VACCINES IN THE
PIPELINE:
WHAT’S NEW OR
COMING SOON
Sharon Rush, R.Ph.
Clinical Assistant Professor
University of Texas College of Pharmacy
Objectives
 Review the effect of immunizations on
morbidity and mortality rates of vaccinepreventable diseases in the United States
 Review how vaccines evoke an immune
response and provide immunity
 Discuss recently approved vaccines for
general use
 Discuss vaccines under FDA review or Phase
III
Calvin and Hobbes is one of the
best cartoon strips ever!
1. Yes, it rocks!
2. No, the kid is a brat!
3. Calvin who??
Hobbes who??
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0%
2.
0%
3.
MORBIDITY AND MORTALITY
Morbidity Rates
DISEASE
1950
1960
1970
1980
1990
2000
2011
Diphtheria
5796
918
435
3
4
1
0
Tetanus
486
368
148
95
64
35
9
Pertussis
120,718
14,809
4,249
1,730
4,570
7,867
15,216
Polio
(paralytic)
33,300
3,190
33
9
6
0
0
Measles
319,124
441,703
47,351
13,506
27,786
86
212
Mumps
NR
NR
104,953
8,576
5,292
338
370
Rubella
NR
NR
56,552
3,904
1,125
176
4
Hepatitis A
NR
NR
56,797
29,087
31,441
13,397
1,139
Hepatitis B
NR
NR
8,310
19,015
21,102
8,036
2,495
Varicella
NR
NR
NR
190,894
173,099
27,382
12,041
*www.cdc.gov/vaccines Morbidity and Mortality Report - May, 2011
Why are Pertussis cases
increasing?
1. People are no longer
getting the pertussis
vaccine
2. Immunity from the
pertussis vaccine
wanes over time
3. I have no idea!
0%
1.
0%
2.
0%
3.
Pertussis
 In the June 2013 meeting, ACIP reported preliminary
findings of recent studies involving the pertussis
vaccine duration
 11 to 14 year olds:
 After 1st year  75% effective
 After 3rd year  56% effective
 One to seven years post-vaccination
 41% effectiveness in 15 to 19 year olds
 Ten years post-vaccination
 Close to pre-vaccination status
 ACIP working group does not recommend a second Tdap
dose at this time despite increased burden of disease. New
pregnancy guidelines will hopefully show improvement in
cases.
Mortality Rates
DISEASE
1950
1960
1970
1980
1990
2000
2011
Diphtheria
410
69
30
1
1
0
NA
Tetanus
336
231
79
28
11
5
NA
Pertussis
1,118
118
12
11
12
12
NA
Polio
(paralytic)
1,904
230
7
2
0
0
NA
Measles
468
380
89
11
64
1
NA
Mumps
NR
42
16
2
1
2
NA
Rubella
NR
12
31
1
8
0
NA
Hepatitis A
NR
NR
NA
112
76
106
NA
Hepatitis B
NR
NR
NA
294
816
886
NA
Varicella
NR
NR
NA
78
120
44
NA
*www.cdc.gov/vaccines Morbidity and Mortality Report - May, 2011
Why was there a spike in
measles cases in 1990?
1. Vaccine shortage
2. Failure to vaccinate
children at the
appropriate age
3. Philosophic or
religious
exemptions to
vaccinations
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1.
0%
2.
0%
3.
IMMUNE RESPONSE
Let’s Follow the Flu….
Target
area for
current
influenza
vaccines
*Image from cdc.gov website
• Each microbe
Macrophages
carries its own
engulf antigenset of unique
carrying microbes
antigens.
Identification of
these antigens are
a key step in
creating effective
vaccines
Antigens are
carried back to
the lymph nodes
and
“regurgitated”
Lymphocytes
recognize the
antigen and
destroy it
Memory Cells
 Once the infection is
cleared, the body
converts some of the
lymphocytes into
memory cells. If the
infection occurs again,
these cells can
recognize the antigen
quickly and respond.
Lymphocytes
 T cells
 B cells
 Cell-mediated response
 Humoral immune or
 Do not attack antigen
antibody response
 Make and secrete
antibodies that grab
onto the antigen like a
puzzle.
