Review of Recommended Schedule Presentation to: Presented by: Date:

Disclosure Statements Neither the planners of this session nor I have any financial relationship with pharmaceutical companies, biomedical device manufacturers, or corporations whose products and services are related to the vaccines we discuss. There is no commercial support being received for this event. The mention of specific brands of vaccines in this presentation is for the purpose of providing education and does not constitute endorsement. The GA Immunization Program utilizes ACIP recommendations as the basis for this presentation and for our guidelines, policies, and recommendations. For certain vaccines this may represent a slight departure from or off- label use of the vaccine package insert guidelines.

Disclosure Statement To obtain nursing contact hours for this training, you must be present for the entire training and complete an evaluation Contact hours are available for this training from 02/05/2013 until 02/05/2015

Objectives At the end of this presentation, you will be able to: Explain the difference between a vaccine indication, recommendation and requirement Discuss the ACIP General Recommendations for the use and administration of vaccines Discuss herd immunity and the cocooning strategy Identify the vaccine antigens used for infants, children, adolescents and adults to prevent Vaccine Preventable Diseases Discuss the role of a vaccine champion List at least 2 reliable sources for immunization information

The Impact of Vaccines N/A = Data not available * MMWR 48(12); April 2, 1999 ** MMWR 63(32); August 15, 2014

Indications Recommendations Requirements Indication Information about the appropriate use of the vaccine Recommendation ACIP statement that broadens and further delineates the Indication found in the package insert Basis for standards for best practice Requirement Mandate by a state that a particular vaccine must be administered and documented before entrance to child care and/or school

How Recommendations and Schedules Are Developed: ACIP Committee National committee Membership: – Experts in fields of epidemiology and infectious diseases – Represent areas of academia, research, and public and private providers Meets 3 times a year Has sole authority to add vaccines to the VFC Program

Immunization Schedules All staff must use the same immunization schedule Four Schedules:  Children & Adolescents 0 through 18 years  Catch-up schedule for ages 4 months -18 years  Adult 19 years and older  Adult based on medical and other indications READ THE FOOTNOTES

GENERAL RECOMMENDATIONS ON IMMUNIZATION Published January 2011

General Recommendations # 1 Simultaneous Administration There are no contraindications to simultaneous administration of any of the routinely recommended vaccines included on the childhood and adult schedules. Exception: PCV13 and PPSV23 must be separated by 8 weeks #2 Non-Simultaneous Administration If two inactivated vaccines are not administered simultaneously, there is no minimal time interval. PPSV23 and PCV13 should not be administered on the same day and should be administered at least 8 weeks apart. #3 Two live-vaccines If two different live vaccines are not administered simultaneously, they must be separated by at least 28 days. #4 Violation of minimal time interval for live vaccines If two different live vaccines are given <28 days apart the vaccine given second should be repeated. #5 Minimum time and age intervals Vaccine doses should not be given at intervals less than the minimum intervals or earlier than the minimum age. Table 1 in the Gen Recommendations document addresses this. This table contains a listing of every dose of every commonly used vaccine.

General Recommendations #6 Violation of minimum time and age intervals/ Grace Period This is ACIP’s recommendation that vaccine doses administered up to four days before the minimum interval or age can be counted as valid. Grace period does not apply to time intervals between 2 different live vaccines (28 days) #7 Administration of vaccine later than recommended schedule If vaccines are administered later than the recommended schedule: Do not need to repeat doses, Do not need to start over. #8 Vaccine Administration Principles ACIP strongly discourages the administration of any vaccine by any route or in any site other than those stated in the package insert. #9 General recommendations for administering combination 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. #10 Contraindications and Precautions A contraindication is a condition in a recipient that increases the risk for a serious adverse reaction. A vaccine should not be administered when a contraindication is present A precaution is a condition in a recipient that might increase the risk for a serious adverse reaction or that might compromise the ability of the vaccine to produce immunity. In general, vaccinations should be deferred when a precaution is present.

