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Immunization Update. Andrew Kroger, MD, MPH National Center for Immunization and Respiratory Diseases. North Carolina Statewide Immunization Conference Greensboro, NC August 10, 2011. Disclosures.

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Immunization update

Andrew Kroger, MD, MPH

National Center for Immunization and Respiratory Diseases

North Carolina Statewide Immunization Conference

Greensboro, NC

August 10, 2011


Andrew Kroger is a federal government employee with no financial interest or conflict with the manufacturer of any product named in this presentation

Andrew Kroger will not discuss a vaccine not currently licensed by the FDA


  • Andrew Kroger will discuss off-label uses meningococcal conjugate vaccine (MCV4) and tetanus-reduced-diphtheria-toxoid acellular pertussis vaccine (Tdap)

Comparison of 20 th century annual morbidity and current morbidity vaccine preventable diseases

National Center for Immunization & Respiratory Diseases

Comparison of 20th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases

†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
What’s New in Immunization

MCV4 vaccine

Measles Outbreaks

Influenza Vaccine

Tdap vaccine

Adult immunization schedule indications by age group 2011
Adult Immunization ScheduleIndications by Age Group - 2011

Adult immunization schedule indications by condition 2011
Adult Immunization ScheduleIndications by Condition - 2011

Persons at highest risk of meningococcal disease or suboptimal vaccine response
Persons at Highest Risk of Meningococcal Disease or Suboptimal Vaccine Response

Complement deficiency

  • High-risk of disease

  • Very high antibody titer required to compensate for complement deficiency


  • High-risk of disease

  • evidence of suboptimal response

Persons with suboptimal vaccine response
Persons with Suboptimal Vaccine Response Suboptimal Vaccine Response

  • HIV infection

    • evidence of suboptimal response

  • Single dose primary series may not be sufficient to confer protection for persons with these high-risk conditions

Mcv4 primary series recommendation
MCV4 Primary Series Recommendation Suboptimal Vaccine Response

MMWR 2011;60(No. 3):72-6.

Administer 2 doses of MCV4 at least 8 weeks apart to persons with persistent complement component deficiency and anatomic or functional asplenia

Mcv4 primary series recommendation1
MCV4 Primary Series Recommendation Suboptimal Vaccine Response

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.

Fda approval menactra
FDA Approval: Menactra Suboptimal Vaccine Response

  • June 2011: Menactra approved for high-risk infants

  • 2 dose series at 9 months and 12 months

New mcv4 recommendations
New MCV4 Recommendations Suboptimal Vaccine Response

Certain persons recommended for infant series

Persistent complement component deficiency

Travelers to high-risk meningococcal areas

Persons in a meningococcal outbreak

HIV infection (permitted)

New mcv4 recommendations1
New MCV4 Recommendations Suboptimal Vaccine Response

  • Infant vaccination 2 dose series

  • Dose 1: 9 months

  • Dose 2: 12 months

  • Minimum interval between doses 2 months

Infant vaccination asplenia
Infant Vaccination: Asplenia Suboptimal Vaccine Response

  • Persons with functional or anatomic asplenia NOT recommended for infant vaccination

  • Still recommended for 2 dose series beginning at age 2 years

Asplenia Suboptimal Vaccine Response

  • 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 PCV13

  • Because 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
Rates of Meningococcal Disease (C and Y) by Age, 1999-2008 Suboptimal Vaccine Response

Age for routine vaccination

Active Bacterial Core surveillance (ABCs), 1998-2008

Meningococcal conjugate mcv4 routine revaccination
Meningococcal Conjugate (MCV4) Routine Revaccination Suboptimal Vaccine Response

  • 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 reported

MMWR 2009;58(No. 37):1042-3

Seroprotection rates following mcv vaccination
Seroprotection Rates Following MCV Vaccination Suboptimal Vaccine Response

MMWR 2009;58(No. 37):1042-3

New mcv4 recommendations2
New MCV4 Recommendations* Suboptimal Vaccine Response

*off-label recommendation. MMWR 2011;60(No. 3):72-6.

  • 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

New mcv4 adolescent vaccination recommendations
New MCV4 Adolescent Vaccination Recommendations Suboptimal Vaccine Response

The 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
MCV4 vs MPSV4 Suboptimal Vaccine Response

  • 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
MCV Revaccination Recommendations Suboptimal Vaccine Response

  • 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 Suboptimal Vaccine Response

As of June 17, 2011

Over 156 cases of measles reported in U.S.

