TABLE OF CONTENTS Pediatric Immunization Standards Adult Immunization Standards General Recommendations Immunization Resources Screening Tools Vaccine Administration Anaphylaxis VAERS Georgia School Requirements (3231 REQ) Vaccine Storage and Handling Recommended & Minimum Ages & Intervals Comvax DTaP Td/Tdap Catch-up Vaccination for Td/Tdap Haemophilus Influenzae type B (Hib) Hib Vaccination Schedule Tables Hepatitis A (HepA) Hepatitis B (HepB) Human Papillomavirus Vaccine (HPV) Influenza (IIV3 & IIV4) Influenza (LAIV) Polio (IPV) Meningococcal Conjugate Vaccine B Meningococcal (MCV4) Meningococcal (MPSV4) Meningococcal Vaccination Recommendations Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, Varicella (MMRV) Varicella MMR/VAR/IG and Antibody Table Pediarix Pentacel PPSV 23 PCV13 (Prevnar 13) Rotavirus vaccine Herpes Zoster Vaccine (Zostavax) 4 5-6 7 9 11-14 15-16 17 18 19-20 21 23-24 25 27 29 31 33 34 35 37 39 41 42 45 47 49 50 51 53 57 59 63 65 67 69 71 73 75 1 2 FROM THE EDITOR VACS FACTS was developed and produced by the EPIC (Educating Physicians In their Communities) program at the Georgia Chapter of the American Academy of Pediatrics and the Immunization Office, Georgia Department of Public Health. A special thanks to Penny Conner, BSN, RN, Janet McGruder, MSN, RN and Ben Sloat, MPH with the Immunization Office for their hard work and dedication which made this edition of VACS FACTS possible. The editors would also like to thank the Georgia Chapter American Academy of Pediatrics and other EPIC partners, the Georgia Academy of Family Physicians, Georgia OBGyn Society, Georgia Chapter-American College of Physicians (Internal Medicine) and the Immunization Office for their support & participation in the EPIC Immunization Program. The contents of this handbook were derived from the following publications & source documents: -Department of Health & Human Services - National Vaccine Advisory Committee -Immunization Action Coalition -2012 Report of the Committee on Infectious Disease, American Academy of Pediatrics, Red Book -CDC Advisory Committee on Immunization Practices recommendations The material published in this edition of VACS FACTS is current as of March 2015. For the most up-to-date immunization information readers are advised to visit the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) website at: www.cdc.gov/vaccines/acip/index.html For more information on EPIC or to schedule an EPIC Immunization Program in your office, contact the Georgia EPIC program by calling 404-881-5054 or email: smcclain@gaaap.org or visit our website at www.GAepic.org 3 STANDARDS FOR CHILD & ADOLESCENT IMMUNIZATION PRACTICES Availability of vaccines 1. Vaccination services are readily available. 2. Vaccinations are coordinated with other health care services and provided in a medical home when possible. 3. Barriers to vaccination are identified and minimized. 4. Patient costs are minimized. Assessment of vaccination status 5. Health care professionals review the vaccination and health status of patients at every encounter to determine which vaccines are indicated. 6. Health care professionals assess for and follow only medically accepted contraindications. Effective communication about vaccine benefits and risks 7. Parents/guardians and patients are educated about the benefits and risks of vaccination in a culturally appropriate manner and in easy-to-understand language. Proper storage and administration of vaccines and documentation of vaccinations 8. Health care professionals follow appropriate procedures for vaccine storage and handling. 9. Up-to-date, written vaccination protocols are accessible at all locations where vaccines are administered. 10. People who administer vaccines and staff who manage or support vaccine administration are knowledgeable and receive ongoing education. 11. Health care professionals simultaneously administer as many indicated vaccine doses as possible. 12. Vaccination records for patients are accurate, complete, and easily accessible. 13. Health care professionals report adverse events after vaccination promptly and accurately to the Vaccine Adverse Events Reporting System (VAERS) and are aware of a separate program, the Vaccine Injury Compensation Program (VICP). 14. All personnel who have contact with patients are appropriately vaccinated. Implementation of strategies to improve vaccination coverage 15. Systems are used to remind parents/guardians, patients, and health care professionals when vaccinations are due and to recall those who are overdue. 16. Office or clinic-based patient record reviews and vaccination coverage assessments are performed annually. 17. Health care professionals practice community-based approaches. From the National Vaccine Advisory Committee (NVAC), 2003 4 5 " !# $ $ %& %& " $ ## ! ! " $ " $ %""! &" $ ! %&! " $ " $ %&" $ " $ %&" $ " $ ! " $ " $ ## " $ ## " $ " $ " 5 + !% ' + " ! ! !% ' + !( $( " ! !% "! ! # ! " $!% ! # " " $' + ! $&" $& ! !% ' + " )" ! !! ! # # ) #"!% " ! ! ' + # !% ! " " # ! " & " & ! ' + ! !% ' + & $%& !% ' + "! ! " !' + !% " ' + !% $ !$" " ! ' + " $ !% !' + ! $ ! " ) " ' + #&! & ! !% ' ! ( *.,-/(!-.0 6 GENERAL RECOMMENDATIONS APPLYING TO SPACING AND ADMINISTRATION OF ROUTINELY RECOMMENDED CHILDHOOD VACCINES 1) Simultaneous administration. This recommendation states that there are no contraindications to the simultaneous administration of any of the routinely recommended vaccines included on the current ACIP schedule. The only exception to this rule is that PCV and PPV should be separated by 8 weeks. 2) No minimum time intervals between the administration of 2 different inactivated vaccines. For example, you could give a DTaP one day and a HIB the next, or 2 weeks later. Again, the one exception is for doses of PCV and PPV. 3) If 2 different live virus vaccines are not administered on the same day, they must be separated by at least 4 weeks. This would apply specifically to doses of MMR and varicella, if not administered on the same day. 4) If 2 different live injectable vaccines are given <28 days apart, the one given second should be repeated 28 days after the second or invalid dose. 5) This recommendation states that vaccine doses should not be given at intervals less than the minimum intervals or earlier than the minimum age. Table 1 of the General Recommendations gives all the minimum intervals and ages for each dose of the recommended childhood vaccines. 6) The 4 day grace period In 2002 the ACIP instituted what is referred to as the grace period, for use in evaluating immunization records. Basically, it states that doses given 4 days before the minimum age or interval may be counted as valid doses. The exception to this is in regard to the spacing of doses of MMR and varicella. This rule should be used primarily for evaluating records, NOT for scheduling visits. In Georgia, this rule does not conflict with the requirements for school and day care. This is not true in some states. 7) If vaccines are administered later than the recommended schedule: Do not start over Do not repeat doses Continue with the rest of the series according to recommended intervals and ages. 8) The importance of administering vaccines by the recommended routes and sites. It does, however, state that in evaluating records, all doses given by nonstandard routes and sites may be accepted except: Rabies and hepatitis B given in the gluteus Hepatitis B not given IM Continue to discard and repeat vaccines given in "divided doses" Do not mix vaccines unless they are licensed to be mixed. 9) The use of a combination vaccine generally is preferred over separate injections of its equivalent component vaccines. Considerations should include provider assessment*, patient preference, and the potential for adverse events. *Provider assessment should include the number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, and storage and cost consideration. 10) Contraindications and precautions are circumstances that dictate when vaccines should not be administered. A contraindication is a condition in the recipient that increases the risk for a serious adverse reaction. A precaution is a condition in the recipient that might increase the risk for a serious adverse reaction. In some circumstances it may be necessary to weigh benefits vs. risks, as in an outbreak. 06/2010 7 8 IMMUNIZATION RESOURCE LIST American College of Physicians (Internal Medicine) www.acponline.org CDC National Immunization Information Hotline English (800) 232-2522 Spanish (800) 232-0233 www.cdc.gov/vaccines Georgia Academy of Family Physicians (404) 321-7445 www.gafp.org The American Congress of Obstetricians and Gynecologists www.acog.org Georgia Chapter - American Academy of Pediatrics (404) 881-5094 www.gaaap.org Georgia Office of Immunization (Department of Public Health) (404) 657-3158 www.dph.georgia.gov/immunization-section Georgia VFC Program (Department of Public Health) 404-657-5013 Vaccines for Children Program (800) 848-3868 www.dph.georgia.gov/vaccines-children-program GRITS (Department of Public Health) 404-463-0810 Health Department Phone #: ______________ Immunization Action Coalition www.immunize.org National Network for Immunization Information (NNII) www.immunizationinfo.org 9 10 Patient name: Date of birth: (mo.) (day) (yr.) Screening Checklist for Contraindications to Vaccines for Children and Teens For parents/guardians: The following questions will help us determine which vaccines your child may be given today. If you answer "yes" to any question, it does not necessarily mean your child should not be vaccinated. It just means additional questions must be asked. If a question is not clear, please ask your healthcare provider to explain it. Don't Yes No Know 1. Is the child sick today? 2. Does the child have allergies to medications, food, a vaccine component, or latex? 3. Has the child had a serious reaction to a vaccine in the past? 4. Has the child had a health problem with lung, heart, kidney or metabolic disease (e.g., diabetes), asthma, or a blood disorder? Is he/she on long-term aspirin therapy? 5. If the child to be vaccinated is 2 through 4 years of age, has a healthcare provider told you that the child had wheezing or asthma in the past 12 months? 6. If your child is a baby, have you ever been told he or she has had intussusception? 7. Has the child, a sibling, or a parent had a seizure; has the child had brain or other nervous system problems? 8. Does the child have cancer, leukemia, HIV/AIDS, or any other immune system problem? 9. In the past 3 months, has the child taken medications that weaken their immune system, such as cortisone, prednisone, other steroids, or anticancer drugs, or had radiation treatments? 10. In the past year, has the child received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? 11. Is the child/teen pregnant or is there a chance she could become pregnant during the next month? 12. Has the child received vaccinations in the past 4 weeks? Form completed by: ___________________________________________ Date:_________________ Form reviewed by: ___________________________________________ Date:_________________ Did you bring your child's immunization record card with you? yes no It is important to have a personal record of your child's vaccinations. If you don't have one, ask the child's healthcare provider to give you one with all your child's vaccinations on it. Keep it in a safe place and bring it with you every time you seek medical care for your child. Your child will need this document to enter day care or school, for employment, or for international travel. Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition Saint Paul, Minnesota 651-647-9009 www.immunize.org www.vaccineinformation.org www.immunize.org/catg.d/p4060.pdf Item #P4060 (1/15) 11 Information for Health Professionals about the Screening Checklist for Contraindications (Children & Teens) Are you interested in knowing why we included a certain question on the screening checklist? If so, read the information below. If you want to find out even more, consult the references listed at the bottom of this page. 1. Is the child sick today? [all vaccines] There is no evidence that acute illness reduces vaccine efficacy or increases vaccine adverse events (1, 2). However, as a precaution with moderate or severe acute illness, all vaccines should be delayed until the illness has improved. Mild illnesses (such as otitis media, upper respiratory infections, and diarrhea) are NOT contraindications to vaccination. Do not withhold vaccination if a person is taking antibiotics. 2. Does the child have allergies to medications, food, a vaccine component, or latex? [all vaccines] If a person has anaphylaxis after eating gelatin, do not administer MMR, MMRV, or varicella vaccine. A local reaction following a prior vaccine dose is not a contraindication to a subsequent dose. For a table of vaccines supplied in vials or syringes that contain latex, go to www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/ latex-table.pdf. For an extensive list of vaccine components, see reference 3. An eggfree recombinant influenza vaccine (RIV3) may be used in people age 18 years and older with egg allergy of any severity who have no other contraindications. Children and teens younger than age 18 years who have experienced a serious systemic or anaphylactic reaction (e.g., hives, swelling of the lips or tongue, acute respiratory distress, or collapse) after eating eggs can usually be vaccinated with inactivated influenza vaccine (IIV); consult ACIP recommendations (see reference 4). 3. Has the child had a serious reaction to a vaccine in the past? [all vaccines] History of anaphylactic reaction (see question 2) to a previous dose of vaccine or vaccine component is a contraindication for subsequent doses (1). History of encephalopathy within 7 days following DTP/DTaP is a contraindication for further doses of pertussis-containing vaccine. Precautions to DTaP (not Tdap) include the following: (a) seizure within 3 days of a dose, (b) pale or limp episode or collapse within 48 hours of a dose, (c) continuous crying for 3 or more hours within 48 hours of a dose, and (d) fever of 105F (40C) within 48 hours of a previous dose. There are other adverse events that might have occurred following vaccination that constitute contraindications or precautions to future doses. Under normal circumstances, vaccines are deferred when a precaution is present. However, situations may arise when the benefit outweighs the risk (e.g., during a community pertussis outbreak). 4. Has the child had a health problem with lung, heart, kidney, or metabolic disease (e.g., diabetes), asthma, or a blood disorder? Is he/she on long-term aspirin therapy? [LAIV] The safety of LAIV in children and teens with lung, heart, kidney, or metabolic disease (e.g., diabetes), or a blood disorder has not been established. These conditions, including asthma in children ages 5 years and older, should be considered precautions for the use of LAIV. Children on long-term aspirin therapy should not be given LAIV; instead, they should be given IIV. 5. If the child to be vaccinated is 2 through 4 years of age, has a healthcare provider told you that the child had wheezing or asthma in the past 12 months? [LAIV] Children ages 2 through 4 years who have had a wheezing episode within the past 12 months should not be given LAIV. Instead, these children should be given IIV. 6. If your child is a baby, have you ever been told that he or she has had intussusception? [Rotavirus] Infants who have a history of intussusception (i.e., the telescoping of one portion of the intestine into another) should not be given rotavirus vaccine. 