Frequently Asked Question? Why do ACIP recommendations not always agree with vaccine package inserts? There is usually very close agreement between vaccine package inserts and ACIP statements. The Food and Drug Administration (FDA) must approve the package insert, and requires documentation for all claims and recommendations made in the insert. Occasionally, ACIP may use different data to formulate its recommendations, or try to add flexibility to its recommendations, which results in wording different than on the package insert. ACIP sometimes makes recommendations based on expert opinion and public health considerations. Published recommendations of national advisory groups (such as ACIP or AAP's Committee on Infectious Diseases) should be considered equally as authoritative as those on the package insert. Source: IAC’s Ask the Experts

Why Do We Immunize? We Immunize To Prevent These Diseases

Herd Immunity Immunized individuals block infection from reaching those who are unimmunized INFECTED UNIMMUNIZED INFECTED = immunized

The Impact of Vaccines N/A = Data not available * MMWR 48(12); April 2, 1999 ** MMWR 63(32); August 15, 2014

Herd Immunity Immunized individuals block infection from reaching those who are unimmunized INFECTED UNIMMUNIZED INFECTED = immunized

Diphtheria Pertussis Tetanus Required for school and child care attendance

Diphtheria, Tetanus and Pertussis Vaccines for Children and Adolescents Infants and young children: 5 dose series of DTaP -At 2, 4, 6, months and 4-6 years -Do not give DTaP after 6 years of age Older Children and Adolescents: Booster Dose of Tdap* - one dose to all 11 through 12 years; Catch-up for all adolescents who have not received Tdap -Use Tdap regardless of interval since last Td Ref: Updated Recommendations for Use of Tdap Vaccine from ACIP, 2010 MMWR 2011; 60(01);13-15 Jan 14, 2011

Cocooning Strategy Siblings Child Care Provider Healthcare Worker Grandparents Parents

Immunize Pregnant Adolescents with Tdap Reference: 1. MMWR February 22, 2013; 62 (7); One dose of Tdap should be administered during each pregnancy, irrespective of the prior history of receiving Tdap. -To maximize the maternal antibody response and passive antibody transfer to the infant the optimal timing for the administration of Tdap is between 27 and 36 weeks gestation. -If Tdap is not given during pregnancy, and has not been given previously, administer Tdap immediately postpartum 3. With the exception for pregnant women, ACIP does not recommend a second dose of Tdap for adolescents and adults.

Hepatitis B Required for school and child care attendance

Hepatitis B Vaccine Dose birth Dose 4 months of age – at least 1 month after first dose Dose 6-18 months of age: – Minimum of 4 months after the first dose – Minimum of 2 months after the second dose but not before an infant is 24 weeks of age

Recommended Routine Hepatitis B Vaccine Schedule For Infants Born to HBsAg-Negative Mothers Give the first dose at birth Give the second dose by 4 months of age – at least 1 month after first dose Give the third dose at 6-18 months of age: – Minimum of 4 months after the first dose – Minimum of 2 months after the second dose but not before an infant is 24 weeks of age

For Infants Born to HBsAg-Positive Mothers 1st dose within 12 hours of birth plus 0.5 mL of HBIG 2nd dose at 1-2 months of age 3rd dose at 6 months of age, but not before 24 weeks of age Test infant for Hepatitis B surface antigen (HBsAg) and antibody (Anti-HBs quantitative) at 9-18 months of age

Recommended Hepatitis B Schedule for Infants< 2000 Grams Infants under 2000 grams (4.4 lbs) respond poorly to vaccine Premature infants born to HBsAg- negative moms: vaccinate at the chronological age of 1 month, regardless of weight. Premature infants born to HBsAg- positive moms: vaccinate at birth – Next dose : 1 month of age, chronologically – Third dose: 1-2 months after the second dose – Fourth dose: At 6 months of age, but not before 24 weeks of age

Every person being evaluated or treated for an STD, who is not already vaccinated, should receive hepatitis b vaccination

Haemophilus influenzaeType b (Hib) Required only for child care and pre-K attendance

Haemophilus influenzae type b (Hib) Infants: 3 or 4 dose schedule Dose 2 months of age Dose 4 months of age Dose 6 months of age (Not required if Pedvax HIB® or Comvax® administered at 2 and 4 months of age) Booster 12 through 15 months of age MenHibrix ® approved for use in children 6 weeks of age through 18 months of age; MenHibrix is recommended by ACIP only for infants at increased risk for meningococcal disease. Hiberix ® can only be used as a booster dose (final) for children who have previously received the primary 2 or 3 dose series of Hib vaccine.

For infants & children: 4 doses of IPV: 2, 4, and 6 – 18 months of age (usually administered at 12 – 18 months) Dose 4 through 6 years of age Polio Final dose at 4 years of age or older regardless of the number of previous doses; at least 6 months following previous dose required Ref. MMWR 2009; 58 (30); (August 7, 2009) Single lifetime booster for travel to polio-endemic countries (Check Source: World Health Organization Required for school and childcare attendance

Measles (M) Mumps (M) Rubella (R) Congenital Rubella (R) Measles, Mumps, Rubella Source: Creative Commons Source: American Academy of Pediatrics Red Book On Line Visual Library

