Childhood Vaccines
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Transcript of Childhood Vaccines
Childhood Vaccines
Educational Learning ObjectivesAt the conclusion of this presentation, the participant should be able to:
• Discuss the indications and recommendations for the most current immunization schedules for childhood, adolescent, and adult populations
• Respond to frequently encountered questions and situations during patient discussions including safety, efficacy, and possible misinformation
• Implement strategies for improving immunization rates within one’s clinical practice, taking into account current immunization schedules and guidelines
Routine Childhood Immunization Schedule, 1983
Birth 1 mo
2 mo
4 mo
6 mo
12 mo 15 mo 18 mo
24 mo
4-6 y
11-12 y
14-16 y
DTP DTPDTP DTP DTP
MMR
OPV OPV OPV* OPV OPV
Td
*A third dose of OPV is optional but may be given in areas of high endemicity for poliomyelitis
CDC. MMWR Morb Mortal Wkly Rep. 1983;32(1):1-8,13-17.
DTP = Diphtheria, tetanus, pertussisOPV = Oral polio (trivalent)MMR = Measles, mumps, rubella
VAC
CIN
E
2010 Child Immunization Schedule
HepB = Hepatitis B; RV = Rotavirus; DTaP = Diphtheria, Tetanus, Pertussis; Hib = Haemophilus influenzae type b; PCV = Pneumococcal; IPV = Inactivated Poliovirus; MMR = Measles, Mumps, Rubella; HepA = Hepatitis A; MCV = Meningococcal; PPSV = Pneumococcal Polysaccharide
ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.
Childhood Catch-up Schedule
ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.
Vaccination Coverage Children 19–35 Months, United States, N = 18,430
CDC. MMWR Morb Mortal Wkly Rep. 2009;58(33):913-940.
0
10
20
30
40
50
60
70
80
90
100
DTaP/DT≥ 3 Doses
Poliovirus MMR ≥ 1 Dose
Hib ≥ 3 Doses
Hepatitis B≥ 3 Doses
Varicella≥ 1 Dose
PCV7 PCV7 ≥ 4 Doses
Hepatitis A≥ 2 Doses
Vacc
inat
ion
Cov
erag
e (%
)
20042005200620072008
≥ 3 Doses≥ 4 Doses
*
*Data for previous years not available
DTaP/DT
2008–2010 Changes in Child Schedule
• Influenza – Universal annual vaccination ≥ 6 months
• Rotavirus – Two schedules available: age 2, 4 mos and age 2, 4, and 6 months
• Polio– Emphasize importance of booster dose at age ≥ 4 yrs
• Meningococcal Conjugate Vaccine– Two vaccines now approved; MCV4-D (Menactra®) and MenACWY-
CRM197 (Menveo®)– Booster
• Hib– Booster reinstatement, shortage issues are over
• Pneumococcal– Addition of PCV13– Booster for PPSV23
Immunization Timelines
• 8% of children immunized too early to be valid • 58% of children received at least one vaccine later
than recommended• Thirty-five million adolescents may be missing at
least one recommended vaccination
Luman ET, et al. Pediatrics. 2002;110:935-939.
Hepatitis B
Dose # Recommended Age
Minimum Age
Recommended Interval
Minimum Interval
1 Birth* Birth 1-4 mo 4 wk2 1-2 mo 4 wk 2-17 mo 8 wk3 6-18 mo 24 wk
• Dose 3 should be administered ≥ 16 wk after dose 1• Combination vaccines cannot be used for the birth
dose
Adapted from Table 1, ACIP General Recommendations on Immunization: MMWR Recomm Rep. 2006;55(RR-15):1-48.
* HB Immunoglobulin should also be administered at birth for infants whose mothers are HBsAg positive
Hepatitis B Perinatal Transmission*
• If mother positive for HBsAg and HBeAg– 70%–90% of infants infected– 90% of infected infants become chronically infected
• If positive for HBsAg only– 5%–20% of infants infected– 90% of infected infants become chronically infected
*in the absence of postexposure prophylaxis
Why Rotavirus?
• > 400,000 physician visits• > 200,000 ED visits• > 50,000 hospitalizations• > $1 billion in total health care costs
CDC. MMWR Recomm Rep. 2006;55(RR12):1-13.
Rotavirus Vaccines and Schedules
CDC. MMWR Recomm Rep. 2009;58(RR2):1-25.
CDC. MMWR Recomm Rep. 2009;58(RR2):1-25.
