1. Influenza Vaccine Manufacturing
Industry Perspective for NH Vaccine Supply
The FDA CBER requested this annual summary of information from influenza vaccine manufacturers supplying the U.S., for purposes of a general presentation to the VRBPAC. This summary has been prepared  from a variety of public sources, and was reviewed by AstraZeneca, bioCSL, GSK, Novartis, Protein Sciences, and Sanofi Pasteur.

2. Industry Comments, VRBPAC 28 February 2014
Influenza Vaccines
~134 million doses distributed through 31 January 2014 and in line with season1
Transition to quadrivalent influenza vaccine (QIV) began during season with QIV volume ~20% of total doses
QIV volume will likely increase to over 50% for the season
As the variety of influenza vaccines has increased in recent years, healthcare providers are choosing different presentations for different patients
Timely strain selection by VRBPAC in February 2013 was very helpful
Challenges
A(H3N2) recommendation was “an H3N2 virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011” (clarified for WHO 2014 SH and NH recommendations)
Source: 1 (as of 12 Feb 2014)
Industry Comments, VRBPAC 28 February 2014

3. Vaccination Rates in 2012-13 Higher than in 2011-12
Overall immunization rate of 45% for individuals 6 months of age and older during the season
Significant increase in the 6 months - 17 years of age group (to 56.6%)
Slight increase in the 18 years of age and older group (to 41.5%)
According to the National Immunization Survey, overall immunizations grew slightly in the season; however, these rates are far below the current Healthy People 2020 goals of 80-90% coverage, depending on age group.
Source: (as of 12 Feb 2014)
Industry Comments, VRBPAC 28 February 2014

4. Total Cumulative Influenza Vaccine Claims in 2013-14 Higher than in 2012-13
~6%
Data suggest immunizations are up ~6% vs. prior year
Source: IMS Health Custom Study, Medical Claims Data, Week Ending 25 Jan 2014
Industry Comments, VRBPAC 28 February 2014

5. Influenza Vaccine Strain Changes
Season
A(H1N1)
A(H3N2)
B-Vic
B-Yam
Comment
First selection for QIV
n/a
No strain change
Three strain changes
Industry Comments, VRBPAC 28 February 2014

6. Influenza Vaccine Manufacturing Timeline
Jan
Dec
Nov
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct 4
FDA
Strain Selection
Annual
License
Approval
Vaccination
Produce &
Standardize Reagents
Surveillance &
Reassortants
Production
(may be at risk) 4
Production
(at risk)
Strain
Balancing 4
Formulation
Produce
Working
Seed
Filling &
Packaging
Distribution
Industry Comments, VRBPAC 28 February 2014

7. Influenza Vaccine Manufacturing Critical Factors
Global timing of strain selection ensures large vaccine supply
Available time to manufacture influenza vaccine is determined by
Need to distribute & administer vaccine well before the peak season
Availability of last vaccine strain
To ensure timely availability of influenza vaccine, manufacturing of at least one strain starts at risk before VRBPAC recommendations
Productivity of the least productive monovalent strain determines supply quantity
Availability of potency test reagents
Complex process to prepare and standardize potency reagents for new strains
Linked to global timing of strain selection for new strains
Availability of calibrated reagents determines start of influenza vaccine formulation
Industry Comments, VRBPAC 28 February 2014

8. Vaccine Strains under Evaluation for 2014-15 NH Vaccine
A(H1N1): A/California/7/2009-like
A/California/7/2009 and reassortants (IIV and LAIV)
A/Christchurch/16/2010 and reassortants (IIV)
A/Brisbane/10/2010 and reassortants
A(H3N2): A/Victoria/361/2011 cell-derived-like
A/Texas/50/2012 and reassortants (IIV and LAIV)
A/New York/39/2012 and reassortants
A/Almaty/2958/2013 and reassortants
Industry Comments, VRBPAC 28 February 2014

9. Vaccine Strains under Evaluation for 2014-15 NH Vaccine
B Yamagata lineage
B/Massachusetts/2/2012 and reassortants (IIV and LAIV)
B Victoria lineage
B/Brisbane/60/2008 and reassortants (IIV and LAIV)
B/Hong Kong/259/2010 and reassortants (IIV)
B/Nevada/3/2011 and reassortants (IIV and LAIV)
B/Texas/2/2013 and reassortants
Industry Comments, VRBPAC 28 February 2014

10. Industry Comments, VRBPAC 28 February 2014
Industry Agency Shared Responsibility for Successful Influenza Vaccine Production & Supply
Communication
Continued timely sharing of surveillance and candidate virus information
Bi-weekly WHO teleconferences key in challenging situations
Strain selection
Timely review and selection of the appropriate viral strains
Balanced consideration of strain surveillance, selection timing, and impact to vaccine availability
Virus and reagent availability
Early access of all reassortant labs (NYMC, NIBSC, bioCSL, AstraZeneca, etc) to wild-type viruses
Opportunity for manufacturers to evaluate growth characteristics of potential strain candidates
Availability of potency test reagents for new strains by June
Vaccine approval and release
Timely approval of annual license supplement
In-season lot review and release process
Industry Comments, VRBPAC 28 February 2014