Protecting the Childhood Vaccine Schedule

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• Protecting the Childhood Vaccine Schedule

William L. Atkinson, MD, MPH National Center for
Immunization and Respiratory Diseases
North Carolina Immunization Conference Greensboro,
North Carolina August 12, 2009
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Disclosures

• The speaker is a federal government employee with
  no financial interest or conflict with the
  manufacturer of any product named in this
  presentation
• The speaker will discuss the off-label use of
  Pentacel, Kinrix and meningococcal conjugate
  vaccines
• The speaker will discuss a vaccine for H1N1
  influenza virus that is not currently licensed by
  the Food and Drug Administration

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Novel H1N1 Influenza Virus 2009

• April 15 first U.S. case confirmed by CDC
  (California)
• April 26 U.S. Government declares a public
  health emergency
• May CDC provides prototype vaccine virus to
  manufacturers
• June 11 World Health Organization raises
  pandemic level to 6
• June 19 novel H1N1 infections reported by all
  50 states

www.cdc.gov/h1n1flu www.who.int/csr/disease/sw
ineflu/en/index.html
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Novel Influenza A (H1N1) Virus - 2009

• Virus continues to spread
• Spreading along with seasonal influenza viruses
  in the southern hemisphere
• Virus transmission has continued into the summer
  in the United States

http//www.cdc.gov/h1n1flu/
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Novel H1N1 Influenza Virus 2009

• U.S. 43,711 confirmed and probable human
  infections
• 50 states and the District of Columbia
• 302 deaths
• Worldwide 134,503 cases, 816 deaths
• Both the U.S. and WHO ceased reporting case
  counts in July 2009

as of July 24, 2009 www.cdc.gov/h1n1flu
www.who.int/csr/disease/swineflu/en/index.html
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Age Distribution of Laboratory-Confirmed Novel
H1N1 Infection
as of July 24, 2009, (n43,771)
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Deaths by Age Group of Laboratory-Confirmed Novel
H1N1 Infection
41
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16
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as of July 24, 2009, (n302)
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Novel H1N1 Influenza Virus Vaccine

• Prototype vaccine virus has been provided to all
  U.S. manufacturers
• Clinical trials conducted by manufacturers and
  NIH are starting now
• Number of doses (1 or 2) and need for adjuvant
  will depend on results of clinical trials
• Vaccine expected to be available by late October
  (if everything goes right)

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ACIP-Recommended Initial Target Groups for Novel
H1N1 Influenza Virus Vaccine

• Pregnant women
• Household and caregiver contacts of children
  younger than 6 months of age
• Healthcare and emergency medical services
  personnel
• Children from 6 months through 24 years of age
• Persons 25 through 64 years who have high risk
  medical conditions

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ACIP Recommendations for Novel H1N1 Influenza
Virus Vaccine

• When vaccine availability is sufficient at the
  local level to routinely vaccinate initial target
  populations, vaccination against pandemic
  influenza is recommended for healthy adults 25
  through 64 years of age
• Vaccination should be offered to persons 65 years
  and older once vaccination programs are capable
  of meeting demand for vaccination of younger age
  groups

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2009 Immunization Schedules for Persons 0 Through
18 Years

• Published in MMWR on January 2, 2009
• Same basic format as 2008
• Revisions
• new age recommendations for rotavirus vaccines
• revised influenza vaccine recommen-dations (6
  months through 18 years)
• Hib vaccine for persons 5 years and older
• revised minimum intervals for HPV vaccine

Available at www.cdc.gov/vaccines/recs/schedules/
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2009 ScheduleNew Hib Footnote

• Hib vaccine is not generally recommended for
  persons aged 5 years or older. No efficacy data
  are available on which to base a recommendation
  concerning use of Hib vaccine for older children
  and adults. However, studies suggest good
  immunogenicity in persons who have sickle cell
  disease, leukemia, or HIV infection, or who have
  had a splenectomy administering 1 dose of Hib
  vaccine to these persons who have not previously
  received Hib vaccine is not contraindicated.

