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Immunization UpdateImmunization UpdateAndrew Kroger, MD, MPH
National Center for Immunization and Respiratory Diseases
Andrew Kroger, MD, MPHNational Center for Immunization and
Respiratory Diseases
North Carolina Statewide Immunization Conference
Greensboro, NCAugust 10, 2011
North Carolina Statewide Immunization Conference
Greensboro, NCAugust 10, 2011
Disclosures
Andrew Kroger is a federal government employee with no
financial interest or conflict with the manufacturer of any product
named in this presentationAndrew Kroger will not discuss a vaccine not currently licensed by
the FDA
Disclosures
Andrew Kroger will discuss off-label uses meningococcal conjugate vaccine (MCV4)
and tetanus-reduced-diphtheria-toxoid acellular pertussis vaccine (Tdap)
National Center for Immunization & Respiratory Diseases
Comparison of 20th Century Annual
Morbidity and Current Morbidity:
Vaccine-Preventable Diseases
Disease20th Century
Annual Morbidity†
2010Reported Cases † †
Percent Decrease
Smallpox 29,005 0 100%
Diphtheria 21,053 0 100%
Measles 530,217 61 > 99%
Mumps 162,344 2,528 98%
Pertussis 200,752 21,291 89%
Polio (paralytic) 16,316 0 100%
Rubella 47,745 6 > 99%
Congenital Rubella Syndrome 152 0 100%
Tetanus 580 8 99%
Haemophilus influenzae 20,000 270* 99%
†Source: JAMA. 2007;298(18):2155-2163† † Source: CDC. MMWR January 7, 2011;59(52);1704-1716. (provisional MMWR week 52 data) * 16 type b and 254 unknown serotype (< 5 years of age)
What’s New in Immunization
MCV4 vaccine
Measles Outbreaks
Influenza Vaccine
Tdap vaccine
Adult Immunization ScheduleIndications by Age Group - 2011
Adult Immunization ScheduleIndications by Condition - 2011
Persons at Highest Risk of Meningococcal Disease or
Suboptimal Vaccine ResponseComplement deficiency
– High-risk of disease– Very high antibody titer required to
compensate for complement deficiency Asplenia
– High-risk of disease– evidence of suboptimal response
Persons with Suboptimal Vaccine Response
HIV infection
– evidence of suboptimal responseSingle dose primary series may not be sufficient to
confer protection for persons with these high-risk conditions
MCV4 Primary Series Recommendation
Administer 2 doses of MCV4 at least 8 weeks apart to persons
with persistent complement component deficiency and
anatomic or functional asplenia
MMWR 2011;60(No. 3):72-6.MMWR 2011;60(No. 3):72-6.
MCV4 Primary Series Recommendation
HIV infection is not an indication for MCV4 vaccination
However, some persons with HIV infection should receive MCV4 (adolescents, some international travelers, microbiologists,
etc)Persons with HIV infection who are
vaccinated with MCV4 should receive 2 doses at least 8 weeks apart
MMWR 2011;60(No. 3):72-6.MMWR 2011;60(No. 3):72-6.
FDA Approval: Menactra
June 2011: Menactra approved for high-risk infants
2 dose series at 9 months and 12 months
New MCV4 Recommendations
Certain persons recommended for infant series
Persistent complement component deficiency
Travelers to high-risk meningococcal areasPersons in a meningococcal outbreakHIV infection (permitted)
Infant vaccination 2 dose series
Dose 1: 9 monthsDose 2: 12 monthsMinimum interval
between doses 2 months
New MCV4 Recommendations
Infant Vaccination: Asplenia
Persons with functional or anatomic asplenia NOT recommended for infant
vaccinationStill recommended for 2 dose
series beginning at age 2 years
Asplenia
Persons with asplenia are at higher risk for invasive pneumococcal disease
Dose of PCV13 recommended at 12 – 18 months of age
Evidence of interaction between PCV13 and MCV4 affecting the immune response to
PCV13Because of the risk of interaction, MCV4 not
recommended for asplenic children when they should be receiving PCV13
Rates of Meningococcal Disease (C and Y) by Age,
1999-2008
Active Bacterial Core surveillance (ABCs), 1998-2008Active Bacterial Core surveillance (ABCs), 1998-2008
Age for routine vaccination
Age for routine vaccination
Meningococcal Conjugate (MCV4) Routine Revaccination
In its 2005 recommendations for MCV, ACIP made no recommendation about
revaccination pending the availability of additional data
Serologic data are now available from the manufacturer that show significant decline
in antibody 3-5 years after vaccination although few “breakthrough” cases have
been reportedMMWR 2009;58(No. 37):1042-3MMWR 2009;58(No. 37):1042-3
Seroprotection Rates Following MCV Vaccination
75
55
8694
0102030405060708090
100
3 years 5 years
Years after MCV vaccination
% >
/= S
BA
1:1
28
C Y
75
55
8694
0102030405060708090
100
3 years 5 years
Years after MCV vaccination
% >
/= S
BA
1:1
28
C Y
MMWR 2009;58(No. 37):1042-3MMWR 2009;58(No. 37):1042-3
New MCV4 Recommendations*– administer MCV4 at age 11 or 12 years
with a booster dose at 16 years of age
– administer 1 dose at age 13 through 15 years if not previously vaccinated
– for persons vaccinated at age 13 through 15 years administer a 1-time booster dose is recommended, preferably at or after 16 through 18 years of age
*off-label recommendation. MMWR 2011;60(No. 3):72-6.*off-label recommendation. MMWR 2011;60(No. 3):72-6.
