A Vaccine Supply Update For The U'S' Market

1
A Vaccine Supply Update For The U.S. Market

• A Presentation At National Advisory Committee
  Meeting
• February 4, 2003

Dean Mason Chief, Program Support Branch NIP/ISD
2
National Distribution of Tetanus and Diphtheria
(Td) Toxoids1February 4, 2003
Doses in Millions
1Source Biologic Surveillance System. All
figures are provisional until officially
published. Due to under reporting, the real
national distribution figures may be around 18
million doses for CY 1997 1999.
3
Td Supply

• AV P list price 10.00 per dose, including
  excise tax 10 dose vial
• Minnesota Multi-State contract 10.00 per dose,
  including excise tax
• Massachusetts Biologic Laboratories is producing
  limited quantities of Td
• 15 dose vial 9.99 per dose, including excise
  tax - purchase through Schein/GIV/Caligor

4
Td OutlookFebruary 4, 2003

• Td supply now sufficient for a return to the
  recommended schedule for all providers
• This includes a return to Td booster doses,
  re-institution of school enforcement provisions
  and recall

5
DTaP Vaccine-Recent National Supply Experience

• Estimate the annual national need to be 20
  million doses
• CY 2001 supply was 18.7 million doses
• CY 2002 supply was 20.3 million doses
• CDC contract need is about 60 of total market.
  In the 13 month period, Jan 2001 Jan 2002, only
  49 of supply went through CDC contract
• Feb-Dec 2002, 61 supply through CDC contract

6
DTaP Vaccine Supply For U.S. Market, CDC
Contract and Private SectorJanuary 2001
December 2002
CDC Contract Monthly Need (1 million)
Average National Monthly Need (1.7 million)
2.5 1.5
2.4 1.3
2.3 1.4
2.1 .8
2.0 .8
2.0 1.1
1.9 .8
1.9 .8
1.9 1.2
1.7 1.0
1.7 1.1
1.7 1.1
1.5 .9
1.5 1.0
1.2 .6
1.4 .6
1.5 1.0
1.3 .6
1.3 .6
1.2 .6
1.1 .6
1.4 .8
.8 .4
.7 .4
2001
2002
Figure includes DTaP/HIB Source Biologic
Surveillance/AvP and GSK
7
DTaP Vaccine OutlookFebruary 4, 2003

• FDA licensed PEDIARIX on Dec. 13, 2002
• Licensed for 3 doses in primary series through
  age 6 years
• FDA licensed DAPTACEL on May 14, 2002
• CDC established a contract for DAPTACEL on June
  20, 2002. CDC contract price is 12.75 per dose,
  including excise tax. Private list price is
  20.24 per dose, including excise tax
• AvPs Tripedia CDC contract price is 11.75
  per dose GSKs Infanrix price is 11.75 per
  dose in vial and 12.00 per dose Tip-Lok
• July 12, 2002 MMWR publication announced a return
  to the full dosing schedule.
• CDC will await ACIP recommendation for the
  establishment of a DTaP/Hep B/IPV contract with
  GSK for PEDIARIX

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MMR Vaccine-RecentSupply Experience

• Annual national need is about 1.08 million doses
  per month (CDC contract about 60)
• CY 2001 11.7 million doses supplied
• CY 2002 12.5 million doses supplied
• Problem Between Oct 2001 and Feb 2002 the
  average monthly supply was only 735,000 doses or
  73 of national need

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MMR VACCINE DISTRIBUTION U.S. MARKET January
2001 December 2002
CDC Contract Monthly Need (600,000)
Average National Monthly Need (1 million)
2001
2002
Source Biologic Surveillance - Merck
10
MMR Vaccine Outlook February 4, 2003

• Supply is now stable
• No backorders over 15 days duration now in
  system.
• A return to the recommended full dosing schedule
  for MMR was published in the MMWR on July 12, 2002

11
Varicella Vaccine-Recent National Supply
Experience

• Annual need est 6 to 7 million doses or 550,000
  per month (CDC contract need about 60)
• CY 2000 6.3 million doses supplied
• CY 2001 6.0 million doses supplied
• CY 2002 6.6 million doses supplied
• Jan.-Oct. 2001 avg. monthly supply 600,000 doses
• Nov.-Jan. 2002 avg 210,000 doses - a 65
  decline from previous 10 month avg.
• Significant increase in supply began in April
  2002

