Pediatric Immunizations Part 1 Support for this program is made possible by the AAFP Foundation through a grant from Pfizer Inc.

Pediatric Immunizations Developed for AFMRD by Gail Colby, M.D. and Wendy Biggs, M.D. Midland Family Medicine Residency 2010 Ehab Molokhia, MD and Gerald Liu, MD University of South Alabama Family Medicine Residency Updated 2012

Pediatric Immunizations Objectives Medical knowledge –List at least 5 vaccine-preventable diseases –List the vaccines given to children that are live attenuated vaccines –Recall common combination vaccines for childhood immunizations –Describe routine vaccine schedules for common childhood vaccines

Pediatric Immunizations Objectives Interpersonal communication –Explain to parents or guardian the rationale for immunization against childhood diseases Patient care –Recall Hepatitis B vaccine must be given to neonate –Explain the age restriction for Hib vaccine

Pediatric Immunizations Objectives Systems-based practice –Utilize resources to find vaccine recommendations –Describe how a child qualifies for the Vaccines for Children program

Pediatric Immunizations A moment’s cry in the name of prevention

Pediatric Immunizations Name some vaccine preventable diseases

Pediatric Immunizations Vaccine Preventable Diseases Tetanus Diphtheria Pertussis (Whooping Cough) Hemophilis influenza type b (Hib) Polio Hepatitis A Hepatitis B Rotavirus Mumps Measles Rubella (German Measles) Varicella (Chickenpox) Pneumococcus Meningococcus Influenza Human Papilloma Virus (HPV)

Pediatric Immunizations Vaccine Preventable Diseases Herd immunity plus aggressive immunization has made most of these diseases rare Most current residents and medical students haven’t seen these diseases

Pediatric Immunizations Herd Immunity Most of population immunized Disease itself still exists, but spread prevented by lack of available hosts Unimmunized person less likely to come in contact with infected person

Pediatric Immunizations Vaccine Preventable Diseases To comprehend why we immunize, you –Need to have basic childhood disease knowledge –Need to know the combinations of vaccines available to prevent the illnesses

Pediatric Immunizations Tanya brings her 2-month-old infant to your office for a well-child appointment. She also has a 4- year-old son and twin 12-year-olds – one boy and one girl. She states: Case

Pediatric Immunizations “I know the baby needs shots, but I don’t have insurance that pays for vaccines. I’m not sure how I am going to afford them.” Case What do you tell Tanya about vaccine coverage? Case

Pediatric Immunizations Vaccines For Children Program (VFC) Federally funded Provides free vaccines to doctors who serve eligible children –Medicaid-eligible or uninsured –American Indian/Alaskan Native

Pediatric Immunizations Vaccine For Children Program (VFC) Office can charge an administration fee to give vaccine –Fee charged set regionally Vaccines cannot be denied to eligible children Covers all ACIP recommended vaccines

Pediatric Immunizations You tell Tanya that vaccines for all her children will be covered under your state’s VFC program. She is relieved to hear this. Case “But Doctor, what diseases do the vaccines prevent?” Case

Pediatric Immunizations Diphtheria Polio HIb Hepatitis A Pneumococcus Meningococcus Influenza Pertussis Case From what diseases does Tanya’s baby need protection? Case

Pediatric Immunizations Diphtheria Caused by Corynebacterium diphtheriae Incubation 2-5 days Early – malaise, sore throat, difficulty in swallowing, loss of appetite, hoarseness, mild fever Within 2-3 days, adherent, gray membrane on oral mucous membranes –Extensive membrane - life-threatening airway obstruction. Toxin – serious systemic complications including myocarditis Death rate 5%-10% Photo from Image in public domain.

Pediatric Immunizations Tetanus Spread by contact with soil containing bacterium Clostridium tetani Most infections from contaminated wounds Incubation 1-2 weeks Not contagious Produces exotoxin

Pediatric Immunizations Tetanus 1-2 weeks after infection – progressive muscle tightening, descending pattern –Trismus (lockjaw) –Neck stiffness –Difficulty swallowing –Abdominal muscle rigidity Neonatal tetanus due to no maternal immunity and cutting the umbilical cord with a contaminated instrument (e.g. bamboo in Haiti)

Pediatric Immunizations Tetanus Neonatal tetanus This patient is displaying a bodily posture known as “opisthotonos” due to tetanus. Child with painful muscle contractions from tetanus Photos from Images in public domain.

Pediatric Immunizations Pertussis Caused by Bordetella pertussis Highly contagious 90% of household contacts will acquire Starts as URI After 1-2 weeks – paroxysms of severe coughing followed by “whoop” with loud inspiration Worse for very young Photo from Image in public domain.

