# Presentation: 369680

## 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**

## National Distribution of Tetanus and Diphtheria (Td) Toxoids1February 4, 2003

- 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 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

## 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 

**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

-  .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 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 ****®**

## 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**

## 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) **

## 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

**Source: Biologic Surveillance/Merck**

-     2001                                                                      2002

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

## 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**

## 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 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) **

## 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

## 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.**

## 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 DistributionFor 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).

- Doses (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 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.**