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Varicella Vaccine Distribution U.S. Market, Jan
2001- December 2002
CDC Contract Monthly Need (330,000)
Average National Monthly Need (550,000)
Source Biologic Surveillance/Merck
2001
2002
13
Varicella Vaccine OutlookFebruary 4, 2003

• Supply is now stable
• No backorders over 15 days duration now in system
• A return to the routine schedule was published
  in the MMWR on August 2, 2002
• Allows for full dosing and re-institution of day
  care, head start and school attendance
  requirements as well as recall programs

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PCV-7- Recent National Supply Experience

• For CY 2001, 15.5 million doses shipped with 52
  supplied through CDCs contract
• For CY 2002, 11.4 million does shipped with 53
  supplied through CDCs contract
• About 71 of the national need was supplied in CY
  2002
• Beginning July 2001, significant month-to-month
  variance in both public and private sectors
• Only 4 times in CY 2002 and11 times in the past
  24 months has the amount of vaccine purchased met
  CDCs estimates of national need
• May, July, and Dec. 2002, almost no vaccine
  supplied
• Over 2 million doses supplied in Nov. but less
  than 15 of national need supplied in Dec. 2002

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Pneumococcal Conjugate Vaccine SupplyU.S.
MarketJanuary 2001 January 2003
CDC Contract Monthly Need (700,000)
Average National Monthly Need (1.33 Million)
2001
2002
Source Biologic Surveillance/Wyeth-Vaccines Janu
ary 2003 data is provisional
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A Comparison Of PCV-7 Vaccine Backorders
October 2001 January 2003

• Source Wyeth Vaccines for all months except
  March March data is from CDC records
• All numbers reflect backorders through CDCs
  contracts that are pending
• gt 15 working days

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PCV-7 OutlookFebruary 4, 2003

• Significant month-to-month variance in supply
  continues
• Both public and private sectors have experienced
  vaccine shortages in equitable manner
• Expect significant supply for the next 6 to 8
  weeks
• Supply may be sufficient to return to the
  routine schedule in the early second quarter,
  2003.

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Reasons Given For The PCV-7 Shortages And Delays

• Rapid implementation in public sector
• Demand exceeded manufacturing projections
• Good Manufacturing Practice issues
• Production interruptions continue to occur

19
HIB Vaccine Supply February 4, 2003

• Wyeths HIB vaccine market share for CY 2000
  2001 averaged about 30 of the national supply
• Wyeths HIB supply for last 6 months of CY 2002
  was nominal
• Estimate the national need for all HIB containing
  vaccine (HIB, DTaP/HIB and HepB/HIB) at 18
  million doses 54 CDC contract
• AvP and Merck to date have been able to supply
  HIB vaccine in sufficient quantities to make up
  for Wyeths shortages

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Cumulative Monthly Influenza Vaccine
DistributionFor 1999, 2000, 2001, and 20021
Doses (Millions)
83
82.7
50.7
14.5
2
1. Data presented in this figure were supplied
by the influenza vaccine manufacturers to the
Centers for Disease Control and Prevention (CDC).
21
Outlook For Other Vaccines

• Av Ps Meningococcal Vaccine Company states
  supply is sufficient to meet all requests
• Other Vaccines
• Hepatitis A and B vaccine supply is sufficient to
  meet demand
• HIB Orders from Merck are taking 4 to 6 weeks to
  fill. We anticipate normal supply from Merck in
  early February, 2003. Full supply from AvP
• Merck is filling all orders for Hep B/HIB
  combination vaccine on time
• Merck is the only remaining supplier of PPV

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Vaccine Supply SummaryFebruary 4, 2003

• The supply of DTaP, Td, MMR and Varicella is
  sufficient for a return to the full dosing
  schedule
• PCV-7 supply remains sporadic and must continue
  to be prioritized to high risk children
• Some reason for optimism that PCV-7 supply will
  stabilize and be sufficient in April of May 2003
• Expect some delay from Merck for HIB until early
  February. Hep B/HIB from Merck is being
  delivered without delay
• We believe that AvP and Merck have the potential
  to supply HIB vaccine in sufficient amounts to
  meet national need. This will be especially true
  if Wyeth re-enters the HIB vaccine market in
  early fall, 2003.