7. Has the child, a sibling, or a parent had a seizure; has the child had brain or other nervous system problem? [DTaP, Td, Tdap, IIV, LAIV, MMRV] DTaP and Tdap are contraindicated in children who have a history of encephalopathy within 7 days following DTP/DTaP. An unstable progressive neurologic problem is a precaution to the use of DTaP and Tdap. For children with stable neurologic disorders (including seizures) unrelated to vaccination, or for children with a family history of seizures, vaccinate as usual (exception: children with a personal or family [i.e., parent or sibling] history of seizures generally should not be vaccinated with MMRV; they should receive separate MMR and VAR vaccines). A history of GuillainBarr syndrome (GBS) is a consideration with the following: 1) Td/Tdap: if GBS has occurred within 6 weeks of a tetanus-containing vaccine and decision is made to continue vaccination, give age-appropriate Tdap instead of Td if no history of prior Tdap, to improve pertussis protection; 2) Influenza vaccine (IIV or LAIV): if GBS has occurred within 6 weeks of a prior influenza vaccination, vaccinate with IIV if at high risk for severe influenza complications. 8. Does the child have cancer, leukemia, HIV/AIDS, or any other immune system problem? [LAIV, MMR, MMRV, RV, VAR] Live virus vaccines (e.g., MMR, MMRV, varicella, rotavirus, and the intranasal live, attenuated influenza vaccine [LAIV]) are usually contraindicated in immunocompromised children. However, there are exceptions. For example, MMR is recommended for asymptomatic HIV-infected children who do not have evidence of severe immunosuppression. Likewise, varicella vaccine should be considered for HIV-infected children with age-specific CD4+ T-lymphocyte percentage at 15% or greater and may be considered for children age 8 years and older with CD4+ T-lymphocyte counts of greater than or equal to 200 cells/L. Immunosuppressed children should not receive LAIV. Infants who have been diagnosed with severe combined immunodeficiency (SCID) should not be given a live virus vaccine, including rotavirus (RV) vaccine. Other forms of immunosuppression are a precaution, not a contraindication, to rotavirus vaccine. For details, consult the ACIP recommendations (1, 5, 6). 9. In the past 3 months, has the child taken medications that weaken their immune system, such as cortisone, prednisone, other steroids, or anticancer drugs, or had radiation treatments? [LAIV, MMR, MMRV, VAR] Live virus vaccines (e.g., MMR, MMRV, varicella, LAIV) should be postponed until after chemotherapy or long-term high-dose steroid therapy has ended. For details and length of time to postpone, consult the ACIP statement (1). To find specific vaccination schedules for stem cell transplant (bone marrow transplant) patients, see reference 7. LAIV can be given only to healthy non-pregnant individuals age 2 through 49 years. 10. In the past year, has the child received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? [LAIV, MMR, MMRV, VAR] Certain live virus vaccines (e.g., LAIV, MMR, MMRV, varicella) may need to be deferred, depending on several variables. Consult the most current ACIP recommendations or the current Red Book for the most current information on intervals between antiviral drugs, immune globulin or blood product administration and live virus vaccines (1, 2). 11. Is the child/teen pregnant or is there a chance she could become pregnant during the next month? [LAIV, MMR, MMRV, VAR] Live virus vaccines (e.g., MMR, MMRV, varicella, LAIV) are contraindicated one month before and during pregnancy because of the theoretical risk of virus transmission to the fetus (1, 3). Sexually active young women who receive a live virus vaccine should be instructed to practice careful contraception for one month following receipt of the vaccine (6, 8). On theoretical grounds, inactivated poliovirus vaccine should not be given during pregnancy; however, it may be given if risk of exposure is imminent (e.g., travel to endemic areas) and immediate protection is needed. Use of Td or Tdap is not contraindicated in pregnancy. At the provider's discretion, either vaccine may be administered during the 2nd or 3rd trimester (9). 12. Has the child received vaccinations in the past 4 weeks? [LAIV, MMR, MMRV, VAR, yellow fever] Children who were given either LAIV or an injectable live virus vaccine (e.g., MMR, MMRV, varicella, yellow fever) should wait 28 days before receiving another vaccination of this type. Inactivated vaccines may be given at the same time or at any spacing interval. References: 1. CDC. General recommendations on immunization, at www.cdc.gov/vaccines/pubs/acip-list.htm. 2. AAP. Red Book: Report of the Committee on Infectious Diseases at www.aapredbook.org. 3. Table of Vaccine Components: www.cdc.gov/vaccines/pubs/pinkbook/downloads/ appendices/B/excipient-table-2.pdf. 4. CDC. Prevention and control of seasonal influenza with vaccines: Recommendations of the ACIP--20142015 Influenza Season at www.cdc.gov/mmwr/pdf/wk/mm6332.pdf, pages 6917. 5. CDC. Measles, mumps, and rubella--vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps. MMWR 1998; 47 (RR-8). 6. CDC. Prevention of varicella: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2007; 56 (RR-4). 7. Tomblyn M, Einsele H, et al. Guidelines for preventing infectious complications among hemato- poietic stem cell transplant recipients: a global perspective. Biol Blood Marrow Transplant 15:1143 1238; 2009 at www.cdc.gov/vaccines/pubs/hemato-cell-transplts.htm. 8. CDC. Notice to readers: Revised ACIP recommendation for avoiding pregnancy after receiving a rubella-containing vaccine. MMWR 2001; 50 (49). 9. CDC. Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants: Recommendations of the ACIP. MMWR 2008; 57 (RR-4). Immunization Action Coalition Item #P4060 p. 2 12 Patient name: Date of birth: (mo.) (day) (yr.) Screening Checklist for Contraindications to Vaccines for Adults For patients: The following questions will help us determine which vaccines you may be given today. If you answer "yes" to any question, it does not necessarily mean you should not be vaccinated. It just means additional questions must be asked. If a question is not clear, please ask your healthcare provider to explain it. Don't Yes No Know 1. Are you sick today? 2. Do you have allergies to medications, food, a vaccine component, or latex? 3. Have you ever had a serious reaction after receiving a vaccination? 4. Do you have a long-term health problem with heart disease, lung disease, asthma, kidney disease, metabolic disease (e.g., diabetes), anemia, or other blood disorder? 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? 6. In the past 3 months, have you taken medications that weaken your immune system, such as cortisone, prednisone, other steroids, or anticancer drugs, or have you had radiation treatments? 7. Have you had a seizure or a brain or other nervous system problem? 8. During the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? 9. For women: Are you pregnant or is there a chance you could become pregnant during the next month? 10. Have you received any vaccinations in the past 4 weeks? Form completed by: ___________________________________________ Date:_________________ Form reviewed by: ___________________________________________ Date:_________________ Did you bring your immunization record card with you? yes no It is important for you to have a personal record of your vaccinations. If you don't have a personal record, ask your healthcare provider to give you one. Keep this record in a safe place and bring it with you every time you seek medical care. Make sure your healthcare provider records all your vaccinations on it. Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition Saint Paul, Minnesota 651-647-9009 www.immunize.org www.vaccineinformation.org www.immunize.org/catg.d/p4065.pdf Item #P4065 (1/15) 13 Information for Health Professionals about the Screening Checklist for Contraindications To Vaccines for Adults Are you interested in knowing why we included a certain question on the screening checklist? If so, read the information below. If you want to find out even more, consult the references listed at the bottom of this page. 1. Are you sick today? [all vaccines] There is no evidence that acute illness reduces vaccine efficacy or increases vaccine adverse events (1). However, as a precaution with moderate or severe acute illness, all vaccines should be delayed until the illness has improved. Mild illnesses (such as upper respiratory infections or diarrhea) are NOT contraindications to vaccination. Do not withhold vaccination if a person is taking antibiotics. 2. Do you have allergies to medications, food, a vaccine component, or latex? [all vaccines] If a person has anaphylaxis after eating gelatin, do not administer MMR or varicella vaccine. A local reaction to a prior vaccine dose or vaccine components (e.g., latex) is not a contraindication to a subsequent dose or vaccine containing that component. For a table of vaccines supplied in vials or syringes that contain latex, go to www.cdc.gov/vaccines/pubs/pinkbook/downloads/ appendices/B/latex-table.pdf. For an extensive list of vaccine components, see reference 2. An egg-free recombinant influenza vaccine (RIV3) may be used in people age 18 years and older with egg allergy of any severity who have no other contraindications. People younger than age 18 years who have experienced a serious systemic or anaphylactic reaction (e.g., hives, swelling of the lips or tongue, acute respiratory distress, or collapse) after eating eggs can usually be vaccinated with inactivated influenza vaccine (IIV); consult ACIP recommendations (see reference 3). 3. Have you ever had a serious reaction after receiving a vaccination? [all vaccines] History of anaphylactic reaction (see question 2) to a previous dose of vaccine or vaccine component is a contraindication for subsequent doses (1). Under normal circumstances, vaccines are deferred when a precaution is present. However, situations may arise when the benefit outweighs the risk (e.g., during a community pertussis outbreak). 4. Do you have a long-term health problem with heart disease, lung disease, asthma, kidney disease, metabolic disease (e.g., diabetes), anemia, or other blood disorder? [LAIV] The safety of intranasal live attenuated influenza vaccine (LAIV) in people with these conditions has not been established. These conditions, including asthma in adults, should be considered precautions for the use of LAIV. 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? [LAIV, MMR, VAR, ZOS] Live virus vaccines (e.g., LAIV, measles-mumps-rubella [MMR], varicella [VAR], zoster [ZOS]) are usually contraindicated in immunocompromised people. However, there are exceptions. For example, MMR vaccine is recommended and varicella vaccine should be considered for adults with CD4+ T-lymphocyte counts of greater than or equal to 200 cells/L. Immunosuppressed people should not receive LAIV. For details, consult the ACIP recommendations (1, 4, 5). 6. In the past 3 months, have you taken medications that weaken your immune system, such as cortisone, prednisone, other steroids, or anticancer drugs, or have you had radiation treatments? [LAIV, MMR, VAR, ZOS] Live virus vaccines (e.g., LAIV, MMR, VAR, ZOS) should be postponed until after chemotherapy or long-term high-dose steroid therapy has ended. For details and length of time to postpone, consult the ACIP statement (1, 3). To find specific vaccination schedules for stem cell transplant (bone marrow transplant) patients, see reference 6. LAIV can be given only to healthy non-pregnant people younger than age 50 years. 7. Have you had a seizure or a brain or other nervous system problem? [influenza, Td/Tdap] Tdap is contraindicated in people who have a history of encephalopathy within 7 days following DTP/DTaP given before age 7 years. An unstable progressive neurologic problem is a precaution to the use of Tdap. For people with stable neurologic disorders (including seizures) unrelated to vaccination, or for people with a family history of seizure, vaccinate as usual. A history of Guillain-Barr syndrome (GBS) is a consideration with the following: 1) Td/Tdap: if GBS has occurred within 6 weeks of a tetanus-containing vaccine and decision is made to continue vaccination, give Tdap instead of Td if no history of prior Tdap; 2) Influenza vaccine (IIV/LAIV): if GBS has occurred within 6 weeks of a prior influenza vaccine, vaccinate with IIV if at high risk for severe influenza complications. 8. During the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? [LAIV, MMR, VAR] Certain live virus vaccines (e.g., LAIV, MMR, VAR, ZOS) may need to be deferred, depending on several variables. Consult the most current ACIP recommendations for current information on intervals between antiviral drugs, immune globulin or blood product administration and live virus vaccines. (1) 9. For women: Are you pregnant or is there a chance you could become pregnant during the next month? [MMR, LAIV, VAR, ZOS] Live virus vaccines (e.g., MMR, VAR, ZOS, LAIV) are contraindicated one month before and during pregnancy because of the theoretical risk of virus transmission to the fetus. Sexually active women in their childbearing years who receive live virus vaccines should be instructed to practice careful contraception for one month following receipt of the vaccine. On theoretical grounds, inactivated poliovirus vaccine should not be given during pregnancy; however, it may be given if risk of exposure is imminent and immediate protection is needed (e.g., travel to endemic areas). Use of Td or Tdap is not contraindicated in pregnancy. At the provider's discretion, either vaccine may be administered during the 2nd or 3rd trimester. (1, 3, 4, 5, 7, 8) 10. Have you received any vaccinations in the past 4 weeks? [LAIV, MMR, VAR, yellow fever] People who were given either LAIV or an injectable live virus vaccine (e.g., MMR, VAR, ZOS, yellow fever) should wait 28 days before receiving another vaccination of this type. Inactivated vaccines may be given at any spacing interval if they are not administered simultaneously. References: 1. CDC. General recommendations on immunization, at www.cdc.gov/vaccines/ pubs/acip-list.htm 2. Table of Vaccine Components: www.cdc.gov/vaccines/pubs/pinkbook/downloads/ appendices/B/excipient-table-2.pdf. 3. CDC. Prevention and control of seasonal influenza with vaccines: Recommendations of the ACIP--20142015 Influenza Season at www.cdc.gov/mmwr/pdf/wk/ mm6332.pdf, pages 6917. 