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Rising to the Challenge: An Analysis of the Influenza Vaccine Landscape in Response to the Swine Flu Pandemic
CitelinePharma intelligence |
Gabrielle GessnerAssociate Director, Infectious& Genitourinary Diseases
Sean McDonnellDrug Analyst II
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Influenza viral outbreaks occur annually around the world, with some tropical regions experiencing year round viral circulation (WHO, 2013). Influenza viruses change, or drift, constantly, leading to different virus strains circulating each flu season or sometimes within a single season (CDC, 2013). Worldwide, these annual epidemics result in approximately three to five million cases of severe illness each year, and about 250,000 to 500,000 deaths (WHO, 2013).
The swine influenza pandemic in 2009/10 highlighted numerous challenges in providing effective influenza vaccine coverage. These include the long lag time between flu virus selection by government agencies and actual shipment of vaccine, resulting in possible mismatch of vaccine strains; the lack of production capacity; and the reluctance of some individuals to get vaccinated due to intramuscular administration or exclusionary conditions (ex. egg allergy).
This paper evaluates the methods manufacturers pursued in response to the swine flu pandemic, with an analysis of alternate manufacturing methods and routes of administration. We analyzed the clinical landscape of influenza vaccines since 2010, including approved vaccines and trial metrics, to identify how manufacturers addressed these issues and how effective they have been. Have the major players in influenza vaccines shifted? Are trial timelines or other characteristics different? With the recent emergence of novel viruses such as the MERS coronavirus, flexible vaccine production and short development timelines become even more vital in addressing future pandemics.
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addressing the challenges in influenza Vaccine ProductionManufacturers investigated various strategies since 2009 to address the challenges associated with
effective influenza vaccination. Traditionally, influenza vaccines have been produced in chicken eggs which
requires a long production time, so the vaccine strains have to be chosen 7-8 months prior to vaccine delivery.
Since the circulating influenza strains are not known this far in advance, virus strains that are not a close
match to the strains that actually circulate during the upcoming flu season may be selected, resulting in
reduced vaccine efficacy against clinical infection. Other issues associated with effective influenza vaccination
include limited vaccine supplies or patient preferences. As such, manufacturers explored ways to counteract
these obstacles by shortening vaccine production time via alternate manufacturing methods, adding
additional virus strains into the vaccine, and developing alternate routes of administration.
alternate Manufacturing Methods
Using cell culture techniques in the manufacturing process of influenza vaccines is one way to vastly reduce
the vaccine production time, primarily by eliminating the long lead time needed to grow the vaccine seed
virus in chicken eggs. This gives manufacturers the ability to provide additional vaccine supplies during a
season if needed or manufacture a new strain quickly in the event of a pandemic. Cell culture also offers
higher purity and provides a larger initial production volume than traditional egg-based processes. In
addition, cell culture eliminates any possibility of residual egg proteins remaining in the vaccine, making
the vaccine safe for individuals with an egg allergy.
In total, 38 cell culture vaccines were developed targeting influenza since the early 1990s (Figure 1).
Seasonal vaccines make up 37% (14) of these; however, the majority have been developed for specific
monovalent vaccines.
Source: Pipeline®, August 2013 Citeline
Figure 1. Cell Cultured Influenza Vaccines By Strain
H3N2, (1)
H5N1, (12)
H7N9, (1)
H9N2, (1)
H1N1, (6)
Pandemic(Unspecified),
(3)
Seasonal, (14)
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Source: Pipeline®, August 2013 Citeline
Figure 2. Companies Developing Cell Culture Manufactured Influnza Vaccines
0 1 2 3 4 5 6 7 Vivaldi Biosciences
UMN Pharma Takeda
SK Holdings Sanofi
Protein Sciences Polymun Petrovax Novavax Novartis
Non-industrial source Merck & Co
Medigen Biotechnology LG Life Sciences
Kaketsuken Johnson & Johnson
GlaxoSmithKline GE Healthcare Daiichi Sankyo
Cadila BioDiem
Bharat Biotech Baxter International
AstraZeneca Astellas
ADImmune Abbott
Number of Influenza Vaccines
Dev
elop
ing
Com
pan
y
Cell culture (unspecified)
EB66 duck cell
Insect (baculovirus)
Mammalian (unspecified)
MDCK
Vero
Of the 38 cell culture vaccines in development, 27 different companies have been involved (including
licensees) (Figure 2, Table 1). The clear leader in this field is Baxter, who invested in 6 separate Vero cell
culture vaccines, of which 3 have been successfully launched (PreFluCel, Celvapan H1N1 & Celvapan
H5N1). Novartis is also well established in this area with 5 vaccines, including their Phase II MDCK cell-based
H5N1 product. Rounding out the Top 3 is GlaxoSmithKline (GSK), developing 4 alternatives to traditional
egg-based methods.
