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PCV13 Program Implementation National Immunization Conference Atlanta, Georgia April 21, 2010 Andrew Kroger, MD Abigail Shefer, MD Associate Director for.

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Presentation on theme: "PCV13 Program Implementation National Immunization Conference Atlanta, Georgia April 21, 2010 Andrew Kroger, MD Abigail Shefer, MD Associate Director for."— Presentation transcript:

1 PCV13 Program Implementation National Immunization Conference Atlanta, Georgia April 21, 2010 Andrew Kroger, MD Abigail Shefer, MD Associate Director for Science, ISD

2 Outline  Implementation  Challenges  Communication and educational materials  Monitoring uptake and evaluation activities

3 ImplementationImplementation

4 Implementation  Inventory management  Licensure and recommendations  Logistics of implementation

5 Inventory management  Worked with state immunization programs to prepare for PCV13 transition – Inventory of PCV7 brought down to ~3 weeks in state McKesson depots – Effort to minimize wastage of PCV7  Letter to Grantees – Dec 2009 and Jan 2010 – Place smaller more frequent orders – Communicate with providers

6 Schedule of events  Feb 24 - PCV13 licensed (same day as ACIP meeting)  Feb 24 – ACIP meeting and vote to recommend PV13  March 3 – Posting of provisional recs  March 12 – ACIP recs published in MMWR

7 The purpose of this resolution is to reflect the replacement of the seven valent pneumococcal conjugate vaccine (PCV7) with the thirteen valent conjugate vaccine (PCV13). Note: Until the transition between seven valent pneumococcal conjugate vaccine (PCV7) and thirteen valent pneumococcal conjugate vaccine (PCV13) is complete and providers have sufficient supplies of thirteen valent pneumococcal conjugate vaccine in their offices to meet demand among VFC eligible children, the VFC program will continue to include seven valent pneumococcal conjugate vaccine and the schedule provided in VFC resolution 2/09-1 should be followed for administration of PCV7 during that time. VFC resolution 2/09-1 is repealed and replaced by the following: The purpose of this resolution is to reflect the replacement of the seven valent pneumococcal conjugate vaccine (PCV7) with the thirteen valent conjugate vaccine (PCV13). Note: Until the transition between seven valent pneumococcal conjugate vaccine (PCV7) and thirteen valent pneumococcal conjugate vaccine (PCV13) is complete and providers have sufficient supplies of thirteen valent pneumococcal conjugate vaccine in their offices to meet demand among VFC eligible children, the VFC program will continue to include seven valent pneumococcal conjugate vaccine and the schedule provided in VFC resolution 2/09-1 should be followed for administration of PCV7 during that time. VFC resolution 2/09-1 is repealed and replaced by the following: VFC Resolution

8 Vaccine distribution and use  Private – orders started being shipped 3/15 – Pfizer accepting returns for PCV7, even for partial returns  Public – contract negotiations completed within 2 weeks and available for ordering 3/18 – McKesson inventory – swap out PCV13 for PCV7 and pay difference – Providers should contact their state immunization programs for guidance on returns of PCV7 vaccine purchased with public funds – In order to receive credit, all unused PCV7 must be returned to McKesson by May 10  CDC policy on two directional borrowing between VFC and private stock vaccine

9 Can a provider borrow between private stock and VFC stock of PCV13? *  According to CDC’s policy on two directional borrowing between VFC and private stock vaccine, CDC allows borrowing of VFC vaccine to be administered to non-VFC eligible patients in limited circumstances due to an unexpected lack of private stock vaccine. Providers are required to document these situations and also situations when it is necessary to borrow from private stock due to lack of VFC vaccine. The practice is not allowed in all states and providers should check with their state immunization or VFC program office * Guidance sent out to Grantees Oct 2009 and posted on VFC website

10 Highlights of implementation recommendations  PCV13 preferred if both available in provider office  Don’t discard your PCV7 doses until supplies are fully transitioned  Give PCV7 if that is only pneumococcal conjugate vaccine in office and child is indicated  Supplemental dose should be given at next medical visit (no active recall)  Supplies of PCV13 should be adequate to allow providers to implement routine and supplemental doses