4. CDC. Measles, mumps, and rubella--vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps. MMWR 1998; 47 (RR-8). 5. CDC. Prevention of varicella: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2007; 56 (RR-4). 6. Tomblyn M, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic stem cell transplant recipients: a global perspective. Biol Blood Marrow Transplant 15:11431238; 2009 at www.cdc.gov/vaccines/pubs/hematocell-transplts.htm. 7. CDC. Notice to readers: Revised ACIP recommendation for avoiding pregnancy after receiving a rubella-containing vaccine. MMWR 2001; 50 (49). 8. CDC. Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants: Recommendations of the ACIP. MMWR 2008; 57 (RR-4). Immunization Action Coalition Item #P4065 p. 2 14 How to Administer Intramuscular (IM) Vaccine Injections Administer these vaccines by the intramuscular (IM) route: diphtheria-tetanus-pertussis (DTaP, Tdap); diphtheria-tetanus (DT, Td); Haemophilus influenzae type b (Hib); hepatitis A (HepA); hepatitis B (HepB); human papillomavirus (HPV); inactivated influenza (TIV); quadrivalent meningococcal conjugate (MCV4); and pneumococcal conjugate (PCV). Administer inactivated polio (IPV) and pneumococcal polysaccharide (PPSV23) either IM or SC. Patient age Injection site Needle size Needle insertion Newborn (028 days) Infant (112 months) Toddler (12 years) Children (318 years) Adults 19 years and older Anterolateral thigh muscle Anterolateral thigh muscle Anterolateral thigh muscle Alternate site: Deltoid muscle of arm if muscle mass is adequate Deltoid muscle (upper arm) Alternate site: Anterolateral thigh muscle Deltoid muscle (upper arm) Alternate site: Anterolateral thigh muscle "* (2225 gauge) 1"* (2225 gauge) 11" (2225 gauge) 1"* (2225 gauge) 1"* (2225 gauge) 11" (2225 gauge) 11"* (2225 gauge) 11" (2225 gauge) Use a needle long enough to reach deep into the muscle. Insert needle at a 90 angle to the skin with a quick thrust. (Before administering an injection of vaccine, it is not necessary to aspirate, i.e., to pull back on the syringe plunger after needle insertion.) Multiple injections given in the same extremity should be separated by a minimum of 1", if possible. 90 angle skin subcutaneous tissue muscle *A " needle usually is adequate for neonates (first 28 days of life), preterm infants, and children ages 1 through 18 years if the skin is stretched flat between the thumb and forefinger and the needle is inserted at a 90 angle to the skin. A " needle is sufficent in adults weighing less than 130 lbs (<60 kg) if the subcutaneous tissue is not bunched and the injection is made at a 90-degree angle; a 1" needle is sufficient in adults weighing 130152 lbs (6070 kg); a 11" needle is recommended in women weighing 152200 lbs (7090 kg) and men weighing 152260 lbs (70118 kg); a 1" needle is recommended in women weighing more than 200 lbs (>90 kg) or men weighing more than 260 lbs (>118 kg). CDC. "ACIP General Recommendations on Immunization" at www.immunize.org/acip IM site for infants and toddlers IM site for children and adults level of axilla (armpit) acromion IM injection site (shaded area) IM injection site (shaded area) elbow Insert needle at a 90 angle into the anterolateral thigh muscle. Insert needle at a 90 angle into thickest portion of deltoid muscle -- above the level of the axilla and below the acromion. Technical content reviewed by the Centers for Disease Control and Prevention. www.immunize.org/catg.d/p2020.pdf Item #P2020 (10/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN 55104 (651) 647-9009 www.immunize.org www.vaccineinformation.org admin@immunize.org 15 16 How to Administer Subcutaneous (SC) Vaccine Injections Administer these vaccines by the subcutaneous (SC) route: measles, mumps, and rubella (MMR), varicella (VAR), meningococcal polysaccharide (MPSV4), and zoster (shingles [ZOS]). Administer inactivated polio (IPV) and pneumococcal polysaccharide (PPSV23) vaccines either SC or IM. Patient age Injection site Needle size Needle insertion Birth to 12 mos. Fatty tissue over the anterolateral thigh muscle " needle, 2325 gauge 12 mos. and older Fatty tissue over anterolateral thigh or fatty tissue over triceps " needle, 2325 gauge Pinch up on subcutaneous (SC) tissue to prevent injection into muscle. Insert needle at 45 angle to the skin. (Before administering an injection of vaccine, it is not necessary to aspirate, i.e., to pull back on the syringe plunger after needle insertion.*) Multiple injections given in the same extremity should be separated by a minimum of 1". *CDC. "ACIP General Recommendations on Immunization" at www.immunize.org/acip skin subcutaneous tissue muscle 45 angle SC site for infants SC site for children (after the 1st birthday) and adults SC injection site (shaded area) acromion SC injection site (shaded area) elbow Insert needle at a 45 angle into fatty tissue of the anterolateral thigh. Make sure you pinch up on SC tissue to prevent injection into the muscle. Insert needle at a 45 angle into the fatty tissue over the triceps muscle. Make sure you pinch up on the SC tissue to prevent injection into the muscle. Technical content reviewed by the Centers for Disease Control and Prevention. www.immunize.org/catg.d/p2020.pdf Item #P2020 (10/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN 55104 (651) 647-9009 www.immunize.org www.vaccineinformation.org admin@immunize.org ANAPHYLAXIS Anaphylaxis is a medical emergency. Onset and severity of anaphylaxis may vary considerably. Anaphylaxis usually begins within minutes of exposure to the causative agent, and, in general, the more rapid the onset, the more severe the overall course. Anyone administering vaccine should be prepared to recognize and treat systemic anaphylaxis. Signs and symptoms of Anaphylactic Reactions include: (1) cutaneous: pruritis, flushing, urticaria, angioedema; (2) respiratory: hoarse voice and stridor, cough, wheeze, dyspnea, cyanosis; (3) cardiovascular: rapid weak pulse, hypotension, arrhythmias; (4) gastrointestinal: cramps, vomiting, diarrhea, dry mouth From: Red Book - 2012 Report of the Committee on Infectious Diseases, American Academy of Pediatrics, p.67. 17 What is VAERS? VAERS The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse events following immunization. By monitoring such events, VAERS helps to identify any important new safety concerns and thereby assists in ensuring that the benefits of vaccines continue to be far greater than the risks. What events should I report to VAERS? VAERS encourages the reporting of any clinically significant adverse event that occurs after the administration of any vaccine licensed in the United States. You should report clinically significant adverse events even if you are unsure whether a vaccine caused the event. The National Childhood Vaccine Injury Act requires health care providers to report: Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine. Any event listed in the Reportable Events Table* that occurs within the specified time period after vaccination. * A copy of the Reportable Events Table can be obtained from the VAERS web site at https://vaers.hhs.gov/esub/index or by calling VAERS at 1-800-822-7967. Who can report to VAERS? Anyone can report to VAERS: healthcare providers, vaccine manufacturers, state immunization programs, vaccine recipients and / or their families. How do I report to VAERS? There are three ways to report to VAERS Online https://vaers.hhs.gov/esub/index Fax Fax a completed VAERS Form to (877) 721-0366 Mail Mail a completed VAERS Form to VAERS, P.O. Box 1100, Rockville, MD 20849-1100. A pre-paid postage stamp is included on the back of the form Private health care providers should send completed VAERS forms directly to VAERS via options listed above. Public health care providers should send completed VAERS forms to the state immunization program by fax to 404-657-1463 or mail to: 2 Peachtree Street, Atlanta, Georgia 30303. 18 Policy Guide 3231REQ Vaccine Requirements for Attending Facilities and Schools in Georgia Relative to the Certificate of Immunization (Form 3231) Required Doses for Attendance in Facilities and Schools For Children Who Started Immunizations Before Age 7 Years* Required Vaccines with footnote numbers in [ ] [1] DTP, DTaP, DT [2]Hepatitis B [3]Hib PRP-T or [3]Hib PRP-OMP [4]Polio [5]MMR [6] Varicella [7] PCV [8] Hepatitis A 2 Months 4 Months 6 Months of Age of Age of Age 1 2 3 1 2 1 2 3 1 2 1 2 1 2 3 12 15 Months Months of Age of Age 4 3 4 3 3 1 1 4 1 18 Months of Age 24 Months of Age 4-6 Yrs.* (School Entry) 5 4 2 2 2 Total Doses Required** For Checking Complete For School Attendance Box on Immunization Certificate 4 or 5 (See Footnote [1]) 3 (See Footnote [2]) N/A for school (See Footnote [3]) N/A for school (See Footnote [3]) 3 or 4 (See Footnote [4]) 2 (See Footnote [5]) 2 (See Footnote [6]) N/A for school (See Footnote [7]) (See Footnote [8]) Side 1 *These requirements were established in accordance with the current Recommended Childhood and Catch-Up Immunization Schedules, United States. (See references on reverse side.) Georgia requirements for Kindergarten (5 years) include doses indicated for 4-6 years. **Children who are behind schedule may attend while in the process of completing the requirements with minimum intervals as indicated below. Vaccine [1] DTP/DTaP (DT) [2] Hepatitis B [3]Hib(Primary Series) PRP-T (ActHIB) PRP-OMP (Pedvax) [4] Polio [5] MMR [6] Varicella [7] PCV [8] Hepatitis A Minimum Age For For First Dose 6 weeks birth 6 weeks 6 weeks 6 weeks 12 months 12 months 6 weeks 12 months Minimum Ages For Initial Immunization And Minimum Intervals Between Doses Minimum interval from dose 1 to 2 1 month 1 month 1 month 1 month 1 month 1 month 3 months 1 month 6 months Minimum interval from dose 2 to 3 1 month See Footnote [2] 1 month See Footnote [3] 1 month N/A N/A 1 month Minimum interval from dose 3 to 4 6 months N/A See Footnote [3] N/A See Footnote [4] N/A N/A See Footnote [7] Minimum interval With respect to these intervals, 1 month from dose 4 to 5 is a minimum of 4 weeks or 28 days. See Footnote [1] N/A Don't restart any series, no matter how long since the previous dose. Doses given 4 days N/A before the minimum age or the minimum N/A interval may be counted as valid. Two N/A different live vaccines must be given on the N/A same day or spaced at least 28 days apart. N/A N/A [1] One dose of DTP/DTaP/DT must be on or after the 4th birthday. If the 4th dose was on or after the 4th birthday, the 5th dose is not needed. The 4th dose should be administered a minimum of 6 months after the 3rd dose. However, the 4th dose does not need to be repeated if administered 4 months after dose 3. Total doses of diphtheria and tetanus toxoids should not exceed 6 before the 7th birthday. [2] The 3rd dose of Hepatitis B vaccine should be given a minimum of 4 months after the 1st dose and 2 months after the 2nd dose and not before 24 weeks of age. [3] The number of doses of Hib depends on age at 1st dose and brand of vaccine given. The last dose in the series, whether 3rd or 4th, should be given at least 2 months after the previous dose and not before 12 months of age. Hib is required for children younger than 5 years attending facilities. Hib is not required for admission to kindergarten (5 years) through grade 12 and is not indicated for children who have reached the 5th birthday. One dose is sufficient if it is given at age 15 months or later. Brand names for PRP-T is ActHIB. The brand name for PRP-OMP is Pedvax Hib and the Hib component of Comvax(Hepatitis B-Hib) is Pedvax Hib. [4] Booster dose must be given on or after the 4th birthday and a 6 month interval is required between the last dose of the primary series and the booster dose. If the 3rd dose of all IPV or all OPV series is given on or after the 4th birthday, a 4th dose is not required provided there is a 6 month interval since the previous dose. [5] The MMR requirement is 2 doses of measles vaccine, 2 doses of mumps vaccine and 1 dose of rubella vaccine . The vaccines may be given as MMR or MMRV (combined antigens) or as single antigens. single antigens. [6] The varicella requirement is for 2 doses of varicella-containing vaccine for entry into any level, K-12. (See Side 2 of REQ, Footnote [4]).These may be administered as single dose varicella or in combination as MMRV. [7] The number of doses in the PCV series depends on age at 1st dose. The last dose in the series should be given at least 2 months after the previous dose and not before 12 months of age. [8] Hepatitis A vaccine should be administered to all children born on or after 1-1-06. Rev. 07/2014 19 20 Policy Guide 3231REQ Vaccine Requirements for Attending Facilities and Schools in Georgia Relative to the Certificate of Immunization (Form 3231) Side 2 Required Doses for Attendance in Schools For Children Who Started Immunizations At Age 7 Years or Older* Required Vaccines** First 1 Month 1 Month 1 Month 4 Months 6 Months Total Doses Required*** For Checking with footnote Visit After After After After After Complete For School Attendance numbers in [ ] First Second Third First Previous Box on Immunization Certificate [1]Hepatitis B Engerix 10 mcg or 1 2 3 3 (See Footnote [1]) Recombivax 5 mcg Recombivax 10 mcg (11-15 years only) 1 2 2 (See Footnote [1]) [2]Polio 1 2 3 4 or 3 4 or 3 (See Footnote [2]) [3]MMR 1 2 2 (See Footnote [3]) [4]Varicella 1 2 2 (See Footnote [4]) [5]Td/Tdap 1(Tdap) 2(Td) 3(Td) 3 (See Footnote [5]) [6] Meningococcal 1 1 (See Footnote [6]) *These requirements were established in accordance with the current Recommended Childhood Immunization Schedule, United States. See References. **There are other vaccines included in the Childhood Immunization Schedule that are recommended routinely but are not required in GA for child care or school attendance. ***Children who are behind schedule may attend while in the process of completing requirements with minimum intervals indicated above. With respect to these intervals, 1 month is a minimum of 4 weeks or 28 days. Footnotes: [1] The 3rd dose of Hepatitis B Engerix-B 10 mcg or Recombivax-HB 5 mcg should be given a minimum of 4 months after the 1st dose and 2 months after the 2nd dose. A 3rd dose is not needed when 2 doses of Adult Recombivax-HB 10 mcg are given when a child is 11-15 years old and the 2 doses are at least 4 months apart. Documentation of the vaccine brand of this alternate schedule is very important, especially when issuing the 3231 certificate. [2] If the 3rd dose of all IPV or OPV series is given on or after the 4th birthday, a 4th dose is not required provided there is a 6 month interval since the previous dose. [3] The MMR requirement is 2 doses of measles vaccine, 2 doses of mumps vaccine and 1 dose of rubella vaccine . The vaccines may be given as MMR or MMRV (combined antigens) or as single antigens. [4] Two doses of varicella vaccine are required for children entering school at any level, K-12, for the first time. For children already enrolled, the second dose is required at 6th grade. If given before age 12, the doses should be separated by 3 months, however, the 2nd dose does not need to be repeated