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New Permissive Hib Recommendation

• Same wording as in the adult immunization
  schedule
• Intended to encourage Hib vaccination of certain
  high risk children who have not previously
  received Hib vaccine
• Will primarily be applicable to adoptees and
  immigrants (routine childhood Hib vaccination has
  been recommended in the US since 1991)

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The Sears Alternative Immunization Schedule

• No more than 2 vaccines per visit
• Requires 15 visits over 42 months to complete the
  series for all recommended childhood vaccines
• Uses single antigen measles, mumps and rubella
  vaccines
• Completes most vaccine series within age range
  recommended by ACIP except
• HepB vaccine delayed until 30-42 months
• Measles vaccine delayed until 3 years of age

Sears R. The Vaccine Book. New York Little
Brown and Co, 2007234-42 See commentary by
Offit Pediatrics 2009123e164-9 Available on
Pediatrics website at http//pediatrics.aappublica
tions.org/
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Single Antigen MMR

• As of 2009 Merck no longer produces single
  antigen measles, mumps or rubella vaccine for
  distribution
• Only MMR is available
• Unknown if single antigen products will be
  available in the future
• MMRV expected to be available later in 2009

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Perinatal Transmission of Hepatitis B Virus

• 24,000 women with chronic HBV infection give
  birth every year in the United States
• Every infant born to a woman infected with HBV is
  at risk of perinatal infection
• Mistakes can lead to failure to provide
  postexposure prophylaxis for the infant
• orders for the wrong serologic test
• misinterpretation of the test results
• laboratory errors
• The hepatitis B birth dose is a critical safety
  net to prevent transmission of HBV to infants
  from unknowingly infected women, or from exposure
  in the home after leaving the hospital

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Other Problems with the Sears Book

• Factual errors (see listing on the program
  updates and resources web page)
• Misrepresentation of VAERS data
• Does not acknowledge that
• many reports represent coincidental medical
  events
• VAERS reports cannot be used to determine the
  true incidence of vaccine adverse reactions
• Gross underestimate of the risk of a
  vaccine-preventable disease

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Bottom Line on the Sears Schedule

• Only the most reliable parents in your practice
  should be considered for the Sears schedule
• You should have a very low threshold for
  abandoning it should the child fall behind
• Be sure the parents understand the large number
  of visits required, and the financial
  implications
• You should
• insist on a hepatitis B birth dose
• insist on MMR at 12 to 15 months of age
• Have the parent read Dr. Paul Offits article
  about this schedule (Pediatrics 2009123e164-9)

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KINRIXTM Vaccine

• Contains DTaP (Infanrix) and IPV
• Approved ONLY for the 5th dose of DTaP and 4th
  dose of IPV in children 4 through 6 years of age
• Do NOT use for earlier doses in the DTaP or IPV
  series
• Use of KINRIX for any dose other than DTaP5 and
  IPV4 is off-label, and should be considered a
  medication error (but dose does not need to be
  repeated)

whose previous doses have been with Infanrix
and/or Pediarix for the first 3 doses and
Infanrix for the 4th dose
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Pentacel Vaccine

• Contains DTaP, Hib, and IPV
• Approved for doses 1 through 4 among children 6
  weeks through 4 years of age
• Do NOT use for in children 5 years or older
• Package contains lyophilized Hib (ActHib) that is
  reconstituted with a liquid DTaP (Daptacel)/IPV
  solution

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Pentacel Vaccine

• If the DTaP-IPV solution is administered
  separately there will be no diluent for the Hib
  component!
• You will be unable to use the Hib dose because
• Hib must only be reconstituted with DTaP-IPV or
  specific ActHib diluent (NOT with MMR/varicella
  diluent, normal saline or any other vaccine)

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Pentacel Vaccine

• Do NOT use the Hib (ActHib) and liquid DTaP/IPV
  solution separately
• If Hib reconstituted with an inappropriate
  diluent is administered it should NOT be counted
  as a valid dose and should be repeated as soon as
  possible
• Keep components together in the box to avoid
  administration errors
• Guidance for clinicians for the use of Pentacel
• www.cdc.gov/vaccines/pubs/pentacel-guidance.htm

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Hib Vaccine Shortage

• Production of Merck Hib vaccine products remains
  suspended
• A limited supply of PedvaxHIB will be available
  in the 4th quarter of 2009
• Full availability of PedvaxHIB is expected in the
  first quarter of 2010

www.cdc.gov/vaccines/vac-gen/shortages/default.htm
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Hib Vaccine Shortage

