physicians’ webinar 2007: keeping track of pediatric vaccine issues

Physicians’ Webinar Physicians’ Webinar 2007:2007:

Keeping Track of Keeping Track of Pediatric Vaccine IssuesPediatric Vaccine Issues

May 15, 2007 12:30-1:30pm PTBrought to you by:

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Webinar ObjectivesWebinar Objectives1.1. List changes for 2007 in vaccine List changes for 2007 in vaccine

recommendations for children.recommendations for children.2.2. Identify current legislative proposals Identify current legislative proposals

in California related to immunizations.in California related to immunizations.3.3. Describe current challenges with Describe current challenges with

vaccine financing in California.vaccine financing in California.4.4. Have an opportunity to further discuss Have an opportunity to further discuss

any vaccine issues with the speakers.any vaccine issues with the speakers.

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Changing Pediatric Changing Pediatric Vaccination Vaccination

RecommendationsRecommendationsMay 15, 2007May 15, 2007

John Bradley MDJohn Bradley MDDivision of Infectious DiseasesDivision of Infectious DiseasesChildren’s Hospital San DiegoChildren’s Hospital San Diego

Update on Vaccine Update on Vaccine RecommendationsRecommendations

• What’s new with old, licensed What’s new with old, licensed vaccines?vaccines?– New Dosing RecommendationsNew Dosing Recommendations– New Safety DataNew Safety Data

• What new vaccines are coming? What new vaccines are coming?


• New Dosing Recommendations for New Dosing Recommendations for licensed vaccines:licensed vaccines:

– Varicella VaccineVaricella Vaccine– Hepatitis VaccineHepatitis Vaccine– Influenza VaccineInfluenza Vaccine


Varicella Zoster VirusVaricella Zoster Virus


• Varicella Virus VaccineVaricella Virus Vaccine– The second dose is now recommended The second dose is now recommended

(Early Release: April 9, 2007)(Early Release: April 9, 2007)– Rationale: About 15% of children do Rationale: About 15% of children do

not have a full “take” with the first not have a full “take” with the first dose, based on current gpELISA VZV dose, based on current gpELISA VZV serology assays. The second dose serology assays. The second dose gets us to > 99% seroprotectedgets us to > 99% seroprotected


• Varicella Virus VaccineVaricella Virus Vaccine– The first dose is still recommended at 12-The first dose is still recommended at 12-

15 months of age15 months of age– The second dose is now recommended at The second dose is now recommended at

4-6 years of age, but can be given 3 4-6 years of age, but can be given 3 months after the first dosemonths after the first dose

– For teenagers ≥ 13 years of age (and For teenagers ≥ 13 years of age (and adults up to 65 years of age), the second adults up to 65 years of age), the second dose may be provided 28 days after the dose may be provided 28 days after the first dosefirst dose


• Varicella Virus VaccineVaricella Virus Vaccine– Risk of Breakthrough Varicella Risk of Breakthrough Varicella

when observed for 10 years post when observed for 10 years post vaccine:vaccine:

–7.3% with 1 dose7.3% with 1 dose–2.2% with 2 doses2.2% with 2 doses

P < .001P < .001


• Varicella Virus VaccineVaricella Virus Vaccine– Current problems with unexpectedly Current problems with unexpectedly

low yield of cultured vaccine virus low yield of cultured vaccine virus from human diploid MRC-5 cellsfrom human diploid MRC-5 cells

– ProQuad takes about 7-8 X more ProQuad takes about 7-8 X more virus, per dose than Varivax, virus, per dose than Varivax, therefore ProQuad will not be therefore ProQuad will not be manufactured until the problem is manufactured until the problem is solvedsolved

– No anticipated shortage of VarivaxNo anticipated shortage of Varivax


Hepatitis A VirusHepatitis A Virus


• Hepatitis A virus vaccineHepatitis A virus vaccine– Both Vaqta® and Havrix® are FDA-Both Vaqta® and Havrix® are FDA-

licensed for children down to 12 licensed for children down to 12 months of agemonths of age

– On April 9, 2007 (Early Release from On April 9, 2007 (Early Release from the AAP) the recommended age for the AAP) the recommended age for routine immunization has been routine immunization has been lowered from 24 months of age, to 12 lowered from 24 months of age, to 12 months of agemonths of age


• Hepatitis A virus vaccineHepatitis A virus vaccine– Two doses are still recommendedTwo doses are still recommended– The second dose can be provided with The second dose can be provided with

either vaccineeither vaccine– Protection lasts at least 10 years, and Protection lasts at least 10 years, and

possibly more than 25 yearspossibly more than 25 years


Hepatitis A cases in Israel Hepatitis A cases in Israel following universal following universal immunization at 18 and 24 immunization at 18 and 24 months of age.months of age.