if administered 1 month after 1st dose. If given on or after the 13th birthday, the doses should be separated by 4 or more weeks. [5] One dose of Tdap is required for 7th grade. Tdap can be administered regardless of the interval since the last Td. If a primary series is indicated, one dose preferably the first dose, should be Tdap. A dose of Tdap given on or after the 7th birthday meets school requirement. [6] One dose of MCV4 is required for 7th grade; administer MCV4 vaccine routinely at age 11-12 years. A dose of MCV4 given on or after the 10th birthday meets school requirement. References: Official Code of Georgia Annotated, Section 20-2-771 Recommended Childhood & Catch-Up Immunization Schedules, U.S.: Rules of the Department of Public Health, Chapter 511-2-2 Centers for Disease Control and Prevention Georgia Immunization Program Manual American Academy of Pediatrics (AAP) Georgia VFC Program Manual Approved by ACIP, AAP and American Academy of Family Physicians Recommendations of the Advisory Committee on Immunization Practices (ACIP) (AAFP) The Red Book - Report of the Committee on Infectious Diseases Rev. 07/2014 TIPS for Vaccine Storage and Handling Assign Responsibility of Handling Vaccines One person should take primary responsibility for handling vaccines, but a back-up person should also be designated. Every employee should know what to do if a vaccine shipment arrives. Check Vaccine Shipments Examine shipments carefully, checking the cooler and contents for physical damage. Compare contents to packing slips. Check the shipping date. Document vaccines received on inventory log. Store in Appropriate Type of Refrigerator or Freezer CDC recommends stand-alone units, meaning self-contained units that only refrigerate or freeze suitable for vaccine storage (no dorm-style refrigerators). Food and beverages should not be stored with vaccines! Store in Appropriate Location in Refrigerator and Freezer Vaccines should be stored in the center, allowing for proper ventilation. Do NOT store in doors, vegetable bins, loc-tight containers, on the bottom, or near the sides of the unit. Keep Vaccines Organized Rotate stock, routinely checking expiration dates. Label open vials. Keep VFC stock separate from privately purchased vaccines. Check and Document Temperatures It is a requirement for VFC providers (and a recommendation for all providers) that every refrigerator and freezer unit temperatures be read using a calibrated thermometer and documented twice each workday. Take all temperatures in either Fahrenheit or Celsius Record ambient room temperature as well (a standard household thermometer is sufficient for this purpose Keep temperature log posted on refrigerator and keep records for at least 3 years If Temperatures are Outside of Ranges for the Refrigerator and/or Freezer, Take Appropriate Actions Notify primary/alternate vaccine coordinator or immediate supervisor Store the vaccine under proper conditions as quickly as possible Temporarily mark exposed vaccines "DO NOT USE" until you have verified whether or not the vaccine may be used Phone manufacturer of vaccine or VFC (404-657-5013) to check on viability of vaccine. Do NOT immediately discard vaccine! Document the action taken Have a Routine Vaccine S&H Plan/Emergency Vaccine Retrieval and Storage Plan Identify alternate personnel, locations and equipment to provide temporary storage for vaccines in the event of a power failure or natural disaster. Update plan annually! Take Other Preventive Measures Avoid using power outlets with built-in circuit switches. Use a safety-lock or an outlet cover. Post warning signs at the plug and on the refrigerator/freezer units. Label fuses and circuit breakers. Install a temperature alarm. Use water bottles and frozen coolant packs. Check door seals. Clean the coils and motor. Install back-up generators. Required Temperature Ranges Fahrenheit Min Max Celsius Min Max Freezer -58 5 Freezer -50 -15 Refrigerator 35 46 Refrigerator 2 8 2251 22 Recommended and Minimum Ages and Intervals Between Doses of Routinely Recommended Vaccines1,2 Vaccine and dose number Recommended age for this dose Minimum age for this dose Recommended Minimum interval to next interval to next dose dose Hepatitis B (HepB)-13 Birth Birth 1-4 months 4 weeks HepB-2 HepB-34 Diphtheria-tetanus-acellular pertussis (DTaP)-13 1-2 months 6-18 months 2 months 4 weeks 24 weeks 6 weeks 2-17 months -- 2 months 8 weeks -- 4 weeks DTaP-2 DTaP-3 DTaP-4 4 months 6 months 15-18 months 10 weeks 14 weeks 12 months 2 months 6-12 months 3 years 4 weeks 6 months5,6 6 months5 DTaP-5 Haemophilus influenzae type b (Hib)-13,7 4-6 years 2 months 4 years 6 weeks -- 2 months -- 4 weeks Hib-2 Hib-38 4 months 6 months 10 weeks 14 weeks 2 months 6-9 months 4 weeks 8 weeks Hib-4 Inactivated poliovirus (IPV)-13 12-15 months 2 months 12 months 6 weeks -- 2 months -- 4 weeks IPV-2 4 months 10 weeks 2-14 months 4 weeks IPV-3 IPV-49 Pneumococcal conjugate (PCV)-17 6-18 months 4-6 years 2 months 14 weeks 4 years 6 weeks 3-5 years -- 8 weeks 6 months -- 4 weeks PCV-2 4 months 10 weeks 8 weeks 4 weeks PCV-3 6 months 14 weeks 6 months 8 weeks PCV-4 Measles-mumps-rubella (MMR)-110 MMR-210 Varicella (Var)-110 Var-210 Hepatitis A (HepA)-1 12-15 months 12-15 months 4-6 years 12-15 months 4-6 years 12-23 months 12 months 12 months 13 months 12 months 15 months 12 months -- 3-5 years -- 3-5 years -- 6-18 months5 -- 4 weeks -- 12 weeks11 -- 6 months5 HepA-2 Influenza, inactivated (TIV)12 Influenza, live attenuated (LAIV)12 Meningococcal conjugate (MCV4)-114 >18 months >6 months 2-49 years 11-12 years 18 months 6 months13 2 years 2 years -- 1 month 1 month 4-5 years -- 4 weeks 4 weeks 8 weeks MCV4-2 Meningococcal polysaccharide (MPSV4)-114 16 years -- 11 years (+ 8 weeks) 2 years15 -- 5 years -- 5 years MPSV4-2 -- 7 years -- -- Tetanus-diphtheria (Td) Tetanus-diphtheria-acellular pertussis (Tdap)16 11-12 years >11 years 7 years 7 years 10 years -- 5 years -- Pneumococcal polysaccharide (PPSV)-1 PPSV-217 Human papillomavirus (HPV)-118 -- -- 11-12 years 2 years 7 years 9 years 5 years -- 2 months 5 years -- 4 weeks HPV-2 11-12 years (+ 2 months) 9 years (+ 4 weeks) 4 months 12 weeks19 HPV-319 Rotavirus (RV)-121 11-12 years (+ 6 months) 2 months 9 years (+24 weeks) 6 weeks -- 2 months -- 4 weeks RV-2 RV-321 Herpes zoster22 4 months 6 months >60 years 10 weeks 14 weeks 60 years 2 months -- -- 4 weeks -- -- 23 1 Combination vaccines are available. Use of licensed combination vaccines is generally preferred to separate injections of their equivalent component vaccines. When administering combination vaccines, the minimum age for administration is the oldest age for any of the individual components; the minimum interval between doses is equal to the greatest interval of any of the individual components. 2 Information on travel vaccines including typhoid, Japanese encephalitis, and yellow fever, is available at www.cdc.gov/travel. Information on other vaccines that are licensed in the US but not distributed, including anthrax and smallpox, is available at www.bt.cdc.gov. 3 Combination vaccines containing a hepatitis B component (Comvax, Pediarix, and Twinrix) are available. These vaccines should not be administered to infants younger than 6 weeks because of the other components (i.e., Hib, DTaP, HepA, and IPV). 4 HepB-3 should be administered at least 8 weeks after HepB-2 and at least 16 weeks after HepB-1, and should not be administered before age 24 weeks. 5 Calendar months. 6 The minimum recommended interval between DTaP-3 and DTaP-4 is 6 months. However, DTaP-4 need not be repeated if administered at least 4 months after DTaP-3. 7 Children receiving the first dose of Hib or PCV vaccine at age 7 months or older require fewer doses to complete the series. 8 If PRP-OMP (Pedvax-Hib) was administered at ages 2 and 4 months, a dose at age 6 months is not required. 9 A fourth dose is not needed if the third dose was administered on or after the 4th birthday and at least 6 months after the previous dose. 10 Combination measles-mumps-rubella-varicella (MMRV) vaccine can be used for children aged 12 months through 12 years. (See CDC. General recommendations on Immunization: recommendations of the ACIP. MMWR 2011;60[No. RR-2],7.) 11 For persons beginning the series on or after the 13th birthday, the minimum interval from varicella-1 to varicella-2 is 4 weeks. 12 One dose of influenza vaccine per season is recommended for most people. Children younger than 9 years of age who are receiving influenza vaccine for the first time should receive 2 doses this season. See current influenza recommendations for other factors affecting the decision to administer one vs. two doses to children younger than 9 years. 13 The minimum age for inactivated influenza vaccine varies by vaccine manufacturer and formulation. See package inserts for vaccinespecific minimum ages. 14 Revaccination with meningococcal vaccine is recommended for previously vaccinated persons who remain at high risk for meningococcal disease. (See CDC. Updated recommendations from the ACIP for vaccination of persons at prolonged increased risk for meningococcal disease. MMWR 2009;58:[1042-3]) 15 Menactra may be given as young as 9 months for high-risk children. 16 Only one dose of Tdap is recommended. Subsequent doses should be given as Td. For one brand of Tdap (Adacel), the minimum age is 11 years. For management of a tetanus-prone wound in a person who has received a primary series of a tetanus-toxoid containing vaccine, there is no minimum interval between a previous dose of any tetanus-containing vaccine and Tdap. 17 A second dose of PPSV 5 years after the first dose is recommended for persons <65 years of age at highest risk for serious pneumococcal infection, and for those who are likely to have a rapid decline in pneumococcal antibody concentration. (See CDC. Prevention of pneumococcal disease: recommendations of the ACIP. MMWR 1997;46[No. RR-8].) 18 Bivalent HPV vaccine (Cervarix) is approved for females 10 through 25 years of age. Quadravalent HPV vaccine (Gardasil) is approved for males and females 9 through 26 years of age. 19 The minimum age for HPV-3 is based on the baseline minimum age for the first dose (108 months) and the minimum interval of 24 weeks between the first and third doses. Dose 3 need not be repeated if it is given at least 16 weeks after the first dose (and if the intervals between doses 1 and 2 and doses 2 and 3 are maintained at 4 weeks and 12 weeks, respectively). 20 The first dose of rotavirus must be administered between 6 weeks 0 days and 14 weeks 6 days. The vaccine series should not be started after age 15 weeks 0 days. Rotavirus should not be administered to children older than 8 months 0 days, regardless of the number of doses received before that age. 21 If two doses of Rotarix are administered as age appropriate, a third dose is not necessary. 22 Herpes zoster vaccine is recommended as a single dose for persons 60 years of age and older. Adapted from Table 1, ACIP General Recommendations on Immunization. 24 February 2012 Pathophysiology Vaccine Description Comvax Hepatitis B & Hib combination vaccine (See Hep B & Hib information cards) Combination inactivated hepatitis B - Hib Dose & Route Administration Schedule vaccine 0.5 mL given IM Dose Recommended Age 1 ............... 2 months 2 ............... 4 months Minimum Intervals 3 ............... 12 - 15 months Dose Minimum Interval and Ages 1 ........... 6 weeks of age - Comvax cannot be used for the birth dose of hepatitis B because of the Hib component. 2 ........... 4 weeks from dose 1 3 ........... 2 months from dose 2 and 4 months from dose 1 and should not be given Contraindications prior to 12 months of age Anaphylactic reaction following a prior dose of HepB, Hib or Comvax or to any of the components of these vaccines (yeast, aluminum hydroxide, or formaldehyde) Defer vaccination in persons with moderate Special Instructions or severe acute illness until illness subsides Hib is required for children younger than age 5 attending childcare facilities. Hib is NOT required for admission into kindergarten through grade 12. Hib is not routinely indicated for children 5 years of age and older. Hepatitis B is required for admission to childcare and school entry. 35 25 Recommendations for Administration of COMVAX COMVAX vaccine is a combination of Haemophilus b Conjugate (PRP-OMPC) PedvaxHIB and hepatitis B vaccine (Recombinant pediatric formula) or Recombivax. Infants of HBsAg negative moms who received hepatitis B vaccine at birth or shortly after, may be administered COMVAX as is indicated below. Possible schedules for administering COMVAX to infants who begin receiving COMVAX at 2 months of age are also indicated. Birth 2 Months 4 Months 6 Months 12-15 Months Hep B Hep B COMVAX COMVAX PedvaxHIB COMVAX OR Hep B PedvaxHIB COMVAX Hep B Hep B COMVAX COMVAX ------------------------- COMVAX COMVAX PedvaxHIB ActHIB or HibTITER COMVAX COMVAX --------------------- ActHIB or HibTITER and Hep B OR COMVAX --------------------Hep B COMVAX HIB (any conjugate type) COMVAX HIB (any conjugate type) 36 26 DTaP Diphtheria, Tetanus, & Pertussis Pathophysiology Diphtheria: Bacteria Respiratory transmission Incubation 2-5 days Tetanus: Bacteria Enters the body through a wound Incubation3-21 days Pertussis: Bacteria Respiratory transmission Incubation 5-10 days Vaccine Description Inactivated polysaccharide vaccine, containing diphtheria toxoid, tetanus toxoid & acellular pertussis. This vaccine is licensed for administration only to children 6 weeks through 6 years of age. If child is 7 years of age or older, only Td and Tdap vaccines should be administered. (See Td/Tdap section of this booklet) Dose & Route 0.5 mL given IM Administration Schedule Dose Recommended Age *Dose #4 may be administered at 12 months of age if separated by at least 6 months from Dose #3. Dose #4 does not need to be repeated if it has been inadvertently administered > 4 months after Dose #3. The #5 Booster Dose is not needed if Dose #4 is given on or after the 4th birthday. 