A Vaccine Supply Update For The U.S. Market

A Presentation At The National Vaccine Advisory Committee

MeetingJune 3, 2003

Dean MasonChief, Program Support BranchNIP/ISD

16.6

6

14.4

11.2

12.713.8

16.1

15.3

02468

101214161820

1997 1998 1999 2000 2001 2002 Jan-May2003

Jan- DecProjected

Doses in Millions

1Source: Biologic Surveillance System. All figures are provisional until officially published.

National Distribution of Tetanus and Diphtheria (Td) Toxoids1

June 3, 2003

Td Outlook June 3, 2003

A return to the recommended full dosing schedule for Td was published in the MMWR on June 21, 2002

This includes a return to Td booster doses, re-institution of school enforcement provisions and recall

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

January 2001 – April 2003

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 Ap

rMay Ju

n Jul

Aug

Sep

OctNov Dec Ja

nFe

bMar Ap

rMay

June Ju

lyAu

gSe

pOct

Nov Dec Jan

Feb

Mar Ap

r

CDC Contract Supply Private Supply

Figure includes DTaP/HIB and DTaP/Hep B/IPVSource: 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 2003

1.9

1.2

1.5

1.0 .7

.4

2.6

1.7

2.2

1.3

1.8

1.1

1.5

.9

DTaP Vaccine Outlook June 3, 2003

FDA licensed PEDIARIX ® (DTap/Hep B/IPV) on Dec. 13, 2002.

Licensed for 3 doses in primary series through age 6 years. PEDIARIX ® (DTaP/Hep B/IPV) was added to CDC’s VFC

contract on Feb. 27, 2003. The contract price is $32.75 per dose.

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

GSK’s Infanrix® price is $12.75 per dose in vial and $13.00 per dose TIP-LOK.

July 12, 2002 MMWR publication announced a return to the full dosing schedule.

MMR VACCINE DISTRIBUTION – U.S. MARKET January 2001 – April 2003

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

Jan

Feb

Mar Ap

rMay Ju

n Jul

Aug

Sep

OctNov Dec Ja

nFe

bMar Ap

rMay

June Ju

lyAu

gSe

pt OctNov Dec Ja

nFe

bMar Ap

r

CDC Contract Private Supply

Source: Biologic Surveillance - Merck

2001 2002 2003

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

MMR Vaccine Outlook June 3, 2003

Supply is stable

Orders being filled through CDC’s contract within 2 to 5 days of order receipt by Merck

A return to the recommended full dosing schedule was published in the MMWR on July 12, 2002

Varicella Vaccine Distribution U.S. Market, January 2001- April 2003

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

900,000

1,000,000

Jan

Feb

Mar Ap

rMay Ju

n Jul

Aug

Sep

OctNov Dec Ja

nFe

bMar Ap

rMay

June Ju

lyAu

gSe

pOct

Nov Dec Jan

Feb

Mar Ap

r

CDC Contract Private Supply

Source: Biologic Surveillance/Merck

2001 2002 2003

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

Varicella Vaccine Outlook June 3, 2003

Supply is stable

Orders being filled through CDC’s contract within 2 to 5 days of order receipt by Merck

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

PCV-7- Recent National Supply Experience

Estimate the national need to be about 16 million doses annually

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 that continued through Jan 2003

Only 4 times in CY 2002 and 11 times in CY 2001 – 2002 has the amount of vaccine purchased met CDC’s estimates of national need

May, July, and Dec. 2002, almost no vaccine supplied Wyeth supply for Feb-April 2003 substantially exceeded

national need

Pneumococcal Conjugate Vaccine SupplyU.S. Market

January 2001 – May 2003

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

Jan

Feb

Mar Ap

rMay Ju

n Jul

Aug

Sep

OctNov Dec Ja

nFe

bMar Ap

rMay

June Ju

lyAu

gSe

pt OctNov Dec Ja

nFe

bMar Ap

rMay

CDC Contract Private Supply

Source: Biologic Surveillance/Wyeth-Vaccines

2001 2002 2003

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

A Comparison Of PCV-7 Backorders Through CDC’s Contracts

October 2001 – May 2003

515,610

961,930

238,805

131,385

583,580

695,610

641,340

1,000,000

1,410,645

1,127,410

1,250,530

718,790683,370

0

644,980

988,960

399,815

605,365

0 00

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 Feb Mar Apr May

•Source: Wyeth Vaccines•All numbers reflect backorders through CDC’s contracts that are pending > 15 working days

2001 2002 2003

PCV-7 Outlook June 3, 2003

PCV-7 supply has stabilized and is sufficient to meet national need

Supply for the 4-month period Feb-May, 2003 was the largest amount supplied for any 4 consecutive months since licensure

A return to the routine schedule was published in the MMWR on May 11, 2003

Allows for full dosing and catch-up programs

HIB Vaccine Supply June 3, 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 annual 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

To ensure that Hib vaccine is adequate, Wyeth must begin supplying by September 2003

Av P’s Meningococcal Vaccine – Company states supply is sufficient to meet all requests though the vaccine is only available in 10-dose vials. AvP is giving credit for up to 5 doses if unused vaccine is returned. Anticipate single dose vials will again be available by 3rd quarter of 2003

Other Vaccines Hepatitis A and B vaccine supply is sufficient to meet demand Hib vaccine supply is timely from both AvP and Merck Merck is filling all orders for Hep B/HIB combination vaccine on

time Merck is the only remaining supplier of PPV The 2003-2004 trivalent strains of influenza vaccine will be

the same as 2002-2003 (A/Moscow, A/New Caledonia and B/Hong Kong

Only 2 manufacturers for 2003-2004: AvP and Evans Predict sufficient supply and timely delivery

Outlook For Other Vaccines June 3, 2003

Vaccine Supply Summary June 3, 2003

The supply of all routinely recommended pediatric vaccines is sufficient for a return to the full dosing schedule

PCV-7 supply is meeting national need and projections are very positive

There is potential for a shortage of Hib vaccine in CY 2003 if Wyeth does not re-enter the market