and improve the health and safety of all Hoosiers.2 North Meridian Street Indianapolis, Indiana 46204 317-233-1325 health.in.govAn equal opportunity employer.

Standing Order for Administration of Vaccines – Other Providers December 15, 2020Page 2E.–Protocol, Facility, and EquipmentEligible providers who administer vaccines under this protocol shall review a currentcopy of this protocol.F.Patient ConsentBefore administering a vaccine to an individual according to this protocol, the provider mustreceive the consent of one (1) of the following:– If the individual to whom the vaccine is to be administered is at least eleven (11) yearsof age but less than eighteen (18) years of age, the parent or legal guardian of theindividual.– If the individual to whom the vaccine is to be administered is at least eighteen (18)years of age but has a legal guardian, the legal guardian of the individual.– If the individual to whom the vaccine is to be administered is at least eighteen (18)years of age but has no legal guardian, the individual.A parent or legal guardian who is required to give consent under this subdivision must bepresent at the time of vaccination or must provide prior written or verbal consent for theadministration of the vaccine.G.–––Vaccination RecordA vaccination record (see Appendix D and Appendix E as examples) shall be createdfor the patient;A copy of the patient’s vaccination record and notification of vaccination to thepatient’s primary care provider shall be kept for seven (7) years in accordance with IC16-39-7-1;The vaccination record shall contain the following information as recommended bythe ACIP General Best Practice Guidelines for Immunization:o Patient’s nameo Patient’s date of birtho Date the vaccine was administeredo Vaccine administration route/siteo Vaccine manufacturero Vaccine lot numbero Edition date of vaccine immunization schedule (VIS) distributedo Date of VIS was distributed to the patiento Name and title of the provider who administered the vaccineo Address of location vaccine was administered

Standing Order for Administration of Vaccines – Other Providers December 15, 2020Page 3H.––I.––Reporting RequirementsProviders who administer vaccines under this protocol shall electronically report thevaccination of each patient to the immunization data registry maintained by the statedepartment of health under IC 16-38-5.o The following patients shall be excluded from immunization data registryreporting requirements: a written immunization data exception form has been completedand filed in accordance with IC 16-38-5-2; oro Pursuant to IC 16-38-5-2, the minimum vaccination data that must be providedare the following: Patient identification number Patient first and last name Patient date of birth Patient address Patient race Patient gender Vaccine for Children program eligibility, if the patient is eligible forthe Vaccine for Children program Dose at the administration level under the Vaccination for childrenprogram, if the patient is eligible for the Vaccine for Childrenprogram Vaccination presentation or vaccination code using approvedImmunization Information System (IIS) code type Immunization Date administered Lot number of the administered vaccineThe State department may expand or modify the list of minimum data thatmust be provided under this section based on Centers for Disease ControlImmunization Information System (IIS) minimum field requirements.The provider who administers the vaccine shall report vaccination-related adverseevents the provider has knowledge of to the Vaccine Adverse Events ReportingSystems (VAERS), the cooperative program for vaccine safety of the Centers forDisease Control and Prevention and the Food and Drug Administration.Management of Adverse EventsPer ACIP General Best Practice Guidelines for Immunization, the patient who isadministered a vaccine should be monitored for adverse effects for at least fifteen (15)minutes in the general vicinity of the administering provider.In the event of an adverse reaction, the administering provider is to follow theprocedures for the management of the reaction. The procedures for managingadverse reactions are set forth in Appendix F and Appendix G.

Standing Order for Administration of Vaccines – Other Providers December 15, 2020Page 4J.–VaccinesEligible providers who administer vaccines under this protocol shall be authorized toadminister any vaccine that is recommended by ACIP in the absence ofcontraindication to the vaccine. This includes any FDA authorized COVID-19 vaccine.This protocol shall be reviewed annually by the state department of health and revised asneeded. This protocol shall remain valid for the duration of the standing order. AppendixesA-L shall be updated as necessary.Last Updated December 15, 2020