 These antibodies bind to
the microbe and render
it unable to function
directly
 Use chemicals to
eliminate infected cells
Antigen Load in Vaccines
 The goal of most current vaccines is to stimulate
the humoral immune or antibody response in B
cells. Many infectious microbes can be defeated
by antibodies alone.
 One antibody fits with one antigen, so millions of
antibodies need to be present.
 Once vaccine is administered, the body
recognizes it as an antigen and develops B and T
cells particular to that antigen. Memory cells are
produced for future infections.
 This cycle usually takes about 2 weeks to
complete.
How many kinds of T cells are
there in the immune response?
1. One
2. Two
3. Three
4. Millions!
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0%
2.
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3.
0%
4.
T Cells
 “Killer”
 “Helper”
 Offensive T cells
 Defensive T cells
 Programmed by
 Secrete chemical
prior exposure to the
antigen
 “Sense” infected
cells
signals that direct
the activity of other
immune system
cells. They activate
“killer” T cells and B
cells.
Remember the role that these T cells play in the immune response.
These T cells play a key role in new vaccine development.
RECENTLY APPROVED VACCINES
Which of the following influenza
vaccines were available in 20132014?
1. Trivalent
2. Quadrivalent
3. Recombinant egg-
free
4. All of the above
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2.
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Influenza Vaccine 2013-2014
 Trivalent (IIV3)*
 An A/California/7/2009 (H1N1)
 An A/Victoria/361/2011 (H3N2)
 A B/Massachusetts/2/2012-like virus
 Quadrivalent (IIV4 or LAIV4)*
 Addition of a B/Brisbane/60/2008-like virus
*Note new abbreviations
Influenza Vaccine 2013-2014
VACCINE AND MANUFACTURER
SPECIAL NOTES
TYPE
Afluria (CSL Biotherapies)
IIV3
Agriflu (Novartis)
IIV3
Fluarix Quadrivalent (GSK)
IIV4
FluLaval & FluLaval Quadrivalent (GSK)
•
•
MDV – preservatives
Pre-filled syringes PF
Fluvirin (Novartis)
Fluzone & Fluzone Quadrivalent (sanofi
pasteur)
IIV3 &
IIV4
IIV3
Quadrivalent
•Only one available for 6
months to 2 yrs of age
•No preservatives or latex
•Pre-filled syringes or
single dose vials
IIV3 &
IIV4
Fluzone High-Dose (sanofi pasteur)
IIV3 only
Fluzone Intradermal (sanofi pasteur)
IIV3 only
*Note that all of these have differing age requirements – refer to package insert
Influenza Vaccine 2013-2014
*No egg protein detectable in the final product due to multiple dilutions
The New Kids on the Block…
 Flucelvax®
 Cell-based
 Flublok®
 Uses baculovirus-insect
 Virus grown in liquid
culture of animal cells
 Vaccine seed strain is
passaged in eggs so could
contain minute amount of
albumin  egg allergy
potential
 Potentially affords a faster
manufacturing response to
a pandemic




cell system
Contains recombinant
protein
Only influenza vaccine
considered 100% egg-free
Potentially affords a faster
manufacturing response to
a pandemic
Short shelf life of 16 weeks
from production date
Influenza Vaccine 2014-2015
 A/California/7/2009 (H1N1) pdm09-like virus
 A/Texas/50/2012 (H3N2)-like virus
 B/Massachusetts/2/2012-like virus
Quadrivalent vaccines will add:
 B/Brisbane/60/2008-like virus
H5N1
 Since December 2013 – 652 cases with 387
deaths confirmed in 16 countries. No evidence
of sustained human-to-human transmission.¹
 January 8, 2014 – Public Health Agency of
Canada reported first confirmed case of human
infection with avian influenza A (H5N1)
 Person had traveled to Beijing, China Dec 27, 2013 and
died January 3, 2014
 No reported cases in the United States
¹World Health Organization. Recommended composition of influenza virus vaccines for use in the 2014-2015 northern hemisphere influenza season report. February 20, 2014.