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table 1. cell-cultured influenza Vaccines
Drug name Global status originator licensee Manufacturing influenza type
Flucelvax Launched NovartisMammalian (unspecified)
Seasonal
PreFluCel LaunchedBaxter International
Vero Seasonal
Celvapan, H5N1 LaunchedBaxter International
Vero H5N1
Celltura Launched NovartisCell culture (unspecified)
Pandemic (H1N1)
HN-VAC LaunchedBharat Biotech
Cell culture (unspecified)
Pandemic (H1N1)
Celvapan, H1N1 LaunchedBaxter International
VeroPandemic (H1N1)
MonoGrippol Neo Launched PetrovaxAbbVieAbbott
Cell culture (unspecified)
Pandemic (H1N1)
live attenuated influenza vaccine, BioDiem/Nobilon
Launched BioDiem Merck & Co Cell culture (unspecified) Seasonal
Influvac TC Registered Abbott AbbVie MDCK Seasonal
Flublok RegisteredProtein Sciences
AstellasUMN Pharma
Cell culture (unspecified)
Seasonal
Vapacel Registered TakedaBaxter International
Vero H5N1
influenza, H5N1, cell culture, Kitasato Daiichi Sankyo
Pre- registration
Daiichi SankyoCell culture (unspecified)
H5N1
influenza vaccine, PER.C6 Inflexal V, Crucell
Phase IIJohnson & Johnson
Cell culture (unspecified)
Seasonal
trivalent influenza vaccine (H3N2/H1N1/B), Novavax
Phase II Novavax
CadilaGE Health-careLG Life Sciences
Insect (baculovirus)
Seasonal
H5N1 pre-pandemic influenza vaccine, cell culture, Novartis
Phase II Novartis MDCK H5N1
VLP vaccine, influenza H5N1, Novavax
Phase II Novavax
Bharat BiotechLG Life Sciences
Insect (baculovirus)
H5N1
Panblok Phase IIProtein Sciences
UMN PharmaAstellasSanofi
Insect (baculovirus)
H5N1
Vero-Vac Phase I Polymun Vero Seasonal
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AT-301 Phase IMedigen Biotechnology
MDCK H5N1
H3N2c vaccine, Novartis Phase I NovartisCell culture (unspecified)
H3N2
H5N1 LAIV influenza vaccine, BioDiem
Phase I BioDiem Merck & CoCell culture (unspecified)
H5N1
H5N1 influenza vaccine, Baxter/DynPort
Phase IBaxter International
Vero H5N1
UMN-0901 Preclinical UMN PharmaInsect (baculovirus)
H9N2
H7N9 influenza vaccine, Novartis
Preclinical NovartisCell culture (unspecified)
H7N9
influenza vaccine, GSK, seasonal, cell culture
PreclinicalGlaxoSmith-Kline
KaketsukenEB66 duck cell
Seasonal
influenza vaccine, cell-culture, SK Chemicals
Preclinical SK HoldingsCell culture (unspecified)
Pandemic (Unspecified)
FluCell quadrivalent PreclinicalJohnson & Johnson
Cell Culture Seasonal
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Initially developed targeting avian influenza strains, the cell culture vaccines have exploded onto the
influenza landscape in response to the swine flu pandemic. These vaccines have addressed multiple
challenges of influenza vaccines, shortening production timelines and opening the market to additional
populations, such as those with egg allergies.
Quadrivalent Vaccines
The other method used to combat the strain drift of influenza added an additional strain to the existing
approved seasonal influenza vaccines, producing quadrivalent instead of trivalent vaccines. A number of
sponsors pursued this method with successful results.