MMR Vaccine 2 Dose Series for children – Dose 12 through 15 months of age – Dose 4 through 6 years of age Required for school and child care attendance Acceptable presumptive evidence of MMR immunity 1 Documentation of age appropriate vaccination with MMR vaccine Laboratory evidence of immunity Laboratory confirmation of disease Birth before 1957 Birth date not acceptable evidence of rubella immunity for women who could become pregnant 1. Recommendations and Reports June 14, 2013 / 62(RR04);1-34

Routine Recommendations for Varicella Vaccine Dose 12 months through 15 months of age Dose 4 through 6 years of age* Those 13 years of age or older without evidence of immunity should receive 2 doses separated by 4 to 8 weeks. Required for school and child care attendance *Second dose can be administered at an earlier age provided the interval between the first and second dose is at least 3 months. © Copyright American Academy of Pediatrics Varicella (Chickenpox)

Varicella Immunity What are the criteria for evidence of immunity to varicella? ACIP considers evidence of immunity to varicella to be: Documentation of 2 doses of vaccine given no earlier than age 12 months, with at least 3 months between doses for children younger than age 13 years, or at least 4 weeks between doses for people age 13 years and older U.S.-born before 1980* A healthcare provider's diagnosis of varicella or verification of history of varicella disease History of herpes zoster, based on healthcare provider diagnosis Laboratory evidence of immunity or laboratory confirmation of disease *Note: year of birth is not considered as evidence of immunity for healthcare personnel, immunosuppressed people, and pregnant women.

Combination Vaccine for MMR and Varicella (ProQuad ® ) Recommended Vaccine Schedule: Dose mL subQ – Dose 1: months – Dose 2: 4-6 years MMRV should only be used when both of the component vaccines (MMR and Varicella ) are indicated and the child is 12 months through 12 years of age.

Spacing of Live Virus Vaccines and Other Products PPD and live virus vaccine – Apply PPD at same visit as MMR – If MMR given first, delay PPD 4 weeks or longer – Apply PPD first, then give MMR when skin test read Spacing with antibody-containing products such as immune globulin (IG)

Pneumococcal Disease Required for child care and pre-K attendance

PCV13 and PPSV23 In August 2014, the ACIP voted to recommended pneumococcal conjugate vaccine (PCV13) for all adults 65 years or older. Both PCV13 and PPSV23 should be routinely administered in series to all adults 65 years or older  For pneumococcal vaccine-naïve adults: Adults 65 years of age or older who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed 6 to 12 months later by a dose of PPSV23 If PPSV23 cannot be given during the 6 to 12 month time window, the dose of PPSV23 should be given during the next visit after 12 months. PPSV23 should not be given less than 8 weeks after the PCV13 dose

PCV13 and PPSV23 In August 2014, the ACIP voted to recommended pneumococcal conjugate vaccine (PCV13) for all adults 65 years or older. Both PCV13 and PPSV23 should be routinely administered in series to all adults 65 years or older  For adults previously vaccinated with PPSV23: Adults 65 years of age or older who have previously received one or more doses of PPSV23 should also receive a dose of PCV13 if they have not yet received it. A dose of PCV13 should be given at least 1 year after the receipt of the most recent PPSV23 dose. For those for whom an additional dose of PPSV23 is indicated (i.e., persons with functional or anatomic asplenia and immunocompromised persons), this subsequent PPSV23 dose should be given 6 to 12 months after PCV13 and at least 5 years since the most recent dose of PPSV23. The minimum acceptable interval between PCV13 followed by PPSV23 should be 8 weeks.

Pneumococcal Polysaccharide Vaccine for Adults (PPSV23) Recommended for: – Adults 65 years and older – Persons aged 2 through 64 years with medical conditions that increase their risk for pneumococcal infection – Persons 19 through 64 years with asthma – Cigarette smokers 19 years of age and older Persons who received PPSV23 before age 65 years should receive a second dose of vaccine at age 65 years or later if at least 5 years have passed since the previous dose. A third dose of PPSV23 may be recommended for persons with immunocompromising conditions, and/or functional or anatomic asplenia. Ref: Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) MMWR 2010; 59(34); September 3, 2010

Hepatitis A Required for school or child care attendance for children born on or after

Hepatitis A Vaccination of Children All children should receive first dose of hepatitis A vaccine at 1 year of age (12 through 23 months) and second dose according to schedule Catch-up vaccination of children 2 through 18 years can be considered if vaccine supply is adequate

Hepatitis A Recommendations All children aged 12 through 23 months are recommended to receive this vaccine Children not vaccinated by age 2 years can be vaccinated at subsequent visits Continues to be recommended for persons 2 years of age and older who are at high risk for disease Requirement for entrance to school and child care as of for those children born on or after

Influenza Vaccine Not required for school or child care attendance

Composition of Influenza Vaccines for Season in the U.S.