Dagan et al. PIDJ 2007Dagan et al. PIDJ 2007


Influenza VirusInfluenza Virus


• Influenza Vaccine for 2006-7 season:Influenza Vaccine for 2006-7 season:– Routine immunization of ALL children up Routine immunization of ALL children up

to 59 months of age (no longer just high to 59 months of age (no longer just high risk children 24 - 59 months of age)risk children 24 - 59 months of age)

– Published data document increased Published data document increased hospitalization rates in children under 5 hospitalization rates in children under 5 years, compared with those ≥ 5 years years, compared with those ≥ 5 years

Influenza Virus Vaccine (TIV)Influenza Virus Vaccine (TIV)

ACIP Recommendations for 2006-7 Season. ACIP Recommendations for 2006-7 Season. MMWR MMWR


• Influenza Virus VaccineInfluenza Virus Vaccine– Immunization is now recommended for Immunization is now recommended for

all care-providers of all children less all care-providers of all children less than 5 years of age, all high risk than 5 years of age, all high risk children, and particularly all children children, and particularly all children less than 6 months of age (not less than 6 months of age (not candidates for either vaccine or for candidates for either vaccine or for antiviral therapy)antiviral therapy)


• Influenza Virus Vaccine (TIV)Influenza Virus Vaccine (TIV)– For children under 9 years of age, who For children under 9 years of age, who

usually get two doses of vaccine the usually get two doses of vaccine the first year that they receive TIV:first year that they receive TIV:•If they only got one of two doses If they only got one of two doses during the prior season, then the during the prior season, then the following fall they need TWO doses, following fall they need TWO doses, not just one, to get optimal not just one, to get optimal responses responses

Influenza Influenza Virus Vaccine Virus Vaccine

(TIV)(TIV)

COID, Pediatrics April COID, Pediatrics April 20072007

Influenza Virus Vaccine (TIV)Influenza Virus Vaccine (TIV)

Walter EB et al. Pediatrics Walter EB et al. Pediatrics 2006;118:e570 2006;118:e570


• Influenza immunization is now Influenza immunization is now recommended for all susceptible recommended for all susceptible children THROUGHOUT the flu season, up children THROUGHOUT the flu season, up until May 1until May 1stst

1976-2006:1976-2006:Percentage Percentage

of years with of years with peak peak

activity, by activity, by month month

MayMay

Update on Vaccine SafetyUpdate on Vaccine Safety

• Menactra and Guillain-Barre SyndromeMenactra and Guillain-Barre Syndrome– Ongoing surveillance has failed to detect a Ongoing surveillance has failed to detect a

statistically significant association at this statistically significant association at this time, but the CDC is still collecting data time, but the CDC is still collecting data

– When age groups are examined separately:When age groups are examined separately:•No increase at all in 11-14 year oldsNo increase at all in 11-14 year olds•Possible increase in 15-18 year olds, but Possible increase in 15-18 year olds, but not yet statistically significantnot yet statistically significant


• Menactra and Guillain-Barre SyndromeMenactra and Guillain-Barre Syndrome– The current GBS rate appears to be just The current GBS rate appears to be just

under 1 case per million doses of Menactraunder 1 case per million doses of Menactra– In the same cohort, Menactra will save 5 In the same cohort, Menactra will save 5

lives vs unvaccinated childrenlives vs unvaccinated children– The CDC and AAP believe that the The CDC and AAP believe that the

POSSIBLE risk is more than offset by the POSSIBLE risk is more than offset by the documented benefit in prevention of documented benefit in prevention of infectioninfection


• RotaTeq and IntussusceptionRotaTeq and Intussusception– There was no increase in reported There was no increase in reported

intussusception post-licensure of RotaTeqintussusception post-licensure of RotaTeq– The CDC just wanted to remind everyone The CDC just wanted to remind everyone

that they needed to report intussusception!that they needed to report intussusception!•With extra reporting, there is STILL no With extra reporting, there is STILL no increase in a “signal” for intussusceptionincrease in a “signal” for intussusception