1...................2 months 2...................4 months 3...................6 months 4*..................15-18 months (1st booster dose) 5*..................4-6 years (2nd booster dose) Booster doses: *15-18 months of age *4-6 years of age 11-12 years of age o Tdap vaccine (one time dose) should be given as a booster at 11-12 years of age, provided it has been 5 years since last dose of tetanus containing vaccine. (See Td/Tdap section of this booklet) o Two diphtheria, tetanus and acellular pertussis vaccines (Tdap) are licensed: o BoostrixTM for administration to persons 10 years of age and older o AdacelTM for administration to persons 10-64 years of age Every 10 years thereafter for life o Td vaccine should be given every 10 years after the administration of Tdap at 11-12 years of age. (See Td/Tdap section of this booklet) Minimum Intervals Dose Minimum Interval 1.................6 weeks of age 2.................4 weeks from dose 1 3.................4 weeks from dose 2 4*...............No less than 6 months from dose 3 5*...............No less than 6 months from dose 4 25 27 Contraindications Precautions Anaphylactic reaction to any of the vaccine components. Life threatening allergic reaction after a previous dose of DTaP or DT (Pediatric diphtheria and tetanus vaccine which is used in lieu of DTaP only if there is a contraindication to pertussis vaccine.) Encephalopathy within 7 days of a previous dose not attributable to another identifiable cause Progressive neurological disorder, uncontrolled epilepsy, or progressive encephalopathy until treatment regimen has been established and condition stabilized Acute, moderate or severe illness with or without fever. Immunize as soon as illness subsides. Temperature of 105 degrees within 48 hours after with a previous dose of DTP/DTaP Collapse or shock-like state within 48 hours after receiving a previous dose of DTP/DTaP Persistent, inconsolable crying lasting >3 hours, occurring within 48 hours Convulsions with or without fever occurring within 3 days 26 28 Td/Tdap Tetanus, Diphtheria & Tetanus. Diphtheria and Pertussis Pathophysiology Diphtheria: Bacteria Respiratory transmission Incubation 2-5 days Tetanus: Bacteria Enters the body through a wound Incubation 3-21 days Pertussis: Bacteria Respiratory transmission Vaccine Description Incubation 5-10 days Inactivated polysaccharide vaccine, containing diphtheria toxoid, tetanus toxoid & acellular pertussis Two diphtheria, tetanus and acellular pertussis vaccines (Tdap) are licensed: o BoostrixTM for administration to persons 10 years of age and older o AdacelTM for administration to persons 10-64 years of age Dose & Route 0.5 mL given IM Administration Schedule Children 7 through 10 years Those never vaccinated against tetanus, diphtheria or Tdap can be administered regardless of interval since the last tetanus-or diphtheria-toxoid containing vaccine. pertussis or who have unknown vaccination status should receive a series of three vaccinations containing tetanus and diphtheria toxoids. The first dose of these three doses should be Tdap. Dose Minimal Dose Intervals 1...................0 2...................4 weeks after dose #1 3...................6 months after dose #2 Administration schedule for Td/ Tdap booster doses following a primary DTaP/Td series:* Adolescents 11-18 years For routine use, adolescents aged 11 through 18 years who have completed the recommended childhood DTP/DTaP vaccination series should receive a single dose of Tdap.* *Fully vaccinated is defined as 5 doses of DTaP or 4 doses of DTaP if the fourth dose was administered on or after the fourth birthday. 29 27 Adults aged 19 and older Contraindications for Td and Tdap Precautions Special Considerations 30 Administration Schedule for Td/ Tdap booster doses following a primary DTaP/Td series:* Td should be given every 10 years following a dose of Tdap. Adults 19-64 years of age, especially those who have close contact with infants < 1 year of age, should receive a single dose of Tdap to replace a single dose of Td as a booster immunization if they have not already received Tdap. Adults 65 years and older who have or anticipate having close contact with an infant aged less than 12 months should receive a single dose of Tdap. Other adults 65 years and older may be given a single dose of Tdap. Td and Tdap: Anaphylactic reaction to any of the vaccine components. Life threatening allergic reaction after a previous dose of DTP, DTaP, DT, Td or Tdap Tdap: Encephalopathy not attributed to another identifiable cause within 7 days of a previous dose of a pertussis containing vaccine Td, Tdap: Acute, moderate or severe illness with or without fever Arthus-type hypersensitivity reactions Guillain-Barr syndrome (GBS) within 6 wks. after a previous dose of tetanus toxoid containing vaccine Tdap: Progressive neurological disorder, uncontrolled epilepsy, or progressive encephalopathy until treatment regimen has been established and condition stabilized Pregnancy/Postpartum: Pregnant women should receive a dose of Tdap during each pregnancy irrespective of their prior history of receiving Tdap. Optimal timing for Tdap administration is between 27 and 36 weeks of gestation for women not previously vaccinated with Tdap, If Tdap is not administered during pregnancy, Tdap should be administered immediately postpartum. Wound management: For detailed guidelines, refer to wound management guidelines in the ACIP Recommendation Statements for Td and Tdap located at: http://www.cdc.gov/vaccines/hcp/aciprecs/index.html Simultaneous Administration: Tdap and MCV4 should be administered to adolescents 11-18 during the same visit if both vaccines are indicated and available. 31 32 Pathophysiology Hib Haemophilus Influenzae type B Bacteria Humans are the only known reservoir Vaccine Description Dose & Route Administration Schedule Respiratory transmission is presumed Inactivated vaccine 0.5 mL given IM Dose Recommended Age 1 ............... 2 months MenHibrix [Hib-MenCY-TT] is licensed for children aged 6 weeks through 18 months. Infants at increased risk for meningococcal disease should be vaccinated with a 4-dose series of Hib-MenCY-TT. Minimum Intervals 2 ............... 4 months 3 ............... 6 months - If Pedvax HIBTM or Comvax vaccines are used at 2 and 4 months of age, a dose at 6 months is not required. Booster ......... 12-15 months Regardless of which vaccine is used for primary series Dose Minimum Interval and Ages 1 ........... Must be at least 6 weeks of age 2 ........... 4 weeks from dose 1 3 ........... 4 weeks from dose 2 - if dose 3 is required Booster... 8 weeks from dose 2 or dose 3 and no earlier than 12 months of age Contraindications Anaphylactic reaction following a prior dose of Hib Defer vaccination in children with moderate or severe acute illness until illness subsides. Hib conjugate vaccines are contraindicated in children younger than 6 weeks of age. persons known to have a severe allergic reaction to any component of the vaccine. Hiberix prefilled syringes might contain natural rubber latex, and the vial stoppers for Comvax, ActHib, and PedvaxHIB contain natural rubber latex, which might cause allergic reactions in persons who are latex-sensitive Vaccination with Comvax is contraindicated in Special Considerations patients with a hypersensitivity to yeast Comvax vaccine (combination HepB & Hib) and Pentacel (combination DTaP/IPV/Hib) can also be used to vaccinate children against Hib infection. The total number of doses As with all pertussis-containing vaccines, benefits and required depends upon the age of the child at first dose (See ACIP risk should be considered before administering Pentacel to persons with a history of fever 40.5oC, recommendations) hypotonic-hyporesponsive episode, persistent inconsolable crying lasting 3 hours within 48 hours after receipt of a pertussis-containing vaccine, or seizures within 3 days after receiving a pertussis- containing vaccine 31 33 ACIP Recommended Haemophilus influenzae type b (Hib) Routine Vaccination Schedule Vaccine HbOC (HibTITERTM) PRP-T (ActHIBTM or OmniHIBTM) PRP-OMP (PedvaxHIBTM) Hiberix 2 months Dose 1 Dose 1 Dose 1 4 months Dose 2 Dose 2 Dose 2 6 months Dose 3 Dose 3 12-15 months Booster Booster Booster Booster Detailed Vaccination Schedule Haemophilus influenzae type b Conjugate Vaccines Vaccine HBOC/PRP-T (HibTITERTM) (ActHIBTM or OmniHIBTM) PRP-OMP (PedvaxHIBTM) PRP-D (Connaught) Age at 1st dose (months) 2-6 7-11 12-14 15-59 2-6 7-11 12-14 15-59 15-59 Primary Series 3 Doses, 2 months apart 2 doses, 2 months apart 1 dose 1 dose 2 doses, 2 months apart 2 doses, 2 months apart 1 dose 1 dose 1 dose Booster 12-15 months 12-18 months 2 months later -12-15 months 12-18 months 2 months later --- Haemophilus influenzae type b (Hib) Schedule for Children With a Lapse in Administration Age at Presentation (mo) 7-11 Previous Immunization History 1dose of HbOC or PRP-T (HibTITER,TM ActHIBTM or OmniHIBTM) 7-11 12-14 12-14 15-59 2 doses of HbOC or PRP-T(HibTITER,TM ActHIBTM or OmniHIBTM) or 1 dose of PRP-OMP (PedvaxHIBTM) 2 doses of HbOC or PRP-T(HibTITER,TM ActHIBTM or OmniHIBTM) or PRP-OMP (PedvaxHIBTM) vaccine before 12 mo of age 1 dose of HbOC or PRP-T(HibTITER,TM ActHIBTM or OmniHIBTM) or PRP-OMP (PedvaxHIBTM) vaccine before 12 mo of age Any incomplete schedule Recommended Regimen 1 dose of conjugate vaccine at 7-11 mo of age with a booster dose given at least 2 mos. later at 12-15 mos. of age 1dose of conjugate vaccine at 7-11 mos. of age with a booster dose given at least 2 mos. later at 12-15 mos. of age A single dose of any licensed conjugate vaccine 2 additional doses of any licensed conjugate vaccine, separated by 2 mos. A single dose of any licensed conjugate vaccine 34 32 HepA Hepatitis A (HAV) Pathophysiology Virus Transmitted by fecal-oral route Incubation 15-50 days Vaccine Description Dose & Route Inactivated whole virus vaccine HavrixTM Pediatric (12 mos. through 0.5 mL given IM Note: Both brands are produced in pediatric and adult formulations and are packaged as single dose vials or pre-filled syringes 18 years) Adult (19 years) VaqtaTM 1 mL given IM Pediatric (12 mos. through 25 units given IM 18 years) Adult (19 years) TwinrixTM (HepA & 50 units given IM HepB) Adult (18 years) 1 mL given IM Administration Schedule & HavrixTM 2 doses Minimum Intervals VaqtaTM 0, 6-12 months 2 doses 0, 6-18 months TwinrixTM 3 doses (HepA & 0, 1, 6 months Contraindications HepB) Anaphylactic reaction following a prior dose of Hep A or to any of its components (alum, 2- phenoxyethanol) Defer vaccination in persons with moderate or Special Considerations & severe acute illness until illness subsides. Required for children attending child care Instructions facilities and schools. Recommended for all children 12-23 months of age. International travel: give 1st dose 28 days prior to travel. High risk groups: men who have sex with men, users of illegal drugs, persons with chronic liver disease or clotting factor disorders Persons working with HAV infected primates or with HAV in a laboratory Setting Post-exposure prophylaxis: healthy persons aged 12 mos. 40 yrs. who have recently been exposed to HAV and not previously immunized with hepatitis A vaccine, should receive an age- appropriate dose of vaccine in preference to IG. 35 36 HepB Hepatitis B Vaccine Pathophysiology Hepatitis B Virus (HBV) Transmitted by parenteral or mucosal exposure to HBsAg-positive blood and body fluids Incubation 60-150 days Vaccine Description Recombinant hepatitis B vaccine Dose & Route: Intramuscular. Hepatitis B vaccine administered by any route or site other than IM in the anterolateral thigh or deltoid muscle should not be counted as valid. Recombivax HB Engerix-B Age Group Dose (mcg) Volume (mL) Dose (mcg) Volume (mL) Infants (< 1 yr) 5 0.5 10 0.5 Children (1-10yrs) 5 0.5 10 0.5 Adolescents 11-15 yrs 10 0.5 N/A N/A (2-dose Schedule) 11-19 yrs 5 0.5 10 0.5 Adults ( 20 yrs) 10 1.0 20 1.0 Hemodialysis pts. & other immuno- compromised persons < 20 yrs 5 0.5 10 0.5 20 yrs 40 1.0 40 2.0 (3-dose schedule at (4 dose schedule at 0,1 & 6 months) 0,1, 2 & 6 months) Combination Vaccine Comvax Pediarix Twinrix Age Groups Dose (mcg) Volume Dose (mcg) Volume Dose (mcg) Volume (mL) (mL) (mL) Infants (< 1 yr) 5 0.5 10 0.5 N/A N/A Children (1-10yrs) 5 0.5 10 0.5 N/A N/A Adults ( 20 yrs) N/A N/A N/A N/A 20 1.0 Administration Schedule Dose Recommended Age Minimum Interval 1............Birth 2............1-2 months..................4 weeks from dose 1 3............6-18 months.................At least 8 weeks after 2nd dose and at least 16 weeks after 1st dose and infants must be at least 24 weeks of age All children and adolescents < 19 years and not previously vaccinated with hepatitis B series should be vaccinated at the earliest opportunity. It is permissible to administer 4 doses of hepatitis B vaccine (e.g., when combination vaccines are given after the birth dose). 37 Contraindications Special Instructions Perinatal HepB website: dph.georgia.gov/perinatalhepatitis-b High Risk Populations Hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years of age. Unvaccinated adults with diabetes who are 60 years and older, hepatitis B vaccination at the discretion of their health care provider. Adults aged 20 years at risk for hepatitis B infection should receive 1 mL x 3 doses typically given at 0, 2 & 6 months. Anaphylactic reaction following a prior dose of HepB Persons with hypersensitivity to yeast, yeast products or any vaccine component Defer vaccination in persons with moderate or severe acute illness until illness subsides. Prefilled syringes might contain natural rubber latex, and the vial stoppers for Comvax contain natural rubber latex, which might cause allergic reactions in persons who are latex-sensitive Infants born to hepatitis B positive (HBsAg) women must receive hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12 hours of birth. Intervention Recommended Age 1st dose............................Birth (within 12 hours) HBIG..............................Birth (within 12 hours) 2nd dose...........................1-2 months 3rd dose............................6 months PVT*..............................9-18 months *PVT: Post vaccination Test-includes Hepatitis B Surface Antigen/ HBsAg (infection) and Hepatitis B Surface Antibody/Anti-HBs (antibody protection) Protocol available on GIP website at http://dph.georgia.gov/nurse-protocols For infants weighing less than 2000 gms at birth: If the mother is HBsAg negative, the 1st dose should be given at birth or at next doctor's visit If the mother is HBsAg positive or her status is unknown, the infant should receive the 1st dose at birth, dose #2 at age 1 month, dose #3 at 2-4 months, and dose #4 at age 6 months. The infant should be tested at 9-18 months of age for infection and antibody. If the mother is HBsAg positive, the infant should also receive HBIG at birth or within 1 week. Clients seen at STD treatment centers Clients in institutions and nonresidential daycare facilities for developmentally disabled HIV testing and treatment centers Immigrants/refugees from areas of high endemic HBV Patients of hemodialysis units IV drug users Homosexual males Household contacts of HBV carriers Recipients of certain blood products Alaska Natives, Asian/Pacific Islanders, African, Eastern European Infants born to HBV- infected mothers 38 Human Papillomavirus Vaccine Pathophysiology Vaccine Description Certain types of human papillomavirus can cause squamous cell cervical cancer, cervical adenocarcinoma, and genital warts. HPV4 (GardasilTM) HPV types 6,11,16, and 18 HPV9 (GardasilTM) HPV types 6,11,16,18, 31, 33, 45, 52 and 58 HPV2 (Cervarix) HPV types 16 and 18 Dose & Route 0.5 mL given intramuscularly Administration Schedule & Minimum Intervals If the HPV vaccine schedule is interrupted, the vaccine series does not need to be restarted. Dose Dose 1 Dose 2 Dose 3 Recommended Minimum Ages Intervals 11-12 years of age (see Minimum Age below) 2 months after Dose 1.....4 weeks from Dose 1 6 months after Dose 1....12 weeks from Dose 2 and 24 weeks from Dose 1 Minimum Age Contraindications Precautions Also recommended for males and females ages 13 through 26 who did not receive the vaccine previously May be given at the same visit with other vaccines Should be given to persons with a previous history of HPV infection recommended for gay and bisexual men Recommended for men and women with compromised immune systems (including people living with HIV/AIDS) through age 26, if they did not get fully vaccinated when they were younger. Minimum age for all HPV vaccine is 9 years. Anaphylactic reaction to any vaccine component or to previous dose of vaccine Not recommended for use in pregnant women Not intended for treatment of active genital warts or cervical cancer Moderate or severe acute illness with fever 39 Special Considerations Remember there is a VIS just for HPV9. Vaccination in no way should replace: routine, periodic cervical cancer screening protective sexual behaviors Syncope can occur after vaccination, most commonly among adolescents and young adults. To avoid serious injury related to syncope episode, observation for 15 minutes after administration is recommended. HPV vaccines are most effective for both males and females when given before first exposure to HPV through sexual contact. HPV vaccines are not recommended for use in pregnant women. However, pregnancy testing is not needed before vaccination. If a woman is found to be pregnant after initiating the vaccination series, no intervention is needed; the remainder of the 3-dose series should be delayed until completion of pregnancy. 