2. Vaccines and the Diseases They Prevent Immunization update Joni Reynolds, RNC, MSN

3. Disclosure I have no relevant financial interests in any commercial interests or company mentioned in this presentation.

4. Overview Vaccine Terminology Childhood and Adolescent Vaccines Grace Periods Contraindications VIS Conversations with Parents Documentation Storage and Handling

5. What Is a Vaccine ? A vaccine is the deliberate stimulation of adaptive immunity. Vaccines: Work by mimicking what happens during natural infection without causing illness. Use altered versions of viruses or bacteria to trigger an immune response. Are the most effective means of controlling infectious diseases. Not only protect those who get them, but they also help keep diseases at bay in the community; this is called herd immunity.

6. How do Infections Work? During natural infection: The immune system recognizes a pathogen as foreign and makes an immune response to it. When a pathogen causes an immune response, it is known as an antigen. Unfortunately, while the immune response is gaining strength, the person is likely to be ill as the struggle between the pathogen and the immune response is decided. One part of the immune response creates antibodies; this is known as the antibody-mediated or humoral immune response. Antibodies are specific to antigens and have the ability to remember them, so that if the same (or a very similar) antigen tries to infect the person again, the immune response will be stronger and faster thereby protecting the person from infection—and illness.

7. How Do Vaccines Work ? With a vaccine: The immune system recognizes the vaccine as foreign and makes an immune response to it. The vaccine serves as an antigen in that it causes the immune system to respond to it. One part of the immune response creates antibodies; this is known as the antibody-mediated or humoral immune response. Antibodies are specific to the vaccine and have the ability to remember it, so that if the vaccine or a very similar antigen is seen again, the immune response will be stronger and faster thereby protecting the person from infection. The main difference between a vaccine and natural infection is that the person does not become ill while the immune system is responding to the vaccine.

8. I’m Good Video

9. Vaccine Terminology Live, attenuated –MMR, VAR (Varicella), MMRV, –LAIV (Flumist  ) –RV1 (Rotarix), RV5 (RotaTeq) Inactivated –Acellular pertussis, diphtheria, tetanus (DTaP, Tdap) hepatitis A, hepatitis B, Hib, influenza, IPV, meningococcal conjugate (Menactra), meningococcal polysaccharide (Menomune), pneumococcal conjugate (Prevnar), pneumococcal polysaccharide (Pneumovax), Human Papilloma Virus (HPV),

10. Childhood Immunization Schedule  2011 Schedule  Updated annually in January  Use for age birth through 18 years  Birth to age 6 years  Age 7-18 years ACIP Advisory Committee on Immunization Practices

11. 2011 Changes Guidance added for the Hep B vaccine schedule for children who did not receive a birth dose Use of 13-valent pneumococcal conjugate vaccine Seasonal influenza vaccine for all children Use of Tdap vaccine for children aged 7- 10 years of age

12. 2011 Changes Footnotes for use of HPV vaccine have been condensed Routine 2-dose schedule of quadrivalent meningococcal conjugate vaccine (MCV4) And Booster dose of MCV4 have been added Guidance for use of Haemophilus influenzae type b (Hib) in persons 5 years+

16. Infants and Children 0 Through 6 Years of Age – Vaccines Hepatitis B Rotavirus Diphtheria, Tetanus and Pertussis Haemophilus influenzae type b Pneumococcus Polio Influenza Measles, Mumps and Rubella Varicella Hepatitis A

17. Hepatitis B Vaccine Given IM –Birth –1-2 months –6-12 months No booster doses recommended Do NOT re-start series if interrupted Administration of 4 doses to infants is acceptable when combination vaccines containing HepB are administered after the birth dose.

18. Hepatitis B Vaccine Reminders  Minimum Interval Schedule  4 weeks between doses 1 and 2  8 weeks between doses 2 and 3  16 weeks between doses 1 and 3 (- 4 days)  Minimum age for dose 3 is now 24 weeks, and the 4 day grace period applies  Remember, adolescents and high risk adults need the vaccine too!