Appendix Table of ContentsAppendix A: Children and Teenagers Vaccination Screening FormAppendix B:HPV, MenACWY, MenB, and Tdap Vaccination Screening FormAppendix C: Adult Vaccination Screening FormAppendix D: Children and Teen Vaccination Record FormAppendix E:Adult Vaccination Record FormAppendix F:Management of Vaccination-related Adverse Reactions in Children and TeensAppendix G: Management of Vaccination-related Adverse Reactions in AdultsAppendix H: Vaccine Specific InformationAppendix I:CDC Children Immunization ScheduleAppendix J:CDC Catch-Up Immunization ScheduleAppendix K:CDC Adult Immunization ScheduleAppendix L:Travel Vaccination ResourceIn the event of a conflict between information provided in the package inserts and ACIP guidelines,providers administering vaccines pursuant to this protocol should adhere to ACIP guidelines.5

Appendix A: Children and Teenagers Vaccination Screening FormThis form is available at Screening Checklist for Contraindications to vaccines for Children andTeens.6

Appendix B: HPV, MenACWY, MenB, and Tdap Vaccination Screening FormThis form is available at Screening Checklist for Contraindications to HPV, MenACWY, MenB, andTdap.7

Appendix C: Adult Vaccination Screening FormThis form is available at Screening Checklist for Contraindications to Vaccines for Adults.8

Appendix D: Children and Teen Vaccination Record FormThis form is available at Vaccine Administration Record for Children and Teens.9

Appendix E: Adult Vaccination Record FormThis form is available at Vaccine Administration Record for Adults.10

Appendix F: Management of Vaccination-related Adverse Reactions in ChildrenThis form is available at Medical Management of Vaccine Reaction in Children and Teens.11

Appendix G: Management of Vaccination-related Adverse Reactions in AdultsThis form is available at Medical Management of Vaccine Reactions in Adult Patients.12

Appendix H: Vaccine Specific InformationThe following information was obtained from current ACIP guidelines, CDC Travelers’ Health, and CDC's U.S Vaccine Names:ImmunizationDiphtheria andtetanus toxoids(DT)Tetanus anddiphtheriatoxoids (Td)Name/StrengthDTTenivac PatientPopulation6 months-6yearsDose0.5 mLRoute tionsPrecautions1.2.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine component3. 7 years4.tetanus toxoid,reduceddiphtheriatoxoid, andacellularpertussis(Tdap)Adacel Boostrix 10-64 years0.5 mLIMDeltoid5.6.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentEncephalopathy (e.g.,coma, decreased levelof consciousness,prolonged seizures), notattributable to anotheridentifiable cause,within 7 days ofadministration ofprevious dose of DTP,DTaP, or Tdap7.8.GBS 6 weeks afterprevious dose oftetanus-toxoid–containing vaccineHistory of Arthus-typehypersensitivityreactions after aprevious dose ofdiphtheria-toxoid—containing or tetanustoxoid–containingvaccine; deferimmunization until atleast 10 years haveelapsed since the lasttetanus-toxoidcontaining vaccineModerate or severeacute illness with orwithout feverGBS 6 weeks after aprevious dose oftetanus-toxoid–containing vaccineProgressive orunstable neurologicaldisorder, uncontrolledseizures, orprogressiveencephalopathy untila treatment regimenhas been establishedand the condition hasstabilized

9.10.Diphtheria andtetanus toxoidsand acellularpertussis(DTaP)Daptacel Infanrix 6 weeks-6years0.5 mLIMDeltoid11.12.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentEncephalopathy (e.g.,coma, decreased levelof consciousness,prolonged seizures), notattributable to anotheridentifiable cause,within 7 days ofadministration ofprevious dose of DTP orDTaP13.14.15.16.17.14History of Arthus-typehypersensitivityreactions after aprevious dose ofdiphtheria-toxoid—containing or tetanustoxoid–containingvaccine; deferimmunization until atleast 10 years haveelapsed since the lasttetanus-toxoid–containing vaccineModerate or severeacute illness with orwithout feverProgressiveneurologic disorder,including infantilespasms, uncontrolledepilepsy, progressiveencephalopathy;defer DTaP untilneurologic statusclarified andstabilizedTemperature of 105 F ( 40.5 C) within48 hours afterimmunization with aprevious dose of DTPor DTaPCollapse or shock-likestate (i.e., hypotonichyporesponsiveepisode) within 48hours after receivinga previous dose ofDTP/DTaPSeizure 3 days afterreceiving a previousdose of DTP/DTaPPersistent,inconsolable crying