Pediatric Immunizations Pertussis Symptoms can last several weeks –Severe coughing –Whooping –Post-tussive vomiting 1 in 10 cases develop pneumonia 1 in 50 cases develop convulsions 1 in 250 cases develop encephalopathy

Pediatric Immunizations DTaP Capital letter denotes full dose vaccine Small “a” for acellular Compared to Td or Tdap –Small letter denotes half dose vaccine for booster effect Diphtheria and Pertussis vaccines only given as combination with Tetanus

Pediatric Immunizations DTaP Diphtheria Tetanus Acellular pertussis Primary series –2, 4, 6 months –12-18 months (at least 6 months from the 3 rd dose) –4 years –12-14 years Tdap –Then Td boosters every 10 years

Pediatric Immunizations DTaP Contraindications –Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a vaccine component –Encephalopathy (e.g., coma, decreased level of consciousness; prolonged seizures) not attributable to another identifiable cause within 7 days of administration of previous dose of DTP or DTaP –Progressive neurologic disorder including infantile spasms uncontrolled epilepsy progressive encephalopathy –Defer DTaP until neurologic status clarified and stabilized

Pediatric Immunizations DTaP Precautions –Temperature of >104°F (>40.5°C) For <48 hours after a previous dose of DTP or DTaP –Collapse or shock-like state Occurs <48 hours after a previous dose of DTP/DTaP –Seizure <3 days after a previous dose of DTP/DTaP –Persistent, inconsolable crying lasting >3 hours within 48 hours of a dose of DTP/DTaP –Guillain-Barre syndrome (GBS) <6 weeks after dose of tetanus toxoid-containing vaccine –Moderate or severe acute illness with or without fever

Pediatric Immunizations Safe Situations to Administer DTaP Temperature of <105°F (<40.5°C) after dose Fussiness after dose Mild drowsiness after dose Family history of seizures Family history of sudden infant death syndrome Family history of an adverse event after vaccine Stable neurologic conditions –cerebral palsy –well-controlled seizure disorder –developmental delay

Pediatric Immunizations Polio Very infectious virus Up to 95% of people infected with polio have no symptoms 4-8% minor symptoms – fatigue, myalgias, stiffness <1% have paralysis from virus attacking motor neurons Photo from Image in public domain.

Pediatric Immunizations IPV Inactivated polio vaccine 4 dose series –2, 4, 6-18 months –Booster at 4 years Dose 4 must be 6 months after 3 rd dose If dose 3 is after 4 years old and >6 months from dose 2, a 4 th dose is not needed If 4 doses received prior to 4 years old, a 5 th dose is required

Pediatric Immunizations Hepatitis B Viral infection can be transmitted perinatally from Hepatitis B infected mothers Symptoms range from none to severe hepatitis & liver failure Up to 90% of infected neonates become chronic carriers Ascites and jaundice due to liver failure. Photo by Charle Goldberg, M.D.

Pediatric Immunizations Engerix-B® (HBV) Recombinant Hepatitis B Dose should be given shortly after birth –If not given to infant Document your order to hold vaccine Copy of negative maternal Hepatitis B surface antigen (HbsAg) in chart and documented by physician If mom HBsAg positive –Give HBV and Hepatitis B immunoglobulin (HBIG) within 12 hours of birth –Test for HbsAg and HbsAb 1-2 months after completed vaccine series at age 9-18 months

Pediatric Immunizations Hemophilus Influenza B (Hib) Prior to vaccine, Hib was leading cause of childhood –Bacterial meningitis –Epiglottitis –Pneumonia –Empyema –Pericarditis –Bacteremia –Septic arthritis Photo courtesy of Children’s Immunization Project, St. Paul, Minnesota

Pediatric Immunizations Hemophilus Influenza B (Hib) 2 vaccines available –1 is 3-dose series (PedvaxHIB ® ) –1 is 4-dose series (ActHIB ® ) Vaccines are interchangeable –If changed at 2 or 4 months of age, need a 6-month dose of either vaccine –Either vaccine may be given for the 12-month booster dose

Pediatric Immunizations Hemophilus Influenza B (Hib) Cannot give any form of Hib to infants less than 6 weeks old –Have decreased immune response to polysaccharide capsule (PRP) of Hib May also prevent future ability to develop antibodies

Pediatric Immunizations PedvaxHIB® Hemophilus influenza type b vaccine Antigen conjugated to Meningococcal Group B outer membrane protein (PRP-OMP) 2-dose primary series plus booster 2, 4 months and month booster Also comes in a combination vaccine with Hepatitis B (Comvax ® )