Traditional seasonal influenza vaccines consist of the two main influenza type A strains and one influenza type
B strain. However, the 2013/14 season is the first where we will see the availability of several quadrivalent
vaccines, which contain an additional B strain. There are currently 4 quadrivalent vaccines approved for use
in the upcoming 2013-14 influenza season, with a further 5 vaccines advancing through the pipeline (Table 2).
table 1. cell-cultured influenza Vaccines (continued)
Drug name Global status originator licensee Manufacturing influenza type
Source: Pipeline®, August 2013 Citeline
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Source: Pipeline®, August 2013 Citeline
AstraZeneca’s (MedImmune’s) quadrivalent formulation of FluMist was the first quadrivalent influenza
vaccine to be approved worldwide (February 2012 in the US), and is also the only quadrivalent vaccine
available that is administered intranasally. It is currently awaiting EU approval from the EMA.
GSK’s quadrivalent Fluarix vaccine was the next to be approved in the US in December 2012. It is crucially
also approved in the UK (as Fluarix Tetra) and Germany (as Influsplit Tetra), and is currently awaiting further
regulatory rulings in Australia, Switzerland, and Taiwan. Being the only quadrivalent influenza vaccine
currently available outside of the US should give GSK a huge untapped market for the 2013/14 influenza
season, which will no doubt be reflected in their sales revenue for the 4th quarter of 2013.
Sanofi’s quadrivalent Fluzone formulation was approved in the US in June 2013. While arriving later to
an already crowded field, Sanofi has a major advantage over both AstraZeneca (MedImmune) and GSK
in that Fluzone quadrivalent is approved for infants as young as 6 months old, which is a full 18 months
earlier than FluMist quadrivalent and 30 months earlier than Fluarix quadrivalent. This gives Sanofi
complete exclusivity on all quadrivalent vaccine inoculations of infants and toddlers aged 6 months to
2 years of age in the US, a particularly vulnerable population for influenza infection.
The 4th and final quadrivalent vaccine approved in time for the 2013/14 influenza season is GSK’s second
quadrivalent influenza vaccine, FluLaval quadrivalent, which was approved in the US in August 2013. While
currently approved, GSK concedes that only a limited amount of FluLaval quadrivalent will be available in
2013. However, from 2014 onward, GSK should have the capacity to supply Flulaval quadrivalent to the US
from its manufacturing plant in Quebec, Canada and will also continue to manufacture Fluarix quadrivalent
from its facilities in Dresden, Germany and Pennsylvania, US.
table 2. Quadrivalent influenza Vaccines
Drug name Global status originator licensee Manufacturing Delivery route
FluMist quadrivalent LaunchedMedImmune (AstraZeneca)
Egg-based Inhaled, transnasal
Fluarix quadrivalent Launched GlaxoSmithKline Egg-basedInjectable, intramuscular
Fluzone quadrivalent vaccine, Sanofi
Launched Sanofi Egg-based
Injectable, intradermalInjectable, intramuscular
FluLaval quadrivalent Registered GlaxoSmithKline Egg-basedInjectable, intramuscular
influenza vaccine, Vaxigrip quadrivalent, Sanofi
Pre- registration
Sanofi Egg-basedInjectable, intramuscular
quadrivalent VLP seasonal flu vaccine, Novavax
Phase II NovavaxLG Life Sciences
Egg-basedInjectable, intramuscular
influenza vaccine, quadrivalent (MF59-adj), Novartis
Phase II Novartis Egg-basedInjectable, intramuscular
seasonal influenza vaccine, quadrivalent, Medicago
Phase I Medicago Plant based Unspecified
FluCell quadrivalent PreclinicalJohnson & Johnson
Cell CultureInjectable, intramuscular
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Figure 3. Quadrivalent Vaccine Trials by Phase
0
2
4
6
8
10
12
AstraZeneca GSK Medicago Novartis Novavax Sanofi
Sponsor
Num
ber
of
Tria
ls
Trial Phase
IV
III
II/III
II
8
current landscape in Quadrivalent Vaccine Development
Not surprising given their double threat in approved quadrivalent vaccines, GSK has conducted the
highest number of trials using quadrivalent influenza vaccines at 10 trials, followed by Sanofi with 8 trials
(Figures 3, 4). Almost all of GSK’s (9 out of 10 trials) and Sanofi’s (7 out of 8 trials) trials were in Phase III,
while AstraZeneca (MedImmune) is the only sponsor conducting Phase IV trials using their FluMist
quadrivalent vaccine, as of August 2013. Sanofi has the largest number of ongoing (planned, open, or
closed) quadrivalent vaccine trials (3 out of 8). Of note, there are no Phase I trials for quadrivalent vaccines,
primarily because this first crop were based on trivalent vaccines to speed development.