18.19.Haemophilusinfluenzae typeb (Hib)ActHIB Hiberix PedvaxHIB Unimmunized:1 dose0.5 mLIMDeltoid20.Hepatitis A(HepA)Harvix Vaqta 18 years0.5 mLIMDeltoid21.23. 19 years1.0 mL 19 years0.5 mL(a)IMDeltoid25.Hepatitis B(HepB)RecombivaxHB ; EngerixB 26.Heplisav-B 18 years0.5 mLIMDeltoid28.29.RecombivaxHB ; EngerixB 20 years1.0 mLIMDeltoid1531.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentAge 6 weeksSevere allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentSevere allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentHypersensitivity toyeastSevere allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentHypersensitivity toyeastSevere allergic reaction(e.g., anaphylaxis) after22.lasting 3 hours within48 hours afterreceiving a previousdose of DTP/DTaPGBS 6 weeks afterprevious dose oftetanus-toxoid–containing vaccineHistory of Arthus-typehypersensitivityreactions after aprevious dose ofdiphtheria-toxoid–containing or tetanustoxoid–containingvaccine; deferimmunization until atleast 10 years haveelapsedModerate or severeacute illness with orwithout fever24.Moderate or severeacute illness with orwithout fever27.Moderate or severeacute illness with orwithout fever30.Moderate or severeacute illness with orwithout fever33.Moderate or severeacute illness with orwithout fever

32.HepA-HepBTwinrix 18 years1.0 ine (IIV3)Quadrivalentinactivatedinfluenzavaccine (IIV4)Afluria 5 yearsFluvirin 4 yearsFluzone 6 monthsAfluria 5 yearsFluarix 3 yearsFluLaval 6 monthsFluzone 6 months0.5 mLIMDeltoid37.0.5 mLIMDeltoid41.16a previous dose or to avaccine componentHypersensitivity toyeastSevere allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentHypersensitivity toyeastSevere allergic reaction(e.g., anaphylaxis) afterprevious dose ofinfluenza vaccine or tovaccine component.Severe allergic reaction(e.g., anaphylaxis) afterprevious dose ofinfluenza vaccine or tovaccine component.36.38.Moderate or severeacute illness with orwithout feverGBS 6 weeks after aprevious dose ofinfluenza vaccine39.Moderate or severeacute illness with orwithout fever40.Egg allergy otherthan hives, e.g.,angioedema,respiratory distress,lightheadedness,recurrent emesis; orrequired epinephrineor anotheremergency medicalintervention (IIV maybe administered in aninpatient or outpatientmedical setting andunder the supervisionof a health careprovider who is ableto recognize andmanage severeallergic conditions).42.GBS 6 weeks after aprevious dose ofinfluenza vaccine43.Moderate or severeacute illness with orwithout feverEgg allergy other than hives,e.g., angioedema, respiratorydistress, lightheadedness,

Trivalentinactivatedinfluenzavaccine (IIV3)Fluad Fluzone HighDose 65 years0.5 mLIMDeltoid44.Severe allergic reaction(e.g., anaphylaxis) afterprevious dose ofinfluenza vaccine or tovaccine component.Trivalent cellculture basedinactivatedinfluenzavaccine (ccIIV3)Flucelvax 4 years0.5 mLIMDeltoid48.Severe allergic reaction(e.g., anaphylaxis) afterprevious dose ofinfluenza vaccine or tovaccine component.17recurrent emesis; or requiredepinephrine or anotheremergency medicalintervention (IIV may beadministered in an inpatient oroutpatient medical setting andunder the supervision of ahealth care provider who isable to recognize and managesevere allergic conditions).45.GBS 6 weeks after aprevious dose ofinfluenza vaccine46.Moderate or severeacute illness with orwithout fever47.Egg allergy otherthan hives, e.g.,angioedema,respiratory distress,lightheadedness,recurrent emesis; orrequired epinephrineor anotheremergency medicalintervention (IIV maybe administered in aninpatient or outpatientmedical setting andunder the supervisionof a health careprovider who is ableto recognize andmanage severeallergic conditions).49.GBS 6 weeks after aprevious dose ofinfluenza vaccine50.The tip caps of thepre-filled syringesmay contain naturalrubber latex whichmay cause allergic

