pediatric immunizations part 1 support for this program is made possible by the aafp foundation...
TRANSCRIPT
Pediatric ImmunizationsPart 1
Support for this program is made possible by the AAFP Foundation through a grant from Pfizer Inc.
Pediatric Immunizations
Developed for AFMRD byGail 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.”
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What do you tell Tanya about vaccine coverage?
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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
http://www.sanantonio.gov/health/images/immunizations/Immunizations-VFC_clip_image002.jpg
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.
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“But Doctor, what diseases do the vaccines prevent?”
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Pediatric Immunizations
DiphtheriaPolioPolio
HIb
Hepatitis A
PneumococcusMeningococcus
Influenza Pertussis
Case From what diseases does Tanya’s
baby need protection?
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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 www.cdc.gov. 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 www.cdc.gov. 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 youngPhoto from www.cdc.gov. 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 3rd 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 www.cdc.gov. 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 3rd dose• If dose 3 is after 4 years old and >6 months
from dose 2, a 4th dose is not needed• If 4 doses received prior to 4 years old, a
5th 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. http://meded.ucsd.edu/clinicalmed/abdomen.htm
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 12-15 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 12-15
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!”
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Do any vaccines come in combination?
YES!
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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®
Diphtheria Hepatitis A Pneumococcus
Tetanus Hepatitis B Meningococcus
Pertussis Rotavirus Influenza
Hib MMR HPV
Polio Varicella
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®
Tetanus Hepatitis A Pneumococcus
Diphtheria Hepatitis B Meningococcus
Pertussis Rotavirus Influenza
Hib MMR HPV
Polio Varicella
Pediatric Immunizations
Combination Vaccines: Pediarix®• Given 2, 4, 6 months• 4 weeks minimum interval• OK to get a 4th dose of Hep B• Maximum 3 doses of Pediarix®
Pediatric Immunizations
Combination Vaccines: TriHibIt®
Diphtheria Hepatitis A Pneumococcus
Tetanus Hepatitis B Meningococcus
Pertussis Rotavirus Influenza
Hib MMR HPV
Polio Varicella
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®
Tetanus Hepatitis A Pneumococcus
Diphtheria Hepatitis B Meningococcus
Pertussis Rotavirus Influenza
Hib MMR HPV
Polio Varicella
Pediatric Immunizations
Combination Vaccines: Pentacel®• Combination vaccine
– DTaP– IPV – ActHIB®
• Recommended for 2, 4, 6, and 12-15 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?”
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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 www.cdc.gov. 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 24-59 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 DosingAge at examination (mos)
Vaccination history: total number of PCV7 and/or PCV13 doses received previously
Recommended PCV13 Regimen
2 through 6 mos:
0 doses 3 doses, 8 weeks apart; fourth dose at age 12–15 mos
1 dose 2 doses, 8 weeks apart; fourth dose at age 12–15 mos
2 doses 1 dose, 8 weeks after the most recent dose; fourth dose at age 12-15 mos
http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf
Pediatric Immunizations
PCV-13 Transition DosingAge at examination (mos)
Vaccination history: total number of PCV7 and/or PCV13 doses received previously
Recommended PCV13 Regimen
12 through 23 mos
0 doses 2 doses, ≥ 8 weeks apart
1 dose before age 12 mo 2 doses, ≥ 8 weeks apart
1 dose at ≥12 mo 1 dose, ≥ 8 weeks after the most recent dose
2 or 3 doses before age 12 mo
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 dosehttp://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf
Pediatric Immunizations
PCV-13 Transition DosingAge at examination (mos)
Vaccination history: total number of PCV7 and/or PCV13 doses received previously
Recommended PCV13 Regimen
24 through 59 mos 0 doses 1 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
http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf
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).
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Pediatric Immunizations
Tanya asks, “Are all the vaccines shots? I thought some were given orally.”
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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
VACCINE VFC PRIVATE PAY
DTaP $13.25-14.25 $20.96-23.76
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 $96.08-108.73 $128.75-130.27
Hib $8.66-11.51 $22.77-23.61
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
http://www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm
Pediatric Immunizations
Vaccines are ExpensiveVACCINE VFC PRIVATE PAY
MMRV $85.72 $128.90
MMR $18.64 $48.31
Meningococcal $79.75 $102.66
Rotavirus $59.18-93.75 $69.59-102.50
PCV13 $91.75 $108.75
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, 2010
http://www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm
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?”
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Pediatric Immunizations
What are the routine recommendations for follow-up vaccines?
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Pediatric Immunizations
Case The routine recommendations are
immunizations at:
– 2, 4, 6 and 12-15 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• www.cdc.gov/vaccines
• (National Immunization Program)
• www.immunize.org/childrules • (Immunization Action Coalition)
• www.cdc.gov/vaccines/programs/iis/contact-state.htm
• State Health Department immunization programs
• Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book: Course Textbook 12th Edition