Pediatric Immunizations Act-HIB® Hemophilus influenza type b vaccine Conjugated to tetanus toxoid (PRP-T) 3-dose primary series plus booster 2, 4, 6 months and booster at months Also comes in 2 combination vaccines –With DTaP, and IPV (Pentacel ® ) Primary series –With DTaP (TriHibIt ® ) Booster dose only

Pediatric Immunizations Tanya exclaims, “Those are scary diseases! That’s a lot of shots!” Case Do any vaccines come in combination? YES! Case

Pediatric Immunizations Combination Vaccines Many vaccines come in combinations However, different manufacturers make different components –Multiple different combinations –Vaccination schedule may vary based on which vaccines given or available

Pediatric Immunizations Combination Vaccines: Comvax® DiphtheriaHepatitis APneumococcus TetanusHepatitis BMeningococcus PertussisRotavirusInfluenza HibMMRHPV PolioVaricella

Pediatric Immunizations Combination Vaccines: Comvax® Hepatitis B + Hib (PedvaxHIB ® ) Remember – cannot give Hib before 6 weeks of age –Cannot use Comvax ® as Hepatitis B birth or 1 month dose Doses at 2, 4, >12 months –Final dose after age 12 months –Interchangable with PedvaxHIB ®

Pediatric Immunizations Combination Vaccines: Pediarix® TetanusHepatitis APneumococcus DiphtheriaHepatitis BMeningococcus PertussisRotavirusInfluenza HibMMRHPV PolioVaricella

Pediatric Immunizations Combination Vaccines: Pediarix® Given 2, 4, 6 months 4 weeks minimum interval OK to get a 4 th dose of Hep B Maximum 3 doses of Pediarix ®

Pediatric Immunizations Combination Vaccines: TriHibIt® DiphtheriaHepatitis APneumococcus TetanusHepatitis BMeningococcus PertussisRotavirusInfluenza HibMMRHPV PolioVaricella

Pediatric Immunizations Combination Vaccines: TriHibIt® DTaP + ActHIB ® Only for booster dose (dose #4) –Decreased Hib immunogenicity when combined with DTaP, no effect on DTaP NOT for use as a primary series –If used as primary will need to repeat Hib series –DTaP series portion can be counted Do not use if child has not received any Hib vaccines

Pediatric Immunizations Combination Vaccines: Pentacel® TetanusHepatitis APneumococcus DiphtheriaHepatitis BMeningococcus PertussisRotavirusInfluenza HibMMRHPV PolioVaricella

Pediatric Immunizations Combination Vaccines: Pentacel® Combination vaccine –DTaP –IPV –ActHIB ® Recommended for 2, 4, 6, and months Can give if any of the components are indicated and none contraindicated Hib immunogenicity not affected

Pediatric Immunizations Tanya ponders,“Wasn’t there some vaccine that was going to stop my baby from having ear infections? Which one is that?” Case

Pediatric Immunizations Pneumococcal Disease Streptococcus pneumoniae –Common cause of community acquired pneumonia and otitis media Can cause invasive disease –Bacteremia –Meningitis –Sepsis Invasive risk related to serotype present pneumococcal meningitis at autopsy Photo from Image in public domain.

Pediatric Immunizations Prevnar® (PCV-7) Pneumococcal conjugate 7 valent vaccine 2, 4, 6 and 12 months Recommended for all children 2-23 months Give if months old with risk factors Not for children >5 years old Replaced by PCV-13 Spring 2010

Pediatric Immunizations PCV-7 PCV-13 (Prevnar™13) ACIP voted 2/24/10 to replace PCV-7 Transition guidelines published Protects against 13 instead of 7 strains Expanded vaccination for high-risk groups to 72 months Same dosing interval as PCV-7 for never vaccinated children X

Pediatric Immunizations PCV-13 High risk children include –Immunocompetent children with Cyanotic congenital heart defects Chronic lung disease Asthma needing oral steroid treatment Diabetes CSF leaks Cochlear implants Asplenia (congenital or acquired) Sickle cell and other hemoglobinopathies

Pediatric Immunizations PCV-13 High risk children include –Immunocompromised children HIV Chronic renal failure Nephrotic syndrome Lymphoma and leukemia Chemotherapy Organ transplant Congenital immunodeficiencies