Rotavirus Vaccine Harmonized Recommendations
Dose # RV1(Rotarix)
RV5(RotaTeq)
ACIPRecommendation
Usual schedule 2, 4 mo 2, 4, 6 mo Same1
Earliest Latest
6 wk20 wk
6 wk12 wk
6 wk14 wk 6 day
2 Earliest Latest
10 wk24 wk
10 wk32 wk
10 wk8 mo 0 day
3 Earliest Latest
------
14 wk32 wk
14 wk8 mo 0 day
“..vaccination should not be deferred because the product used for previous dose(s) is not available or is unknown. In these situations, the provider should continue or complete the series with the product available. If any dose in the series was RV5, or the vaccine product is unknown for any dose in the series, a total of 3 doses of rotavirus vaccine should be administered.”
• In March 2010, the FDA recommended that health care providers temporarily suspend the use of Rotarix vaccine for rotavirus immunization in the United States while the agency learned more about components of an extraneous virus detected in the vaccine
• An independent research team using a novel technique found DNA from PCV1 in Rotarix
• Fragments of PCV1 and PCV2 DNA were subsequently detected in RotaTeq using sensitive assay methods
• The FDA has no evidence that PCV1 or PCV2 present a safety risk for humans; PCV1 and PCV2 are not known to cause infection or illness in humans
• Both rotavirus vaccines have strong safety records, including clinical trials (tens of thousands of patients) and clinical experience with millions of vaccine recipients
• The benefits of the vaccines are substantial, including prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the US
• The FDA now recommends that health care providers resume use of Rotarix and continue use of RotaTeq
Rotavirus Vaccines – Porcine Circovirus (PCV)
FDA. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm. Accessed May 2010.
Rotavirus• Contraindications
– History of serious allergic reaction to a previous dose of vaccine
– History of severe hypersensitivity to any component of the vaccine
• Precautions – Altered immunocompetence – Moderate to severe illness, including acute gastroenteritis – Preexisting chronic gastrointestinal disease – Previous history of intussusception
CDC. MMWR Recomm Rep. 2009;58(RR2):1-25.
Family Physicians and Rotavirus Vaccine
• 2008 Survey* – 45% provided rotavirus vaccine on site
• ½ rate of other vaccines– 35% referred elsewhere– 24% did neither
• 3x rate of other vaccines
*Campos-Outcalt D, et al. Immunization Practices of Family Physicians.43rd National Immunization Conference, Dallas TX, March 31, 2009. Abstract PS19.
DTaP
Dose #Recommended
AgeMinimum
AgeRecommended
IntervalMinimum Interval
1 2 mo 6 wk 2 mo 4 wk2 4 mo 10 wk 2 mo 4 wk
3 6 mo 14 wk 6-12 mo 6 mo4 15-18 mo 12 mo 3 yr 6 mo5 4-6 yr 4 yr
• Dose 5 not needed if dose 4 is given after age 4 yrs
Adapted from Table 1, ACIP General Recommendations on Immunization. CDC. MMWR Recomm Rep. 2006;55(RR15):1-48.
Hib
Dose #Recommended
AgeMinimum
AgeRecommende
d IntervalMinimum Interval
1 2 mo 6 wk 2 mo 4 wk
2 4 mo 10 wk 2 mo 4 wk
3 6 mo 14 wk 6-9 mo 8 wk
4 12-15 mo 12 mo
• Dose at 6 mo of age not necessary if first 2 doses are PRP-OMP• Fewer doses required if series initiated at ≥ 7 mo of age• Supply shortage over, reinstate 12-15 mo booster and catch-up• Approved products
– PedvaxHib (Merck)– ActHIB (Sanofi)– Hiberix (GSK)---booster only
CDC. MMWR Morb Mortal Wkly Rep. 2009;58(24):673-674.
Summer 2009 HIB Updated Recommendations
• Re-institute routine booster• Catch up on those who missed their booster
at their next regular check up• No recall of all those who missed booster
immediately • Changed in late summer to recall of those
who missed
CDC. http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-hcp-ltr-7-30-09.pdf. Accessed September 2009.CDC, personal communication.
Hib Products
Product Description Primary Series Booster
PedvaxHIB (Merck) Monovalent Hib vaccine 2,4 months 12-15 months*
Comvax(Merck)
Combined Hib/hepatitis B vaccine 2,4 months 12-15 months*
Act HIB (Sanofi Pasteur) Monovalent Hib vaccine 2,4,6 months 12-15 months*
TriHIBit (Sanofi Pasteur) DTaP/Hib vaccine Not licensed for this
age group 15-18 months*
HIBERIX(GSK)
Hib conjugate (tetanus toxoid conjugate) --- 15 months*
*Can immunize through age 59 months
Haemophilus influenzae type b. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hib.pdf. Accessed September 2009.HIBERIX PI. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM179530.pdf. Accessed September 2009.
