A Vaccine Supply Update For The U.S. Market

A Presentation At National Advisory Committee Meeting

February 4, 2003

Dean MasonChief, Program Support BranchNIP/ISD

National Distribution of Tetanus and Diphtheria (Td) Toxoids1

February 4, 2003

16.615.3

16.1

13.8 12.711.2

02468

101214161820

1997 1998 1999 2000 2001 2002

Actual distribution Estimated national need

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.

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

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

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

DTaP Vaccine Supply For U.S. Market, CDC Contract and Private Sector

January 2001 – December 2002

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

1,800,000

2,000,000

2,200,000

2,400,000

2,600,000

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec

CDC Contract Supply 16.1 million Private Supply 14.9 million

Figure includes DTaP/HIBSource: Biologic Surveillance/AvP and GSK

1.2

.6

1.3

.6

1.3

.6

1.2

.6

1.1

.6

1.4

.6

2.3

1.4

2.4

1.3

2.1

.8

1.7

1.0

1.9

.8

.8

.4

CDC Contract Monthly Need (1 million) Average National Monthly Need (1.7 million)

2.0

.8

1.7

1.1

1.7

1.1

1.5

1.0

2.0

1.1

1.5

.9

1.9

.8

2.5

1.5

1.4

.8

2001 2002

1.9

1.2

1.5

1.0 .7

.4

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

AvP’s Tripedia ® CDC contract price is $11.75 per dose; GSK’s 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 ®

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 suppliedProblem: Between Oct 2001 and Feb

2002 the average monthly supply was only 735,000 doses or 73% of national need

MMR VACCINE DISTRIBUTION – U.S. MARKET January 2001 – December 2002

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec

CDC Contract Private Supply

Source: Biologic Surveillance - Merck

2001 2002

CDC Contract Monthly Need (600,000) Average National Monthly Need (1 million)

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

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

Varicella Vaccine Distribution U.S. Market, Jan 2001- December 2002

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

900,000

1,000,000

CDC Contract Private Supply

Source: Biologic Surveillance/Merck

2001 2002

CDC Contract Monthly Need (330,000) Average National Monthly Need (550,000)

Varicella Vaccine OutlookFebruary 4, 2003

Supply is now stableNo backorders over 15 days duration now in

systemA return to the routine schedule was

published in the MMWR on August 2, 2002Allows for full dosing and re-institution of day

care, head start and school attendance requirements as well as recall programs

PCV-7- Recent National Supply Experience

For CY 2001, 15.5 million doses shipped with 52% supplied through CDC’s contract

For CY 2002, 11.4 million does shipped with 53% supplied through CDC’s 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 CDC’s 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

Pneumococcal Conjugate Vaccine SupplyU.S. Market

January 2001 – January 2003

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

J an

Feb

Mar Ap

rMay Ju

n Jul

Aug

Sep

OctNov Dec Ja

nFe

bMar Ap

rMay

June

July

Aug

Sept Oct

Nov Dec Jan

CDC Contract Private Supply

Source: Biologic Surveillance/Wyeth-Vaccines*January 2003 data is provisional

2001 2002

CDC Contract Monthly Need (700,000) Average National Monthly Need (1.33 Million)

A Comparison Of PCV-7 Vaccine Backorders October 2001 – January 2003

515,610

961,930

238,805

131,385

583,580

695,610641,340

1,000,000

1,410,645

1,127,410

1,250,530

718,790683,370

0

644,980

988,960

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

Oct Nov Dec Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec Jan

•Source: Wyeth Vaccines for all months except March; March data is from CDC records•All numbers reflect backorders through CDC’s contracts that are pending > 15 working days

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.

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

HIB Vaccine Supply February 4, 2003

Wyeth’s HIB vaccine market share for CY 2000 – 2001 averaged about 30% of the national supply

Wyeth’s 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 Wyeth’s shortages

Cumulative Monthly Influenza Vaccine DistributionFor 1999, 2000, 2001, and 20021

1. Data presented in this figure were supplied by the influenza vaccine manufacturers to the Centers for Disease Control and Prevention (CDC).

9.5

26.623.9

43

29.1

75.8

44.3

76.876.8

16.6

70.4

48.2

7.4

76.2

2.7

77.7

0

10

20

30

40

50

60

70

80

90

July Aug Sept Oct Nov Dec

1999 2000 2001 2002Doses (Millions)

2

14.5

50.7

82.7

83

Outlook For Other Vaccines

Av P’s 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

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.