New MCV4 Adolescent Vaccination
RecommendationsThe minimum interval between doses is 8 weeks
A booster dose is not recommended for healthy persons if the first dose is administered at 16-21 years of age
The booster dose is generally not recommended after the 19th birthday; however, both an initial dose and/or a booster
dose can be given to someone entering college between 19 through 21 years old.
Booster dose is permitted if an individual is already identified as being in college between 19 through 21 years old.
MCV4 vs MPSV4
Conjugate vaccines boost the immune response
If MPSV4 is substituted for MCV4 for the booster dose, or for a
primary series dose in high-risk, the dose should be repeated
MCV Revaccination Recommendations
Other high-risk persons recommended for revaccination
– microbiologists with prolonged exposure to Neisseria meningitidis
– frequent travelers to or persons living in areas with high rates of meningococcal disease
Revaccinate every 5 years as long as the person remains at increased risk
Every 3 years if first dose given between 2 through 6 years of age
– MCV4 for persons 2 through 55 years of age
– MPSV for persons 56 years and older
Measles
As of June 17, 2011Over 156 cases of measles reported
in U.S.Highest number
since 1996
MMR
A dose is recommended for travelers between 6 through 12
months of ageDoes NOT count toward the two
dose routine seriesHigh-risk countries: France, India
(generally Europe, Africa, Asia)
Influenza
2011-2012 Influenza Vaccine Composition
Same strains this year as last year:Same strains this year as last year:– A/California/7/2009-like H1N1 A/California/7/2009-like H1N1 – A/Perth/16/2009-like H3N2A/Perth/16/2009-like H3N2– B/Brisbane/60/2008B/Brisbane/60/2008
Duration of Immunity Following Influenza
Vaccination
Skowronski et al. J Infect Dis 2008;197:490-502
Protection against viruses that are similar antigenically to those contained in the vaccine extends for at least 6-8 months
There is no clear evidence that immunity declines more rapidly in the elderly
Additional vaccine doses during the same season do not increase the antibody response
The frequency of breakthrough infections has not been shown to be higher among persons vaccinated early in the season
Annual influenza vaccination is now recommended for
every person in the United States 6 months of age and
older
Influenza Vaccination Recommendation
MMWR 2010;59(RR-8)MMWR 2010;59(RR-8)
Influenza Vaccine Presentations 2011-2012
Vaccine Doseform AgeFluzone TIVFluzone TIV(sanofi pasteur)(sanofi pasteur)
SDS, SDV, SDS, SDV, MDV MDV
6 months and older6 months and older
Fluarix TIVFluarix TIVFluLaval TIVFluLaval TIV(GSK)(GSK)
SDSSDSMDVMDV
3 years and older3 years and older18 years and older18 years and older
Fluvirin TIVFluvirin TIV SDS, MDVSDS, MDV 4 years and older4 years and older
Afluria TIVAfluria TIV(CSL)(CSL)
SDSSDS 9 years and older9 years and older
Flumist LAIVFlumist LAIV(MedImmune)(MedImmune)
Nasal sprayNasal spray 2-49 years (healthy, 2-49 years (healthy, nonpregnant)nonpregnant)
SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial
Fluzone High-Dose
Manufactured by Sanofi Pasteur
Contains 4 X amount of influenza antigen than regular Fluzone
Approved only for persons 65 years and older
Produced higher antibody levels; slightly higher local reactions
Studies underway to assess relative effectiveness
These expected for the 2012-2013 season
No preference stated by ACIP for HD or regular influenza vaccination
Fluzone IntradermalLicensed by FDA in May 2011
Approved only for persons 18 through 64 years of age
Dose is 0.1 mL administered in the deltoid area by a specially designed microneedle
and injector systemFormulated to contain more HA (27 mcg)
than a 0.1 mL dose of regular Fluzone formulation (9 mcg)
Inactivated Influenza Vaccine Schedule
AgeGroup
6-35 mos
3-8 yrs
9 yrs and older
AgeGroup
6-35 mos
3-8 yrs
9 yrs and older
Dose0.25 mL
0.50 mL
0.50 mL
Dose0.25 mL
0.50 mL
0.50 mL
No.Doses1 or 2
1 or 2
1
No.Doses1 or 2
1 or 2
1
Influenza Vaccination Schedule
One dose is recommended for most people
2 doses are recommended for children 6 months through 8 years of age