65 40 Influenza (IIV) Inactivated Influenza Vaccine Recombinant Influenza (RIV) and cell culture-based (ccIIV3) Pathophysiology Virus Highly contagious Respiratory transmission Virus shed in respiratory secretions for 3-10 days Vaccine Description IIV 3 -Trivalent- Inactivated, split-virus vaccine composed of 3 virus strains two type A and one type B IIV4 -Quadrivalent -Inactivated, split-virus vaccine composed of 4 virus strains two types A and two type B RIV3 Recombinant influenza vaccine trivalent ccIIV3- cell culture-based Dose & Route Age 6-35 months of age 0.25 mL given IM Age 3 years 0.5 mL given IM Brand Information * ACIP recommends Afluria not be used in children aged 6 months through 8 years because of increased risk for febrile reactions noted in this age group. Recommendations Contraindications Special Considerations Fluzone sanofi-pasteur Approved for persons 6 months of age and older Fluzone High Dose sanofi-pasteur Approved for persons 65 years and older Fluzone Intradermal sanofi-pasteur Approved for persons 18 through 64 years of age Afluria CSL Approved for persons 9 years and older* FluarixTM GSK Approved for persons 3 years of age and older FluvirinTM Novartis Approved for persons 4 years of age and older Flulaval TM GSK Approved for persons 18 years of age and older Agriflu TM Novartis Approved for persons 18 years of age and older Flubok Approved for persons 18 years and older Annual influenza vaccination is recommended for all people ages 6 months and older. Severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine or to a vaccine component, including egg protein. Moderate or severe acute illness with or without fever. History of Guillain-Barre Syndrome (GBS) within 6 weeks of previous influenza vaccination. The best time to give influenza vaccine is October November; however, influenza vaccine can be administered through May. It takes approximately 2 weeks for influenza vaccine to be protective. Immunity from influenza vaccine rarely exceeds 1 year and the vaccine virus strains may vary each year. 41 Pathophysiology Influenza (LAIV) Live Attenuated Influenza - FluMistTM Virus Highly contagious Respiratory transmission Vaccine Description Dose & Route Virus shed in respiratory secretions for 3-10 days Live, attenuated, cold-adapted, 0.2ml intranasal quadrivalent vaccine composed of 4 virus strains - two type A and two type B 0.2 mL dose (0.1 mL per nostril), sprayed into each nostril. If the vaccine recipient sneezes after administration, the dose should not be repeated. However, if nasal congestion is present that might impede delivery of the vaccine to the nasopharyngeal mucosa, deferral of administration should be considered until resolution of the illness, or IIV should be administered instead. Administration Schedule & Minimum Intervals Administer annually prior to influenza season to healthy, non-pregnant persons 2-49 years of age* *Children 2-8 years of age receiving influenza vaccine for the first time should receive 2 doses separated by at least 28 days. See algorithm below Recommendations Administer influenza vaccine annually to all children beginning at age 6 months. For most healthy, nonpregnant persons aged 2 through 49 years, either LAIV or IIV may be used. However, LAIV should NOT be administered to some persons, including 1) those with asthma, 2) children 2 through 4 years who had wheezing in the past 12 months, or 3) those who have any other underlying medical conditions that predispose them to influenza complications. When immediately available, LAIV should be used for healthy children aged 2 through 8 years who have no contraindications or precautions. 42 57 Contraindications Moderate or severe acute illness with or without fever. History of GBS within 6 weeks of previous influenza vaccination. Receipt of specific antivirals (i.e., amantadine, rimantadine, zanamivir, or oseltamivir) 48 hours before vaccination. Avoid use of these antiviral drugs for 14 days after vaccination. Persons aged <2 years or >49 years Those with contraindications listed in the package insert Children aged 2 through 17 years who are receiving aspirin or aspirin-containing products Persons who have experienced severe allergic reactions to the vaccine or any of its components, or to a previous dose of any influenza vaccine Pregnant women Immunosuppressed persons Persons with a history of egg allergy Asthma in persons aged 5 years and older. Children aged 2 through 4 years who have asthma or who have had a wheezing episode noted in the medical record within the past 12 months, or for whom parents report that a health care provider stated that they had wheezing or asthma within the last 12 months Persons who have taken influenza antiviral medications within the previous 48 hours. Persons who care for severely immunosuppressed persons who require a protective environment should not receive LAIV, or should avoid contact with such persons for 7 days after receipt, given the theoretical risk for transmission Precautions of the live attenuated vaccine virus. Persons of any age with asthma might be at increased risk for wheezing after administration of LAIV Persons with other underlying medical conditions that might predispose them to complications after wild-type influenza infection (e.g., chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes mellitus] has not been established. These conditions, in addition to asthma in persons aged 5 years, Special Considerations should be considered precautions for the use of LAIV. The best time to give influenza vaccine is October - November, however, influenza vaccine can be administered through May. http://www.cdc.gov/flu/pdf/freeresources/general/take3_step_vac.pdf Immunity from influenza vaccine rarely exceeds 1 year and the vaccine virus strains may vary each year 57 43 Recommendations regarding influenza vaccination of persons who report allergy to eggs -- Advisory Committee on Immunization Practices, United States, 201415 influenza season 44 57 Pathophysiology IPV Inactivated Poliovirus Virus Enters through the mouth Vaccine Description Dose & Route Administration Schedule Incubation 6-20 days Inactivated poliovirus vaccine 0.5 mL given subQ or IM Dose Recommended Age 1 ............... 2 months 2 ............... 4 months 3 ............... 6 - 18 months 4 ............... 4-6 years Final dose should be administered at >4 years of age regardless of the number of previous doses; the minimum interval from dose 3 to dose 4 is extended from 4 weeks to 6 months; the minimum interval from dose 1 to dose 2, and from dose 2 to dose 3, remains 4 weeks; the minimum age for dose 1 remains age 6 weeks. Minimum Intervals Dose Minimum Interval and Ages 1 ........... 6 weeks of age 2 ........... 4 weeks from dose 1 3 ........... 4 weeks from dose 2 Contraindications 4 ........... 6 month from dose 3 Anaphylactic reaction following a prior dose of IPV or to any of its components (neomycin, streptomycin, or Polymyxin B) Defer vaccination in persons with moderate or severe acute illness until illness subsides Special Considerations The combination vaccine Pediarix (IPV, DTaP and Hep B) is approved for the first 3 doses of the IPV and DTaP series. Pediarix is not approved for booster doses nor indicated for children > 6 years of age Pediarix should not be used for infants younger than 6 weeks of age or children over 6 years of age. PentacelTM is approved for the primary series and first booster dose (doses 1-4). It is not indicated for children 5 years. KinrixTM is approved for the booster dose at age 4-6. Not to be administered to children aged < 4 years or 7 years. 45 Measles, mumps, rubella, varicella and hepatitis serology are listed as accepted evidence of immunity in both the current editions of Pink Book and Red Book. Neither resource makes any recommendation regarding accepting serology for polio as proof of immunity. The Georgia Immunization Program requires vaccination for polio immunity for attendance in Georgia child care and school facilities. 46 Pathophysiology Vaccine Description Dose & Route Administration Indications Contraindications Precautions Meningococcal Conjugate Vaccine B Bacteria Respiratory and throat secretions transmission Incubation 3-7 days Inactivated conjugate vaccine, containing Neisseria meningitidis serogroup B. TRUMENBA (Pfizer) 3-dose series at months 0, 2 and 6 BEXSERO (Norvartis) - two doses at least 1 month apart. 0.5 mL given IM 10 through 25 year olds High-risk patients for meningococcal B infection include: persons with complement deficiencies, persons presently taking eculizumab (Soliris-- Alexion), persons that are asplenic, microbiologists, those exposed during outbreaks of disease. Severe allergic reaction after a previous dose of Trumenba. Hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO. The tip caps for of the pre-filled Bexsero syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. 47 48 Meningococcal Conjugate Vaccine (MCV4) Pathophysiology Vaccine Description Dose & Route Administration Schedule / Dose Indications Contraindications Special Instructions For booster doses among persons with high-risk conditions refer to http://www.cdc.gov/vaccines/pubs/aciplist.htm#mening. All 11-12 year olds should be vaccinated with meningococcal conjugate vaccine (MCV4). Now, a booster dose should be given at age 16 years. For adolescents who received the first dose at age 13 through 15 years, a one-time booster dose should be administered, preferably at age 16 through 18 years, before the peak in increased risk. Adolescents who receive their first dose of MCV4 at or after age 16 years do not need a booster dose. Bacteria Direct contact with large droplet respiratory secretions transmission Incubation 3-7 days Inactivated conjugate vaccine, containing N. meningitidis serogroups A, C, Y, and W-135 Menactra TM Approved for use in ages 9 months through 55 years Menveo Approved for use in ages 2 months through 55 years MenHibrix Bivalent meningococcal conjugate vaccine and Haemophilus influenza type b conjugate vaccine HibMenCY approved for use in ages 6 weeks through 18 months. 0.5 mL given IM 1 dose for persons 2-55 years of age who are at risk for meningococcal disease Persons who previously were vaccinated at age 7 years and are at prolonged increased risk should be revaccinated 5 years after their previous meningococcal vaccine, and persons who previously were vaccinated at ages 2--6 years and are at prolonged increased risk should be revaccinated 3 years after their previous meningococcal vaccine. Adolescents 11-18 years of age Persons with asplenia, terminal complement deficiency, HIV infection Persons traveling to countries where meningitis is hyperendemic or epidemic Military recruits Research or laboratory personnel routinely exposed to N. meningitidis Allergy to vaccine components o Anaphylaxis to either MCV4 or MPSV4 or their components o Diphtheria toxoid o Previous history of Guillain-Barr syndrome (GBS) o Dry natural rubber latex Acute, moderate, or severe illness with or without fever Use of MCV4 has not been studied sufficiently in pregnant women. For pregnant women in need of protection against N. meningitidis, MPSV4 may be considered. Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. If syncope develops, patients should be observed until the symptoms resolve. 49 Meningococcal Polysaccharide Vaccine (MPSV4) Pathophysiology Vaccine Description Dose & Route Administration Schedule Bacteria Inactivated polysaccharide vaccine, containing N. meningitidis serogroups A, C, Y, and W-135 0.5 mL given subcutaneously Dose- See recommendations for age and/or risk factor at http://www.immunize.org/catg.d/p2018.pdf Revaccination with MCV4 every 5 years is recommended for adults previously vaccinated with MCV4 or MPSV4 who remain at increased risk for infection (e.g., adults with anatomic or functional asplenia or persistent complement component deficiencies). Indications **MCV4 is preferred for adults with any of the preceding indications who are aged 55 years and younger; Meningococcal polysaccharide vaccine (MPSV4) is preferred for adults aged 56 years and older for travel with no previous MCV4 dose and no high risk conditions. Contraindications Special Instructions **Consider vaccination for: Persons with terminal complement component deficiency or asplenia Persons with HIV infection College freshmen living in dormitories not previously vaccinated Research or laboratory personnel routinely exposed to N. meningitidis Military recruits Persons traveling to countries where meningitis is hyperendemic or epidemic Persons who might have been exposed to meningococcal disease during an outbreak Anaphylactic reaction following a prior dose of vaccine or any vaccine component Defer vaccination in persons with moderate or severe acute illness until illness subsides. Not effective in children under 2 years of age See CDC ACIP Recommendation at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6202a1. htm for more information on primary & booster doses 50 Meningococcal Vaccination Recommendations This table summarizes the recommendations of CDC's Advisory Committee on Immunization Practices for the use of meningococcal vaccine. by Age and/or Risk Factor MCV4 = Menactra (sanofi) and Menveo (Novartis) MCV4-D = Menactra MCV4-CRM = Menveo Hib-MenCY = MenHibrix (GlaxoSmithKline) MPSV = Menomune (sanofi) Targeted group by age and/or risk factor Primary dose(s) Booster dose(s) People ages 11 through 18 years Give 1 dose of MCV4, preferably at age 11 or 12 years1 Give booster at age 16 years if primary dose given at age 12 years or younger Give booster at age 16 through 18 years if primary dose given at age 13 through 15 