# Presentation: 189613

## Planning for the 2005-2006 Influenza Season:Will it be Rain, Shine, or Hurricane?

**National Vaccine Advisory Committee**
**June 7, 2005**
**Washington, DC**
**Raymond A. Strikas, MD**
**Immunization Services Division**
**National Immunization Program**

## Key Lessons from 2004

- Plan with partners
- Implement public sector direction of allocation/distribution with partners
- Offer flexibility to local areas in recommendations’ implementation
- Provide real-time information (e.g., BRFSS)
- Plan for contingencies – multiple scenarios
- Using IND vaccine routinely problematic
- Extending vaccination season difficult
- Improve vaccine manufacturing capacity

## Planning Strategy

**Supply-based scenarios**
**Monitoring**
**Insurance policies**
**Communications**

## Three Scenarios

**Base**
**Best**
**Worst**

## Base Case Scenario: Rain

**Base Case Scenario: Rain**

## Base Case Scenario: 63M Doses

**TIV**
**sanofi pasteur only**
**60 M doses**
**50M by end of November**
**10M by end of year**
**LAIV**
**MedImmune**
**3 M doses**
**Depends on vaccine virus growth characteristics**

## Best Case Scenario: Shine

**Best Case Scenario: Shine**

## Best Case Scenario: >> 63M Doses

**TIV**
**sanofi pasteur**
**50 to 60 M doses**
**Chiron in U.S. market:  25M-30M doses**
**GSK licensed:  10 M doses**
**LAIV: 3 M doses**

## Worst Case Scenario: Hurricane

**Worst Case Scenario: Hurricane**

## Worst Case Scenario: << 63M Doses

**Sanofi pasteur production failure**
**No other TIV manufacturer in the U.S. market**
**Result – substantially fewer TIV doses than last season**

## Planning Activities

## 2005-06 Influenza Season Planning Group

**Scope – next season; non-pandemic**
**Charge**
**Identify priority activities **
**Determine who will lead / produce the activity**
**Develop time line**
**Monitor completion**
**Comprehensive and strategic representation**
**Primary planning group for CDC, in collaboration with NVPO, FDA, ASTHO, NACCHO, AIM**

**Notes:**
CDC has formed an internal planning group whose scope of effort involves planning routine vaccination during the 2005-06 influenza season.  This group has been given the following charge: 
identify priority activities for CDC and our partners
determine who will have the lead/produce the activity
develop a time line
monitor the timeline
The team involves persons with expertise in technical as well as programmatic areas across CDC, many of whom were part of this year’s influenza response teams.
This group represents the primary planning group for CDC on this issue and is working collaboratively with NVPO and FDA.  Input and collaboration from other key stakeholders include the Association of State and Territorial Health Officiatls (ASTHO), the National Association of County and City Health Officials (NACCHO), and the Association of Immunization Program Managers (AIM).

## Supply Projection Monitoring

**Adjusts scenario likelihoods **
**NVPO, FDA, and CDC activity**
**Process: calls to manufacturers**
**Production milestones **
**Regulatory milestones**

## Prioritization Recommendation Development

**Last season, priorities developed in an emergency ACIP session**
**ACIP Influenza Working Group met in January to sub-prioritize for next season**
**Four work groups**
**Disease impact (Kathy Neuzil Lead)**
**Disease reduction from vaccination (Kristin Nichol Lead)**
**Herd Immunity (Arnold Monto Lead)**
**Economic aspects (Lisa Prosser Lead)**
**ACIP approved the sub-prioritization recommendations in February**

## Proposed ACIP Priority Groups for Influenza Vaccination, 2005-06

| 1a:  <20 million persons

>65 years with medical conditions

Nursing home residents | 1b: ~70 million persons

Persons 2-64 years with high risk conditions
Pregnant women
Persons without high risk conditions >65 years
Children 6-23 months old | 1c:  ~12 million persons

Health care workers

Close contacts to children <6 months of age

 |
| --- | --- | --- |
| 2:   ~98 million persons
Contacts of all other high risk persons

Healthy persons 50-64 years |  |  |
| 3:  ~96 million persons

Healthy persons 2-49 years of age (everybody else) |  |  |

**Notes:**
The ACIP recommended tiers of priority include somewhat less than 20 million persons in tier 1a, persons >65 years with medical conditions increasing their risk for complications of influenza, and persons residing in long-term care facilities.  

