Immunizations

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Immunizations

• W. Griff Thompson, MD

Saint Joseph Family Practice
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How are we doing? (FPC)Audit Early 19991yr olds
- 3 DPT, 2 Polio, 2 Hib, 2 HepB - 672yr olds -
4DPT, 3 Polio, 1MMR, 3 Hib, 3 Hep B - 49
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Outline

• Bask in Success
• Visit an old disease
• Recent changes - Var, MMR, DTaP, IPV
• Review Recommendations/ Questions often asked -
  catch-up, premie
• New developments - HAV, Rota, Pneumo
• Contraindications - real and imagined
• Barriers - patient medical system

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Success Stories -
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Success Stories -New Wave
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Possible New Vaccines(Old Slide)

• Rotavirus - Live oral
• DTaP-Hib combo for infants
• DTaP-HepB combo
• Lyme - inactivated
• Influenza - Live attenuated Nasal Spray
• Pneumococcal Tetravalent conjugate
• ??? Group B Strep

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Word association

• Franklin
• Crutches
• Wheelchair
• Iron Lung
• FDR

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Poliomyelitis

• Enterovirus three serotypes
• Highly contagious
• Most cases non-specific febrile illness
• A few (1100 to 11000) cases followed by
  paralytic disease
• Fatal in 2-10 of paralytic cases
• Transmission person to person, primarily
  fecal-oral

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Poliomyelitis Eradication

• Widespread use of vaccine mid 1950s
• gt20,000 cases in 1952, lt100 cases in the mid
  1960s (U.S.)
• Last indigenous U.S. case of wild poliovirus in
  1979
• Western Hemisphere certified free of indigenous
  polio in 1994
• Global Eradication goal year 2000 (?2003)

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Question

• Which is better, IPV or OPV?

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OPV (Sabin)

• Live attenuated virus - trivalent
• Induces GI immunity
• gt95 immunity (probably lifelong) to all three
  serotypes after 3 doses
• VAPP 8 or 9 cases average annually in US

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Vaccine-Associated Paralytic Poliomyelitis (VAPP)

• Risk 1case in 750,000 first dose OPV
• U.S. 1980-94 - 125 Cases VAPP
• 30 in immunodeficient (either received OPV or had
  direct contact of OPV recipient)
• 6 in community contacts
• 40 in healthy close contacts
• 49 in healthy vaccine recipients
• 8 or 9 cases annually in US average

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IPV (Salk)

• Introduced 1955 widely used until OPV available
  in early 1960s
• Inferior GI immunity - Conceivable to be
  subsequently infected with and excrete wild-type
  or vaccine-virus strains in feces, but
  epidemiologic studies in Netherlands showed IPV
  prevented circulation of wild poliovirus
• No VAPP

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IPV - Efficacy

• Current IPV more immunogenic than prior
• Protective antibody
• 90-100 after 2 doses
• 99-100 after 3 doses
• Long-term antibody persistence
• US data lacking
• gt90 after 25 years in Sweden (lower Antigen
  content)

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Polio

• IPV _at_ 2, 4, 6-18mos 4-6 yrs
• OPV only in special circumstances
• Mass Vaccination campaign in Outbreak control
• Unvaccinated and traveling to endemic area in lt 4
  weeks
• Parents who insist and understand VAPP

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When Polio is gone, should we still vaccinate?

• Possible discontinuance after global eradication
• Problems with cessation of vaccination
• Biological terrorism
• Maintaining Vaccine stocks
• Accidental release
• Persistence in the environment
• At a minimum continue until IPV available
  worldwide

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Word Association

• One Nut
• German
• Chipmunk
• Koplick

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MMR

• What is minimum time between doses?

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MMR

• All children should receive 2 doses MMR, unless
  contraindicated, after 1st birthday
• First dose MMR at 12-15 months
• Second MMR at 4-6 yrs, but can be given as early
  as 1 month after 1st dose (New)
• Review records at 11-12 years to be certain that
  two doses after first birthday

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MMR - Why 2nd dose?