19. A Comment on Minimum Intervals: When to Calculate Days-vs-Weeks-vs-Months Customarily, if the dosing interval is 4 months or more, it is common to use calendar months (e.g., 6 months from October 1 is April 1). If the interval is less than 4 months, it is common to convert months into days or weeks (e.g., 1 month = 4 weeks = 28 days).

20. Rotarix® (RV1) and Rotateq® (RV5) Two Very Different Products RV (Rotarix®) –2 dose schedule –Max age 1 st dose 20 wks –Max age any dose 24 wks RV5 (Rotateq®) –3 dose schedule –Max age 1 st dose 12 wks –Max age any dose 32 wks Confusing, complicated, challenging! –No data on schedules that include receiving both RV1 and RV5 –ACIP worked >1 year to develop and have approved recommendations for the use of interchanging these products

21. Recommendations for Routine Rotavirus Vaccination Rotarix ® (RV1) RotaTeq ® (RV5) ACIP Recs Doses23___ Minimum age 6 wks Max age 1 st dose 20 wks12 wks14 wks and 6 days* Max age any dose 24 wks32 wks8 mos and 0 days* *Off-label. See MMWR 2009;58(RR-2)

22. Recommendations for Routine Rotavirus Vaccination Safety and Efficacy demonstrated for both products in prelicensure clinical trials – 85%-98% effective against severe rotavirus disease –74%-87% effective against rotavirus disease of any severity through approx first rotavirus season Contraindication: life-threatening allergy to latex, do NOT use Rotarix ®, use RotaTeq ® instead

23. Recommendations for Routine Rotavirus Vaccination Infants receiving dose 1 inadvertantly after 15 wks 0 days or later should complete series according to schedule and by 8 mos 0 days age. Infants with hx of rotavirus GE disease should still start or complete vaccination series according to age and interval recommendations.

24. Recommendations for Routine Rotavirus Vaccination Complete rotavirus vaccine series with same product whenever possible Do not defer vaccination if product used for prior doses is not known or is unavailable Continue series with product in stock If any dose in series was RV5, or the brand used for any prior dose in the series is unknown, a total of 3 rotavirus vaccines must be used to complete the series

25. DTaP Vaccine Diphtheria, Tetanus, acellular Pertussis Given IM  2 months  4 months  6 months  12-18 months  4-6 years Minimum 6 months between doses 3 and 4. 4 th dose may be given as early as 12 mos (must have 6 mos interval from dose 3.) Record Review: if dose #4 was given at least 4 months after dose #3, it does not need to be repeated. –This interval should not be used for scheduling vaccine appointments.

26. DTaP Reminders  Same DTaP preferred throughout series but can be interchanged  Give DTaP simultaneously with other vaccines  No DTaP after the age of 6  Tdap booster

27. Tdap Vaccine Tetanus, diphtheria, acellular pertussis  Given IM –Recommended at age10-12 years* –Tdap 1x –Additional Td every 10 yrs  Persons 10-18 years that have not received Tdap should get 1 dose  Tdap used as booster; however, a shorter interval may be used when pertussis immunity is needed.

28. Hib Vaccine Given IM –2 months –4 months –6 months –12-15 months 3-4 dose series depending on brand of vaccine used All Hib vaccines are interchangeable Children 15-59 months with no prior doses need only one dose

29. Pneumococcal Conjugate Vaccine (Prevnar 13) PCV13 recommended for routine administration as 4- dose series for infants at: –2 months –4 months –6 months and –12-15 months Catch-up recommended for children <24 months, using fewer doses depending on age of 1 st dose. Total doses for a complete series depends on the age at time of visit Minimum intervals: for primary series = 4 weeks for booster dose = 8 weeks

30. Recommendations for Pneumococcal Conjugate Vaccine Children 24 months through 59 months:  Healthy children who have not completed any PCV13 schedule, give 1 dose  Those with underlying medical conditions* and have received 3 prior doses, give 1 dose  Those with underlying medical conditions and have received <3 prior doses, give 2 doses at least 8 weeks apart  The minimum interval between all doses PCV7 for all children 24-59 months is 8 weeks. *immunocompromising conditions, selected chronic illnesses, sickle cell disease, functional and anatomic asplenia, HIV