years2 People ages 19 through 21 years who are first year college students living in residence halls Give 1 dose of MCV41 Give booster if previous dose given at age younger than 16 years Travelers to or residents of countries where meningococcal disease is hyperendemic or epidemic,3 people present during outbreaks caused by a vaccine serogroup,4 and other people with prolonged increased risk for exposure (e.g., microbiologists routinely working with Neisseria meningitidis) for children age 2 through 18 months for children age 7 through 23 months who have not initiated a series of MCV4-CRM or Hib-MenCY Give MCV4-CRM at ages 2, 4, 6 and 1215 months5 Give 2 doses, separated by 3 months,6 of MCV4-CRM (if age 723 months)7 or MCV4-D (if age 923 months) If risk continues, give initial booster after 3 years followed by boosters every 5 years for age 2 through 55 years Give 1 dose of MCV41 Boost every 5 years with MCV48,9 for age 56 years and older If no previous MCV4 dose and either shortterm travel or outbreak-related, give 1 dose of MPSV; all others, give 1 dose of MCV4 People with persistent complement component deficiencies10 Boost every 5 years with MCV49 for age 2 through 18 months for children age 7 through 23 months who have not initiated a series of MCV4-CRM or Hib-MenCY Give MCV4-CRM or Hib-MenCY at ages 2, 4, 6 and 1215 months Give 2 doses, separated by 3 months, of MCV4-CRM (if age 723 months)7 or MCV4-D (if age 923 months) Give MCV4 booster after 3 years followed by boosters every 5 years thereafter for ages 2 through 55 years Give 2 doses of MCV4, 2 months apart Boost every 5 years with MCV48,11 for age 56 years and older Give 2 doses of MCV4, 2 months apart Boost every 5 years with MCV411 People with functional or anatomic asplenia, including sickle cell disease for age 2 through 18 months for children age 19 through 23 months who have not initiated a series of MCV4-CRM or Hib-MenCY Give MCV4-CRM or Hib-MenCY at ages 2, 4, 6 and 1215 months Give 2 doses of MCV4-CRM, 3 months apart Give MCV4 booster after 3 years followed by boosters every 5 years thereafter for ages 2 through 55 years Give 2 doses of MCV4, 2 months apart12 Boost every 5 years with MCV48,11 for age 56 years and older Give 2 doses of MCV4, 2 months apart Boost every 5 years with MCV411 footnotes 7. If using MCV4-CRM, dose 2 should be given no younger than age 12 months. 1. If the person is HIV-positive, give 2 doses, 2 months apart. 8. If primary dose(s) given when younger than age 7 years, give initial 2. The minimum interval between doses of MCV4 is 8 weeks. booster after 3 years, followed by boosters every 5 years. 3. Prior receipt of Hib-MenCY is not sufficient for children traveling to the 9. Booster doses are recommended if the person remains at increased risk. Hajj or African meningitis belt as it doesn't provide protection against sero- 10. Persistent complement component deficiencies include C3, C5C9, groups A or W. properdin, factor H, and factor D. 4. Seek advice of local public health authorities to determine if vaccination 11. If the person received a 1-dose primary series, give booster at the earliest is recommended. opportunity, then boost every 5 years. 5. Children ages 2 through 18 months who are present during outbreaks 12. Children with functional or anatomic asplenia should complete an age- caused by serogroups C or Y may be given an age-appropriate series of appropriate series of PCV13 vaccine before vaccination with MCV4-D; Hib-MenCY. MCV4-D should be given at least 4 weeks following last dose of PCV13. 6. If a child age 7 through 23 months will enter an endemic area in less than MCV4-CRM or Hib-MenCY may be given at any time before or after PCV13. 3 months, give doses as close as 2 months apart. Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition St. Paul, Minnesota 651-647-9009 www.immunize.org www.vaccineinformation.org www.immunize.org/catg.d/p2018.pdf Item #P2018 (2/14) 51 52 MMR Measles, Mumps, Rubella Pathophysiology Measles: Virus Respiratory transmission Incubation 10-12 days Mumps: Virus Respiratory transmission Incubation 14-18 days Rubella: Virus Respiratory transmission Incubation 12-23 days Vaccine Description Live attenuated vaccine Dose & Route 0.5 mL reconstituted vaccine given subQ Administration Schedule Dose Recommended Age 1 ............... 12 - 15 months (see Minimum Intervals below) 2 ............... 4 - 6 years (see Minimum Intervals below) Minimum Intervals Dose Minimum Interval and Ages 1 ........ MUST be at least 12 months of age 2* ........ At least 28 days after dose #1; usually given at 4-6 years of age. *Children who have received 2 doses of MMR with dose #1 no earlier than the 1st birthday and dose #2 at least 4 weeks after dose #1 do not need an additional dose for school entry. Combination Vaccine Administration *See page 48 for information on MMRV / Febrile Seizures ProQuad (MMRV) may be used to simultaneously administer MMR and varicella vaccine to children ages 12 mos. through 12 yrs. when both vaccines are indicated. Spacing and timing of MMRV from individual component vaccines (MMR and varicella): o At least 1 month between a dose of a measles-containing vaccine and a dose of MMRV o At least 3 months between a dose of varicella vaccine and a dose of MMRV o However, if varicella vaccine and MMRV are inadvertently given at least 28 days apart, the doses may be counted as valid. 53 Contraindications Precautions Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component. Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised). Pregnancy. Moderate or severe acute illness with or without fever. Recent (within 11 months) receipt of antibody-containing blood product (specific interval depends on product).Refer to Recommended intervals between administration of immune globulin preparations and measles- or varicellacontaining vaccine table after Varicella in VAC FACTS History of thrombocytopenia or thrombocytopenic purpura. Need for tuberculin skin testing. 54 Special Considerations & Instructions Vaccine should be stored in the refrigerator. Diluent may be stored at room temperature. For corticosteroid recipients: administration of MMR should be avoided for at least 1 month after cessation of high dose therapy (see Contraindications). Pregnancy should be avoided for 1 month following MMR vaccine. If PPD is needed and not given the same day as MMR, PPD testing should be delayed 4-6 weeks after MMR vaccination. Vaccine must be used within 8 hours of reconstitution, kept refrigerated and protected from exposure to light. Mumps protection in a non-outbreak setting o One dose of mumps-containing vaccine for pre-school children and non-high risk adults o 2 doses of mumps-containing vaccine for children in grades K-12 (school requirement) and adults at high risk Persons working in health care facilities International travelers Students attending post-high school educational institutions o Birth prior to 1957 o Laboratory evidence of immunity o Documentation of provider- diagnosed disease is not considered acceptable evidence of immunity for measles, mumps, or rubella. Mumps protection in an outbreak setting (depending on the epidemiology of the outbreak) o Second dose of vaccine should be considered for adults. o Two doses of vaccine for children ages 1-4 years of age if affected by the outbreak 1st dose should be administered at 12 months of age 2nd dose should be given 28 or more days after the 1st dose At this time, children K-12 must be immunized with 2 doses of a measlescontaining vaccine, 2 mumps, and 1 rubella, or provide laboratory evidence of immunity to measles, mumps, and rubella. This also applies to University System of Georgia students born in 1957 or later. 55 56 MMRV Measles, Mumps, Rubella Varicella Pathophysiology Measles: Virus Respiratory transmission Incubation 10-12 days Mumps: Virus Respiratory transmission Incubation 14-18 days Rubella: Virus Respiratory transmission Incubation 12-23 days Varicella Zoster Virus: Respiratory transmission Incubation 14-16 days Vaccine Description Live attenuated vaccine Dose & Route 0.5 mL reconstituted vaccine given subQ Administration Schedule Dose Recommended Age 1 ............... 12 - 15 months* Publication of ACIP 2 ............... 4 - 6 years** recommendations for administering *MMRV vaccine may be administered to this vaccine is found at http://www.cdc.gov/mmwr/ preview/mmwrhtml/rr5903a1. htm?s_cid=rr5903a1_e children 12 months through 12 years of age when all components of the vaccine are needed for completion of the vaccine series or when any single component of the vaccine series is not available at the time of immunization. **Children who received 2 doses of MMR with dose #1 no earlier than the 1st birthday and dose #2 at least 4 weeks after dose #1 do not need an additional dose for school entry. Minimum Intervals ProQuad (MMRV) may be used to simultaneously administer MMR and varicella vaccine to children ages 12 mos. through 12 yrs. when both vaccines are indicated. Spacing and timing of MMRV from individual component vaccines (MMR and varicella): o At least 1 month between a dose of a measles-containing vaccine and a dose of MMRV o At least 3 months between a dose of varicella vaccine and a dose of MMRV o However, if varicella vaccine and MMRV are inadvertently given 28 days or more apart, the doses may be counted as valid. 4757 Contraindications Special Considerations & Instructions Anaphylactic reaction following a prior dose of MMR, Varicella or to any of its components (gelatin or neomycin) Immunosuppression Recent recipient of blood products (See ACIP general recommendations for correct spacing) Persons receiving large doses of corticosteroids (>2mg/kg per day or >20mg per day of prednisone) for 14 days or more Pregnancy Defer vaccination in persons with moderate or severe acute illness until illness subsides TB - untreated, active HIV Positive Children- MMRV should not be administered to HIV infected children. Only single antigen varicella should be considered for HIV infected children in CDC class N2, A2 or B2 with CD4+ T-lymphocyte percentages > 15%. Personal or family history of seizures is a precaution for MMRV vaccination. Vaccine must be stored frozen at 5o F. or colder. Once reconstituted, vaccine should be discarded if not used within 30 minutes. Diluent may be stored at room temperature or in the refrigerator. For corticosteroid recipients: administration of MMRV should be avoided for at least 1 month after cessation of high dose therapy (see Contraindications). Pregnancy should be avoided for 1 month following MMRV vaccine. If PPD is needed and not given the same day as MMRV, PPD testing should be delayed 4-6 weeks after MMRV vaccination. May be administered simultaneously with other vaccines recommended at ages 12 mos. through 12 yrs. MMRV and Febrile Seizures http://www.cdc.gov/vaccines/vpdvac/combovaccines/mmrv/vacopt-factsheethcp.pdf Dose 1 at Ages 12 through 47 Months Either MMR and varicella or MMRV vaccine can be used. Providers should discuss the benefits and risks of both vaccination options with the parents or caregivers. Use of MMRV vaccine results in one fewer injection but is associated with a higher risk for fever/febrile seizures 5 through 12 days after the first dose among children aged 12 through 23 months. CDC recommends that MMR vaccine and varicella vaccine should be administered as separate injections for the first dose in children 1247 months of age. Dose 1 at Ages 48 Months and Older and Dose 2 at any Age: Use of MMRV vaccine generally is preferred over separate injections of its equivalent component vaccines 58 Pathophysiology Vaccine Description Dose & Route Administration Schedule Catch-up Vaccination Minimum Intervals Combination Vaccine Administration Varicella Chicken Pox Vaccine Varicella Zoster Virus Respiratory transmission Incubation 14-16 days Live attenuated vaccine 0.5 mL reconstituted vaccine given subQ Dose Recommended Age 1 12 months - 15 months 2 4-6 years* *The 2nd dose can be administered at an earlier age provided the interval between the 1st and 2nd dose is at least 3 months. If the 2nd dose is inadvertently given at least 28 days after the 1st dose, the 2nd dose does not need to be repeated. Varicella vaccination is recommended for children who are older than 15 months of age and do not have evidence of immunity. Minimum Age at Dose 1 Minimum Interval to Dose 2 12 months 3 mos. if Dose 1 given at <13 yrs. of age 1 mo. if Dose 1 given at 13 yrs. of age ProQuad (MMRV) may be used to simultaneously administer MMR and varicella vaccine to children ages 12 mos. through 12 yrs. when both vaccines are indicated. Spacing and timing of MMRV from individual component vaccines (MMR and varicella): o At least 1 month between a dose of a measles-containing vaccine and a dose of MMRV o At least 3 months between a dose of varicella vaccine and a dose of MMRV o However, if varicella vaccine and MMRV are inadvertently given 28 days or more apart, the doses may be counted as valid. 59 Contraindications Evidence of Immunity to Varicella Anaphylactic reaction following a prior dose of Varicella (VarivaxTM) or to any of its components (gelatin or neomycin) Immunosuppression Recent recipient of antibody-containing blood products (Refer to Recommended intervals between administration of immune globulin preparations and measles- or varicella-containing vaccine table after Varicella in VAC FACTS) Pregnancy Defer vaccination in persons with moderate or severe acute illness until illness subsides TB - untreated, active Vaccination of persons who have severe illness should be postponed until recovery Documentation of age-appropriate varicella vaccination; Preschool-age children (i.e., age 12 months through 3 years): 1 dose School-age children, adolescents, adults: 2 doses Laboratory evidence of immunity or laboratory confirmation of disease Birth in the United States before 1980 (Should not be considered evidence of immunity for health care personnel, pregnant women, and immunocompromised persons) Diagnosis or verification of a history of varicella or herpes zoster by a health care provider To verify a history of varicella, health care providers should inquire about: an epidemiologic link to another typical varicella case or to a laboratory confirmed case, or evidence of laboratory confirmation, if testing was performed at the time of acute disease. Persons who have neither an epidemiologic link nor laboratory confirmation of varicella should not be considered as having a valid history of disease. For these persons, a second dose of vaccine is recommended if they previously received only one dose. If a health care provider verifies the diagnosis based on the above criteria, then vaccination is not needed. 