• 2-5 Primary vaccine failure
• Vaccinate too early when maternal Antibody
  present
• Technical problems such as improper storage
• recent IG
• gt96 initial seronegative children will respond
  to revaccination

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Word Association

• Grey
• Nail
• Inconsolable crying
• Whoop

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Diptheria-Tetanus-Pertussis

• Use DTaP, not DTP
• Less reactogenic
• DTaP/Hib combo not OK for 2, 4, 6 months
• lower immune response
• Adolescents/ Adults
• Recent article - Pediatr Infect Dis J April 2000
• TdaP/IPV - safe and immunogenic

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Pertussis

• Significant worldwide problem 50 Million cases
  300,000 deaths
• Cases U.S.
• 1934 - 260,000
• 1976 - 1,010
• 1993 - 6,586
• Increase in all age groups, but greatest increase
  in agegt5, though infants at highest risk for
  pertussis complications

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Pertussis - Increase

• Has occurred despite increasing vaccination
  levels
• Possible reasons
• decreased vaccine efficacy
• waning immunity
• increased diagnosis and reporting

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Whole-cell Pertussis Vaccine

• Licensed in 1940s
• 70-90 effective in preventing serious dz
• Common severe local adverse events (pain,
  erythema, swelling), fever, mild systemic
  (drowsy, fretful, anorexia)
• More severe systemic events (sz, hypotonic-
  hyporesponsive) less often 1 in 1,750 doses
• Acute Encephalopathy 0-10 per 1,000,000

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Acellular Pertussis Vaccine

• Development prompted by concerns over safety of
  whole cell vaccine
• Licensed for use at all 5 doses
• Efficacy possibly slightly less 59-89
• Substantially less endotoxin (3000 vs 4
  Antigens) Less Reactogenic

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Acellular Pertussis Vaccine

• Less Reactogenic
• Local/mild systemic - down
• Inconsolable cry - down 4x
• Fever gt105 - down 3x
• Seizure - down
• Hypotonic-hyporesponsive - down
• Encephalopathy - ?

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DTP/ DTaP Recommendations

• DTaP is the preferred vaccine for all doses in
  the series (2,4,6, 15-18mo, 4-6 yr)
• DTP is an acceptable alternative
• Td at 11-12 years old if at least 5 years since
  last dose of DTP/DTaP
• TD subsequent every 10 years
• DTaP-Hib combo not yet licensed for doses 1, 2, 3

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Question

• 7 week old in earlyfor Well Child Visit
• Can you immunize?
• When is it too early?

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Word Association

• No big deal
• Death
• Encephalitis
• Pneumonia
• Calamine
• Benadryl
• Acyclovir

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Varicella

• Just do it!!!! .......Unless
• Contraindicated or
• You are smarter than CDC, AAFP, ACIP, AAP
• Hesitancy has centered around three questions
• How efficacious and for how long?
• 86 against any disease, 100 against severe
  disease. Duration probably gt 20 yrs.

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Varicella

• At risk for more frequent or severe zoster?
• NO. Less likely to develop zoster.
• Do benefits outweigh cost?
• Can cause significant morbidity and mortality
• 4 million cases/year
• 4000-9000 hospitalizations/year
• 100 deaths/year

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Varicella

• Susceptible children may receive Varicella during
  any visit after their first birthday and
  unvaccinated persons who lack a reliable history
  of chickenpox should be vaccinated during the
  11-12 year old visit.
• Susceptible persons gt 13 should receive 2 doses
  at least 1 month apart

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Varicella Vaccine

• Licensed Spring 1995
• Expanded Recommendations May 1999
• ACIP recommends states require proof of disease
  prior to day care or school entry.and consider a
  middle school requirement
• Colorado plan
• Effective for post exposure prophylaxis if given
  within 3 days of exposure, possibly up to 5 days

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Varicella Vaccine

• Strengthened recommendation for gt 12
• teachers, day care institutional settings
• college, military, correctional inst
• non-pregnant women
• live in household with kids
• international travelers
• Consider in asymptomatic HIV with CD4 gt25

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Varicella Vaccine

• Most common adverse event?
• Rash
• rash within 2 weeks after vaccination is usually
  wild type virus
• transmission of vaccine virus documented only 3
  times out of 15 million doses

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Rotavirus

• Highly infectious
• Clinical manifestations range from asymptomatic
  shedding to life-threatening GE with severe V/D
  dehydration
• Majority of cases in winter months
• Fecal-oral transmission most likely
• Washin hands aint workin
• Most common cause severe diarrhea among young
  children in US

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Rotavirus - Burden of Suffering