31. Pneumococcal Polysaccharide Vaccine (PPV23) Given IM or SQ –Routinely for all adults >65 years age –Persons >2 years with: chronic illness, anatomic or functional asplenia, immunocompromised, HIV infection, environments or settings with increased risk, cochlear implant –Adults 19-64 years who smoke or have asthma should receive a single dose of PPV23 Should not be administered simultaneously with PCV13; must be given 8 weeks apart A second dose of PPV23 is recommended 5 years after the first PPV23 for persons >2 years who are immuno- compromised, have sickle cell disease, or functional or anatomic asplenia

32. Pneumococcal Polysaccharide Vaccine (PPV23) Revised recommendation in use of PPV23 for American Indian and Alaskan Natives –24-59 months age – use of PPV23 after PCV7 or PCV13 not recommended, unless in special circumstances, PH authorities may recommend in those living in areas of high risk for the disease. –Routine use not recommended in those <65 yrs. Unless they have underlying medical conditions; May be recommended for those 50-64 living in areas of high risk for the disease.

33. Polio Vaccine Given IM or SQ –2 months –4 months –6-18 months and –4-6 years 3 doses with one after age 4 = complete series Schedule that includes both OPV & IPV MUST be four doses

34. Meningococcal Conjugate Minimum age: 2 yrs for Meningococcal Conjugate Vaccine (MCV4) Menanctra ® MCV = children 2-10 yrs in certain high-risk groups Administer routinely at age 11-12 years, or at age 13-18 if not previously vaccinated Given IM Administer to previously unvaccinated college freshman living in a dormitory. Revaccinate with MCV if person received MPSV >3 years previously and remain at increased risk for meningococcal disease

35. Influenza Vaccine Given IM –Administer annually to all children ages 6 months to 18 years –6 months-8 years 1-2* dose(s) –  9 years one single dose Healthy, non-pregnant persons 2-49 years may receive either TIV or LAIV Dosage for children 6- 35 mos receiving TIV = 0.25 ml; those >3 years = 0.5 ml *Children <9 years receiving influenza vaccine for first time or were vaccinated first time last year but only received 1 dose should receive 2 doses at least 4 weeks apart

36. Influenza LAIV Given to children 2 years of age on up, through age 49 years Same intervals as TIV, same annual recommendations Screen for history of wheezing

37. MMR Vaccine 2 doses given SQ – Dose 1 at  12 months – Dose 2 at 4-6 years Second dose must be at least 4 weeks after first dose Second dose may be given before 4 years provided at least 28 days have elapsed since dose 1 Assure that all children and adolescents receive 2 doses

38. Varicella Vaccine 2 doses given SQ –Dose 1 at >12 months –Dose 2 at 4-6 years Second dose may be given before 4 years provided at least 3 months have elapsed since dose 1 Recommended for all children & adolescents without evidence of immunity to chickenpox disease Children 12 mos through 12 years – 3 month minimum interval between doses –If 2 nd dose administered at least 28 days after dose 1 it can be accepted as valid For persons >13 years the minimum interval between doses is 28 days. If not given on same day as MMR, wait 4 weeks

39. Hepatitis A Vaccine Given IM –Children 12-23 months –Two doses at least 6 mos apart Children not fully vaccinated by age 2 yrs can be vaccinated at subsequent visits Also recommended for children older than age 1 year who live in areas where vaccination programs target older children or who are at increased risk for infection Not licensed for use in children under 1 year

40. Children and Teens 7 Through 18 Years of Age – Vaccines Tetanus, diphtheria and pertussis Human papillomavirus (HPV) Meningococcus Influenza

41. Tdap Booster Required in Colorado for entry to Middle and High Schools Remember: –ACIP recommendations for Tdap for adolescents, parents of newborns, HCW, Child Care providers, grandparents.