PCV7
Dose #Recommended
AgeMinimum
AgeRecommended
IntervalMinimum Interval
1 2 mo 6 wk 2 mo 4 wk
2 4 mo 10 wk 2 mo 4 wk
3 6 mo 14 wk 6 mo 8 wk
4 12-15 mo 12 mo
ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Sept 2009.
13-Valent Pneumococcal Conjugate Vaccine(PCV13)
• Licensed by FDA on February 24, 2010• Serotypes in PCV13
– PCV7 types: 4, 6B, 9V, 14, 18C, 19F, 23F– Additional serotypes: 1, 3, 5, 6A, 7F, 19A
• Approved for use in children 6 weeks through 5 years (before the 6th birthday) – 4-dose series at ages 2, 4, 6, and 12-15 months
• Indications– Prevention of invasive pneumococcal disease (IPD) caused
by the 13 vaccine serotypes– Prevention of otitis media caused by PCV7 serotypes
CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.
PCV13 Recommended Schedules for Children < 24 Months
CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010.
Age at Examination (mos)
Vaccination History: Total PCV7 and/or PCV13 Doses
Received PreviouslyRecommended PCV13 Regimen
2 through 6 mos
0 doses 3 doses, 8 wks apart; 4th dose at age 12-15 mos
1 dose 2 doses, 8 wks apart; 4th dose at age 12-15 mos
2 doses 1 dose, 8 wks after the most recent dose; 4th dose at age 12-15 mos
7 through 11 mos0 doses 2 doses, 8 wks apart; 3rd dose at 12-15 mos
1 or 2 doses before age 7 mo 1 dose at age 7-11 mos, 2nd dose at 12-15 mos, ≥ 8 wks later
12 through 23 mos
0 doses 2 doses, ≥ 8 wks apart
1 dose before age 12 mo 2 doses, ≥ 8 wks apart
1 dose at ≥ 12 mo 1 dose, ≥ 8 wks after the most recent dose
2 or 3 doses before age 12 mo 1 dose, ≥ 8 wks after the most recent dose
4 doses of PCV 7 or other age-appropriate, complete PCV7 schedule
1 supplemental dose, ≥ 8 wks after the most recent dose
Transition from PCV7 to PCV13 According to Number of Doses Previously Received
Primary Infant Series Booster Dose Supplemental PCV13 Dose
2 mos 4 mos 6 mos ≥ 12 mos* 14-59 mos**
PCV7 PCV13 PCV13 PCV13 --
PCV7 PCV7 PCV13 PCV13 --
PCV7 PCV7 PCV7 PCV13 --
PCV7 PCV7 PCV7 PCV7 PCV13
*No additional PCV13 doses are indicated for children 12-23 months who received 2 or 3 doses or PCV7 before age 12 months and at least 1 dose of PCV13 at age ≥ 12months**For children with underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age
CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.
PCV13 Recommended Schedules for Children ≥ 24 Months
CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010.
Age at Examination (mos)
Vaccination History: Total PCV7 and/or PCV13 Doses Received
PreviouslyRecommended PCV13 Regimen
Healthy children 24 through 59 mos
Unvaccinated or any incomplete schedule 1 dose, ≥ 8 wks after the most recent dose
4 doses of PCV7 or other age-appropriate, complete PCV7 schedule
1 supplemental dose, ≥ 8 wks after the most recent dose
Children 24 through 71 mos with
underlying medical conditions
Unvaccinated or any incomplete schedule of < 3 doses
2 doses, one ≥ 8 wks after the most recent dose and another dose ≥ 8 wks later
Any incomplete schedule of 3 doses 1 dose, ≥ 8 wks after the most recent dose
4 doses of PCV 7 or other age-appropriate, complete PCV7 schedule
1 supplemental dose, ≥ 8 wks after the most recent dose*
*For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age
PCV13 – Children 6 through 18 Years of Age with High-risk Conditions
• A single dose of PCV13 may be administered for children 6 through 18 years of age who are at increased risk for invasive pneumococcal disease because of their sickle cell disease, HIV infection or other immunocompromising condition, cochlear implant or cerebrospinal fluid leaks, regardless of whether they have previously received PCV7 or PPSV23
CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010.
This recommendation is an off-label use of PCV13, which is indicated for children 6 weeks through 5 years of age (prior to the 6th birthday)
PPSV23 After PCV13 for Children ≥ 2 Years of Age with Underlying Medical Conditions
Group Schedule for PPSV23 Revaccination with PPSV23
Children who have sickle cell disease, functional or anatomic asplenia, HIV-infection, or other immunocompromising condition
1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13
1 dose 5 years after the 1st dose of PPSV23
Immunocompetent children with chronic illness
1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13
Not recommended
Doses of PCV13 should be completed before PPSV23is given. No more than 2 PPSV23 doses are recommended.
CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010.
Transition from PCV7 to PCV13• When PCV13 is available in office, unvaccinated and
incompletely vaccinated children should receive PCV13 (not PCV7)
• If only PCV7 is available in office, unvaccinated and incompletely vaccinated children should receive PCV7; these children should complete the series with PCV13 at subsequent visits
• Children for whom the supplemental PCV13 dose is recommended should receive it at their next medical visit. Active recall is not being recommended
CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.
PPSV23
Dose #Recommended
AgeMinimum
AgeRecommended
IntervalMinimum Interval
1 2 yr 5 yr 5 yr2 7 yr
• Second dose recommended for individuals at highest risk
• Second dose is recommended 5 years after first dose in age ≥ 2 years who are immunocompromised, have sickle cell disease, or
functional or anatomic asplenia
• Routine use not recommended for Alaskan Native or American Indian children ages 24-59 months
– May be recommended by local health departments based on community epidemiology
Adapted from Table 1, ACIP General Recommendations on Immunization.MMWR Recomm Rep.2006;55(RR15):1-48.ACIP Provisional Recommendations.www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-Oct-2008-508.pdf. Accessed September 2009.
IPV
Dose #Recommended
AgeMinimum
AgeRecommende
d IntervalMinimum Interval
1 2 mo 6 wk 2 mo 4 wk*2 4 mo 10 wk 2-14 mo 4 wk*3 6-18 mo 14 wk 3-5 yr 6 mo4 4-6 yr 18 wk
*In first 6 months of age, 2 mo intervals are recommended unless accelerated dosing is needed (eg, travel)
• Last dose after age 4 - 6 mo minimum interval from penultimate dose
• DTaP-IPV-Hib (Pentacel): 4 doses at age 2, 4, 6, and 15-18 mos will require a 5th dose at 4-6 years with an age-appropriate IPV vaccine
Adapted from Table 1, ACIP General Recommendations on Immunization.MMWR Recomm Rep.2006;55(RR15):1-48.CDC. MMWR Morb Mortal Wkly Rep. 2009;58(30):829-830.
Annual Influenza Vaccine is Recommended for:
• All people age 6 months and older!
CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.
Seasonal Influenza Vaccination Status of Children 6–23 mos & 2–4 yrs, United States
CDC. MMWR Morb Mortal Wkly Rep. 2009;58(38):1059-1090.
2007–08 season: 6–23 months, N = 302,333; 2–4 years, N = 808,7112008–09 season: 6–23 months, N = 263,597; 2–4 years, N = 767,422
TIV
Dose #Recommended
AgeMinimum
AgeRecommended
IntervalMinimum Interval
1 Yearly 6 mo 4 wk 4 wk*2
*Two doses (4 wks apart) are given for children 6 mo through 8 yr of age who are receiving influenza vaccine for the first time
– If 2nd dose is missed during first vaccination season, administer two doses during next season
• Seasonal influenza products will not confer protection against pandemic H1N1 strains
– Pandemic H1N1 vaccine available
CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.
LAIV
Dose #Recommended
AgeMinimum
AgeRecommended
IntervalMinimum Interval
1 Yearly 2 yr 4 wk 4 wk*2
* Two doses are given for children 2 through 8 yr of age who are receiving influenza vaccine for the first time
– If 2nd dose is missed during first vaccination season, administer two doses during next season
CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.
Trivalent Inactivated (TIV) and Live Attenuated Influenza Virus (LAIV) Vaccines
Category TIV LAIV
Administration IM Intranasal
Primary immune response Serum antibodiesSerum & mucosal antibodies
Formulation Inactivated Live attenuated
Approved age and risk groups ≥ 6 mo (healthy & high risk)
2–49 yrs (healthy)
Storage Refrigerated Refrigerated
CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.
Two Doses for Children Under 9 Years of Age
• Regardless of whether a child receives LAIV or TIV, those younger than 9 years of age who are receiving influenza vaccine for the first time should receive 2 doses, 4 weeks apart. If a child received only 1 dose in the first year, he or she should receive 2 doses, 4 weeks apart, the following year.
CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.
Trivalent Inactivated Virus (TIV) versus Live Attenuated Influenza Virus (LAIV) Vaccines
TIV• Licensed for use in persons age ≥6 mos• Intramuscular injection• TIV contains purified viral particles that have been chemically
inactivated– Purified components from 3 WHO-recommended annual strains– Immunity developed against disrupted/denatured viral proteins, not against
intact virus
LAIV• Licensed for use among nonpregnant persons aged 2-49 years• Administered by nasal spray• LAIV contains intact virus that has been propogated in eggs at 25ºC
– Cold-adaptation results in restricted replication at body temp– More mild flu symptoms– Contains same 3 WHO-recommended annual strains as TIV
CDC. MMWR Recomm Rep. 2009;58(RR8):1-52. Flumist Prescribing Information. www.flumist.com. Accessed Oct 2009.