• Age group lt5 years old in the US
• 70 will become ill, nearly all infected
• 1 in 8 will seek medical care (500,000 visits/yr)
• 1 in 78 will be hospitalized (50,000 admits/yr)
• death is rare in the US (100/yr), but 800,000
  deaths/yr in developing areas of the world

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Rotavirus - Immunization

• Currently under FDA review for licensure
• Feb 1998 ACIP majority voted supportive
• RotaShield (Wyeth Lederle)
• Live attenuated virus
• Tetravalent, covering 4 most common serotypes

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Rotavirus - Immunization

• Oral administration
• 3 dose series at 2, 4, and 6 months
• Minimum 3 weeks between doses
• First dose not after 6 months old(fever)
• 2nd and 3rd doses not after 1 year old (Lack of
  data)
• OK with other immunizations
• Data on premies unclear

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RotaShield - Efficacy

• With 3 doses
• 50 efficacy against any Rotavirus diarrhea
• 70-95 against severe Rotavirus diarrhea
• 100(?) against hospitalization due to Rotavirus
• 1 dose less efficacious, 2 doses no data
• Kids will still squirt mild Rota 50-70 of
  diarrhea hospital admits are non-Rota

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RotaShield - Cost Effectiveness

• Price hasnt been set yet
• Direct medical costs due to Rotavirus est.
  270-450 million, societal cost 1 billion
• Break even at 9/dose on direct costs, 51/dose
  on societal costs
• Probably will be cost effective

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Question

• Two year old who had one set of immunizations at
  age two months now in to get caught up.
• How much time can elapse before you need to start
  over?
• Which immunizations are indicated?
• How many immunizations can you give?

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Hepatitis A

• Routine vaccination of children is the most
  effective way to reduce hepatitis A incidence
  nationwide over time
• ACIP, MMWR October 1, 1999

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Hepatitis A Vaccine (Havrix Vaqta)

• Vaccine licensed for age 2 and older
• different dose _at_ age 18
• 2 doses, 0 6-12 months
• Inactivated and Attenuated vaccine
• 95 Efficacy
• Immunity appears long lasting
• Can be given simultaneous with other vaccines

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Hep A Vaccine Basic Who gets it?

• Targeting only high risk groups has limited
  impact on overall incidence of disease in United
  States
• Certain communities (Alaskan Native, American
  Indian, selected Hispanic, migrant, religious)
• Traveling/ living in countries with high or
  intermediate endemic rates
• Men who have sex with men
• Illegal drug users
• Occupational risks
• Clotting factor disorders
• Chronic liver disease

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Hep A Vaccine Expanded Who gets it?

• Recommended for children living in states or
  communities where rate is gt20/100,000 per yr
  (twice the national average)
• AZ, AK, OR, NM, UT, WA, OK, SD, ID, NV, CA
• Considered for children living in states or
  communities with rates 10-20/100,000 per year
• MO, TX, CO, AR, MT, WY

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Hep A Vaccine - Colorado

• Available through VFC
• Counties targeted by combo of risk (high or
  intermediate) and number at risk
• Include following counties
• Denver, Boulder, Adams, Arapahoe, Jefferson,
  Mesa, Weld
• Denver County had 33 of cases (88-98)
• 41 were MSM
• CDC Web site Map

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Hep A - Postexposure

• Immunoglobulin
• Not needed if Hep A vaccine 1 gt 1 month ago
• Hep A Vaccine can be given simultaneously with IG
• Hep A Vaccine alone not recommended for
  postexposure prophylaxis

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Question

• How do you handle immunizations in the premature
  infant?

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Hepatitis B

• Give before Hospital discharge
• Four doses OK
• Beware intervals - affects efficacy
• Within 12 hours if mom HBsAg or unknown
• Decreased efficacy in premies lt2Kg
• delay unless mom HBsAg/unknown
• doesnt count
• Post Vaccination Testing

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Which vaccines are currently in short supply?
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Pneumococcal Conjugate Vaccine

• Pneumococcal Burden of disease
• 3000 cases meningitis
• 5-10 mortality
• 25-35 long-term morbidity
• 50,000 cases bacteremia
• 125,000 cases hospitalized pneumonia
• 7 million cases otitis media
• Unconjugated 23-valent pneumococcal
  polysaccharide vaccine (Pneumovax) not effective
  in children less than two years old

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Pneumococcal Conjugate Vaccine (Prevnar)

• Contains 7 serotypes which account for 83 of
  invasive dz in children lt4 yrs
• Four Dose Schedule
• 2, 4, 6, and 12-15 months of age
• ACIP Recommendation
• Vaccinate all infants lt 2 years old
• Vaccinate high risk children 2-5 yrs old
• asplenia, SS anemia, nephrotic syndrome,
  immunocompromised

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Pneumococcal Conjugate Vaccine Does It Work?

