# Presentation: 765324

## PEDIATRIC VACCINE STOCKPILES

- A Presentation At The National Vaccine Advisory Committee Meeting
- February 4, 2003

**Dean Mason**
**Chief, Program Support Branch**
**ISD/NIP**

## Background

**NIP has maintained stockpiles for some vaccines dating back to 1983**
**Withdrawals by manufacturers or NIP have occurred at least 12 times**
**There are 8 vaccines routinely used or widely recommended in the pediatric schedule protecting against 12 diseases (DTaP, IPV, MMR, Hep A, Hep B, Hib, PCV-7 and Varicella).  CDC has stockpile contracts for only 3 (IPV, MMR and Varicella).  A 4****th**** contract is for DT (Pediatric).**
**In CY 2001-02 the U.S. experienced unprecedented shortages or delays in the supply of many childhood vaccines including DTaP, Td, MMR, PCV-7 and Varicella**
**Recognition that past policies for vaccine stockpiling were not sufficient to ensure the public health**

## The Rationale For Stockpile Enhancements

**There is widespread support in government, industry and the medical sector**
**The NVAC, IOM and GAO have all made recommendations for stockpile build-up**
**OBRA 93, which created the VFC program, gives authority to the Secretary to establish stockpiles for the vaccines included in the VFC program**

## CDC’s Current and Projected Vaccine Stockpile LevelsFebruary 4, 2003

| Vaccine | Six Month 
Stockpile Goal (Number of Doses) | Number of Doses Now in Stockpile | Doses Purchased – Awaiting Delivery | Number of Doses to be Purchased |
| --- | --- | --- | --- | --- |
| E-IPV |  8,000,000 | 3,655,000 | 4,345,000 |           0  |
| OPV   * |  4,000,000 |           0 |           0 | 4,000,000 |
| MMR |  4,000,000 | 3,451,010 |    548,990 |           0 |
| Hib |  8,000,000 |           0 |           0 | 8,000,000 |
| DTaP | 10,000,000 |           0 |           0 | 10,000,000 |
| DT Pediatric |      150,000 |     150,000 |           0 |           0 |
| Hepatitis B | 6,000,000 |           0 |           0 | 6,000,000 |
| Td | 7,500,000 |           0 |           0 | 7,500,000 |
| PCV | 8,000,000 |           0 |           0 | 8,000,000 |
| Varicella | 2,000,000 |     271,980 |           0 | 1,728,020 |
| Hepatitis A ** | 4,000,000 |           0 |           0 | 1,400,000 |

- *OPV will only be used in an outbreak situation
- **Hepatitis A –Assumes 4 million births with 35% “at risk”

## Vaccine Stockpile Challenges

**Establishing vaccine priorities and manufacturing production timeline**
- Factors include the disease impact, cost, potential for future shortages and product life, number of manufacturers
**Incremental build-up cannot compromise ongoing national supply**
- Must consider manufacturer’s production capacity
- Not clear when we can purchase PCV-7 for the stockpile
**Contracting strategies**
- Multiple awards assures market share but complicates management and efficiency

## Vaccine Stockpile Challenges (Continued)

**Single versus newer combination vaccines**
- How best to maintain and rotate inventory in a changing market
**Storage, rotation and packaging**
- Single versus multiple storage sites
- Preventing loss through vaccine rotation from stockpile to market
- Delivery time frames for labeled, unlabeled and bulk stored vaccines

## Vaccine Stockpiles – Next Steps

**By March 2003 CDC will hire a contractor to develop a strategic plan**
**Stakeholders will have opportunity for input.  **
**The strategic plan will include recommendations for vaccine types and purchase amounts, storage, maintenance of effort, contracting options, communication and evaluation**
**Deliverable by May 1, 2003**