H5N1 Vaccine
 ACIP reports there are two FDA-licensed H5N1
vaccines being stockpiled by the government for use
in pandemics
 ACIP has been instructed to develop recommendations for:
 Use during non-pandemic period
 Used in certain high-risk groups
 Findings to be reported at October 2014 meeting
 Possible vote at February 2015 meeting
 CDC website for detailed info on treatment and
prevention
http://www.cdc.gov/flu/avianflu/h7n9-faq.htm#vaccine
If a patient has anaphylaxis from
eating eggs, can they receive the
influenza vaccine?
1. No
2. Yes
3. Yes, with
limitations
4. Are you kidding?
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2.
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4.
Egg Allergy and Influenza
Vaccine
 New algorithm developed
 Further differentiates reactions
 Includes new recombinant vaccine option
 Addresses allergy testing procedures
Patient can
eat eggs
Yes
No
Patient only has
hives when
eating eggs
Yes
Administer per
Protocol
Administer recombinant
IIV if age 18 to 49
OR
Administer IIV and
observe for 30 minutes
No
Patient has other
symptoms:
CV changes
(hypotension),
anaphylaxis,
respiratory distress,
GI, requires Epi or
medical intervention
Yes
Administer recombinant IIV
if age 18 to 49
OR
Refer to physician with
expertise in allergic
conditions management for
further evaluation
Egg Allergy and other Vaccines
 Egg allergy is specific to each vaccine
 History of egg allergy not relevant – use
current guidelines algorithm
 Influenza
 Varicella
 MMR
 History of egg allergy relevant – “Scratch test”
recommended prior to administration via
desensitization
 Yellow fever
Egg Allergy and other Vaccines
 Previous reaction to vaccine:
 Identify symptoms
 Ascertain risk of disease
 Application of skin tests by physician with
expertise in allergic conditions if applicable
 Vaccination under control protocol based on
results of skin test
Other Allergies and Vaccines
 Not considered a contraindication to
administration of vaccines UNLESS allergy is
deemed severe. Contact allergy is usually not
considered a severe allergy.
 Thimerosol
 Neomycin
 Latex
**FluMist has less flexibility due to its respiratory
component. Wheezing IS a contraindication.
How many pneumococcal shots does a
patient need in a lifetime after the
recommended childhood series?
1. 1 or 2
2. 3
3. Every 5 years
4. It depends on the
disease state
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2.
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3.
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4.
Pneumococcal Vaccine
NOTE: All information applies to patients
after their recommended routine childhood
vaccinations.
 People with no chronic illnesses get one
dose ≥ 65 yrs of age
 People ≥2 y/o and up with chronic illness
will get two to four doses depending on
disease state
When do you Revaccinate?
 Revaccinate once (total of two doses in a lifetime) for:
 Healthy patients ≥65 y/o who received their initial dose
before the age of 65 and ≥5 years ago
 Persons 19 through 64 years of age with the following
conditions are revaccinated 5 years after the first dose and
may receive a third dose depending on age of patient:
 Chronic renal failure or nephrotic syndrome
 Functional or anatomic asplenia
 Immunocompromised patients
Immunocompromised Conditions









Congenital or acquired immunodeficiency
HIV infection
Chronic renal failure
Nephrotic syndrome
Leukemia
Lymphoma
Hodgkin disease
Generalized malignancy
Iatrogenic immunosuppression – diseases requiring treatment
with immunosuppressive drugs, including long-term systemic
corticosteroids and radiation therapy
 Solid organ transplant
 Multiple myeloma
Three Doses of PPSV23
 Patients that are asplenic,
immunocompromised or have chronic renal
failure or nephrotic syndrome may receive up
to three doses in a lifetime depending on time
of diagnosis:
 Receive one dose of PPSV23 at time of diagnosis
 Receive second dose of PPSV23 five years later
 Receive third dose of PPSV23 after the age of 65
if prior two doses were given before the age of 65