11 ChallengesChallenges

12 Challenges  Active recall not required but providers still need to identify children for supplemental doses of PCV13 during medical visits – Strategies to reduce missed opportunities may include provider reminders and flagging charts during office visits  Communicating with parents – Emphasizing that PCV13 provides ‘additional ‘ protection but that PCV7 was not an ineffective vaccine  Provider office with PCV13 in stock for private pay children before VFC doses available  Because of cost difference, anecdotal reports that private providers are keeping their PCV7 to use until supply gone before ordering PCV13

13 Communication and Educational Materials

14 Educational resources  Q & A for parents: April 2010 http://www.cdc.gov/vaccines/vpd- vac/pneumo/vac-faqs.htm http://www.cdc.gov/vaccines/vpd- vac/pneumo/vac-faqs.htm  Q & A for providers: April 2010 http://www.cdc.gov/vaccines/vpd- vac/pneumo/vac-PCV13-hcp-faqs.htm http://www.cdc.gov/vaccines/vpd- vac/pneumo/vac-PCV13-hcp-faqs.htm  Podcast – “New & Improved Vaccine” http://www2c.cdc.gov/podcasts/player.as p?f=1067365 http://www2c.cdc.gov/podcasts/player.as p?f=1067365

15 Monitoring uptake and evaluation activities

16 Monitoring uptake  National Immunization survey – gold standard to monitor uptake of vaccines – ~23,000 households/year used in analyses – Jan 2010 - PCV13 added to provider IHQ (Immunization History questionnaire) so able to identify PCV7 and PCV13 ; ability to capture up to 6 pneumococcal-containing doses (likely that high risk kids might get up to 6 doses) – Describe uptake by provider type, VFC status, income, etc…  Programmatic indicator of uptake – Number of doses PCV13 purchased off the CDC Federal contract – Baseline (Jan –March 2010 (Q2) – Monitor increase for Q4 (expect increase because of supplemental dose)

17 Evaluation Activities  Early uptake and transition to PCV13 – IIS analysis (Fall 2010)  Provider attitudes/practices, barriers – Survey (Fall 2010)  Vaccine Effectiveness – EIP sites (Spring 2011)

18 Evaluation Activities  Uptake and transition to PCV13 – CVX codes incorporated into IIS so that PCV13 can be distinguished from PCV7 – Sentinel IIS site analysis - Fall 2010  AZ, CO, MI, MN, ND, NYC, OR, WI  Earliest window into PCV13 uptake  Provider attitudes, practices, barriers – Sentinel physician (Peds/FP) and Program managers survey - Fall 2010 – Describe pattern of PCV7 and PCV13 administration by public/private, provider type, identify barriers and facilitators of transition

19 Links for CDC resources  http://www.cdc.gov/vaccines/vpd- vac/pneumo/default.htm http://www.cdc.gov/vaccines/vpd- vac/pneumo/default.htm http://www.cdc.gov/vaccines/vpd- vac/pneumo/default.htm  http://www.cdc.gov/vaccines/vpd-vac/pneumo/in- short-both.htm http://www.cdc.gov/vaccines/vpd-vac/pneumo/in- short-both.htm http://www.cdc.gov/vaccines/vpd-vac/pneumo/in- short-both.htm  http://www.cdc.gov/vaccines/vpd-vac/pneumo/vac- faqs.htm http://www.cdc.gov/vaccines/vpd-vac/pneumo/vac- faqs.htm http://www.cdc.gov/vaccines/vpd-vac/pneumo/vac- faqs.htm  http://www.cdc.gov/vaccines/vpd-vac/pneumo/dis- faqs.htm http://www.cdc.gov/vaccines/vpd-vac/pneumo/dis- faqs.htm http://www.cdc.gov/vaccines/vpd-vac/pneumo/dis- faqs.htm

20 Acknowledgements  PCV13 Vaccine Implementation WG – Jeanne Santoli – Pekka Nuorti – Matt Moore – Carolyn Grace Davis – Joyalyn Hill – Andrew Kroger – Bill Atkinson – Mary McCauley – Allison Patti

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