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Implementation of California’s Anti- thimerosal legislation Howard Backer, MD, MPH Chief, Immunization Branch California Department of Health Services.

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Presentation on theme: "Implementation of California’s Anti- thimerosal legislation Howard Backer, MD, MPH Chief, Immunization Branch California Department of Health Services."— Presentation transcript:

1 Implementation of California’s Anti- thimerosal legislation Howard Backer, MD, MPH Chief, Immunization Branch California Department of Health Services Immunization Branch

2 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch AB 2943 Chaptered 9/28/2004 Begins July 1, 2006 Begins July 1, 2006 Affects children under three and women who are “knowingly pregnant” Affects children under three and women who are “knowingly pregnant” Restricts thimerosal content Restricts thimerosal content Influenza vaccine: <1.0 microgram/0.5 mLInfluenza vaccine: <1.0 microgram/0.5 mL All other vaccines: < 0.5 microgram/0.5 mLAll other vaccines: < 0.5 microgram/0.5 mL

3 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch CA Thimerosal Legislation: Exemption 1. Secretary finds and Governor concurs 2. Vaccine needed for –Public health emergency –Shortage of supply 3. Up to 12 months with one extension 4. Notify legislature and justify 5. Notify “interested parties”

4 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Anti-thimerosal legislation status--2/2006 Enacted Enacted –CA –IL (applied for exemption) –IO Passed Passed –MO –NY –DE (awaiting Governor signing) Pending legislation: Pending legislation: CO FL MA MN NM NV NH NJ OR PA RI TN VT WA

5 You don’t want to know how sausages and laws are made. Chinese Fortune Cookie

6 CA Population estimates Group Population estimate Coverage estimate Doses needed Children 6-23 mo 781,00048.4%*378,000 Children 2-3 yrs 560,00018%**-- ? 40% 224,000 Pregnant women 600,00050% 13% † 45,000 * 2004 BRFSS, 6-23 mo only, at least one dose ** Gnansekaran SK, et al. Ambulatory Peds 2006 † † 2003 National Health Interview Survey-state estimates not available

7 Vaccine Current use < 3 yr old Current use pregnant women Alternate available DT, multidose vials (sanofi Pasteur) InfrequentNosingle-dose Td (Massachusetts PH) NoYes S-P product TT, multidose vials (sanofi Pasteur) rarerareNo Japanese Encephalitis (via sanofi Pasteur) rarerareNo MPSV4, multidose vials (sanofi Pasteur) infrequent in 2-3 yr rare single dose syringe and use of MCV4

8 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Sanofi Pasteur Production Production –6.5 million doses (0.25 ml-peds) –1.5 million doses (0.5 ml-adult) –Static until new plant opens in 2008 –50% pediatric doses in federal contract Unused doses last year Unused doses last year (40-45% coverage) Adult p-free might be late season Adult p-free might be late season

9 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch GSK Fluarix prefilled syringe (Dresden plant) Fluarix prefilled syringe (Dresden plant) –≤ 1.25 ug thimerosal/0.5 ml –Licensed ≥ 18 yrs of age (no change 2006) –2005-06 7.5 million doses to U.S. –2006-07 est. 7-9 million doses –No increase for few years ID Biomed (Canada plant) ID Biomed (Canada plant) –20-30 mil doses in multidose vials –Some p-free by 2008-09 Distributed to health care institutions Distributed to health care institutions

10 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Chiron 5 million doses of Fluvirin® individual syringe packaging 5 million doses of Fluvirin® individual syringe packaging –0.098 ug thimerosal/0.5 ml –Late season stockpile doses (after Oct 15) Begravac ® (p-free) available in Europe Begravac ® (p-free) available in Europe –Will not be approved in U.S. for 2006-07

11 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch MedImmune All doses p-free All doses p-free Not licensed 6 mos – 5 yrs for 2006-07 Not licensed 6 mos – 5 yrs for 2006-07 Not licensed for pregnant women Not licensed for pregnant women

12 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch CSL ltd Applying for license 2007-08 Applying for license 2007-08 Some pediatric p-free planned Some pediatric p-free planned

13 Influenza Vaccine PedsAdultDoses(Million)Availability Sanofi-Pasteur Fluzone® Fluzone®YY 6.5 peds 1.5 adult Late season Fluzone® Fluzone®NN Chiron Fluvirin® Fluvirin®NY5 Late season Fluvirin® Fluvirin®NN GSK Fluarix® Fluarix®NPossibly7-9 Contracted for institutions MedImmune FluMist® FluMist®NNN/A

14 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Limitations Production capacity--static Production capacity--static Licensure Licensure Distribution Distribution –Manufacturer policy does not favor states with anti-thimerosal legislation –Small practices not guaranteed access Timing of distribution Timing of distribution

15 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Unknowns Spill over effect: Spill over effect: public demand outside of target groups Effect of new child recommendations Effect of new child recommendations Provider referral to public health clinics Provider referral to public health clinics e.g., obstetricians Role of mass vaccinators Role of mass vaccinators Difficulty in obtaining exemption Difficulty in obtaining exemption Resistance from statute proponents Resistance from statute proponents

16 "Citing cost concerns and a potential shortfall …, the Illinois DPH filed for a 12-month exemption to the Mercury- Free Vaccine Act, passed last summer …. child-health-care advocates who lobbied for the bill's passage are upset by what they believe was a premeditated attempt by IDPH to circumvent state law." R. L. Nave, Illinois Times

17 … vaccines can be made without the mercury preservative, called thimerosal. You can take it out and still protect the health of American children through vaccination, and if you had a shred of doubt about its safety, surely you would. If you keep it in, you had better be right. Dan Olmsted, UPI Dan Olmsted, UPI

18 Too often we enjoy the comfort of opinion without the discomfort of thought. John F. Kennedy

19 Severe Influenza-associated Illness in Children CA 2003-06

20 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Influenza-associated excess hospitalizations—pregnant women Week Gestation Relative Risk 14-201.4 37-424.7 Neuzil KM, et al. Am J Epidemiol 1998

21 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Implementation Plan Letter to providers sent 2/1/2006 Letter to providers sent 2/1/2006 –Community vaccinators unaware of law Further evaluate supply options Further evaluate supply options Japanese Encephalitis Influenza vaccine Objectives Objectives –Protect providers –Assure vaccine availability to public Emphasize p-free use when available Emphasize p-free use when available

22 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Conclusion Influenza vaccine supply not stable Influenza vaccine supply not stable P-free supply will increase---slowly P-free supply will increase---slowly Need to increase influenza vaccine supply and threat of pandemic take precedence Need to increase influenza vaccine supply and threat of pandemic take precedence Thimerosal law creates shortage and anxiety for providers Thimerosal law creates shortage and anxiety for providers Fuels distribution debate Fuels distribution debate

23 Predictions are difficult, particularly when they involve the future. Yogi Berra

24 California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch California Department of Health Services Immunization Branch Acknowledgements Rob Schechter, MD, MPH Rob Schechter, MD, MPH Nisha Gandhi, MPH Nisha Gandhi, MPH

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