• Prospective DBPC Trial _at_ Kaiser - North CA
• Black et al, Ped Inf Dis J, 19187, March 2000
• 38,000 healthy children
• placebo control with Meningococcal C conjugate
  vaccine
• Adverse Effects
• Local reactions in 10-20
• Fever gt 38 C in 15-20
• more severe local or systemic events were
  uncommon and self limited

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Pneumococcal Conjugate Vaccine Does It Work?

• 1 case invasive disease due to vaccine serotypes
  vs. 38 cases in control group
• Efficacy 97.4 (95CI 83-100)
• If you include all serotypes, 6 cases in
  vaccinated group vs. 55 in control group
• Efficacy 89.1 (95CI 74-96)

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Pneumococcal Conjugate Vaccine - Effect on Otitis
Media

• 9 reduction in OM visits
• 7 reduction in OM episodes
• effectiveness of vaccine against frequent OM
  increased from 9.3-22.8 as frequency of episodes
  increased
• 20 reduction in ventilatory tube placement
• Extrapolated for US could eliminate 2,000,000 OM
  visits and 100,000 tubes

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Pneumococcal Conjugate Vaccine -Questions

• Will nonvaccine strains replace vaccine strains
  as cause for disease?
• Will we need to alter management protocols for
  infants with fever without source?
• How will conjugate vaccine affect pneumococcal
  immunization of adults?
• World wide impact? When available in developing
  countries

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Prevnar - temporary shortage

• Maximize limited vaccine
• Highest priority
• All children up to 24 months
• High risk children aged 24-59
• SCD, asplenia, HIV, Immunocompromise, Renal
  failure or nephrotic syndrome, immunosuppressive
  therapy or radiation therapy, chronic illnesses
  including cardiac, non-asthma pulmonary, DM, CSF
  leaks

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What is the difference between DT, dT, DTP, DTaP?
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It is November. Mom of a healthy 9 month old
comes for WCC. Routing immunizations UTD. Any
other immunization recommendations?
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Influenza

• Season peaks Dec through early March
• Abrupt onset
• Fever, myalgias, HA, ST, Non-productive cough
• Age-specific hospitalization rates are high in
  infants, elderly, low-income

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Who should get Influenza Vac?

• Children 6-23 months are encouraged!
• Any gt 6 mos w/out contras who wants it!
• All gt 50
• Pregnant in 2nd or 3rd trimester in season
• Residents Employees _at_ NH Chronic Care
  Facilities
• Any that are Sick CV,Pulm, Metabolic, Renal,
  Immunosuppressed, Heme, etc

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Who should get Influenza Vac?Cont..

• Kids on long term ASA
• Health Care Workers
• Household Members of High Risk persons
• HIV
• Students/ others in institutional setting

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Who should not get Flu Vac?

• Anaphylaxis to eggs
• Anaphylaxis to previous Flu vaccine
• ?? Hx of Guillain-Barre
• Current Moderate or Severe Acute Illness

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Delayed Influenza Vaccine Availability for 2001-02

• Target high risk and health workers in Sept and
  Oct
• Age 65 or older
• Nursing Home/ Chronic care facilities
• Adults and kids with chronic Pulm (Asthma), CV,
  metabolic(DM), renal, hemoglobinopathy,
  immunosuppression
• kids and teens on long term ASA
• Pregnant and in 2nd or 3rd tri during flu season

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Case 17 yr old from Lakewood, college at UConn
in the fall. What Immunizations?