2009–2010 Seasonal Influenza Vaccines
• 2009–2010 seasonal influenza vaccine formulation:– A/Brisbane/59/2007(H1N1)-like virus– A/Brisbane/10/2007 (H3N2)-like virus – B/Brisbane/60/2008-like antigens
• VaccinesTrivalent Inactivated, Injectable Influenza Vaccine
Fluzone® (sanofi): age ≥ 6 months Fluvirin® (Novartis): age ≥ 4 years Fluarix® (GSK): age ≥ 3 years FluLaval™ (ID Biomedical/GSK): age ≥ 18 years Afluria® (CSL): age ≥ 6 months
Live Attenuated, Nasal Spray Influenza Vaccine FluMist ® (MedImmune): age 2 through 49 years (healthy, non-pregnant)
• Seasonal 2009 influenza vaccine does not protect against 2009 (pandemic) H1N1 influenza
CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.CDC. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm. Accessed March 2010.
2009 H1N1 (Pandemic) Influenza VaccinesAs of November 11, 2009: 4 monovalent inactivated vaccines approved• CSL Limited
– Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval)– Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval)– Age ≥ 10 yrs: Single 0.5 mL IM injection– Adults ≥ 18 yrs: Single 0.5 mL IM injection
• Novartis Vaccines and Diagnostics Limited– Age 4-9 yrs: Two 0.5 mL IM doses (4 wk interval)– Age 10-17 yrs: Single 0.5 mL IM injection– Age ≥ 18 yrs: Single 0.5 mL IM injection
• Sanofi Pasteur, Inc.– Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval)– Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval)– Age ≥ 10 yrs: Single 0.5 mL IM injection– Adults ≥ 18 yrs: Single 0.5 mL IM injection
• ID Biomedical/GSK– Adults ≥ 18 yrs: Single 0.5 mL IM injection
1 live attenuated (nasal administration)• MedImmune LLC
– Age 2-9 yrs: Two 0.2 mL doses (0.1 mL per nostril), 4 week interval– Age 10-49 yrs: Single 0.2 mL dose (0.1 mL per nostril)Prescribing information available at:
http://www.cdc.gov/h1n1flu/vaccination/dosage.htm#table1. Accessed December 2009.
2010–2011 Influenza Season• Universal Influenza Vaccination
– All people 6 months and older are now recommended to receive annual influenza vaccination
• 2010-2011 Trivalent Influenza Vaccines:– A/California/7/2009(H1N1)-like virus
• Same strain as in the 2009 H1N1 monovalent vaccine– A/Perth/16/2009(H3N2)-like virus
• New strain for northern hemisphere vaccine• Same strain as 2010 southern hemisphere seasonal strain
– B/Brisbane/60/2008-like virus• No change
CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.
Continued Emphasis on High-risk Groups:– Children aged 6 months through 4 years– Adults ≥ 50 years– Women who will be pregnant during the influenza season– Persons who have chronic pulmonary, cardiovascular, renal,
hepatic, neurological, neuromuscular, hematological or metabolic disorders
– Persons who have immunosuppression (including caused by medication or HIV)
– Residents of nursing homes and other chronic-care facilities– Health care personnel– Household contacts and caregivers of children aged < 5 year and
adults aged ≥ 50 years, with particular emphasis on vaccinating contacts of children < 6 months
– Household contacts and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza
2010–2011 Influenza Season
CDC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-7-flu-vac.pdf. Accessed March 2010.
MMR
Dose #Recommended
AgeMinimum
AgeRecommended
IntervalMinimum Interval
1 12-15 mo 12 mo 3-5 yr 4 wk2 4-6 yr 13 mo
• May be administered as MMRV if 12 mo-12 yr of age, but minimal interval
is 3 mo
ACIP Summary Recommendations. www.immunize.org/catg.d/p2010.pdf. Accessed Oct 2009.
Varicella
Varicella photo. http://www.cdc.gov/vaccines/vpd-vac/varicella/photos.htm. Accessed September 2009.