NOTE: All doses need to be 5 years apart
PCV13
 Prevnar 13®
 Will replace PCV7 in children
 Add one additional dose of PCV13 to current
regimen of PPSV23
 Applies only to the following groups:
 Functional or anatomic asplenia
 Immunocompromised patients
 CSF (cerebrospinal fluid) leaks
 Cochlear implants
 Do NOT add additional dose of PPSV23 instead
– Lack of evidence and possibility of waning
response
PCV13 Additional Dose
Administration
 If patient is vaccine naïve:
PCV13  PPSV23  PPSV23 + PPSV23
≥ 8 weeks
≥ 5 years
65+ yrs of age
PCV13 Additional Dose
Administration
 If patient has received one dose of PPSV23:
5 years between PPSV23 doses
PPSV23  PCV13  PPSV23 + PPSV23
≥ 1 year
≥ 8 weeks
65+ yrs of age
PCV13 Additional Dose
Administration
 If patient has received two doses of PPSV23:
≥ 8 weeks
PPSV23  PPSV23  PCV13 + PPSV23
≥ 5 years
≥ 1 year
65+ yrs of age
PCV13 Additional Dose
Administration
 If patient has received three doses of
PPSV23:
≥ 1 year
PPSV23  PPSV23 + PPSV23  PCV13
≥ 5 years
65+ yrs of age
Meningococcal
Meningococcal and HIV
 Men who have sex with men (MSM)
 Small increased risk, burden of disease is low
 High proportion of cases in HIV-infected patients
 No proposed recommendations at this time but will continue to
study
 HIV-infected patients
 Surveillance data from 8-county area of Atlanta, GA from 1988-1993
revealed HIV-infected adults had almost 24-fold increased risk for
developing meningococcal disease¹
 ACIP Meningococcal Work Group does not propose changes to current
recommendations at this time
 HIV cases declining + low incidence of meningococcal cases
 HIV-infected patients demonstrate short duration of protection
with meningococcal vaccine²
¹Stephens DS, Hajjeh RA, Baughman WS, Harvey RC, Wenger JD, Farley MM. Sporadic meningococcal disease in adults: results of a 5-year population-based study. Ann Intern
Med. 1995: 123:937-40
²ACIP October 23-24, 2013 minutes – Meningococcal Work Group
Meningococcal A Strain
 Meningitis Vaccine Project
 PATH, WHO and Bill & Melinda Gates Foundation
 Serogroup A predominates in Africa and Asia
 MenAfriVac ® - monovalent, serogroup A conjugate
vaccine
 Immunogenic in young children
 Reduces carriage of bacteria in throat secretions
 Very cost-effective due to monovalent vaccine - 40¢/dose
 Mass vaccination campaigns among 1 to 29 year olds
 Successful clinical trials throughout India, Mali,
Senegal and the Gambia
*CDC website, World Health Organization website
Chad Trial
 One of largest countries in Africa
 Meningitis cases
 2009 – 3058
 2010 – 5960
 2011 – 3795
Majority of cases due to
Serogroup A
 Nationwide vaccination of 1 to 29 year olds
from June through December 2012 with 81 to
95% vaccination rates
 Results – No Serogroup A cases during
epidemic season
Adenovirus
Adenovirus
 Viruses
 Common, many types
 Types 4 and 7 – severe outbreaks of respiratory illness among military
 Cause of respiratory problems, headaches, eye infections, sore throat
 Spread easily through the air
 Vaccine
 Used by military from 1971- 1999 but discontinued by manufacturer
 New vaccine by Teva approved by FDA in March 2011 for respiratory
ailments in 17 – 50 years of age
 Live virus given as oral tablets – one with Type 4 and one with Type 7
 For military personnel only – not available to general public
 Contract with Department of Defense included performance criteria that
the vaccine had to provide at least 80% protection of those persons
immunized¹
¹Towle AC, Azad A. How industry developed and manufactured Live Oral ADV4 and 7 Vaccine for a critical customer. Contract Pharma magazine website March 7, 2014
INVESTIGATIONAL VACCINES
What virus goes virtually
undiagnosed in ~80% of patients?
1. HIV
2. Norovirus
3. The common cold
4. Herpes Simplex
0%
1.
0%
2.
0%
3.
0%
4.
Herpes Simplex
HSV-2
 Herpes simplex virus type 2¹
 One of most common sexually transmitted
infections worldwide
 Of those infected, >80% have not received a
diagnosis
 Strong association between HSV-2 and HIV
infections
 Vaccines
 GEN-003 by Genocea Biosciences, Inc.