42. Human Papillomaviruses More than 120 virus types Approximately 40 are spread through sexual contact infecting the oral, anal or genital areas of both men and women HPV infections are very common –Estimated 6.2 million new HPV infections occur annually –Prevalence among adolescent girls is as high as 64% –75% of new infections occur among persons 15-24 years of age –By 50 years of age, 70-80% of women will have acquired genital HPV infection –Most cause minimal or no symptoms and are cleared completely by the immune system within a few weeks or months

43. Human Papillomaviruses Types 16 and 18 –Known as “high-risk” HPV types –Can cause abnormal pap tests and cervical cancer –Together, cause 70% of cervical cancer in US –In men and women – thought to cause 85% of anal cancers, 50% of other anogenital cancers, 20% of cancers of throat and mouth, 10% of cancers of larynx and esophagus Types 6 and 11 –Responsible for more than 90% of genital warts (can be spread from mother to infant and during delivery)

44. HPV Vaccine First vaccine licensed in 2006 –HPV4 (Merck) (types 6, 11, 16 and 18) –HPV2 (GSK) types 16 and 18) Routine recommendation –11-12 year old adolescents –Catch-up recommended for females 13-26 yrs Contraindicated for pregnant women, moderate illness, severe allergy to vaccine component Efficacy –100% in preventing cervical pre-cancers (for vaccine types) –100% effective in preventing vulvar and vaginal pre- cancers and genital warts (for vaccine types) –Higher antibody titers in young girls than older women vaccinated

45. HPV Vaccine HPV2 (bivalent) (16,18) HPV4 (quadrivalent) (6, 11, 16, 18) 3 dose series –Give second dose 2 months after the 1 st and the 3 rd dose 6 months after the 1 st dose (at least 24 wks) Given IM Routine 11 – 12 years –Licensed ages 9 – 26 years –HPV 4 can be given to males 70% of cervical cancer (16,18) Pap testing

46. Meningococcal Vaccine First dose at age 11-12 years Booster dose given 5 years later (16-18) –Advocate for dose given prior to college entry –Note high-risk activities and risk of illness

47. Adolescents and Teens May Need to “Catch-up” on Certain Vaccines Hepatitis A Hepatitis B Poliovirus Measles, Mumps and Rubella Varicella

48. Additional Vaccine Information Combination Vaccines Intervals and Grace Periods True Contraindications VIS Conversations With Parents Documentation Storage and Handling

49. Combination Vaccines Kinrix™ - DTAP + IPV Pentacel® - DTaP + IPV + Hib Pediarix™ - DTaP + Hep B + IPV

50. CDC Imm Update 2008 Webcast Kinrix™ GSK Product; Licensed 6/24/08 DTAP + IPV Approved only for: –5 th DTaP dose AND 4 th IPV dose, IN… –Children 4-6 years of age, WHO… –Received Pediarix™ or Infanrix® for doses 1-3 and Infanrix ® for dose 4 of the DTaP series.

51. CDC Imm Update 2008 Webcast Kinrix™ Limited immunogenicity and safety data on the interchangeability of DTaP brands Whenever feasible, the same manufacturer’s DTaP vaccine should be used throughout the DTaP series. Vaccination should not be deferred if the previous DTaP brand doses are not known or available

52. CDC Imm Update 2008 Webcast Kinrix™ Off label use is not recommended Administering Kinrix™ for any dose other than the 5 th DTaP and the 4 th IPV in the series is considered a vaccine administration error –If inadvertently administered as an earlier dose in the series, do not repeat dose; count dose as valid if minimum age and intervals since last doses are met.