60 Special Considerations & Instructions Vaccine is very fragile and must be stored frozen (+5F or -15C or lower). Reconstituted product must be used within 30 minutes. Pregnancy should be avoided for 1 month following varicella vaccination. Diluent may be stored at room temperature. For corticosteroid recipients: administration of varicella should be avoided for at least 1 month after cessation of high dose therapy. Treatment with low dose (<2mg/kg/day), alternate day, topical, replacement or aerosolized steroid preparations is not a contraindication to varicella vaccination. For chemotherapy recipients: administration of varicella should be avoided for at least 3 months after chemo cessation. Counsel varicella recipients: if a rash develops following vaccination, there is a possibility for these people to infect others but this is extremely rare. Asymptomatic or mildly symptomatic HIV-infected children age > 12 months with age-specific CD4+ T lymphocyte counts > 15% and without evidence of varicella immunity should receive 2 doses of single antigen varicella vaccine 3 months apart. o PROQUAD should not be used in HIV infected children due to the difference in antigen composition. All students in Georgia schools must provide documentation of vaccination or immunity Varicella vaccine administration is recommended as post-exposure prophylaxis for susceptible persons if given within 3-5 days of exposure to varicella disease. 61 62 Recommended intervals between administration of immune globulin preparations and measles- or varicella-containing vaccine Product / Indication Dose, including mg immunoglobulin G (IgG)/kg body weight Recommended interval before measles or varicella-containing1 vaccine administration Botulinum Immune Globulin Intravenous (Human) 1.5 mL/kg (75 mg IgG/kg) IV 6 months Tetanus IG (TIG) 250 units (10 mg IgG/kg) IM 3 months Hepatitis A IG - Contact prophylaxis 0.02 mL/kg (3.3 mg IgG/kg) IM 3 months - International travel 0.06 mL/kg (10 mg IgG/kg) IM 3 months Hepatitis B IG (HBIG) 0.06 mL/kg (10 mg IgG/kg) IM 3 months Rabies IG (RIG) 20 IU/kg (22 mg IgG/kg) IM 4 months Varicella IG 125 units/10 kg (60-200 mg IgG/kg) IM, maximum 625 units 5 months Measles prophylaxis IG - Standard (i.e., nonimmunocompromised) contact 0.25 mL/kg (40 mg IgG/kg) IM 5 months - Immunocompromised contact 0.5 mL/kg (80 mg IgG/kg) IM 6 months Blood transfusion - Red blood cells (RBCs), washed 10 mL/kg (negligible IgG/kg) IV None - RBCs, adenine-saline added - Packed RBCs (hematocrit 65%)2 - Whole blood (hematocrit 35%-50%)2 10 mL/kg (10 mg IgG/kg) IV 10 mL/kg (60 mg IgG/kg) IV 10 mL/kg (80-100 mg IgG/kg) IV 3 months 6 months 6 months - Plasma/platelet products 10 mL/kg (160 mg IgG/kg) IV 7 months Cytomegalovirus IGIV 150 mg/kg maximum 6 months IGIV - Replacement therapy for immune deficiencies3 300-400 mg/kg IV 8 months - Immune thrombocytopenic purpura treatment 400 mg/kg IV 8 months - Immune thrombocytopenic purpura treatment 1,000 mg/kg IV 10 months - Kawasaki disease - Postexposure varicella prophylaxis4 Monoclonal antibody to respiratory syncytial virus F protein (SynagisTM)5 2 g/kg IV 400 mg/kg IV 15 mg/kg (IM) 11 months 8 months None This table is not intended for determining the correct indications and dosages for using antibody-containing products. Unvaccinated persons might not be fully protected against measles during the entire recommended interval, and additional doses of IG or measles vaccine might be indicated after measles exposure. Concentrations of measles antibody in an IG preparation can vary by manufacturer's lot. Rates of antibody clearance after receipt of an IG preparation also might vary. Recommended intervals are extrapolated from an estimated half-life of 30 days for passively acquired antibody and an observed interference with the immune response to measles vaccine for 5 months after a dose of 80 mg IgG/kg. 1 Does not include zoster vaccine. Zoster vaccine may be given with antibody-containing blood products. 2 Assumes a serum IgG concentration of 16 mg/mL. 3 Measles and varicella vaccinations are recommended for children with asymptomatic or mildly symptomatic human immunodeficiency virus (HIV) infection, but are contraindicated for persons with severe immunosuppression from HIV or any other immunosuppressive disorder. 4 The investigational product VariZIG, similar to licensed VZIG, is a purified human IG preparation made from plasma containing high levels of anti-varicella antibodies (IgG). The interval between VariZIG and varicella vaccine (Var or MMRV) is 5 months. 5 Contains antibody only to respiratory syncytial virus Adapted from Table 5, ACIP General Recommendations on Immunization May 2012 63 64 Pediarix DTaP / Hep B / IPV Pathophysiology (See DTaP, Hepatitis B, and IPV cards) Vaccine Description Combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), Hepatitis B recombinant (Hep B), and inactivated polio virus vaccine (IPV) Dose & Route 0.5 ml given IM Administration Schedule* Dose Recommended Age 1 ............... 2 months *Pediarix may only be used in children younger than age 7 years 2 ............... 4 months 3 ............... 6 months Booster Doses Pediarix cannot be used for booster doses. The DTaP series (doses #4 and #5) and the IPV series (dose #4) must be completed with single antigen vaccines Minimum Intervals Dose Minimum Interval and Ages 1 ...... 6 weeks of age Contraindications 2 ...... 4 weeks after dose 1 (10 weeks of age) 3 ...... 8 weeks after dose 2 and 16 weeks after dose 1 and at least 24 weeks of age Anaphylactic reaction following a prior dose of Pediarix or any of its component vaccines Hypersensitivity to any component of the vaccine including yeast, neomycin and polymyxin B History of encephalopathy within 7 days of a previous dose of any pertussis-containing vaccines Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy Guillain-Barre` syndrome (GBS) within 6 weeks after a previous dose of tetanus Precautions toxoid-containing vaccine Defer vaccination in children with moderate or severe acute illness until illness subsides Precautions applying to any of the component vaccines 65 Special Instructions 39 ACIP continues to recommend the birth dose of single antigen Hep B vaccine and has approved PediarixTM to complete the Hep B series regardless of the mother's HBsAg status, provided the minimal age and time intervals for Hep B are observed. It is permissible to administer 4 doses of hepatitis B vaccine when Pediarix is used following a birth dose of hepatitis B vaccine. However, a dose of Hepatitis B vaccine must be administered on or after 24 weeks of age. PediarixTM may be given simultaneously with any other vaccine(s) at separate sites. PediarixTM can be used interchangeably if necessary with single antigen components (DTaP, IPV, Hep B) or with Comvax as long as minimal ages and intervals are observed. 40 66 Pentacel DTaP / Hib / IPV Pathophysiology (See DTaP, Hib, and IPV cards) Vaccine Description Combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), Haemophilus Influenzae type B (Hib), and inactivated polio virus vaccine (IPV) Dose & Route 0.5 ml given IM Administration Schedule* Dose Recommended Age *May only be used for the primary series for 1 ............... 2 months children aged 6 weeks through 6 years 2 ............... 4 months 3 ............... 6 months Booster Doses 15-18 months Minimum Intervals Dose Minimum Interval and Ages 1........6 weeks of age 2..........4 weeks after dose 1 (10 weeks of age) 3..........4 weeks after dose 2 (14 weeks of age) 4........ 6 months after dose 3 (12 months of Contraindications age) History of severe hypersensitivity to any component of the vaccine History of serious allergic reaction to a previous dose of vaccine for any pertussis containing vaccine including Pentacel Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause Progressive neurological disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy Guillain-Barre Syndrome (GBS) within 6 weeks after vaccination For Polio vaccine (IPV) contraindicated if there is a life-threatening allergy to neomycin, Streptomycin or POLYMYXIN B. Because of uncertainty as to which ingredient of the vaccine may be responsible for a severe allergic reaction, none of the ingredients should be administered and they should be referred to an allergist for evaluation if further immunizations are considered. 41 67 Special Instructions Either Pentacel or single antigen Hib vaccine may be used at 12 through 15 months of age for children who are at increased risk of Hib disease or who have not completed a primary Hib schedule. If Pentacel is administered at 12-15 months of age, a dose of DTaP at 15-18 months of age is not needed. 42 68 69 70 Pathophysiology Vaccine Description Prevnar13TM Pneumococcal Conjugate Vaccine (PCV13) Bacteria Common inhabitant of the respiratory tract Respiratory transmission: direct person-to-person via droplets or autoinoculation in persons carrying the bacteria in their upper respiratory tract Inactivated vaccine that contains polysaccharide from 13 pneumococcal serotypes Dose & Route Administration Schedule Minimum Intervals Schedule for Older Infants & Children Contraindications 0.5 mL given IM (shake vial before drawing up) Dose Recommended Age 1 ............... 2 months 2 ............... 4 months 3 ............... 6 months 4 .............. . 12-15 months (booster) Dose Minimum Interval and Ages 1 ........... Must be at least 6 weeks of age 2 ........... 4 weeks from dose 1 3 ........... 4 weeks from dose 2 4 .......... 8 weeks from dose 3 (booster) Age @ 1st Primary Series Booster Dose 7-11 months 2 doses Yes-2 months after dose 2 12-23 months 2 doses at least 8 No weeks apart 24-59 Months Healthy 1 dose No 24-71 months High Risk* 2 doses at least 8 No weeks apart 618 years High Risk* 1 dose No *High Risk: Immunocompromising conditions functional or anatomic asplenia, cerebrospinal fluid (CSF) leaks cochlear implants who have not previously received PCV13. Anaphylactic reaction following a prior dose of PCV13 Defer vaccination in children with moderate or severe acute illness until illness subsides. 71 Special Considerations PCV is required for children younger than 5 years attending a child care facility. PCV13 and PPSV23 should not be administered at the same time; at least 2 mos. should separate the vaccine doses. Children at high risk who received PCV13 should also receive PPSV23 at 2 yrs. of age. PCV13 and DTaP should be administered in separate sites. 72 Pathophysiology Vaccine Description Dose & Route Administration Schedule & Minimum Intervals Rotavirus Vaccine Virus Transmitted by fecal-oral route. However, transmission by fomites and respiratory route may also occur. Incubation 2-4 days Live, oral pentavalent vaccine RotaTeq (RV5) Three (3) 1 ml oral doses Rotarix (RV1) Two (2) 1-ml oral doses Recommended Schedule for Rotavirus Vaccines Note: If an incomplete dose is administered (i.e. infant spits or regurgitates vaccine), a replacement dose is not needed. Continue the series using the recommended intervals and complete before 33 weeks of age. Infants who have had rotavirus gastroenteritis before receiving the full course of rotavirus vaccinations should still initiate or complete the 3-dose schedule because the initial infection frequently provides only partial immunity. Contraindications Rotavirus vaccines are not to be started after 14 weeks, 6 days, and all doses are to be completed by 8 months. Rotateq Rotarix Dose Primary 1 Primary 2 Primary 3 Age 2 months 4 months 6 months Age 2 months 4 months -------- Interchangeability of Rotavirus Vaccines ACIP recommends that the rotavirus vaccine series be completed with the same product whenever possible. However, vaccination should not be deferred if the product used for previous doses is not available or is unknown. In this situation, the provider should continue or complete the series with the product available. If any dose in the series was RotaTeq or the manufacturer is unknown for any dose in the series, a total of three doses of rotavirus vaccine should be given. Demonstrated hypersensitivity to any component of the vaccine 73 63 Precautions Note: The oral applicator of Rotarix Contains latex. Use precaution with infants with a previous hypersensitivity to latex. Special Considerations Acute gastroenteritis Moderate to severe illness Preexisting chronic gastrointestinal disease History of intussusception Altered immunocompetence due to: o Blood dyscrasias o Immunosuppressive therapy o Primary and acquired immunodeficiency such as HIV Shedding of virus in the stool after vaccine administration is possible. Caution is advised when considering administration of vaccine to persons with immunocompromised household contacts. Can be administered on same visit with other routinely recommended vaccines. No restrictions on infant's consumption of food or liquid, including breast milk, before or after receiving vaccine. If an incomplete dose is administered (i.e. infant spits or regurgitates vaccine), a replacement dose is not recommended. Continue the series using intervals as outlined above. Rotavirus may be administered at any time before, concurrent with, or after administration of any blood product including antibody containing product. 74 Herpes Zoster Vaccine Zostavax Pathophysiology Vaccine Description Dose & Route A manifestation of the reactivation of varicella zoster virus which, as a primary infection, produces chickenpox (varicella). Following initial infection, the virus remains latent in the dorsal root or cranial sensory ganglia until it reactivates, producing zoster. Zoster is characterized by a unilateral, painful, vesicular cutaneous eruption with a dermatomal distribution. Live, attenuated virus vaccine 0.65 mL single dose unit given subQ Reconstituted, lyophilized vaccine Administration Schedule & Minimum Intervals Dose 1 dose Minimum Age Age 60 and older* *A single dose of zoster vaccine is recommended for adults aged 60 years and older regardless of whether they report a prior episode of herpes zoster. Although the vaccine is licensed by the Food and Drug Administration (FDA) for use among and can be administered to persons aged 50 years and older by private providers, ACIP recommends that vaccination begins at age 60. Persons aged 60 years and older with chronic medical conditions may be vaccinated unless their condition constitutes a contraindication, such as pregnancy or severe immunodeficiency. Contraindications History of anaphylactic reaction to gelatin, neomycin, or other vaccine components Immunosuppression, including that due to high-dose corticosteroid or other therapy A person who has a weakened immune system because of: o HIV/AIDS or another disease that affects the immune system o cancer treatment such as radiation or chemotherapy o cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma Women who are or might be pregnant 75 Precautions Special Considerations Moderate or severe acute illness with or without fever Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination, if possible; delay resumption of these antiviral drugs for 14 days after vaccination. This vaccine is not a substitute for varicella vaccine and should never be administered to children. Not indicated for treatment of herpes zoster (shingles) or postherpetic neuralgia The duration of protection after vaccination is unknown. Must be stored frozen at a temperature of 50F or colder Must be used within 30 minutes of reconstitution or discarded; may not be refrozen after reconstitution 67 76