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?
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• New Dosing Recommendations for New Dosing Recommendations for licensed vaccines:licensed vaccines:
– Varicella VaccineVaricella Vaccine– Hepatitis VaccineHepatitis Vaccine– Influenza VaccineInfluenza Vaccine
Update on Vaccine Update on Vaccine RecommendationsRecommendations
Varicella Zoster VirusVaricella Zoster Virus
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
Hepatitis A VirusHepatitis A Virus
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
Influenza VirusInfluenza Virus
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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)
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine Update on Vaccine RecommendationsRecommendations
• 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
Update on Vaccine SafetyUpdate on Vaccine Safety
• 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
Update on Vaccine SafetyUpdate on Vaccine Safety
• 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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