Inactivated Influenza Vaccines (IIV) Administer by Injection (Trivalent) IIV3 Fluzone ® sanofi-pasteur - 6 months of age and older Fluarix ® GSK - 3 years of age and older FluLaval ® GSK - 3 years of age and older IIV3 & IIV4 # Fluarix ® Quadrivalent GSK - 3 years of age and older IIV4 Fluvirin ® Novartis - 4 years of age and older Afluria ® CSL - 9 years of age and older Flucelvax ® Novartis - 18 years of age and older (ccIIV3)* FluBlok ® Protein Sciences - 18 through 49 years (RIV3)** Fluzone ® Intradermal sanofi-pasteur - 18 through 64 years Fluzone ® High-Dose sanofi-pasteur - 65 years and older (4 X more antigen) *ccIIV3 = cell culture based trivalent inactivated influenza vaccine **RIV3 = recombinant hemagglutinin influenza vaccine Ref. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2013–2014, September 20, 2013 / 62(RR07);1-43 # Flulaval licensed by FDA for children 3 years and older August 16, 2013

Live, Attenuated Influenza Vaccine (LAIV4) Administer by Nasal spray: FluMist® Medimmune - for healthy persons 2 through 49 years of age - not for pregnant women Ref: Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Influenza Season MMWR /Vol. 63/ No. 32, August 15, 2014 When immediately available, LAIV4 should be used for healthy children aged 2 through 8 years who have no contraindications. If LAIV4 is not immediately available, IIV should be given so that opportunities to vaccinate children are not missed or delayed.

Flucelvax (Novartis) – Approved for persons 18 yrs and older – Vaccine viruses are not propagated in eggs; however, initial reference strains have been passaged in eggs – Cannot be considered egg-free, though expected to contain less egg protein than other IIVs – Abbreviated ccIIV Influenza Vaccines Produced via Non- Egg-Based Technologies

FluBlok (Protein Sciences) – Approved for persons 18 through 49 years – Vaccine contains recombinant influenza virus hemagglutinin Protein is produced in insect cell line No eggs or influenza viruses used in production – Egg-free – Abbreviated (RIV) Influenza Vaccines Produced via Non- Egg-Based Technologies

Influenza Vaccine and Egg Allergy

I got the flu shot and still got the flu… For healthy persons takes about 2 weeks after the shot before your body makes enough antibodies to be protected You are vulnerable to flu infection during this time Flu vaccination does not protect you from colds, sinus infections, and other respiratory illnesses that also circulate during flu season

Frequently Asked Questions Some of my patients refuse influenza vaccination because they insist they "got the flu" after receiving the injectable vaccine in the past. What can I tell them? How long does immunity from influenza last? In which month is it too late to receive influenza vaccine? My patient came in last February and asked for a “flu” shot. Should I have given it to her?

Meningococcal Disease

New 7 th Grade School Requirement

Meningococcal Disease Meningitis ~50% of cases 9-10% fatality rate Meningococcemia 5%-20% of cases Up to 40% fatality rate Rash Vascular damage Disseminated intravascular coagulation Multi-organ failure Shock Death can occur in 24 hours Ref: 1. Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th Edition, May AAP Red Book % of survivors have permanent sequelae

Meningococcal Conjugate Vaccine (MCV4) (Men A,C,Y, W-135) Menactra  licensed for 9 mos. through 55 years Menveo® licensed for ages 2 mos. through 55 years ACIP Recommendation: One dose at 11 or 12 years of age and a booster dose at 16 yrs. If first dose is at years, give one booster dose 5 years after the first dose or sooner if entering college or technical school If first dose given ≥ 16 years of age, a 2 nd dose is not needed Persons aged 21 years or younger attending school or college should have documentation of one dose of MVC4 not more than 5 years before enrollment. Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Recommendations and Reports March 22, 2013 / 62(RR02);1-22

Meningococcal Vaccines for High Risk Children 2 months – 10 years Recommended for children 2 months through 10 years with complement component deficiency, functional or anatomic asplenia, and those who are part of a community outbreak or travelling internationally to regions with endemic meningococcal disease. For details on doses and schedule refer to: Advisory Committee on Immunization Practices, Vaccines For Children Program, Vaccines To Prevent Meningococcal Disease. Adopted October 23, 2013 MENHIBRIX ® (Men C & Y + Hib) licensed for ages 6 weeks through 18 months Menveo® (Men A,C,Y, W-135) licensed for ages 2 mos. through 55 years Menactra  ( (Men A,C,Y, W-135) licensed for 9 mos. through 55 years