Highest number since 1996

Immunization update
MMR Suboptimal Vaccine Response

  • A dose is recommended for travelers between 6 through 12 months of age

  • Does NOT count toward the two dose routine series

  • High-risk countries: France, India (generally Europe, Africa, Asia)

Influenza Suboptimal Vaccine Response

2011 2012 influenza vaccine composition
2011-2012 Influenza Vaccine Composition Suboptimal Vaccine Response

  • Same strains this year as last year:

    • A/California/7/2009-like H1N1

    • A/Perth/16/2009-like H3N2

    • B/Brisbane/60/2008

Duration of immunity following influenza vaccination
Duration of Immunity Following Influenza Vaccination Suboptimal Vaccine Response

  • 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

Influenza vaccination recommendation
Influenza Vaccination Recommendation Suboptimal Vaccine Response

  • Annual influenza vaccination is now recommended for every person in the United States 6 months of age and older

MMWR 2010;59(RR-8)

Influenza vaccine presentations 2011 2012
Influenza Vaccine Presentations 2011-2012 Suboptimal Vaccine Response

SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial

Fluzone high dose
Fluzone High-Dose Suboptimal Vaccine Response

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 intradermal
Fluzone Intradermal Suboptimal Vaccine Response

  • Licensed 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 system

  • Formulated to contain more HA (27 mcg) than a 0.1 mL dose of regular Fluzone formulation (9 mcg)

Immunization update



6-35 mos

3-8 yrs

9 yrs and older



1 or 2

1 or 2



0.25 mL

0.50 mL

0.50 mL

Influenza vaccination schedule
Influenza Vaccination Schedule Suboptimal Vaccine Response

  • 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 Suboptimal Vaccine Response

  • CSL vaccine associated with febrile seizures

  • Risk seen in children 6 months through 4 years of age

  • Risk of fever seen in children 5 years through 8 years

  • Can use Afluria in high-risk children 5 years through 8 years if no other age-approved formulation is available

Live attenuated influenza vaccine indications
Live Attenuated Influenza Vaccine Suboptimal Vaccine ResponseIndications

Persons 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)

Influenza vaccine screening
Influenza Vaccine Screening Suboptimal Vaccine Response

  • Evidence that persons with mild, moderate, or severe allergy to eggs can tolerate TIV

  • Quantity of ovalbumin (egg protein) in dose of TIV less than 0.7 mcg

  • Severe egg allergy now a precaution, not a contraindication for TIV

Immunization update
Tdap Suboptimal Vaccine Response

  • Tdap 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

Tdap recommendations for adolescents adults
Tdap Recommendations for Adolescents/Adults Suboptimal Vaccine Response

  • 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):13-5

New tdap recommendation for adults
New Tdap Recommendation for Adults Suboptimal Vaccine Response

  • 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

New tdap recommendations for adolescents
New Tdap Recommendations for Adolescents Suboptimal Vaccine Response

  • 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

off-label recommendation. MMWR 2011; 60 (No. 1):13-5

Immunization update

New Tdap Recommendations for Adolescents Suboptimal Vaccine Response

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

Immunization update

MMWR Suboptimal Vaccine Response 2011; 60 (No. 1):13-5

Tdap adverse event rates by interval since previous td tt
Tdap Adverse Event Rates by Interval Since Previous Td/TT Suboptimal Vaccine Response

Talbot et al. Vaccine 2010;28:8001-7

New tdap interval recommendations
New Tdap Interval Recommendations* Suboptimal Vaccine Response

*off-label recommendation. MMWR 2011; 60 (No. 1):13-5

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

Tdap and healthcare personnel hcp
Tdap and Healthcare Personnel (HCP)* Suboptimal Vaccine Response

*off-label provisional ACIP recommendation. Approved by ACIP on Feb 23, 2011 – on CDC website

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

Tdap and pregnancy
Tdap and Pregnancy Suboptimal Vaccine Response

  • Providers of pregnant women should recommend Tdap to their patients if not previously received and after 20 weeks gestation

  • ACIP vote June 22, 2011

Thank you
Thank You Suboptimal Vaccine Response

Hotline: 800.CDC.INFO