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Influenza Vaccine Supply 2005-06: Issues and Opportunities Raymond A. Strikas, M.D. National...
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Transcript of Influenza Vaccine Supply 2005-06: Issues and Opportunities Raymond A. Strikas, M.D. National...
Influenza Vaccine Supply 2005-06:
Issues and Opportunities
Influenza Vaccine Supply 2005-06:
Issues and Opportunities
Raymond A. Strikas, M.D.Raymond A. Strikas, M.D.
National Immunization ProgramNational Immunization Program
Coordinating Center for Infectious DiseasesCoordinating Center for Infectious Diseases
Centers for Disease Control and PreventionCenters for Disease Control and Prevention
November 29, 2005November 29, 2005
Planning for the 2005-2006 Planning for the 2005-2006 Influenza SeasonInfluenza Season
Key Planning StakeholdersKey Planning Stakeholders
DHHS (NVPO, CDC, FDA, CMS … )DHHS (NVPO, CDC, FDA, CMS … )
State and local health officialsState and local health officials
National Influenza Vaccine SummitNational Influenza Vaccine Summit
Influenza vaccine manufacturersInfluenza vaccine manufacturers
Supply-Based Scenarios Supply-Based Scenarios 2005-062005-06
ScenarioScenario Total Total dosesdoses
LikelihoodLikelihood ActionsActions
BaseBase 63-71M63-71M ModerateModerate Tough it out—no INDTough it out—no INDDual pre-bookDual pre-bookDual distributionDual distributionPrioritize vaccinePrioritize vaccine
BestBest >> 71M>> 71M Most likelyMost likely Promote vaccine usePromote vaccine use
WorstWorst << 63M<< 63M UnlikelyUnlikely Prioritize vaccinePrioritize vaccineActivate insurance Activate insurance policypolicyConsider IND vaccineConsider IND vaccine
Prioritization Recommendation Prioritization Recommendation DevelopmentDevelopment
Last season, priorities developed in an Last season, priorities developed in an emergency ACIP sessionemergency ACIP session
ACIP Influenza Working Group met in ACIP Influenza Working Group met in January to sub-prioritize for next seasonJanuary to sub-prioritize for next season– Four work groupsFour work groups
Disease impact (Kathy Neuzil Lead)Disease impact (Kathy Neuzil Lead) Disease reduction from vaccination (Kristin Nichol Lead)Disease reduction from vaccination (Kristin Nichol Lead) Herd Immunity (Arnold Monto Lead)Herd Immunity (Arnold Monto Lead) Economic aspects (Lisa Prosser Lead)Economic aspects (Lisa Prosser Lead)
ACIP approved the sub-prioritization ACIP approved the sub-prioritization recommendations in Februaryrecommendations in February
ACIP Priority Groups for Influenza Vaccination, ACIP Priority Groups for Influenza Vaccination, 2005-062005-06
1a: <20 million persons1a: <20 million persons
>65 years with medical >65 years with medical conditionsconditions
Nursing home residentsNursing home residents
1b: ~70 million persons1b: ~70 million persons
Persons 2-64 years with Persons 2-64 years with high risk conditionshigh risk conditionsPregnant womenPregnant womenPersons without high risk Persons without high risk conditions conditions >>65 years65 yearsChildren 6-23 months oldChildren 6-23 months old
1c: ~12 million persons1c: ~12 million persons
Health care workersHealth care workers
Close contacts to Close contacts to children <6 months of agechildren <6 months of age
2: ~98 million persons2: ~98 million personsContacts of all other high risk personsContacts of all other high risk persons
Healthy persons 50-64 yearsHealthy persons 50-64 years
3: ~96 million persons3: ~96 million persons
Healthy persons 2-49 years of age (everybody else)Healthy persons 2-49 years of age (everybody else)
Two-Tiered TIV Pre-BookingTwo-Tiered TIV Pre-Booking
Proposed by sanofi pasteurProposed by sanofi pasteur
Request # doses for targeted groups Request # doses for targeted groups and total # of doses to purchase and total # of doses to purchase
Designed to allow public health Designed to allow public health considerations into vaccine salesconsiderations into vaccine sales
Vaccine DistributionVaccine Distribution
Predominant strategy has been multiple Predominant strategy has been multiple shipments of partial orders to all customersshipments of partial orders to all customers
– Advantage: more vaccination earlyAdvantage: more vaccination early– Was important last seasonWas important last season
When combined with two-tiered pre-booking, When combined with two-tiered pre-booking, this strategy allows public health targeting this strategy allows public health targeting into initial distributioninto initial distribution
– Initial distribution to targeted populationsInitial distribution to targeted populations– May smooth distribution and allow targeted May smooth distribution and allow targeted