Quadrivalentcell culturebasedinactivatedinfluenzavaccine (ccIIV4)FlucelvaxQuadrivalent RecombinantInfluenzavaccine (RIV)Flubok Inactivatedinfluenzavaccine (IIV),IntradermalFluzoneIntradermal (trivalent andquadrivalentavailable) 4 years 18 years withegg allergy18-64 years0.5 mL0.5 mL0.1 mLIMIMIDDeltoidDeltoidDeltoid51.54.57.Severe allergic reaction(e.g., anaphylaxis) afterprevious dose ofinfluenza vaccine or tovaccine component.52.Severe allergic reaction(e.g., anaphylaxis) to anycomponent of thevaccine55.Severe allergic reaction(e.g., anaphylaxis) afterprevious dose ofinfluenza vaccine or tovaccine component.58.53.56.59.60.18reactions in latexsensitive individuals.GBS 6 weeks after aprevious dose ofinfluenza vaccineThe tip caps of thepre-filled syringesmay contain naturalrubber latex whichmay cause allergicreactions in latexsensitive individuals.GBS 6 weeks after aprevious dose ofinfluenza vaccineModerate or severeacute illness with orwithout feverGBS 6 weeks after aprevious dose ofinfluenza vaccineModerate or severeacute illness with orwithout feverEgg allergy otherthan hives, e.g.,angioedema,respiratory distress,lightheadedness,recurrent emesis; orrequired epinephrineor anotheremergency medicalintervention (IIV maybe administered in aninpatient or outpatientmedical setting andunder the supervisionof a health careprovider who is ableto recognize andmanage severeallergic conditions).

Measles,mumps, andrubella(MMR)(b)(c)M-M-R II 12 months0.5 o 2 months-55yearsMenactra 9 idevaccine(MPSV4)MeningococcalSerogroup B(MenB)Menomune Pneumococcalconjugate(PCV13)Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentPregnancyKnown severeimmunodeficiency (e.g.,from hematologic andsolid tumors, receipt mimmunosuppressivetherapy(d) or patientswith HIV infection whoare severelyimmunocompromised)Family history of alteredimmunocompetenceSevere allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine component66.71.Moderate or severeacute illness with orwithout fever67.68.69.Recent ( 11 months)receipt of antibodycontaining bloodproduct (specificinterval depends onproduct)History ofthrombocytopenia orthrombocytopenicpurpuraNeed for tuberculinskin testing orinterferon-gammarelease assay (IGRA)testing(f)Moderate or severeacute illness with orwithout fever0.5 mLIMDeltoid70. 2 years0.5 mLSubcutFattytissueovertriceps72.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine component73.Moderate or severeacute illness with orwithout feverBexsero Trumenba 10-25 years0.5 mLIMDeltoid74.75.Moderate or severeacute illness with orwithout feverPrevnar 13 6 weeks0.5 mLIMDeltoid76.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentSevere allergic reaction(e.g., anaphylaxis) aftera previous dose ofPCV13 or anydiphtheria-toxoid–containing vaccine or toa component of avaccine (PCV13 or any77.Moderate or severeacute illness with orwithout fever19

Pneumococcalpolysaccharide(PPSV23)Pneumovax23 2 years0.5 mLIM orSubcutHumanpapillomavirus(HPV)Gardasil 9Gardasil 9-26 years0.5 mLIMCervarix Females 9-25yearsInactivatedpoliovirus (IPV)Ipol 6 weeks0.5 mLIM or SubcutVaricella(Var)(b)(c)Varivax 12 months0.5 mLSubcutDeltoidor fattytissueovertricepsDeltoid78.80.Deltoidor erate or severeacute illness with orwithout feverSevere allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine component81.82.PregnancyModerate or severeacute illness with orwithout fever83.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine component84.85.PregnancyModerate or severeacute illness with orwithout fever86.Severe allergic reaction(e.g., anaphylaxis) aftera previous dose or to avaccine componentKnown severeimmunodeficiency (e.g.,from hematologic andsolid tumors, receipt mimmunosuppressivetherapy(d) or patientswith HIV infection whoare severelyimmunocomp

Eric J. Holcomb Governor Kristina M. Box, MD, FACOG State Health Commissioner 2 North Meridian Street Indianapolis, Indiana 46204 317-233-1325 health.in.gov An equal opportunity employer. To promote, protect, and improve the health and safety of all Hoosiers. Statewide Protocol for the Administration of Vaccines by Other Providers

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