who did not receive influenza vaccine during the 2010-2011
season
Afluria
CSL vaccine associated with febrile seizuresRisk seen in children 6 months through 4
years of ageRisk of fever seen in children 5 years
through 8 yearsCan use Afluria in high-risk children 5 years
through 8 years if no other age-approved formulation is available
Live Attenuated Influenza Vaccine
IndicationsPersons 2 through 49
years of age – who are healthy (i.e., do not have an underlying
medical condition that increases the risk of complication of influenza)
– who are not pregnant– who do not have contact with a severely
immunosuppressed person (hospitalized and in isolation)
MMWR 2010;59(RR-8)MMWR 2010;59(RR-8)
Influenza Vaccine Screening
Evidence that persons with mild, moderate, or severe allergy to eggs
can tolerate TIVQuantity of ovalbumin (egg protein) in
dose of TIV less than 0.7 mcgSevere egg allergy now a precaution,
not a contraindication for TIV
TdapTdap reduces the risk of pertussis by 60% -
80%Tdap approved ages
– 10 years and older for Boostrix– 11 through 64 years for Adacel
Tdap not approved by the Food and Drug Administration for children 7 years through
9 years
Wei SC et al. Clin Infect Dis 2010;51:315-21 Wei SC et al. Clin Infect Dis 2010;51:315-21
Tdap Recommendations for Adolescents/Adults
Persons 11 through 64 years of age who have not received Tdap should
receive a dose followed by Td booster doses every 10 years
Adolescents should preferably receive Tdap at the 11 to 12 year-
old preventive healthcare visit
MMWR 2011; 60 (No. 1):13-5MMWR 2011; 60 (No. 1):13-5
New Tdap Recommendation for
Adults
MMWR 2011; 60 (No. 1):13-5
Persons 65 years old or older who anticipate or have close contact with
an infant should receive a dose of Tdap if not already received
This is an off-label recommendation if you use Adacel
Persons 7 through 10 years of age who are not fully immunized against
pertussis (including those never vaccinated or with unknown
pertussis vaccination status) should receive a single dose of Tdap
New Tdap Recommendations for Adolescents
off-label recommendation. MMWR 2011; 60 (No. 1):13-5off-label recommendation. MMWR 2011; 60 (No. 1):13-5
“Not fully immunized”– fewer than 4 doses of DTaP
– 4 doses of DTaP and last dose was prior to age 4 years
MMWR 2011; 60 (No. 1):13-5MMWR 2011; 60 (No. 1):13-5
New Tdap Recommendations for Adolescents
MMWR 2011; 60 (No. 1):13-5MMWR 2011; 60 (No. 1):13-5
Tdap Adverse Event Rates by Interval Since Previous Td/TT
0
10
20
30
40
50
60
70
80
Pain Redness Swelling SubjectiveFever
Medical Visits
Solicited Adverse Event
Perc
ent
< 2 yrs since Td/TT ≥ 2 yrs since Td/TT
0
10
20
30
40
50
60
70
80
Pain Redness Swelling SubjectiveFever
Medical Visits
Solicited Adverse Event
Perc
ent
< 2 yrs since Td/TT ≥ 2 yrs since Td/TT
Talbot et al. Vaccine 2010;28:8001-7Talbot et al. Vaccine 2010;28:8001-7
New Tdap Interval Recommendations*
Tdap can be administered regardless of the interval since the last tetanus and
diphtheria containing vaccine
ACIP concluded that while longer intervals between Td and Tdap vaccination could
decrease the occurrence of local reactions, the benefits of protection
against pertussis outweigh the potential risk for adverse events
*off-label recommendation. MMWR 2011; 60 (No. 1):13-5*off-label recommendation. MMWR 2011; 60 (No. 1):13-5
Tdap and Healthcare Personnel (HCP)*
HCP, regardless of age, should receive a single dose of Tdap as soon as feasible if they have not previously received
Tdap and regardless of the time since last Td dose
Post-exposure prophylaxis should be provided to HCP even if vaccinated, although observation for symptoms of
pertussis an option if provider does NOT see hospitalized neonates or pregnant women
*off-label provisional ACIP recommendation. Approved by ACIP on Feb 23, 2011 – on CDC website*off-label provisional ACIP recommendation. Approved by ACIP on Feb 23, 2011 – on CDC website
Tdap and Pregnancy
Providers of pregnant women should recommend Tdap to their patients if not previously received and after 20 weeks gestation
ACIP vote June 22, 2011