Varicella
Dose #Recommended
AgeMinimum
AgeRecommende
d IntervalMinimum Interval
1 12-15 mo 12 mo 3-5 yr 12 wk (age < 13)4-8 wk (age ≥
13)2 4-6 yr 15 mo• Second dose
At ≥ 3 months if 1st dose for age < 13 yrsAt ≥ 4 weeks if 1st dose for age > 13 yrs
“MMRV vaccine can be used in place of trivalent MMR vaccine and monovalent varicella vaccine to implement the recommended 2-dose vaccine policies for prevention of measles, mumps, rubella, and varicella”
Note: a two-fold increase in the risk of febrile seizures is associated with MMRV versus MMR and Varicella vaccines administered separately and simultaneously
CDC MMWR Recomm Rep. 2007;56(RR04):1-40.CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10);258-260Broder K, et al. Presented at the ACIP June 25, 2009.
Hepatitis A
Dose #Recommended
AgeMinimum
AgeRecommended
IntervalMinimum Interval
1 12-23 mo 12 mo 6-18 mo 6 mo2 18-41 mo 18 mo
• New recommendations for families of international adoptees
ACIP Summary Recommendations. http://www.immunize.org/catg.d/p2010.pdf.Accessed September 2009.CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.
Hepatitis A: Families of International Adoptees
– Hepatitis A vaccination is recommended for all previously unvaccinated persons who anticipate close personal contact with an international adoptee from countries of high or intermediate endemicity during the first 60 days following arrival in the US.
– The first dose of hepatitis A vaccine should be administered as soon as adoption is planned. Ideally, the first dose of hepatitis A vaccine should be administered at least two weeks prior to the arrival of the adoptee.
CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.
General Principles• The only vaccines that cannot be given at the same time are
smallpox and varicella• Minimal intervals apply to
– Doses of the same inactivated vaccine– Doses of the same live vaccine– Doses of different live vaccines not given simultaneously, except
• Oral typhoid Ty21a vaccine • Rotavirus vaccine
• Minimal intervals do not apply to doses of different inactivated vaccines
• Minimal intervals define catch-up schedules• A 4-day grace period is granted to all vaccine doses
– Rabies vaccine is an exception– Local regulations may not allow a grace period
Marshall, GS. The Vaccine Handbook: A Practical Guide for Clinicians. West Islip, NY: Professional Communications, Inc.;2008.
Principles of Catch-up Schedules• Age
– Doses administered prior to minimum age should not be considered valid
– Reduce number of doses according to age and schedule (eg, Hib, PCV)
– Do not administer beyond maximum age• Dose intervals
– Minimum• Do not administer subsequent doses at less than minimum
intervals• Unnecessary to repeat series; diminution of immunity is not
expected in the short term• Check formula interchangeability
Erroneous ContraindicationsThe following are NOT contraindications:• Mild acute illness• Mild-moderate local reaction• Concurrent antibiotic therapy• Convalescent phase of illness• Prematurity• Recent exposure to illness• History of non-vaccine allergies• Family history of allergies, SIDS, seizures• Desensitization shots• Breastfeeding• Positive TST• Pregnant household contact (except OPV and smallpox)• Asymptomatic or mildly symptomatic HIV infection• Allergic to eggs but can eat egg-containing products• Mild latex allergy• Autoimmune disease
Combination Vaccines
MMRV: New Issues• Increased risk of febrile seizures among 12- to 23-month-olds receiving dose 1
of MMRV vs MMR and varicella vaccines at the same visit• Limited availability of MMRV due to manufacturing constraints• ACIP position
– Age 12 through 47 months for first dose: no preference– Dose 2 and any dose at age > 48 months
• The use of combinations generally is preferred. Considerations should include provider assessment, patient preference, and the potential for adverse events. Footnote= Provider assessment should include storage costs, number of injections, vaccine availability, vaccination status, likelihood of improved coverage, and likelihood of patient return visits.
CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10):258-260.Resolution No. 06/09-3. http://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/0606mmrv.pdf. Accessed September 2009.
Current US Combination VaccinesProduct TriHIBit Comvax Twinrix Pediarix ProQuad
DTaP Tripedia Infanrix
IPV IPV
Hib conj ActHIB PedvaxHIB
Hep-A Havrix
Hep-B Recom-HB Engerix-B Engerix-B
Measles
MMRIIMumps
Rubella
Varicella Varivax
Current US Combination VaccinesProduct Pentacel Kinrix
DTaP (Daptacel) Infanrix
IPV Poliovax IPV
Hib conj ActHIB
Hep-A
Hep-B
Measles
Mumps
Rubella
Varicella
Combination Vaccine Rule
• The minimum intervals between doses of a combination vaccine are dictated by the single antigen with the longest minimum intervals
Addressing Parental Concerns
Safety
Public Confidence in Vaccines
• Public confidence in vaccines is affected by a number of factors, including:– Product safety and efficacy– Anecdotal experience/information– Prevalence of disease– Recommendations by governmental committees
and professional societies– Physician recommendations– Media coverage– Vaccine monitoring and surveillance systems
Alternative Vaccination Schedules
• The Dr. Bob Sears’ alternative schedule– Dr. Bob Sears’ strategy for addressing parent concerns– Dr. Paul Offit’s analysis of this strategy
Dr. Bob Sears’ Alternative Vaccine Schedule
Sears RW. The Vaccine Book. New York, NY: Little Brown & Company: 2007.
