Physicians’ Webinar 2007:Keeping Track of Pediatric Vaccine Issues May 15, 2007 12:30-1:30pm PT Brought to you by:
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Webinar Objectives • List changes for 2007 in vaccine recommendations for children. • Identify current legislative proposals in California related to immunizations. • Describe current challenges with vaccine financing in California. • Have an opportunity to further discuss any vaccine issues with the speakers.
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Changing Pediatric Vaccination Recommendations May 15, 2007 John Bradley MD Division of Infectious Diseases Children’s Hospital San Diego
Update on Vaccine Recommendations • What’s new with old, licensed vaccines? • New Dosing Recommendations • New Safety Data • What new vaccines are coming?
Update on Vaccine Recommendations • New Dosing Recommendations for licensed vaccines: • Varicella Vaccine • Hepatitis Vaccine • Influenza Vaccine
Update on Vaccine Recommendations Varicella Zoster Virus
Update on Vaccine Recommendations • Varicella Virus Vaccine • The second dose is now recommended (Early Release: April 9, 2007) • Rationale: About 15% of children do not have a full “take” with the first dose, based on current gpELISA VZV serology assays. The second dose gets us to > 99% seroprotected
Update on Vaccine Recommendations • Varicella Virus Vaccine • The first dose is still recommended at 12-15 months of age • The second dose is now recommended at 4-6 years of age, but can be given 3 months after the first dose • For teenagers ≥ 13 years of age (and adults up to 65 years of age), the second dose may be provided 28 days after the first dose
Update on Vaccine Recommendations • Varicella Virus Vaccine • Risk of Breakthrough Varicella when observed for 10 years post vaccine: • 7.3% with 1 dose • 2.2% with 2 doses P < .001
Update on Vaccine Recommendations • Varicella Virus Vaccine • Current problems with unexpectedly low yield of cultured vaccine virus from human diploid MRC-5 cells • ProQuad takes about 7-8 X more virus, per dose than Varivax, therefore ProQuad will not be manufactured until the problem is solved • No anticipated shortage of Varivax
Update on Vaccine Recommendations Hepatitis A Virus
Update on Vaccine Recommendations • Hepatitis A virus vaccine • Both Vaqta® and Havrix® are FDA-licensed for children down to 12 months of age • On April 9, 2007 (Early Release from the AAP) the recommended age for routine immunization has been lowered from 24 months of age, to 12 months of age
Update on Vaccine Recommendations • Hepatitis A virus vaccine • Two doses are still recommended • The second dose can be provided with either vaccine • Protection lasts at least 10 years, and possibly more than 25 years
Update on Vaccine Recommendations Hepatitis A cases in Israel following universal immunization at 18 and 24 months of age. Dagan et al. PIDJ 2007
Update on Vaccine Recommendations Influenza Virus
Update on Vaccine Recommendations • Influenza Vaccine for 2006-7 season: • Routine immunization of ALL children up to 59 months of age (no longer just high risk children 24 - 59 months of age) • Published data document increased hospitalization rates in children under 5 years, compared with those ≥ 5 years
Influenza Virus Vaccine (TIV) ACIP Recommendations for 2006-7 Season. MMWR
Update on Vaccine Recommendations • Influenza Virus Vaccine • Immunization is now recommended for all care-providers of all children less than 5 years of age, all high risk children, and particularly all children less than 6 months of age (not candidates for either vaccine or for antiviral therapy)
Update on Vaccine Recommendations • Influenza Virus Vaccine (TIV) • For children under 9 years of age, who usually get two doses of vaccine the first year that they receive TIV: • If they only got one of two doses during the prior season, then the following fall they need TWO doses, not just one, to get optimal responses
Influenza Virus Vaccine (TIV) COID, Pediatrics April 2007
Influenza Virus Vaccine (TIV) Walter EB et al. Pediatrics 2006;118:e570
Update on Vaccine Recommendations • Influenza immunization is now recommended for all susceptible children THROUGHOUT the flu season, up until May 1st 1976-2006:Percentage of years with peak activity, by month May
Update on Vaccine Safety • Menactra and Guillain-Barre Syndrome • Ongoing surveillance has failed to detect a statistically significant association at this time, but the CDC is still collecting data • When age groups are examined separately: • No increase at all in 11-14 year olds • Possible increase in 15-18 year olds, but not yet statistically significant
