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?