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) Toxoids 1 February 4, 2003 Doses in Millions 1 Source: 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 Outlook February 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 Sector January 2001 – December 2002 Figure includes DTaP/HIB Source: 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 1.9.8.4 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

7. DTaP Vaccine Outlook February 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 ®

8. MMR Vaccine-Recent Supply 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

9. MMR VACCINE DISTRIBUTION – U.S. MARKET January 2001 – December 2002 Source: Biologic Surveillance - Merck 2001 2002 CDC Contract Monthly Need (600,000) Average National Monthly Need (1 million)

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

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

13. Varicella Vaccine Outlook February 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

14. 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

15. Pneumococcal Conjugate Vaccine Supply U.S. Market January 2001 – January 2003 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)

16. 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 CDC’s contracts that are pending > 15 working days

17. PCV-7 Outlook February 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.

18. 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 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

20. Cumulative Monthly Influenza Vaccine Distribution For 1999, 2000, 2001, and 2002 1 1. Data presented in this figure were supplied by the influenza vaccine manufacturers to the Centers for Disease Control and Prevention (CDC). Doses (Millions) 2 14.5 50.7 82.7 83

21. 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

22. Vaccine Supply Summary February 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.