Source: Trialtrove®, August 2013 Citeline
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The other three sponsors testing quadrivalent vaccines in the clinic are Novartis, Novavax, and Medicago
(Figures 4, 5). Novavax is developing their quadrivalent vaccine for pediatric, adult, and elderly populations.
Notably, CSL decided not to pursue a quadrivalent vaccine, despite being a major player in trivalent
seasonal influenza vaccines.
Sponsor
0
2
4
6
8
10
12
AstraZeneca GSK Medicago Novartis Novavax Sanofi
Figure 4. Quadrivalent Vaccine Trials by Status
Num
ber
of
Tria
ls
Trial Status
Terminated
Planned
Open
Completed
Closed
Source: Trialtrove®, August 2013 Citeline
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With both quadrivalent and trivalent vaccines currently available to the public, it remains to be seen if
quadrivalent manufacturers will continue to produce their trivalent vaccines after the 2013/14 influenza
season. Provided there are no surprises during this transition season, the trivalent vaccines may eventually
be phased out in markets where the quadrivalent vaccine is approved.
alternate routes of administration
Various sponsors sought alternate routes of administration to address supply issues and tap into increased
patient preference and/or additional populations. Traditional influenza vaccines are administered intramuscularly
or intranasally. Intradermal (ID) and subcutaneous (SC) administrations have been pursued as dose-sparing
methods since they require less volume to administer. These routes of administration may also be preferable
to some subjects who aren’t eligible for the live intranasal vaccine since they use a smaller needle and don’t
require placement into the muscle tissue. However, intradermal and subcutaneous administration can be more
difficult for health providers to provide consistently without additional training. Additionally, since the intranasal
vaccine is a live viral vaccine, it is contraindicated for people with asthma or respiratory issues. As such, another
route of administration would provide an alternate to intramuscular vaccines for people with these conditions.
Source: Trialtrove®, August 2013 Citeline
Figure 5. Current Landscape for Quadrivalent Vaccines
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0
5
10
15
20
25
30
AbbVie
Astella
s Pha
rma;
UMN P
harm
aBax
ter
CLL P
harm
a
CSL Lt
d
Daiich
i San
kyo
Denka
Seike
n
Echo Th
erap
eutic
s
GSK
Inovio
Pha
rmac
eutic
als
John
son &
John
son
Kaket
suke
n
Med
icago
Novarti
s
Pfizer
Sano
fi
Sano
fi Pas
teur
MSD
SEEK
Valne
va
VaxIn
nate
Figure 6. Intradermal and Subcutaneous Influenza Vaccine Trials
SC
ID & SC
ID
Route of Administration
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Source: Trialtrove®, August 2013 Citeline
Source: Trialtrove®, August 2013 Citeline
Sanofi is followed by Inovio Pharmaceuticals and Novartis with 4 trials each. Inovio is also focusing on intradermal
administration, while Novartis is pursuing both intradermal and subcutaneous formulations. In subcutaneous
formulations, Novartis, VaxInnate and CSL are all active in the clinic with 3 trials each (Figures 7, 8).
0
5
10
15
20
25
30
CLL P
harm
a
Daiich
i San
kyo
Echo Th
erap
eutic
s
GSK
Inovio
Pha
rmac
eutic
als
John
son &
John
son
Med
icago
Novarti
s
Pfizer
Sano
fi
Sano
fi Pas
teur
MSD
Valne
va
VaxIn
nate
Figure 7. Intradermal Vaccine Trials by Phase
IV
III
II
I/II
I
Trial Phase
Sanofi (Sanofi and Sanofi Pasteur MSD) is by far the leader in evaluating vaccines with alternate routes of
administration, with 85% more trials than their nearest competitors (Figure 6). This isn’t surprising considering
they have the only approved intradermal formulation with Fluzone intradermal.
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changes in the influenza Vaccine landscapeTo understand any changes that occurred in the influenza vaccine competitive landscape as a result of the
2009/10 swine flu pandemic, we compared a number of areas before and after January 2010, including
vaccine approvals, sponsors, and trial metrics.
changes in approved influenza Vaccines
The 2009/10 influenza virus pandemic placed government agencies worldwide under enormous pressure
to act swiftly and decisively due to intensified media coverage. One outcome of this was that manufacturers
were encouraged to develop monovalent vaccines against the new H1N1 strain with the promise of
expedited regulatory approval.
