# Presentation: 008347

## Influenza Virus Vaccine2008-2009 Strain Selection

**Jerry P. Weir, Ph.D.**
**Director, Division of Viral Products**
**CBER/FDA**
**Prepared for**
**Vaccines and Related Biological Products**
** ****Advisory Committee**
**21 February 2008**

## VRBPAC Committee Recommendation

- Selection of influenza A (H1N1 and H3N2) and B viruses for 2008-2009 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
Evidence of reduced vaccine effectiveness resulting from antigenic drift observed within 2 years after influenza vaccines first 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
- Evidence of reduced vaccine effectiveness resulting from antigenic drift observed within 2 years after influenza vaccines first licensed for use in United States

**Why Consider Strain Changes ****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?

## Review of Influenza Strain Selectionfor 2007-2008

- H1N1
- 2006-2007 vaccine contained an A/New Caledonia/20/99-like strain
- An increasing % of antigenically distinguishable H1N1 viruses isolated
- Recommendation made to switch H1N1 vaccine strain to A/Solomon Islands/3/2006-like virus for 2007-2008
- H3N2
- 2006-2007 vaccine contained an A/Wisconsin/67/2005-like strain
- An increasing % of antigenically distinguishable H3N2 viruses isolated
- No emergence of a well characterized variant group
- No candidate virus for manufacture was available that gave more complete coverage of entire spectrum of H3N2 isolates
- Recommendation made to retain H3N2 vaccine strain similar to A/Wisconsin/67/2005-like virus for 2007-2008

## Review of Influenza Strain Selectionfor 2007-2008 (2)

- B
- 2006-2007 vaccine contained B/Malaysia/2506/2004-like strain
- Majority of B influenza isolates in February 2007 belonged to the B/Victoria lineage (although both lineages present)
- Recommendation made to retain a B vaccine strain similar to B/Malaysia/2506/2004-like virus for 2007-2008
- Vaccine situation during 2007-2008 influenza season
- Recommendations for U.S. vaccine composition same as WHO
- Preparation of vaccine was on schedule and supply plentiful
- Mismatches noticed between strains included in the vaccine and strains circulating in winter of 2007-2008 (H3N2 and B)

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

- Inactivated seasonal influenza vaccines
- Fluzone (Sanofi-Pasteur)
- Fluvirin (Novartis)
- Fluarix (GSK)
- FluLaval (ID Biomedical [GSK])
- Afluria (CSL)
- Live attenuated seasonal influenza vaccine
- FluMist (MedImmune)

## Timelines for Vaccine Production

**Timelines for Vaccine Production**

## WHO Consultation on the Composition of Vaccines for the Northern Hemisphere, 2008-2009

- February 11-13, 2008
- Analyze the antigenic and genetic characteristics of seasonal influenza strains circulating globally, taking into consideration epidemiological data on influenza obtained from individual countries and regions.
- Make recommendations on the composition of the influenza vaccine for the northern hemisphere 2008 - 2009.
- www.who.int/csr/disease/influenza/recommendations2008_9north/en/index/html

## WHO Recommendations for Influenza Vaccine CompositionNorthern Hemisphere: 2008-2009

- “It is recommended that vaccines for use in the 2008-2009 influenza season (northern hemisphere winter) contain the following:
- an A/Brisbane/59/2007 (H1N1)-like virus
- an A/Brisbane/10/2007 (H3N2)-like virus
- a B/Florida/4/2006-like virus”
- “As in previous years, national control authorities should approve the specific vaccine viruses used in each country” – CBER and VRBPAC

## VRBPAC Committee AgendaFebruary 21, 2008

- Review of recent influenza virus surveillance data in the U.S and vaccine effectiveness
- CDC, Joseph Bresee, M.D.
- Review world surveillance and strain characterization
- CDC, Nancy Cox, Ph.D.
- Review vaccine coverage and effectiveness; sequence analysis of virus isolates
- DOD, Angela Owens, MPH and Thomas Gibbons, Ph.D.
- Review serological responses to current vaccines
- CBER, Zhiping Ye, M.D., Ph.D.
- Update on availability & timing of candidate strains and reagents
- CBER, Rajesh Gupta, Ph.D.
- Comments from manufacturers
- PhRMA, Tony Colegate (Novartis)
- Discuss and recommend which strains should be included for the 2008-2009 influenza virus vaccine in the U.S.

## Committee Discussion

- What strains should be recommended for the antigenic composition of the 2008-2009 influenza virus vaccine based on:
- the epidemiology and antigenic characteristics of influenza virus strains circulating in human populations
- the serologic responses to circulating influenza viruses of persons immunized with current influenza virus vaccines, and
- the availability of suitable vaccine candidate strains

## Options for Strain Composition for 2008-2009 Influenza Vaccines

- Influenza A (H1N1)
- Retain current vaccine strain A/Solomon Islands/3/2006-like virus
- Replace current vaccine strain with alternative H1N1 isolate
- A/Brisbane/59/2007 (H1N1)-like virus
- Others
- Influenza A (H3N2)
- Retain current strain A/Wisconsin/67/2005-like virus
- Replace current vaccine strain with alternative H3N2 isolate
- A/Brisbane/10/2007 (H3N2)-like virus
- Others
- Influenza B
- Retain current B/Malaysia/2506/2004-like virus
- Replace current vaccine strain with alternative
- B/Florida/4/2006-like virus
- Others