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

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

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 Figure includes DTaP/HIB and DTaP/Hep B/IPV Source: Biologic Surveillance/AvP and GSK CDC Contract Monthly Need (1 million) Average National Monthly Need (1.7 million)

DTaP Vaccine Outlook June 3, 2003  FDA licensed PEDIARIX ® (DTap/Hep B/IPV) on Dec. 13, 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, The contract price is $32.75 per dose.  FDA licensed DAPTACEL ® on May 14,  CDC established a contract for DAPTACEL ® on June 20, 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 Source: Biologic Surveillance - Merck 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 April 2003 Source: Biologic Surveillance/Merck 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 Supply U.S. Market January 2001 – May 2003 Source: Biologic Surveillance/Wyeth-Vaccines 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 Source: Wyeth Vaccines All numbers reflect backorders through CDC’s contracts that are pending > 15 working days

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 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 trivalent strains of influenza vaccine will be the same as (A/Moscow, A/New Caledonia and B/Hong Kong Only 2 manufacturers for : 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