• Depo-disulfuram
• dT
• Review Varicella, Hep B, MMR
• ? Hep A (Travel Plans)
• Meningococcus (? Dormitory)
• Lyme

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Question

• Name and spell the organisms targeted in the
  Meningitis, H Flu and Lyme vaccines

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Lyme Disease

• gt12,000 reported cases per year in US
• In highly endemic areas, 15-30 of Ixodes nymphs
  infected (only 0-3 in southern US)
• Risk of getting Lyme disease relates to
• density of vector ticks in the environment
• prevalence of B. burgdorferi infection in the
  vector ticks
• extent of person-tick contact

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Lyme Vaccine (LYMErix)

• Vaccine licensed by FDA Dec 1998
• Three dose series at 0, 1, and 12 months
• Efficacy against definite Lyme disease
• 49 after two doses
• 76 after three doses

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Lyme Vaccine Should be Considered for

• Persons aged 15-70 who reside, work, or recreate
  in areas of high or moderate risk with frequent
  or prolonged exposure
• Travelers to areas of high or moderate risk with
  frequent of prolonged exposure
• Persons with previous history of uncomplicated
  Lyme disease who are at continued high risk

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Lyme Vaccine Could be Considered for

• Persons aged 15-70 who reside, work, or recreate
  in areas of high or moderate risk, but whose
  exposure exposure to tick infested habitat is not
  frequent or prolonged.

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Lyme Vaccine is Not Recommended for

• Persons lt15 years old
• Persons who reside, work or recreate in areas of
  high or moderate risk, but whose exposure to tick
  infested habitats is minimal or none
• Persons in areas of low or no risk
• Pregnant women
• Persons with a previous history of treatment
  resistant Lyme arthritis

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Question

• Which vaccines contain live virus?

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Meningococcal Infections

• Multiple serogroups - B and C most prevalent in
  US (45 each)
• Occurs most often in children lt5 yrs
• Rising number of outbreaks
• Outbreaks have occurred in semi-closed
  communities child care centers, schools,
  colleges, military recruit camps

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Meningococcal Disease

• 2,400-3,000 cases/yr in US
• mostly sporadic, outbreaks are lt3 of total
• rate of 0.8-1.3 cases per 100,000
• rates are highest for infants
• much of neonatal meningococcal dz is type B

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Meningococcal Vaccine

• Quadravalent polysaccharide vaccine against
  groups A, C, Y, and W-135 N meningitidis
• Not group B (poor immunogenicity)
• Single dose
• Recommended for age 2 years and older in high
  risk groups
• asplenia, travelers, outbreak control, military
  recruits

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Risk of Meningococcal Infection in College
Students Harrison et al., JAMA Vol. 281 No.
201906, May 26, 1999

• Maryland cases 1992-1997
• 67 cases aged 16-30
• 14 attended colleges (29 fatality)
• 10/12 cases where serogroup was known were due to
  vaccine serogroups
• Annual incidence not different between college
  and non college individuals
• Among college students, incidence significantly
  higher in on-campus vs off-campus housing 3.24 vs
  0.96 per 100,000)

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Meningococcal Disease - Rate per 100,000

• Children 2-5 1.7
• persons 18-23 1.4
• non-college 18-23 1.5
• college students 0.6
• freshmen college 1.8
• dorm residents 2.2
• freshmen in dorms 4.6

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39 wk AGA infant, 1 day old.Should you give
Hepatitis B Immunization?

• What is Moms Hep B status/risk?
• Do you have preservative free Hep B?

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Thimerosal

• Mercury containing preservative used in many
  vaccines since the 1930s
• FDA modernization act of 1997 called for FDA to
  review and assess the risk of all mercury
  containing foods and drugs
• No thimerosal in OPV, IPV, MMR, Hep A, Varicella,
  Lyme
• Some HIB, DTaP and Hep B products contain
  Thimerosal

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Thimerosal

• Previously, if infant received all thimerosal
  containing vaccines (worst case scenario) in the
  first six months, could have exceeded EPA and FDA
  standards
• No clinical evidence of mercury toxicity has been
  reported in vaccinated children
• Hep B now available thimerosal free

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Question

• Do parents prefer single visit with multiple
  injections or multiple visits?
• What is the maximum number of immunizations that
  can be given in one visit?