Rotavirus Vaccines RotaTeq® (Merck) and Rotarix® (GSK) Both vaccines: – Minimum age for first dose: 6 weeks – Maximum age for first dose: 14 weeks 6 days – Minimum interval between doses: 4 weeks – Maximum age for last dose: 8 months 0 days If any dose is Rotateq®, 3 doses are required Use RotaTeq® if allergy to latex If the child spits out or regurgitates the vaccine, do not re-administer. Continue with the series at recommended intervals. RotaTeq®: 3 doses; ages 2, 4, 6 months Rotarix®: 2 doses; ages 2 and 4 months

Types of Human Papilloma Virus (HPV) Mucosal/Genital ~40 types Cutaneous ~60 types Cervical cancer Anogenital cancer Oropharyngeal Cancer Cancer precursors Low grade cervical disease Genital Warts Laryngeal Papillomas Low grade cervical disease Skin warts Hands and Feet High risk types 16, 18, 31, 45 (and others) Low risk types 6, 11 and others Ref 1.Epidemiology and Prevention of Vaccine Preventable Diseases 12 th Edition, May Red Book – AAP 2012 Report of the Committee on Infectious Diseases

HPV Vaccines Cervarix ® (HPV2) Licensed for prevention of infection with HPV types 16 & 18. Recommended for females 9 through 26 years. (3 dose schedule) Ref: MMWR; December 23, 2011 / 60(50); Gardasil ® (HPV4) Licensed for prevention of infection with HPV types 6, 11, 16, 18. Recommended for females 9 through 26 years & males 9 through 21 years. May be given to males 22 through 26 years. (3 dose schedule)

Herpes Zoster “Shingles”

Zostavax ® One dose recommended for adults 60 years and older, including those who have experienced previous episodes of shingles Overall Efficacy * 51% fewer episodes of zoster and less severe disease 66% less postherpetic neuralgia On March 24, 2011 FDA approved Zostavax for use in ages years ACIP has not made a recommendation for this age group *Ref: Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th Edition, May 2012.

Is Shingles Contagious? Shingles cannot be passed from one person to another. However, a person with shingles can spread the virus to a person who has never had chickenpox. If the person who has never had chickenpox becomes infected with the virus, he or she will develop chickenpox, not shingles.

Frequently Asked Question? Q: The new Zostavax vaccine (Merck) package insert says that Zostavax should not be given simultaneously with pneumococcal polysaccharide vaccine (PPSV). What does ACIP say about this? A: ACIP has not changed its recommendation on the simultaneous administration of these two vaccines (i.e., they can be given at the same time or any time before or after each other). Source: IAC’s Ask the Experts April 7, 2010

Standards for Child, Adolescent, and Adult Immunization Practices Availability of vaccines Assessment of client’s vaccination status Effective communication with client or parent Proper storage and handling of vaccines Accurate documentation of vaccinations Implementation of strategies to improve rates Developing partnerships and community-based approaches to vaccine delivery

Vaccine Adverse Event Reporting System The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration. What Can Be Reported to VAERS? Who Reports to VAERS? Does VAERS Provide General Vaccine Information? or

Vaccine Injury Compensation Program (VICP) National Vaccine Injury Compensation Program provides compensation to individuals found to be injured by or have died from certain childhood vaccines. – Established in 1988 by NCVIA – Federal “no fault” system to compensate those injured – Claim must be filed by individual, parent or guardian – Must show that injury is on “Vaccine Injury Table”

Every Office and Clinic Needs A Vaccine Champion! Lead your immunization team. Educate all staff about new vaccines and recommendations. Teach new staff about vaccine storage, handling, & administration. Initiate processes to improve immunization rates in your practice/facility. Assure immunizations of all staff are up-to-date.

It’s a Team Effort! High Immunization rates begin with a team designed plan! What can your team do to improve rates?

Just as a reminder…… Regardless of: – the availability of vaccine – the funding of the vaccine (VFC, state- supplied, or private stock) – whether the vaccine is required for school or child care or not………. FOLLOW ACIP Recommendations !!!

Healthcare Personnel (HCP) Need These Immunizations Annual influenza vaccine Tdap or Td Hepatitis B (exposure risk) Check immunity Validate immune status of: Varicella Measles, Mumps & Rubella(MMR) Are YOU up to date?

Resources Local health department District Immunization Coordinator GA Immunization Program Office – On call Help line: – GRITS Help Line: – VFC Help Line: – Website – Your local Immunization Program Consultant (IPC) GA Chapter of the AAP GA Academy of Family Physicians