1. A Vaccine Supply Update For The U.S. Market A Presentation At The National Vaccine Advisory Committee Meeting June 3, 2003 Dean Mason Chief, Program Support Branch NIP/ISD

2. Doses in Millions 1 Source: Biologic Surveillance System. All figures are provisional until officially published. National Distribution of Tetanus and Diphtheria (Td) Toxoids 1 June 3, 2003

3. 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

4. DTaP Vaccine Supply For U.S. Market, CDC Contract and Private Sector January 2001 – April 2003 Figure includes DTaP/HIB and DTaP/Hep B/IPV 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 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

5. 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.

6. MMR VACCINE DISTRIBUTION – U.S. MARKET January 2001 – April 2003 Source: Biologic Surveillance - Merck 2001 2002 2003 CDC Contract Monthly Need (600,000) Average National Monthly Need (1 million)

7. 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

8. Varicella Vaccine Distribution U.S. Market, January 2001- April 2003 Source: Biologic Surveillance/Merck 2001 2002 2003 CDC Contract Monthly Need (330,000) Average National Monthly Need (550,000)

9. 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

10. 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

11. Pneumococcal Conjugate Vaccine Supply U.S. Market January 2001 – May 2003 Source: Biologic Surveillance/Wyeth-Vaccines 2001 2002 2003 CDC Contract Monthly Need (700,000) Average National Monthly Need (1.33 Million)

12. A Comparison Of PCV-7 Backorders Through CDC’s Contracts October 2001 – May 2003 Source: Wyeth Vaccines All numbers reflect backorders through CDC’s contracts that are pending > 15 working days 2001 2002 2003

13. 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

14. 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

15.  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 3 rd 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

16. 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