53. CDC Imm Update 2008 Webcast Pentacel® Sanofi Pasteur product; Licensed 6/25/08 DTaP + IPV + Hib –ActHIB™ lyophilized mixed with liquid DTaP/IPV (Daptacel®) Licensed for use as doses 1 through 4 in the DTaP series of children 6 weeks through 4 years of age. –Should not be given for dose 5 in the DTaP series, or for children 5 years or older

54. CDC Imm Update 2008 Webcast Pentacel® Non-inferiority study showed immunological responses to Pentacel to be as great or better than responses to when the antigens are given separately. Adverse reactions (e.g. local reactions and fever) were also shown to be similar

55. CDC Imm Update 2008 Webcast Pentacel® Recommended Schedule: –2, 4, 6, 15-18 months age –Doses 1 through 3 must be separated by 4 weeks; –Doses 3 and 4 must be separated by 6 months; –Dose 4 may be given as early as 12 months of age but only if there have been 6 months since dose 3.

56. CDC Imm Update 2008 Webcast Pentacel® Whenever feasible the same DTaP product should be used throughout the series DTaP vaccination should not be deferred if prior DTaP product used is unknown or unavailable.

57. Pediarix™ DTaP + Hep B + IPV –Approved for 3 doses at 2,4,6 months NOT approved for booster doses Licensed for children 6 weeks to 7 years of age

58. Pediarix™ Minimum age for first dose is 6 weeks NOT approved for 4 th or 5 th booster doses of the DTaP or IPV series Can be used for children not UTD (licensed for use through age 6 years)

59. Pediarix™ May be used interchangeably with other Pertussis containing vaccines, if necessary Can be given at 2, 4, and 6 months to infants who received a birth dose of hepatitis B vaccine (total: 4 Hep B doses) May be used in infants whose mothers are HBsAg postive or status unknown.

60. Use of Combination Vaccines Individual components in a combo vaccine determine the schedule, minimum intervals, and minimum ages for administration Will a combo vaccine work today? –Assess the child’s age; –Determine doses due today; –Identify last doses received; –Determine if minimum dose intervals and minimum age have been met for every dose due; –Identify what combo, if any is appropriate

61. Vaccine Intervals – Routinely Recommended and Minimum General Rules: –Increasing the interval between doses of a multidose vaccine does not diminish the effectiveness of the vaccine. –Decreasing the interval between doses of a multidose vaccine may interfere with the antibody response and protection.

62. Vaccine Intervals – Routinely Recommended –vs– Minimum Recommended ages and intervals between doses of multidose antigens provide optimal protection or have the best evidence of efficacy……..Therefore, Providers should adhere as closely as possible to recommended vaccination schedules.

63. Minimum Intervals To be used on persons that are: –Behind schedule and need to be brought up- to-date as quickly as possible, or –When international travel is impending. Vaccine doses should not be administered at intervals less than the set minimum intervals or ages.

64. Minimum Intervals & DTaP Routinely Recommended at 2, 4, 6, and 15-18 months of age Minimum interval between doses 1 and 2 and 2 and 3 is 4 weeks Minimum interval between 3 and 4 is 6 months Minimum age for the 4 th dose is 12 months

65. Grace Periods ACIP - a four day grace period  live virus vaccines  MMR @ 1 yr  inactivated vaccine intervals (between doses in a series)

66. True Contraindications  Permanent Contraindications –All vaccines Anaphylactic reaction to prior dose of vaccine Anaphylactic reaction to a component of the vaccine –Pertussis-containing Vaccines Encephalopathy within 7 days Temporary Contraindications –All vaccines Moderate-to-severe illness –Live vaccines only Pregnancy Recent receipt of blood products Immunosuppression

67. Vaccine Use for Immunocompromised Patients  Inactivated vaccines may be given  Refer to ACIP recommendations –live vaccines for persons with immunocompromising conditions such as AIDS Leukemia Steroid use Bone marrow transplantation

68. The immunization process is as easy as … Assess - immunization record Check - current recommended schedule Ask - screening questions Educate - the parent Administer - vaccine Document - what you’ve done

69. Vaccine Information Statements (VISs) National Vaccine Injury Act Every time Single antigen or combination All providers

70. Parent Questions and Concerns Ask parents if they have concerns –When you know what their question or concern is, you can better tailor your discussion with them in an interactive manner –Listen to the parents –Guide parents with supportive information that validates concerns and addresses questions

71. Parent Education Vaccine Information Statements foreign languages Discuss concerns and questions Review after care measures Inform when child should return