individuals first access to vaccineindividuals first access to vaccine
Major Advances for the 2005-Major Advances for the 2005-06 Influenza Season06 Influenza Season
CMSCMS– Significant increase in admin fee (> $18)Significant increase in admin fee (> $18)– Requirement to offer vaccine to residents in LTCFsRequirement to offer vaccine to residents in LTCFs– Measurement of LTCF resident vaccination uptake (MDS)Measurement of LTCF resident vaccination uptake (MDS)
FDA FDA – Licensed GSK for U.S. influenza marketLicensed GSK for U.S. influenza market– Worked with UK MHRA regarding Chiron’s remediation Worked with UK MHRA regarding Chiron’s remediation
activities activities
CDCCDC– Planning team meetings weeklyPlanning team meetings weekly– Pre-planned tiered approach to vaccinationPre-planned tiered approach to vaccination
2005 Influenza 2005 Influenza Vaccination Season Vaccination Season
TimingTiming
2005 Influenza 2005 Influenza Vaccination Season Vaccination Season
TimingTiming
Prioritization Until October 24, Prioritization Until October 24, Followed by Open Vaccination, Followed by Open Vaccination,
as Supplies Permitas Supplies Permit
Why start in a tiered system? Why start in a tiered system? Why October 24?Why October 24?
Programs need to plan clinics well in advancePrograms need to plan clinics well in advance
Vaccine demand usually falls off after Vaccine demand usually falls off after November, if not beforeNovember, if not before
Balance competing priorities:Balance competing priorities: Offer vaccine to priority patients firstOffer vaccine to priority patients first Try to use all vaccine availableTry to use all vaccine available
Sufficient time to vaccinate priority patients Sufficient time to vaccinate priority patients and plan for vaccination of other patientsand plan for vaccination of other patients
Influenza Vaccine Distribution, Influenza Vaccine Distribution, United States, 1999-2005United States, 1999-2005
0102030405060708090
100
July Aug Sept Oct Nov Dec Jan
Month
Do
ses o
f vaccin
e
19992000200220042005
Influenza Vaccine Distribution, Influenza Vaccine Distribution, 2005-062005-06
59 million doses distributed by Nov. 159 million doses distributed by Nov. 1
>80 million doses expected by Dec. 1>80 million doses expected by Dec. 1
CDC received funds to purchase additional influenza vaccine CDC received funds to purchase additional influenza vaccine doses for states to remedy shortfallsdoses for states to remedy shortfalls– 800,000 doses of inactivated vaccine from Chiron 800,000 doses of inactivated vaccine from Chiron – 100,000 doses of nasal spray vaccine from MedImmune100,000 doses of nasal spray vaccine from MedImmune– Available in late November or early DecemberAvailable in late November or early December
CDC VFC strategic reserve available in late December/early CDC VFC strategic reserve available in late December/early JanuaryJanuary– 3.5 million doses (sanofi) 3.5 million doses (sanofi) – 680,000 doses (Chiron) 680,000 doses (Chiron) – 100,000 doses (MedImmune)100,000 doses (MedImmune)– Use in non-VFC populations requires additional steps.Use in non-VFC populations requires additional steps.
Problems with Vaccine Supply Problems with Vaccine Supply and Distribution - 1and Distribution - 1
Chiron projected 25m-30m doses’ production early Chiron projected 25m-30m doses’ production early in 2005, will produce <18 millionin 2005, will produce <18 million
Orders for this vaccine were apparently solicited by Orders for this vaccine were apparently solicited by distributors at the higher projectionsdistributors at the higher projections
Customers informed as early as late September that Customers informed as early as late September that they would receive substantially less vaccine than they would receive substantially less vaccine than orderedordered
Chiron’s vaccine distribution began in late October Chiron’s vaccine distribution began in late October
Problems with Vaccine Supply Problems with Vaccine Supply and Distribution – 2and Distribution – 2
Many reports from physicians, community Many reports from physicians, community vaccinators, nursing homes, others of limited vaccinators, nursing homes, others of limited or cancelled ordersor cancelled orders
Some reports of delays with sanofi vaccine Some reports of delays with sanofi vaccine shipmentsshipments
Concern about partial shipments being too Concern about partial shipments being too small initially to permit clinic operationssmall initially to permit clinic operations
Is demand for vaccine increased above Is demand for vaccine increased above expected levels?expected levels?