Dr. Bob Sears’ Alternative Vaccine Schedule
Parameter Dr. Bob Sears ACIPTotal visits to completion 15 visits 4 or 5 visits
Age at completion 42 months 15 or 18 months
Marshall G. The Vaccine Quarterly. 2009;3[1]:17.
Argument The TruthDoctors do not understand vaccines. Parents can educate themselves to know more than doctors.
Doctors may not always review the primary data, but the advisory committees that do are composed of experts whose record has been spot-on.
Government and pharmaceutical companies conspire to misrepresent data.
There is no evidence of conspiracy.
Vaccine-preventable diseases are not that serious and are often not seen in practice.
Vaccine-preventable diseases are serious and can result in death. Anecdotal experience in practice does not trump national surveillance data.
Natural immunity is better than vaccine-induced immunity.
The cost of natural immunity is the risk of serious disease or death.
Vaccines are not adequately tested for safety. Vaccines are among the most thoroughly tested pharmaceuticals. The post-licensure safety net is robust.
Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e169.
Critique of Dr. Bob Sears’ Alternative Schedule
Argument The TruthVaccines are recommended for protection of the
public at large, not individuals. Every individual benefits from receiving
vaccines– they become immune to the disease and, as long as others are immunized, they have
less chance of exposure. Parents’ fears should be indulged by offering
alternative schedules. Parents’ fears should be assuaged by explaining
the scientific findings. Reports in VAERS and language in the Package Insert (PI) constitute accurate profiles of vaccine
side effects.
VAERS reports do not establish causality and the PI lists any reported events, whether
causally related or not. There is a middle ground between causality and
coincidence. This logic is flawed–either vaccines do or don’t
cause certain adverse events. Science fails because it cannot prove there is no
connection between vaccines and certain adverse events.
Science doesn’t work that way– one can only reject or fail to reject the null hypothesis.
Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e169.
Critique of Dr. Bob Sears’ Alternative Schedule
For more discussion on this alternative schedule, visithttp://www.immunize.org/concerns/drsears.asp
Institute of Medicine Immunization Safety Reviews
2004• “…the body of epidemiological evidence favors
rejection of a causal relationship between the MMR vaccine and autism… [and] favors rejection of a causal relationship between thimerosal-containing vaccines and autism.”
1. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10101#toc. Accessed September 2009.
2. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10208#toc. Accessed September 2009.
3. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10997#toc. Accessed September 2009.
US Measles Cases
• Measles increase in 2008 not due to a greater number of imported cases, but was the result of greater transmission after importation
97
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CDC. MMWR Morb Mortal Wkly Rep. 2008;57(33):893-896.
Cases of imported measles* as a proportion of all measles cases–US 1997 to July 2008
Cases of measles by vaccination status (2008)
Madsen KM, et al. N Engl J Med. 2002;347:1477-1482.
Danish Cohort Study
Population of Denmark
Children born between01/01/91 and 12/31/98
The Past
MMR1,647,504 person-yr
No MMR482,360 person-yr
The Present
Autism: 263ASD: 345
Autism: 53ASD: 77
Relative risk:Autism: 0.92 (0.68-1.24)ASD: 0.83 (0.65-1.07)
Hviid A, et al. JAMA. 2003;290:1763-1766.
Danish Cohort Study
Population of Denmark
Children born between01/01/90 and 12/31/96
The Past
Thimerosal1,220,006 person-yr
No thimerosal1,660,159 person-yr
The Present
Autism: 104ASD: 321
Autism: 303ASD: 430
Relative risk:Autism: 0.85 (0.60-1.20)ASD: 1.12 (0.88-1.43)
2-month-old infantsPichichero ME, et al. Pediatrics. 2008;121:e208-e214.
Mercury Levels After Thimerosal-Containing Vaccines
Madsen KM, et al. Pediatrics. 2003;112:604-606.
Autism Incidence After Vaccine Formulation Changes
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Schechter R, Grether JK. Arch Gen Psychiatry. 2008;65:19-24.
Autism in California
Thimerosal in Vaccines. www.fda.gov/cber/vaccine/thimerosal.htm.Accessed September 2009.