Tier 1b includes persons 2-64 years with medical conditions, the remaining persons >65 years, pregnant women, and chldren 6-23 months of age.

Tier 1c includes health care workers and close contacts of children <6 months of age.  Ideally, all of tier 1 would be vaccinated at the same time, but if vaccine supply were severely limited, local areas could sub-prioritize within this larger tier.

Tier 2 includes all other contacts of high risk persons and healthy persons 50-64 years, and Tier 3 includes the rest of the population.

## Concepts

**No use of tiering when supply is adequate**
**However, proposed tiering to be published if necessary**
**Three tiers based on U.S. rates of influenza-associated mortality & hospitalization**
**During influenza vaccine shortages**
**Will recommend tiered vaccination approach**
**Tier 1 should be vaccinated preferentially, followed by Tier 2, and then Tier 3. **

**Notes:**
Ideally, vaccine supply will be adequate and no tiering will be necessary.  The three tiers, again, were based on U.S. data on influenza-related mortality and hospitalization.  Again, if vaccine shortages do occur, tier 1 should be vaccinated first, followed by tier 2 and 3. 

## Concepts

**If local vaccine supply is extremely limited,**
**vaccinate Tier 1A before all other groups. **
**Otherwise, Tiers 1A, 1B, & 1C **
**Considered equivalent**
**Should vaccinate simultaneously. **
**Encourage LAIV for eligible persons in Tier 1C, Tier 2, & Tier 3 **
**Local application of tiering based on local supply**

**Notes:**
If vaccine supply were very limited, tier 1a should be vaccinated before all other groups.  
Live attenuated influenza vaccine should be encouraged for eligible persons, and the tiers can be used to guide local vaccine use, depending on supply.

## Pre-Booking and Distribution

## Two-Tiered TIV Pre-Booking

**Proposed by sanofi pasteur**
**Request # doses for targeted groups and total # of doses to purchase **
**Allows public health considerations into vaccine sales**

## Vaccine Distribution

**Predominant strategy has been partial orders to all customers**
**Advantage: more vaccination early**
**Was important last season**
**Two-tiered pre-booking allows public health targeting into initial distribution**
**Initial distribution to targeted populations**
**May smooth distribution and allow targeted individuals first access to vaccine**

## IND Vaccine in Routine Program

**Challenges**
**IND not optimized for routine use**
**Need to use IRB**
**Co-PI **
**Insurance carriers experience limited**
**A need for routine IND vaccine use   argues for different mechanisms to use imported (unlicensed) vaccine**

## Two Vaccine Insurance Policies

**Vaccine stockpile**
**Purpose: late season demand in excess of vaccine supply**
**For all three scenarios**
**Supported by VFC program**
**Monovalent bulk production solicitation**
**Purchases maximum number of doses for given amount of funding**
**For use in worst case scenario**
**Takes time to combine and package**
**Could be licensed or unlicensed**

## Live Attenuated Influenza Vaccine

**Useful in all three scenarios**
**Each LAIV dose spares a TIV dose**
**Even in subprioritization situation, LAIV has many uses**
**Health care workers**
**Military**
**Household contacts**

## Planning Decisions

## Supply-Based Scenarios 2005-06

| Scenario | Total doses | Likelihood | Actions |
| --- | --- | --- | --- |
| Base | ~63 M | Moderate | Tough it out—no IND
Dual pre-book
Dual distribution
Prioritize vaccine |
| Best | >> 63 M | Most likely | Promote vaccine use |
| Worst | << 63 M | Unlikely | Prioritize vaccine
Activate insurance policy
Consider IND vaccine
 |

## 2005-06 Season Concerns

**Will demand suffer setback from this past season?**
**Will private providers retain interest in vaccinating?**
**Will we be able to communicate the complex messages required for scenario-based planning?**

## Longer Term Considerations

**Increasing vaccine demand, group by group, with an enhanced public health workforce**
**Developing science basis for broader recommendations (e.g., cost effectiveness)**
**Stabilizing and diversifying vaccine supply**
**Selective use of tiering strategies**
**Pandemic preparedness**