September 2009 saw the initial wave of these H1N1 vaccine approvals (7 in total) as the 2009/10 influenza
season began in earnest in the Northern Hemisphere (Figure 9, Table 3). Two vaccines were approved quickly
in the EU: GSK’s Pandemrix H1N1 and Novartis’ Focetria H1N1. Both vaccines were initially authorized
under ‘exceptional circumstances’ by the EMA due to the high medical need, despite a lack of clinical
information. This limited approval was eventually lifted in August 2010 after both companies were able
to supply the necessary clinical data. Similarly, the US also approved 4 H1N1 vaccines in September 2009,
manufactured by Sanofi, CSL, Novartis and AstraZeneca (MedImmune).
Source: Trialtrove®, August 2013 Citeline
0
0.5
1
1.5
2
2.5
3
3.5
AbbVie
Astella
s Pha
rma;
UMN P
harm
aBax
ter
CSL Lt
d
Denka
Seike
n
Kaket
suke
n
Novarti
s
Sano
fi
SEEK
VaxIn
nate
Figure 8. Subcutaneous Vaccine Trials by Phase
IV
III
II/III
II
I/III
Trial Phase
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Source: Pipeline®, August 2013 Citeline
October 2009 saw another 5 first-time approvals for monovalent H1N1 vaccines. Baxter’s Celvapan H1N1,
the only approval that month in the EU, made history by becoming the first cell culture influenza vaccine
approved. Green Cross, Microgen and GSK also gained premier approvals for vaccines during October
2009 in South Korea, Russia and Canada, respectively. The number of new approvals trailed off considerably
after October, with only 4 new vaccines coming to market in 2009, including Novartis’ Celtura and Petrovac’s
MonoGrippol Neo cell culture products. In 2010, a further 5 H1N1 vaccines were approved by regulatory
agencies, 4 in India and 1 in Taiwan.
Sep-09 Oct-09 Nov-09 Dec-09 May-10 Jul-10 Aug-10 Sep-10 Oct-10
ADImmune 0 0 0 0 0 0 0 1 0
AstraZeneca 1 0 0 0 0 0 0 0 0
Baxter International 0 1 0 0 0 0 0 0 0
Bharat Biotech 0 0 0 0 0 0 0 0 1
BioDiem 0 0 0 0 0 1 0 0 0
CSL 1 0 0 0 0 0 0 0 0
GlaxoSmithKline 1 1 0 0 0 0 0 0 0
Green Cross 0 1 0 1 0 0 0 0 0
Microgen 0 2 0 0 0 0 0 0 0
Novartis 2 0 1 0 0 0 0 0 0
Petrovax 0 0 0 2 0 0 0 0 0
Sanofi 1 0 0 0 0 0 0 0 0
Serum Institute of India 0 0 0 0 0 0 1 0 0
Sinovac Biotech 1 0 0 0 0 0 0 0 0
Zydus Cadila 0 0 0 0 1 0 0 0 0
0
1
2
3
4
5
6
7
8
No.
of A
pp
rove
d H
1N1
Vacc
ines
By
Mon
th
Figure 9. Timeline Of H1N1 Vaccine First Approvals By Originator
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changes in trial landscape
There were some shifts seen in the major players in influenza vaccine development after the 2009/10
pandemic (Figures 10, 11). GSK, Sanofi, and Novartis remained the top three sponsors of influenza vaccine
trials both before and after January 2010. However, AstraZeneca (Medimmune), Pfizer, and AbbVie
dropped off the Top 10 sponsors after January 2010, indicating their shift in focus away from influenza
vaccine development. Baxter and CSL remained in the Top 10, with the entrance of Johnson & Johnson,
Serum Institutes of India, AdImmune, and Novavax to round out the Top 10 after January 2010.