•Most cases are more than 3-4 weeks after Most cases are more than 3-4 weeks after immunization with this vaccineimmunization with this vaccine

Vaccine RecommendationsVaccine RecommendationsWhat to Expect in Fall 2007What to Expect in Fall 2007

• Pentacel® (Sanofi Pasteur, DTaP-IPV-Pentacel® (Sanofi Pasteur, DTaP-IPV-HiB) submitted data to the FDA for HiB) submitted data to the FDA for licensure; hope to market by this falllicensure; hope to market by this fall

• MedImmune has submitted data to MedImmune has submitted data to the FDA to drop the age for FluMist® the FDA to drop the age for FluMist® down to 1 year (for children with no down to 1 year (for children with no history of wheezing). FluMist history of wheezing). FluMist prevents slightly more complications prevents slightly more complications than TIVthan TIV

Vaccine RecommendationsVaccine Recommendations

• Change is constantChange is constant• More vaccines are on the way More vaccines are on the way

(currently in early clinical trials)(currently in early clinical trials)• The costs of vaccination just keep The costs of vaccination just keep

going up and up!going up and up!• Mark Sawyer will figure out how Mark Sawyer will figure out how

everyone will be able to get everyone will be able to get reimbursed for all these vaccines reimbursed for all these vaccines

Vaccine Financing and Vaccine Financing and LegislationLegislation

Mark H. Sawyer MDMark H. Sawyer MDUCSD School of MedicineUCSD School of Medicine

Rady Children’s Hospital San Rady Children’s Hospital San DiegoDiego

In Need of a Booster Shot; Rising In Need of a Booster Shot; Rising Costs Make Doctors Balk at Costs Make Doctors Balk at Giving Vaccines Giving Vaccines

By ANDREW POLLACK By ANDREW POLLACK Published: New York Times; March 24, Published: New York Times; March 24,

20072007

Vaccine Financing CrisisVaccine Financing CrisisWhy Now?Why Now?

• Cost of vaccinesCost of vaccines– Cost of the vaccine itselfCost of the vaccine itself– Cost to handle and store the vaccineCost to handle and store the vaccine– Cost to administer the vaccineCost to administer the vaccine

• Private sector manufacturingPrivate sector manufacturing• Both private and public sources of Both private and public sources of

funding for vaccines are threatenedfunding for vaccines are threatened• Growing discrepancy between statesGrowing discrepancy between states

Federal Contract Prices for Vaccines Recommended Federal Contract Prices for Vaccines Recommended Universally for Universally for

Children and Adolescents 1985, 1995, 2006Children and Adolescents 1985, 1995, 2006

$0

$200

$400

$600

$800

$1,000

$1,200

$1,400

1985 1995 2006 est.

Dol

lars

3 HPV3 RV2 Hep A1 Mening1 Td/ Tdap4 PCV76 Influenza 2 Var2-3 Hep B3-4 Hib1-2 MMR4 Polio5 DTaP

Federal contract price shown for 1985 and 1995 are averages that account for price changes within that year.

The 2006 estimated contract prices do not include HPV vaccine, because there is not a federal contract at this time . The catalog price for HPV vaccine is $360 for the 3-dose series.

Adapted from CDC, Unpublished DataCurrent as of November 20, 2006

$45$155

$1182

317 Immunization

Grants 6%

Vaccines for Children (VFC)

43%State

5%

Private Sector46%

Childhood Vaccine Doses Childhood Vaccine Doses Distributed by Funding SourceDistributed by Funding Source

Calendar Year 2005Calendar Year 2005

Source: Vaccine manufacturers Biologics Surveillance Data 2005

Note: Does not include influenza vaccine

CDC, Unpublished Data

Insurance Coverage Insurance Coverage Adolescent Age 11-15 Years OldAdolescent Age 11-15 Years Old

85.2%

14.3%

0.0%0.5%

75.9%

23.2%

0.2%0.7%0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

Health Dental

YesNoDon't KnowMissing

n = 582

San Diego County HHSA, RDD

Cost of Storage and Cost of Storage and HandlingHandling

• Equipment: refrigerator/freezer, Equipment: refrigerator/freezer, temperature monitoring devicestemperature monitoring devices