Pediatric Immunizations PCV-13 Transition Dosing Age at examination (mos)Vaccination history: total number of PCV7 and/or PCV13 doses received previously Recommended PCV13 Regimen 2 through 6 mos: 0 doses3 doses, 8 weeks apart; fourth dose at age 12–15 mos 1 dose2 doses, 8 weeks apart; fourth dose at age 12–15 mos 2 doses1 dose, 8 weeks after the most recent dose; fourth dose at age mos

Pediatric Immunizations PCV-13 Transition Dosing Age at examination (mos) Vaccination history: total number of PCV7 and/or PCV13 doses received previously Recommended PCV13 Regimen 12 through 23 mos0 doses2 doses, ≥ 8 weeks apart 1 dose before age 12 mo2 doses, ≥ 8 weeks apart 1 dose at ≥12 mo1 dose, ≥ 8 weeks after the most recent dose 2 or 3 doses before age 12 mo1 dose, ≥ 8 weeks after the most recent dose 4 doses of PCV7 or other age- appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 weeks after the most recent dose

Pediatric Immunizations PCV-13 Transition Dosing Age at examination (mos) Vaccination history: total number of PCV7 and/or PCV13 doses received previously Recommended PCV13 Regimen 24 through 59 mos0 doses1 doses, ≥ 8 weeks after most recent dose 4 doses of PC7 or other age- appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 weeks after most recent dose Children 24 through 71 mos with underlying medical conditions Unvaccinated or any incomplete schedule of <3 doses 2 doses, one ≥ 8 weeks after the most recent dose and another dose ≥ 8 weeks later Any incomplete schedule of 3 doses 1 dose, ≥ 8 weeks after the most recent dose 4 doses of PCV7 or other age- appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 weeks after the most recent dose

Pediatric Immunizations New for PCV-13 Single dose for children 6-18 years old at increased risk for invasive pneumococcal disease Give regardless of previous PCV-7 or PPSV-23 vaccination Includes: –Sickle cell disease –HIV (or other immunocompromised state) –Cochlear implant –CSF leaks

Pediatric Immunizations You advise Tanya: Ear infections are caused by a lot of different bacteria and viruses, so some ear infections will be prevented by the pneumococcal vaccine, but not all. PCV-13 is more than 90% effective against invasive disease (the really severe infections). Case

Pediatric Immunizations Tanya asks, “Are all the vaccines shots? I thought some were given orally.” Case

Pediatric Immunizations Oral Vaccines Oral Polio no longer available in the U.S. Rotavirus vaccine is given orally

Pediatric Immunizations Rotavirus Most common cause of gastroenteritis worldwide Can cause severe dehydration Prior to vaccine introduction in 2006 –80% of U.S. children had disease by age 5 –410,000 physician visits –205,000 to 272,000 ER visits –55,000 to 70,000 hospitalizations –$1 Billion direct/indirect costs

Pediatric Immunizations Rotavirus Vaccine Contraindications –Severe allergic reaction after a previous dose or to a vaccine component Precautions –Moderate or severe acute illness with or without fever –Immunosuppression –Receipt of an antibody-containing blood product within 6 weeks –Pre-existing gastrointestinal disease –Previous history of intussusception

Pediatric Immunizations Rotavirus Vaccine First vaccine was Rotashield ® (RRV-TV) Licensed 1998 Withdrawn from market less than 1 year later due to increased risk of intussusception New Rotavirus vaccines do not show increased risk for intussusception

Pediatric Immunizations Rotavirus Vaccine 2 currently available are interchangeable for dosing –RotaTeq ® (RV5) –Rotarix ® (RV1) Narrow administration window –First dose must be before 15 weeks –Last dose must be before 8 months

Pediatric Immunizations Rotavirus Efficacy and Safety Trial (REST) 4,512 infants through 1st rotavirus season after vaccination with RV5 Vaccine (RotaTeq ® ) Reduced severe rotavirus gastroenteritis cases by 98% –In other trials – RV1 vaccine (Rotarix ® ) reduced by 96% Reduced any severity case of rotavirus by 74% –RV1 vaccine reduced by 86%

Pediatric Immunizations Rotavirus Efficacy and Safety Trial (REST) RV5 vaccination reduced health care utilization –Reduced ER visits by 93% –Reduced office visits by 86% –Reduced hospitalization rates by 95% –Reduced hospitalization rates for all strains rotavirus gastroenteritis by 58%

Pediatric Immunizations Rotavirus Vaccines RotaTeq ® (RV5) –5 reassortant live rotaviruses from 5 human and 1 bovine strain –3-dose series 2, 4, 6 months –Pre-filled (ready to dose) Rotarix ® (RV1) –Live human rotavirus strain G1P1A –2-dose series 2, 4 months –Requires reconstitution CDC states no preference between formulations

Pediatric Immunizations Tanya’s 2-month-old child can receive the following regimens: –Pediarix ® (Hep B, DTaP, IPV), Hib, PCV13, Rotavirus 3 shots, one oral –Pentacel ® (DTaP, IPV, Hib), Hep B, PCV13, Rotavirus 3 shots, one oral –Comvax ® (Hep B, Hib), DTaP, IPV, PCV13, Rotavirus 4 shots, one oral Case

Pediatric Immunizations Case Tanya is very thankful for all your help explaining the vaccines her infant needs. She asks, though,“I have a friend who said I shouldn’t let my baby get any vaccines because they will make her autistic. Is that really true?”