Thimerosal Status of Current VaccinesVaccine Trade Name Status
Diphtheria, tetanus, pertussis
InfanrixDaptacelTripedia
FreeFree≤ 0.3 mcg Hg/0.5mL
PCV-7 Prevnar Free
Polio IPOL Free
Hepatitis B Recombivax HBEngerix-B
FreeFree
Hib conjugate ActHIBPedvaxHIBHibTITER
FreeFreeFree (single dose)
Hib/Hepatitis B Comvax Free
MMR M-M-R-II Free
Varicella Varivax Free
DTaP/Hep-B/IPV Pediarix Free
Influenza Fluzone T-free Free
Fluvirin P-free < 1.0 mcg Hg/0.5 mL
FluMist Free
Hepatitis A**updated 3/14/08
Vaqta Free
Havrix Free
Marshall GS, et al. The Vaccine Handbook. Lippincott Williams + Wilkins; 2004. VAERS reporting. http://www.cdc.gov/vaccines/Pubs/surv-manual/chpt21-surv-adverse-events.htm#4.Accessed September 2009.CDC. MMWR Morb Mortal Wkly Rep. 1988;37(13):197-200.
Vaccine Adverse Event Reporting System
• Postmarketing surveillance system• Mandatory reporting by health care providers
– Occurrence of events listed as contraindications– Occurrence of events listed in the Reportable
Events Table• Voluntary reporting: any event by any one• Intent: hypothesis generation not hypothesis
testing
Vaccine Safety Datalink Study
MMRV MMR plus V
Number of subjects 43,353 314,599
Rate of febrile seizures 9 per 10,000 4 per 10,000
CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10):258-260.
Adjudication of Febrile Seizure Incidence Following MMRVPre-adjudicated Seizure Reports Adjudicated Seizure Data
Adjudication panel: Drs S. Michael Marcy, Robert Riewerts, and Suresh Gurbani– Reviewed medical records (blinded to vaccination dates)– Confirmed seizure diagnosis based on Brighton Collaboration criteria
Post-adjudication seizure data for days 5-12 postvaccination:– MMRV: 0.70/1000 – MMR + V: 0.32/1000 – Relative risk = 2.2 (95% CI = 1.04, 4.65)
Jacobsen SJ, et al. Vaccine. 2009;27:4656-4661.
Aluminum Adjuvants: Review of the Evidence
Jefferson T, et al. Lancet Infect Dis. 2004;4:84-90.
Aluminum HydroxidevsNo Adjuvant(children up to 18 months of age)
Any AluminumvsNo Adjuvants(children 10-16 years)
Strategies for Improving Childhood Immunization Rates
The Community Guide.http://www.thecommunityguide.org/vaccines/universally/index.html. Accessed September 2009.Briss PA, et al. Am J Prev Med. 2000;18(suppl 1):35-43.
Evidence-based Methods for Improving Immunization Rates
• Community Preventive Services Task Force Recommended Strategies– Reducing client out-of-pocket costs – Vaccination programs in schools– Vaccination programs in WIC settings – Client reminder and recall systems – Vaccination requirements for child care, school, and college attendance– Provider reminder systems when used alone – Standing orders when used alone – Provider assessment and feedback
• The above recommendations have all been upgraded to ‘strong evidence’ based on systematic reviews
Resources
PROTECTTM Website:http://www.francefoundation.com/protect/
Resources for Patients and Parents• Guide to evaluating information on the web
www.cdc.gov/vaccines/vac-gen/evalwebs.htm
• CDC Vaccine Information Statements (VISs) http://www.cdc.gov/vaccines/pubs/vis/default.htm
• Vaccine Safety www.cdc.gov/Features/VaccineSafety
• National Network for Immunization Information (NNII) www.immunizationinfo.org
• Allied Vaccine Group www.vaccine.org
• Immunization Action Coalition (IAC) www.immunize.org • Vaccine Education Center at CHOP www.vaccine.chop.edu
• TCH Center for Vaccine Awareness and Research www.texaschildrens.org/carecenters/vaccine/default.aspx
Resources for Providers• Immunization Schedules
www.cdc.gov/vaccines/recs/schedules/
• ACIP recommendations & provisional recommendationswww.cdc.gov/vaccines/pubs/ACIP-list.htmwww.cdc.gov/vaccines/recs/provisional/default.htm
• The Guide to Community Preventive Services. Vaccine recommendationswww.thecommunityguide.org/vaccines/index.html
• Assessment, Feedback, Incentives, and Exchange (AFIX) www.cdc.gov/vaccines/programs/afix/default.htm
• National Foundation for Infectious Diseaseswww.nfid.org
• Centers for Medicare & Medicaid Serviceswww.cms.hhs.gov
Resources for Providers, Parents, and Patients
• The Immunization Action Coalition: vaccine information for the public and health professionals
www.vaccineinformation.org
• The Immunization Action Coalition: directory of immunization coalitions
www.izcoalitions.org