Vaccine Supply AssessmentsVaccine Supply Assessments
To understand better which providers, and to what extent, have To understand better which providers, and to what extent, have been affected by supply problems, CDC and partners are been affected by supply problems, CDC and partners are surveyingsurveying– Internists, pediatricians, family physicians (AAFP)Internists, pediatricians, family physicians (AAFP)
– Local public health (NACCHO)Local public health (NACCHO)
– State and local immunization granteesState and local immunization grantees
– Community, occupational, and pharmacy vaccinators (National Community, occupational, and pharmacy vaccinators (National Influenza Vaccine Summit, American Pharmacists Association)Influenza Vaccine Summit, American Pharmacists Association)
– Hospitals (AHA)Hospitals (AHA)
– Federally qualified health centers (NACHC, HRSA)Federally qualified health centers (NACHC, HRSA)
– The public (Gallup)The public (Gallup)
Preliminary Results – Physicians’ and Preliminary Results – Physicians’ and Pharmacists SurveysPharmacists SurveysPediatriciansPediatricians
11/17/0511/17/05General InternistsGeneral Internists
11/17/0511/17/05PharmacistsPharmacists
11/14/0511/14/05
Response rateResponse rate 132/283 (47%)132/283 (47%) 127/308 (41%)127/308 (41%) 252/3493 (7%)252/3493 (7%)
Ordered from Ordered from sanofisanofi
76%76% 41%41% 59%59%
Ordered from Ordered from distributor – distributor – Chiron or unknownChiron or unknown
21%21% 43%43% 22%22%
Received >40% Received >40% orderorder
76%76% 60%60% 68%68%
Received >80% Received >80% orderorder
51%51% 35%35% 54%54%
Referred patients Referred patients to MD office, other to MD office, other clinicclinic
50%50% 68%68% 100%100%
Preliminary Results – Federal Immunization Preliminary Results – Federal Immunization Grantees’ Survey, 11/28/05Grantees’ Survey, 11/28/05
45/64 (70%) responded45/64 (70%) responded
25/43 (58%) ordered from sanofi (2 ordered no vaccine)25/43 (58%) ordered from sanofi (2 ordered no vaccine)
4/43 (9%) ordered from distributor – Chiron or unknown4/43 (9%) ordered from distributor – Chiron or unknown
42/43 (99%) received >40% order42/43 (99%) received >40% order
39/43 (91%) received >80% order39/43 (91%) received >80% order
All have received complaints about vaccine supplyAll have received complaints about vaccine supply
36/45 (80%) addressing redistribution by sharing information 36/45 (80%) addressing redistribution by sharing information and/or vaccineand/or vaccine
Recommendations for Providers Recommendations for Providers with Limited Vaccine, 11/18/05with Limited Vaccine, 11/18/05
If not already done, contact distributor, manufacturer, pharmacy or If not already done, contact distributor, manufacturer, pharmacy or other entity from which you ordered vaccine to understand how other entity from which you ordered vaccine to understand how many doses you will receive and when.many doses you will receive and when.
Target vaccine toward priority patients unless you have sufficient Target vaccine toward priority patients unless you have sufficient doses to broaden your vaccination efforts to non-priority patients. doses to broaden your vaccination efforts to non-priority patients.
Contact your local or state public health agency to see if they are Contact your local or state public health agency to see if they are aware of facilities or clinics that may be available to serve priority aware of facilities or clinics that may be available to serve priority patients in your community or if you have influenza vaccine that patients in your community or if you have influenza vaccine that you feel may go unused. you feel may go unused.
If you anticipate having vaccine in December, remind your patients If you anticipate having vaccine in December, remind your patients that vaccination in December and beyond is still beneficial, that vaccination in December and beyond is still beneficial, especially since influenza activity usually does not peak in the U.S. especially since influenza activity usually does not peak in the U.S. until January or later. until January or later.
Consider the nasal spray vaccine (FluMist) for patients (priority and Consider the nasal spray vaccine (FluMist) for patients (priority and non-priority) for whom this vaccine is indicated, healthy, non-non-priority) for whom this vaccine is indicated, healthy, non-pregnant persons aged 5-49.pregnant persons aged 5-49.
Next StepsNext Steps
Review surveys’ data once completeReview surveys’ data once complete
Share with partnersShare with partners
National Influenza Vaccine Summit National Influenza Vaccine Summit meeting Jan. 24-25, 2006meeting Jan. 24-25, 2006
Develop recommendations for vaccine Develop recommendations for vaccine ordering, distribution for 2006ordering, distribution for 2006
Questions?Questions?