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Are there any new vaccines?
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Pediarix

• DTaP, IPV, HBV
• 2,4,6 months schedule
• HBV1 _at_ birth
• GSK Web Site
• Not indicated for booster doses
• Available VFC

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On the Horizon

• Live attenuated Influenza
• Adult acellular pertussis
• HPV
• Meningococcal conjugate
• S. aureus for dialysis patients

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How bout them PDAs

• Www.immunizationed.org

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Immunization Barriers - The Medical system

• Lack of Health Insurance
• Availability of Medical Services
• Vaccine Cost - Who is eligible for VFC?
• Age 0-18
• Medicaid enrolled
• Uninsured
• American Indian or Alaskan Native
• Physician factors

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Immunization Barriers - Provider Factors

• Missed opportunities
• Uncertainty among physicians regarding
  immunization practices
• Confusion about contraindications
• Physician attitudes
• Failure to administer immunizations simultaneously

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Inappropriate Withhold of Immunizations

• General
• Mild acute illness, temp lt101F
• Non-bloody diarrhea, well hydrated
• Allergic Rhinitis
• Prematurity
• Current use of Antibiotics
• PCN Allergy
• Recent exposure to infectious illness

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Inappropriate Withhold of Immunizations

• DTP/DTaP
• Previous fever lt105 to DTP
• Family History Seizures
• Waiting full two months when child behind
  schedule
• MMR
• Mom is pregnant

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Common Misconceptions

• Disease had already begun to disappear before
  vaccines were introduced, because of better
  hygiene and sanitation
• The majority of people who get disease have been
  vaccinated
• There are hot lots of vaccine that have been
  associated with more adverse events.

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Patient Barriers - Misconceptions

• Vaccines cause many harmful side effects,
  illnesses, and even death - not to mention
  possible long term effects we dont even know
  about
• Vaccine-preventable diseases have been virtually
  eliminated from the US so there is no need for my
  child to be vaccinated

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Patient Barriers - Misconceptions

• Giving a child multiple vaccinations for
  different diseases at the same time increases the
  risk of harmful side effects and can overload the
  immune system

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Question

• What is VAERS?

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Rotavirus Vaccine

• Licensed by FDA August 1998
• Rotavirus diarrhea (annual)
• 500,000 physician visits
• 50,000 hospitalizations
• 20 deaths
• Vaccine Efficacy
• 50-80 against all Rotavirus diarrhea
• 69-91 against severe Rotavirus diarrhea

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Rotavirus Vaccine and Intussusception

• In clinical trials .05 vs .02 (pNS) vaccine
  recipients vs placebo developed intussusception
• 3 studies looked at association of natural
  rotavirus infection with intussusception
• Two reported no association
• One reported an association

101
Rotavirus Vaccine and Intussusception

• As of July 7, 1999, 15 cases of intussusception
  following rotavirus vaccine reported via VAERS
• 12 of 15 within 7 days of vaccine
• 13 of 15 occurred after first dose of vaccine

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Rotavirus Vaccine and Intussusception

• Assume 1.5 million doses administered
• Baseline rate of intussusception 51/100,000
  infant years
• Expect 14-16 cases within 1 week of vaccine by
  chance alone
• very unlikely that all cases reported to VAERS

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Rotavirus Vaccine and Intussusception

• July 16, 1999
• temporary suspension of use of Rotavirus vaccine
  by the manufacturer, in consultation with FDA and
  CDC
• By Nov 99, 102 cases following Rotavirus vaccine
  reported to VAERS
• 57 with onset within 7 days of vaccine
• 29/57 had surgery, 7 bowel resection, 1 death

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Rotavirus Vaccine and Intussusception

• CDC case control study After one dose, rate of
  intussusception was increased 25 fold in the 3-7
  days following vaccination
• Studies from Kaiser N. CA also showed increased
  risk, especially in week following first dose

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Rotavirus Vaccine and Intussusception

• October 14, 1999 - Rotavirus vaccine withdrawn
  from the market 1 year after being licensed
• Did our system for licensing vaccines and
  monitoring safety post licensure succeed or
  fail?

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Combo Vaccines Being Developed

• DTaP-Hib
• used in Europe
• DTaP-HBV
• DTaP-IPV
• HAV-HBV
• DTaP-Hib-IPV

• DTaP-HBV-IPV
• Hib-HBV-IPV
• DTaP-Hib-IPV-HBV
• DTaP-Hib-IPV-HBV-HAV
• MMR-V

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Conclusion

• Good things arent always exciting
• Expand Varicella
• Expand Hepatitis A
• Pneumococcal Vaccine
• Consider Meningococcal Vaccine
• Use all opportunities