# Presentation: 335025

## Influenza Virus Vaccine Composition 2006-2007

**Jerry P. Weir, Ph.D.**
**Director, Division of Viral Products**
**CBER/FDA**
**Prepared for**
**Vaccines and Related Biological Products**
** ****Advisory Committee**
**17 February 2006**

## VRBPAC Committee Recommendation

**Selection of influenza A(H1N1 and H3N2) and B viruses for 2006-2007 influenza vaccines for use in the United States**

## Vaccine efficacy relates to:

Vaccine potency (immunogenicity)
Match of vaccine HA/NA with wild-type viruses
Antigenic drift of HA/NA continuous in influenza A and B  viruses
First evidence of reduced vaccine effectiveness because of antigenic drift 2 years after first vaccines licensed for use in United States

**Vaccine potency (immunogenicity)**
**Match of vaccine HA/NA with wild-type viruses**
**Antigenic drift of HA/NA continuous in influenza A and B  viruses**
**First evidence of reduced vaccine effectiveness because of antigenic drift 2 years after first vaccines licensed for use in United States**

**Why Change Strains ****in Influenza Vaccines?**

## Questions to Be Answered forStrain Changes Every Year

**Are new (drifted or shifted) influenza viruses present?**
**Are these new viruses spreading in people?**
**Do current vaccines induce antibodies against the new viruses (HA)?**
**Are strains suitable for vaccines available?**

## Strains Selected for 2005-2006

**A/New Caledonia/20/99(H1N1)-like**
**A/California/7/2004(H3N2)-like  ***(changed from 2004-2005 season)*
**A/New York/55/2004**
**B/Shanghai/361/2002-like  ***(B/Yamagata/16/88 lineage)*
**B/Jilin/20/2003**
**B/Jiangsu/10/2003**

## Current Licensed InfluenzaVaccines (U.S.)

**Inactivated influenza vaccines**
**Sanofi-Pasteur**
**Chiron**
**GSK**
**Live attenuated vaccine**
**MedImmune**

## Timelines for Vaccine Production

**Timelines for Vaccine Production**

## Time to First Trivalent Vaccine Lot after Strain Change

## WHO Consultation on the Composition of Vaccines for the Northern Hemisphere, 2006-2007

**February 13-15, 2006**
**Antigenic and genetic characterization of influenza viruses investigated in the WHO Collaborating Centers for Reference and Research on Influenza**
**Serological studies with inactivated influenza vaccine**
**Recommendations for vaccine composition for 2006-2007 Northern Hemisphere**
**www.who.int/csr/disease/influenza/recommendations2007north/en/**

## WHO Recommendations for Influenza Vaccine CompositionNorthern Hemisphere: 2006-2007

**“**** ****It is recommended that vaccines to be used in the 2006-2007 (northern hemisphere winter) contain the following:**
**an A/New Caledonia/20/99(H1N1)-like virus **
**a A/Wisconsin/67/2005(H3N2)-like virus **
**a B/Malaysia/2506/2004-like virus ”**

## VRBPAC Committee Agenda

**Review surveillance data (epidemiology and antigenic characteristics), serological responses to vaccine, and availability of candidate strains and reagents**
**Discuss which strains should be recommended for the antigenic composition of the 2006-2007 influenza virus vaccine?**

## Options for Strain Composition for 2006-2007 Influenza Vaccines

**Influenza A(H1N1)**
**Retain current vaccine strain recommendation; A/New Caledonia/20/99(H1N1)-like virus**
**Replace current vaccine strain with alternative H1N1 isolate**
** ****Influenza A(H3N2)**
**Retain current strain recommendation; A/California/7/2004(H3N2)-like virus**
**Replace with A/Wisconsin/67/2005 (H3N2)-like virus**
**Replace with alternative H3N2 isolate**
**Influenza B**
**Retain current B/Shanghai/361/2002-like virus**
**Replace with alternative virus from B/Yamagata/16/88 lineage**
**Replace with B/Malaysia/2506/2004-like virus**
**alternative virus from B/Victoria/2/87 lineage**