72. Resources for Parents Immunize For Good –www.immunizeforgood.comwww.immunizeforgood.com Shot by Shot and the Forgotten Stories of VPDs Immunization Action Coalition

73. Injectable Vaccine Administration Table Appropriate –needle length –site Separate injections - 1 inch Reconstituted Vaccines –Use only diluent supplied by the manufacturer

74. Essentials of Documentation Date vaccine administered Manufacturer Lot number Date of VIS (patient informed consent) Date VIS given to patient Person giving the vaccine Name and Address of Clinic/Facility Recommended: site

75. When does this patient need to return for next doses? Schedule next appointment –before patient leaves –assure minimum age & intervals will be met Reminder system

76. What goes where? Varicella MMR DTaP, DT, Td, TdaP IPV Hib Hep A, Hep B Flu, PCV, PPV MCV4, Rotavirus 35°F to 46°F  5°F Check and record refrigerator/freezer temperature 2X/day

77. Vaccine Storage Requirements Maintain required temperature range year- round Large enough to hold year’s largest inventory Have a certified calibrated thermometer in each storage compartment Dedicated to biologics

78. Vaccine Storage

79. Vaccine Storage and Handling  Vaccines are fragile  Must be kept at recommended temperatures  Vaccines exposed to out of range temperatures may not provide protection  Vaccines are expensive

80. Check, Correct and Record Post temp log sheet on door of every storage unit Read thermometer in all compartments of every vaccine storage unit –At least twice daily –In morning upon arrival to clinic and evening upon clinic closure –Regardless of type of thermometer, alarm or recorder

81. Check, Correct and Record Record temperatures on log every time a reading is taken Record the time the thermometers were read –Person must initial log at time of readings If reading is missed, leave log space empty –Do not guess what temperature was

83. Check, Correct and Record TAKE IMMEDIATE ACTION TO PROTECT VACCINES! –Temps found out of range need immediate correction –Document problem, how vaccines were protected, action(s) taken to correct problem, time problem identified and corrected –Mechanical malfunctions and power outages must be documented on log sheet

85. Maintaining Temperature Logs Store completed logs for a minimum of 3 years Do not throw logs away before 3 years Store continuous recording/graphic thermometer readings/paper with logs for 3 years

86. Storage and Handling Plans Every office should have written S&H guidelines –Routine S&H plans –Emergency Retrieval and Storage Plan Written guidelines ensure: –Organization –Quality Assurance VFC requirement Must be kept in prominent and easily accessible location near storage units

87. Vaccine Storage and Handling Protocols Detailed written S&H protocol Emergency Back up Assign responsibilities to 1 person Designate a back-up person Training on vaccine storage and handling

88. Vaccine Shipments  Examine shipment on arrival  Check contents against packing slip  Check vaccine expiration dates  Examine contents for damage  Assure shipping time < 48 hours

90. Additional Preventive Measures Transport inactivated vaccines and MMR in cooler with cold packs Transport varicella vaccine on dry ice Post a warning “Do Not Disconnect” sign at plug Post a warning “Do Not Disconnect” marker on the actual circuit breaker that supplies power to each storage unit Label fuses and circuit breakers

91. “Pre-filling” Syringes Discouraged –Vaccine administration errors –vaccine wastage –possible bacterial growth –compromise of vaccine potency

92. “Pre-filling” Syringes Cont’d. Administer promptly after filling Must be discarded at end of clinic day

93. Storage and Handling Take-Home Messages  Colder is NOT better for refrigerated vaccines  Out of range temperature readings require IMMEDIATE action and documentation of actions taken  Millions in lost vaccine

94. Reminders  Assess IZ status at every visit  Administer all needed vaccines  Acknowledge and correct mistakes  Use your resources!

95. Summary Vaccine Terminology Childhood Vaccines Grace Periods Contraindications Clinical implementation VIS Documentation Storage and Handling

96. Questions? Margaret Huffman ND, RN Colorado Immunization Program Margaret.huffman@state.co.us 303-692-2332