 HSV529 by Sanofi Pasteur
¹CDC Morbidity and Mortality Weekly Report. April 23, 2010/59(15): 456-459.
GEN-003
 Designed to treat HSV-2
 Administered with Matrix-M™ adjuvant
 Novel, saponin-derived product that demonstrates a balanced B
and T cell immunostimulatory profile
 Harnesses power of T cell immunity
 Identifies protective T cell antigens from naturally exposed humans
 Can potentially improve effectiveness of vaccine and reduce time
needed to create vaccines
 March 25, 2014 – Phase 1/2a study results
 Double-blind, placebo-controlled, dose-escalation in 143 patients.
 Patients received three injections of assigned treatment at 21-day
intervals and then followed for 1 year.
 Patients receiving 30mcg dose level experienced 72% reduction in
lesion days six months after study initiation. Patients experienced
50% reduction in mean viral shedding that was maintained at six
months.
*Providence Journal website – www.providencejournal.com. Genocea Publishes Preclinical Data for Investigational Vaccine Candidate for HSV-2. March 18, 2013.
*Monthly Prescribing Reference website – www.empr.com. Investigational Vaccine Efficacious in HSV-2 Trial. March 25, 2014.
HSV529
 Prevention of genital herpes
 Phase I trial sponsored by National Institute
of Allergy and Infectious Diseases
 Will test for safety and ability to generate an
immune response in 60 adults aged 18 to 40
years
 Completion expected in October 2016
*The Medical News website – www.news-medical.net. Researchers launch clinical trial of investigational vaccine designed to prevent genital herpes disease. April 21, 2014
HPV
 V503 by Sanofi Pasteur
 9-valent HPV vaccine
 Current types 6, 11, 16 and 18
 Additional types 31, 33,45, 52 and 58
 Phase III study results
 Study involved 16 to 26 year old non-infected females who
received three doses over a 1-year period (N=7099)
 Prevented ~97% of cervical, vaginal and vulvar pre-cancers
 Protocol 002 study involved male subjects age 9 to 15 years and
females age 9 to 26 years (N=3074)
 99.8 to 100% of adolescent males and females (age 9 to 15)
seroconverted
 99.5 to 100% of females aged 16 to 26 years seroconverted
Merck Newsroom Home website – www.mercknewsroom.com. Merck’s Investigational 9-valent HPV Vaccine, V503, Prevented 97 Percent of Cervical, Vaginal and Vulvar Precancers Caused by Five Additional HPV Types, in Phase III Study
HPV – 2 dose versus 3 dose
 Gardasil® by Sanofi Pasteur
 Quadrivalent vaccine currently dosed at 0,2 and 6 months)
 Randomized, Phase III, postlicensure, multicenter, age-stratified,
noninferiority immunogenicity study
 Females aged 9 to 13 years (N=520)
 Females aged 16 to 26 years (N=310)
 Results
 Geometric Mean Titer ratios for 2-dose series noninferior to 3-dose
series for all genotypes to 36 months
 Antibody responses for 2-dose series noninferior to 3-dose series for
all genotypes at month 7
 Not for HPV-18 by month 23
 Not for HPV-6 by month 36
 More data on duration of 2-dose series protection needed before
recommending reduced-dose schedule
Dobson SRM et al. Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women. JAMA, May 1, 2013 – Vol 309, No. 17, 1793-1802.
HIV
 Early studies targeted antibody response
 HIV mutates rapidly and outer spike protein
conceals itself from immune response
 Evolving number of virus subtypes +
recombinations
 Vaccine
 ALVAC® HIV (the prime) by Aventis Pasteur +
AIDSVAX® B/E (the boost)
RV144 Study
 Thailand Ministry of Health and U.S. Army
 Four doses of prime ALVAC® HIV vaccine
followed by two doses containing both vaccines
 Results
 Infection rate 31.2% lower than the placebo group
 Efficacy peaked early through initial 12 months and
then declined quickly suggesting boosting doses
would improve results
 Modest effectiveness but has led to further
research in HIV genome sequences
HIV Research website – www.hivresearch.org. U.S. Military HIV Research Program RV144 Trial
RV305 Study
 Began April 2012
 Evaluate boosting effect in current RV144 study patients
RV306 Study
 Began September 2013
 Using RV144 vaccine regimen to compare additional boosts
 Using 360 new volunteers for more immunogenicity data
Pox-Protein Public-Private Partnership (P5)
 Begin 2016-17
 Improve and prolong the level of immunogenicity
 Extra vaccine boost
 Improved adjuvants
HIV Research website – www.hivresearch.org. U.S. Military HIV Research Program RV144 Trial
Scripps Research Institute
 New vulnerable site on HIV virus identified –
PGT151
 Does not vary from strain to strain
 PGT151 is a protein used to infect cells
 Antibody can attach to PGT151 and leave the virus
incapable of infecting cells
BOTTOM LINE: Great strides are being made
but no vaccine will be available until at least
2020.