• sanofi pasteurs Hib-containing vaccines (ActHIB
  and Pentacel) have been available during the
  shortage
• Beginning in July 2009, sanofi increased the
  number of doses of these two products
• Sufficient supply to reinstate the Hib vaccine
  booster dose

MMWR 200958(No. 24)673-4
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Reinstatement of the Hib Booster Dose

• Children 12 through 15 months of age should
  receive the booster dose on schedule
• Older children for whom the booster dose was
  deferred should receive their Hib booster dose at
  the next routinely scheduled visit or medical
  encounter
• Supply is not yet sufficient to support a mass
  notification process to contact all children with
  deferred Hib booster doses

MMWR 200958(No. 24)673-4
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Reinstatement of the Hib Booster Dose

• Children who need the Hib booster and who already
  have received 4 doses of DTaP should receive
  monovalent Hib vaccine (ActHIB) as their Hib
  booster dose
• If DTaP-IPV/Hib (Pentacel) is the only
  Hib-containing vaccine available, it can be used
  to complete the series of Hib vaccination, even
  if the child already has received all the
  necessary doses of DTaP and IPV

MMWR 200958(No. 24)673-4
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Combination Vaccines Containing Inactivated Polio
Vaccine (IPV)

• Pediarix
• IPV, DTaP and hepatitis B
• Kinrix
• IPV and DTaP (4th dose only)
• Pentacel
• IPV, DTaP and Hib

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Factors Affecting the Response to IPV

• Age and dose intervals
• Maternal antibody level at the time of the first
  dose
• the lower the maternal antibody level the higher
  the seroconversion rate
• Longer intervals between doses
• an interval of at least 6 months between the next
  to last and last dose provides the best
  immunologic effect

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New IPV Recommendations

• No change in the recommended IPV schedule of four
  doses at ages 2 months, 4 months, 6 through 18
  months, and 4 through 6 years
• Minimum interval between the 3rd and 4th doses is
  now 6 months
• Minimum age for the final IPV dose is now 4 years

www.cdc.gov/vaccines/programs/vfc/downloads/resolu
tions/0608polio.pdf
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New IPV Recommendations

• When 4 doses of IPV are administered before the
  4th birthday, an additional dose of age
  appropriate IPV should be given on or after the
  4th birthday
• Minimum interval from dose 4 to dose 5 should be
  at least 6 months

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New IPV Recommendations

• In the first 6 months of life, the minimum age
  and minimum intervals are recommended only if
  the person is at risk for imminent exposure to
  circulating poliovirus, such as travel to a polio
  endemic region or during an outbreak

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Meningococcal Vaccines

• Meningococcal polysaccharide vaccine (MPSV,
  Menomune)
• 2 years of age and older
• subcutaneous injection
• Meningococcal conjugate vaccine (MCV, Menactra)
• 2 through 55 years of age
• intramuscular injection

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Meningococcal VaccineRecommendations

• MCV is the preferred vaccine for persons 2
  through 55 years
• MPSV should be used for persons 56 years of age
  or older, or if the person has a precaution for
  MCV (e.g., a history of Guillain-Barre syndrome)

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MCV Revaccination Recommendations

• Children through age 18 years who received their
  first dose of MCV or MPSV at ages 2 through 6
  years and remain at increased risk for
  meningococcal disease should receive an
  additional dose of MCV 3 years after their first
  dose
• Persons through age 55 years who received a dose
  of MCV or MPSV after age 6 years and remain at
  increased risk for meningococcal disease should
  receive an additional dose of MCV 5 years after
  their previous dose

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MCV Revaccination Recommendations

• High-risk persons who should be revaccinated with
  MCV
• persistent complement component deficiency
• anatomic or functional asplenia
• HIV infection
• frequent travelers to or persons living in areas
  with high rates of meningococcal disease

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MCV Revaccination Recommendations

• MCV revaccination recommendation does NOT apply
  to children who previously received MCV and who
  will be a freshman living in a dormitory

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Post hoc ergo propter hocAfter this therefore
because of thisTemporal association does not
prove causationJust because one event follows
another does not mean that the first caused the
second
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CDC Vaccines and ImmunizationContact Information

• Telephone 800.CDC.INFO
• (for patients and parents)
• Email nipinfo_at_cdc.gov
• (for providers)
• Website www.cdc.gov/vaccines/
• Vaccine Safety
• www.cdc.gov/od/science/iso/