Update on Vaccine Safety • Menactra and Guillain-Barre Syndrome • The current GBS rate appears to be just under 1 case per million doses of Menactra • In the same cohort, Menactra will save 5 lives vs unvaccinated children • The CDC and AAP believe that the POSSIBLE risk is more than offset by the documented benefit in prevention of infection
Update on Vaccine Safety • RotaTeq and Intussusception • There was no increase in reported intussusception post-licensure of RotaTeq • The CDC just wanted to remind everyone that they needed to report intussusception! • With extra reporting, there is STILL no increase in a “signal” for intussusception • Most cases are more than 3-4 weeks after immunization with this vaccine
Vaccine RecommendationsWhat to Expect in Fall 2007 • Pentacel® (Sanofi Pasteur, DTaP-IPV-HiB) submitted data to the FDA for licensure; hope to market by this fall • MedImmune has submitted data to the FDA to drop the age for FluMist® down to 1 year (for children with no history of wheezing). FluMist prevents slightly more complications than TIV
Vaccine Recommendations • Change is constant • More vaccines are on the way (currently in early clinical trials) • The costs of vaccination just keep going up and up! • Mark Sawyer will figure out how everyone will be able to get reimbursed for all these vaccines
Vaccine Financing and Legislation Mark H. Sawyer MD UCSD School of Medicine Rady Children’s Hospital San Diego
In Need of a Booster Shot; Rising Costs Make Doctors Balk at Giving Vaccines By ANDREW POLLACK Published: New York Times; March 24, 2007
Vaccine Financing CrisisWhy Now? • Cost of vaccines • Cost of the vaccine itself • Cost to handle and store the vaccine • Cost to administer the vaccine • Private sector manufacturing • Both private and public sources of funding for vaccines are threatened • Growing discrepancy between states
Federal Contract Prices for Vaccines Recommended Universally for Children and Adolescents 1985, 1995, 2006 $1182 $155 $45 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 Data Current as of November 20, 2006
Childhood Vaccine Doses Distributed by Funding SourceCalendar Year 2005 Source: Vaccine manufacturers Biologics Surveillance Data 2005 Note: Does not include influenza vaccine CDC, Unpublished Data
Insurance Coverage Adolescent Age 11-15 Years Old n = 582 San Diego County HHSA, RDD
Cost of Storage and Handling • Equipment: refrigerator/freezer, temperature monitoring devices • Up front purchase costs • Labor costs to order, track, maintain supply • Backup power • Insurance for inventory
Costs of vaccine administration • Personnel time: administration, documentation • Supplies
Medicaid Fee-For-Service Vaccine Administration Fee by State, 2005 CMS cap CMS match State contribution
Vaccine Cost and ReimbursementPotential solutions • Standards for reimbursement/Achieve equity in Medicaid reimbursement as • Universal purchase by states or federal government • Broaden use of VFC vaccine for underinsured • Work with manufacturers to achieve more favorable terms for payment for vaccines • Adequate incentives for pharmaceutical companies to get into the vaccine business
Vaccine Cost and ReimbursementPotential solutions • Legislation to mandate adequate reimbursement for vaccines • Legislation to make managed care organizations responsible for verifying eligibility • Larger healthcare reform packages
Vaccine Financing ReformNeeds • Good data on true vaccine administration costs • Stabilization of public funding, including for adults • Eliminate underinsured patients
It’s the LawRecent vaccine related laws in California • Healthplan mandate to cover ACIP approved vaccines • Thimerosal prohibition for children < 3 years of age and pregnant women • Influenza vaccine required for hospital-based healthcare workers • Influenza vaccine for residents of long term care facilities
It might become the lawProposed Vaccine Legislation in California 2007 • SB 676 (sponsored by AAP/C3I) • Requires Tdap for middle school entry • Changes process for establishing future school entry requirements • AB 16 • Requires all ACIP approved vaccines for middle school entry after 5 years • SB 533 • Requires conjugated pneumococcal vaccine for day care • AB 106 • Must offer influenza and pneumococcal vaccine to hospitalized seniors
AAP, Chapter 3 State Government Affairs Representatives: Mark Sawyer (email@example.com) Nancy Graff (ngraff @ucsd.edu) Infant Immunization Initiative (I3) of San Diego California Medical Association Follow the legislation (http://www.leginfo.ca.gov) Contact your state legislators Get Involved
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This webinar will be available until June 15, 2007 for continuing education credit. The link to the archive will be found at www.sdiz.org. Thank you for your participation!