Source: Pipeline®, August 2013 Citeline
table 3. H1n1 influenza Vaccines approved Worldwide since 2009/10 Pandemic
Vaccine name originator licenseeDate of 1st approval
region of first approval
Panflu.1 Sinovac Biotech Boryung Sep-09 China
Pandemrix H1N1 GlaxoSmithKline Sep-09 EU
Panenza Sanofi Sep-09 US
Panvax H1N1 CSL Sep-09 US
Focetria H1N1 Novartis Sep-09 EU
Fluvirin H1N1 Novartis Sep-09 US
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
AstraZeneca Sep-09 US
Celvapan, H1N1 Baxter International Oct-09 EU
Green Flu-S Green Cross Oct-09 South Korea
Influvir Microgen Oct-09 Russia
Pandeflu Microgen Oct-09 Russia
Arepanrix GlaxoSmithKline Oct-09 Canada
Celtura Novartis Nov-09 Germany
Green Flu-S Plus Green Cross Dec-09 South Korea
MonoGrippol Neo Petrovax AbbVie Dec-09 Russia
MonoGrippol Plus Petrovax Dec-09 Russia
VaxiFlu-S Zydus Cadila May-10 India
NasoVac BioDiem
Serum Institute of IndiaMerck & CoChangchun BCHT Biotechnology
Jul-10 India
EnzavacSerum Institute of India
Aug-10 India
AdimFlu-S ADImmune Sep-10 Taiwan
HNVAC Bharat Biotech Oct-10 India
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Source: Trialtrove®, August 2013 Citeline
0 50 100 150 200 250
GSK
Novartis
Sanofi
AstraZeneca
Medimmune
Pfizer
CSL
Baxter
AbbVie
Sinovac Biotech
Figure 10. Top 10 Industry Sponsors of Influenza Vaccine Trials Prior to January 2010
avian/pandemic
seasonal
swine/pandemic
Vaccine Type
Number of Trials
Source: Trialtrove®, August 2013 Citeline
Figure 11. Top 10 Industry Sponsors of Influenza Vaccine Trials After January 2010
0 50 100 150 200 250
GSK
Novartis
Sanofi
Johnson & Johnson
ADImmune
Baxter
Novavax
Sanofi Pasteur MSD
Serum Institute of India
CSL avian/pandemic
seasonal
swine/pandemic
Number of Trials
Vaccine Type
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0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
Seas
onal
Swine
Avian
Seas
onal, S
wine
Seas
onal, A
vian
Figure 12. Influenza Vaccine Trial Metrics [Prior to January 2010]
Avg Countries per Trial
Avg Reported Sites per Trial Avg Predicted Max Enroll Period per Trial (months)
16
Source: Trialtrove®, Trialpredict®, August 2013 Citeline
Looking at the comparison between trial metrics before and after January 2010, there does not seem
to be much of a change in the countries per trial or average sites per trial (Figures 12, 13). However, while
the average predicted maximum enrollment rate per trial remained the same for most types of vaccines,
there was a significant increase in the average enrollment rate for seasonal and avian vaccine combination
trials. This could reflect decreased volunteer interest in avian influenza vaccine trials following the swine
influenza pandemic.
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Source: Trialtrove®, Trialpredict®, August 2013 Citeline
During the 2009/10 swine flu pandemic, manufacturers swiftly responded to the public health crisis with
additional influenza vaccine approvals in a very short timeframe. The leaders in influenza vaccines solidified
their presence in this area, with the emergence of some new companies in this area as well.
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
Seas
onal
Swine
Avian
Seas
onal, S
wine
Seas
onal, A
vian
Figure 13. Influenza Vaccine Trial Metrics [After January 2010]
Avg Countries per Trial
Avg Reported Sites per Trial Avg Predicted Max Enroll Period per Trial (months)
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conclusionThe 2009/10 H1N1 influenza pandemic caused a shift in the traditional focus and processes surrounding
influenza vaccine production. Manufacturers rose to the challenge posed by the pandemic and explored
additional options to increase flexibility in influenza vaccine production. This resulted in even greater
innovation and multiple strategies that improved manufacturing processes as well as offering multiple
vaccine types, both of which were successful in addressing this serious public health challenge.
With the emergence of the H7N9 influenza strain in Asia during the spring of 2013, these methods will
be essential in facing new influenza pandemics, and applicable to other viral pandemics that may emerge.
Will manufacturers who focused on one strategy, like GSK’s two quadrivalent vaccines approved in multiple
markets, come out on top? Or will it be the manufacturers that focused on multiple strategies like Sanofi
with a quadrivalent vaccine (Fluzone QIV) in additional populations (infants and toddlers), an intradermal
vaccine (Fluzone ID), and a high-dose vaccine for the elderly (Fluzone HD)? The upcoming Northern Hemis-
phere influenza season will be followed with great interest as we see the answers to these questions play out.
referencesCDC, 2013, http://www.cdc.gov/flu/about/season/flu-season-2013-2014.htm WHO, 2013, http://www.who.int/mediacentre/factsheets/fs211/en/index.html
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