• Up front purchase costsUp front purchase costs• Labor costs to order, track, Labor costs to order, track,

maintain supplymaintain supply• Backup power Backup power • Insurance for inventoryInsurance for inventory

Costs of vaccine Costs of vaccine administrationadministration

• Personnel time: Personnel time: administration, documentationadministration, documentation

• SuppliesSupplies

Medicaid Fee-For-Service Medicaid Fee-For-Service Vaccine Administration Fee Vaccine Administration Fee

by State, 2005by State, 2005

$0

$2

$4

$6

$8

$10

$12

$14

$16

$18

CMS ContributionState ContributionMaximum Cap

State contribution

CMSmatch

CMScap

Vaccine Cost and Vaccine Cost and ReimbursementReimbursement

Potential solutionsPotential solutions• Standards for reimbursement/Achieve equity in Standards for reimbursement/Achieve equity in

Medicaid reimbursement asMedicaid reimbursement as• Universal purchase by states or federal Universal purchase by states or federal

governmentgovernment• Broaden use of VFC vaccine for underinsuredBroaden use of VFC vaccine for underinsured• Work with manufacturers to achieve more Work with manufacturers to achieve more

favorable terms for payment for vaccinesfavorable terms for payment for vaccines• Adequate incentives for pharmaceutical Adequate incentives for pharmaceutical

companies to get into the vaccine businesscompanies to get into the vaccine business

Vaccine Cost and Vaccine Cost and ReimbursementReimbursement

Potential solutionsPotential solutions• Legislation to mandate adequate Legislation to mandate adequate

reimbursement for vaccinesreimbursement for vaccines• Legislation to make managed Legislation to make managed

care organizations responsible care organizations responsible for verifying eligibility for verifying eligibility

• Larger healthcare reform Larger healthcare reform packagespackages

Vaccine Financing ReformVaccine Financing ReformNeedsNeeds

• Good data on true vaccine Good data on true vaccine administration costsadministration costs

• Stabilization of public funding, Stabilization of public funding, including for adultsincluding for adults

• Eliminate underinsured Eliminate underinsured patientspatients

It’s the LawIt’s the LawRecent vaccine related Recent vaccine related

laws in Californialaws in California• Healthplan mandate to cover ACIP Healthplan mandate to cover ACIP

approved vaccinesapproved vaccines• Thimerosal prohibition for children < Thimerosal prohibition for children <

3 years of age and pregnant women3 years of age and pregnant women• Influenza vaccine required for Influenza vaccine required for

hospital-based healthcare workershospital-based healthcare workers• Influenza vaccine for residents of Influenza vaccine for residents of

long term care facilitieslong term care facilities

It might become the lawIt might become the lawProposed Vaccine Proposed Vaccine

Legislation in California Legislation in California 20072007• SB 676 (sponsored by AAP/C3I)SB 676 (sponsored by AAP/C3I)

– Requires Tdap for middle school entryRequires Tdap for middle school entry– Changes process for establishing future school Changes process for establishing future school

entry requirementsentry requirements• AB 16AB 16

– Requires all ACIP approved vaccines for middle Requires all ACIP approved vaccines for middle school entry after 5 yearsschool entry after 5 years

• SB 533SB 533– Requires conjugated pneumococcal vaccine for Requires conjugated pneumococcal vaccine for

day care day care • AB 106AB 106

– Must offer influenza and pneumococcal vaccine to Must offer influenza and pneumococcal vaccine to hospitalized seniorshospitalized seniors

Get InvolvedGet Involved• AAP, Chapter 3AAP, Chapter 3

– State Government Affairs State Government Affairs Representatives: Representatives:

• Mark Sawyer Mark Sawyer ([email protected])([email protected])

• Nancy Graff (ngraff Nancy Graff (ngraff @ucsd.edu)@ucsd.edu)

• Infant Immunization Infant Immunization Initiative (I3) of San DiegoInitiative (I3) of San Diego

• California Medical California Medical AssociationAssociation

• Follow the legislation Follow the legislation (http://www.leginfo.ca.gov(http://www.leginfo.ca.gov))

• Contact your state Contact your state legislatorslegislators

Your Questions?Your Questions?

Question & Answer Question & Answer SessionSession

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This webinar will be available until June This webinar will be available until June 15, 2007 for continuing education 15, 2007 for continuing education

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physicians’ webinar 2007: keeping track of pediatric vaccine issues

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