Pediatric Immunizations Case What is your response to Tanya? Parents often express concerns about the thimerosal preservative in vaccines and the MMR vaccine. Healthcare providers should reassure parents.

Pediatric Immunizations Vaccine Safety Vaccination never been proven associated with autism In 2010, Lancet retracted the 1998 article –Was initial paper linking MMR with autism There are multiple web-based sites that have false information regarding vaccine risks

Pediatric Immunizations Case If the children were foreign-born adoptees and received their immunizations in another country before coming to the U.S., what would you advise Tanya?

Pediatric Immunizations Foreign-Born Children Foreign-received vaccine valid if –Same age and dosing intervals as U.S. –Written documentation If not valid, 2 options: –Repeat series –Serology testing May not predict disease protection Requires accurate interpretation

Pediatric Immunizations Lots of pros. So what’s the con? Vaccines are expensive!!

Pediatric Immunizations VACCINEVFCPRIVATE PAY DTaP$ $ Pediarix ® (DTaP, Hep B, IPV)$49.75$70.72 Pentacel ® (DTaP, IPV, Hib)$50.70$75.33 IPV$11.74$24.71 Comvax ® (Hib, HepB)$29.50$43.56 HPV$ $ Hib$ $ Hepatitis A$13.25$28.74 Hepatitis B$10.25$21.37 CDC Vaccine Price List Prices last reviewed/updated: May 14, 2010 Vaccines Are Expensive

Pediatric Immunizations Vaccines are Expensive VACCINEVFCPRIVATE PAY MMRV$85.72$ MMR$18.64$48.31 Meningococcal$79.75$ Rotavirus$ $ PCV13$91.75$ Varicella$67.08$80.58 Remember: These are the costs for 1 dose. Many series require 3 or 4 doses. CDC Vaccine Price List Prices last reviewed/updated: May 14,

Pediatric Immunizations Tanya asks,“What about when my baby gets older? How many more vaccines will she need? Are there other diseases she needs to be protected against?” Case

Pediatric Immunizations What are the routine recommendations for follow-up vaccines? Case

Pediatric Immunizations Case The routine recommendations are immunizations at: –2, 4, 6 and months of age

Pediatric Immunizations Case Are there vaccines the child needs in the future that she is too young to receive now?

Pediatric Immunizations Case YES There are additional vaccines needed that cannot be administered until after the baby’s first birthday. We will pick up here in “Pediatric Immunizations Part 2”

Pediatric Immunizations Summary Medical Knowledge –Many childhood diseases are rare due to immunizations Diphtheria, tetanus, polio, invasive pneumococcal and meningococcal disease, measles, mumps, rubella –Live vaccines for children are MMR, Varicella and Rotavirus –Vaccines come in multiple combinations which vary by manufacturer

Pediatric Immunizations Summary Medical Knowledge –Birth Hepatitis B –2 Months Hepatitis B, DTaP, IPV, Hib, PCV, Rotavirus –4 Months DTaP, IPV, Hib, PCV, Rotavirus –6 Months Hepatitis B, DTaP, IPV, Hib, PCV, Rotavirus, Influenza (if current flu season)

Pediatric Immunizations Summary Patient Care –Birth dose of Hepatitis B must be given (If not given, reason must be well documented) –Do not give Hib vaccine to an infant less than 6 weeks old due to their immature immune system’s inability to produce an appropriate immune response.

Pediatric Immunizations Summary Systems-based Practice –Vaccines for Children (VFC) is a federal program that provides ACIP recommended vaccines for administration to the Medicaid/uninsured patients and Native American/Alaskan populations Use resources to stay up-to-date with vaccine information Review the immunization schedule regularly

Pediatric Immunizations Resources (National Immunization Program) (Immunization Action Coalition) state.htm state.htm State Health Department immunization programs Epidemiology and Prevention of Vaccine- Preventable Diseases. The Pink Book: Course Textbook 12th Edition