Science Daily website – www.sciencedaily.com. New point of attach on HIV for vaccine development. April 24, 2014
Norovirus
Norovirus
 Leading cause of severe gastrointestinal
infection in the U.S.
 Causes ~90% of all epidemic non-bacterial
outbreaks of gastroenteritis worldwide
 Transmitted via contaminated food or water ,
person-to-person contact or aerosolization of
virus
 Vaccine
 GI/GII by Takeda Pharmaceutical Company
Limited
GI/GII
 Contains genotype GII.4 – most common
 Phase ½ study results
 Randomized, double-blind, placebo-controlled, multi-center




study with 98 healthy adults aged 18 to 50 years receiving
two doses
Well tolerated
Clinically relevant impact on incidence of disease after
challenge
In those that experienced illness, severity was significantly
reduced
Positive trend in reducing viral shedding in stool observed
Takeda website – www.takeda.com. Takeda Highlights Data from Clinical Trial of Investigational Norovirus Vaccine Candidate. October 4 and 7, 2013
Ebola
Ebola
 Mainly seen in Africa
 Fatality rate up to 90%
 Transmitted via direct contact with bodily
secretions from humans or other animals
 No specific treatment available
 Vaccine
 UT College of Pharmacy and two Canadian researchers
 One-dose nasal vaccine proven effective in rodent and
primate subjects
 Issues with human trials
Meninigitis B
Meningitis B
 Serogroups B and C predominate in Europe, the
Americas, Australia and New Zealand
 Current U.S. vaccines cover Serogroup C
 Target outer polysaccharide capsule as the antigen
 MenB vaccine difficult to develop
 Outer coating is not well-recognized by our immune
system as an antigen  no immune response initiated
 Outer membrane proteins vary greatly by strain, so
vaccines have only been able to target specific strains
MenB Investigational Vaccines
 Genome sequence to MenB has been
decoded
 Factor H-binding protein is present in over 1,800
menB isolates – LP2086
 Provides foundation for other new vaccines that
need to protect against numerous and diverse
strains
 Two vaccines undergoing clinical trials
 Pfizer – rLP2086
 Novartis - Bexsero® recombinant vaccine (rMenB)
rLP2086
 Persons 10 to 29 years of age
 Granted Breakthrough Therapy designation March 20, 2014
 Phase 2 study published in Lancet Infectious Diseases
 Vaccine-induced bactericidal antibodies in healthy adolescents aged
11 – 18 years were broadly active against MenB
 Acceptable safety profile
 Phase 2 randomized, placebo-controlled, single-blind study of 2 and 3-
dose schedules in healthy adolescents aged 11 – 18 years presented at
2013 Meningitis Research Foundation meeting
 One month after last dose
 After 3 doses – 86-99% of subjects had functional antibodies
 After 2 doses – 69 – 100% of subjects had functional antibodies
 Additional ongoing immunogenicity and safety studies since November
2012
Bexsero®




Persons aged 2 months and older
Recently licensed in Canada, Australia and Europe
Breakthrough Therapy designation by FDA in April 2014
Two-dose series
 1st dose at 0 months – protection for only a few months
 2nd dose at 1 to 6 months – long-term protection unknown, but
robust responses seen after 2nd dose
 Controlled use by FDA during outbreaks
 Interrupt disease spread  stopping outbreak
 Utilized in recent outbreaks at Princeton University (March-Nov
2013) and University of California-Santa Barbara (Nov 2013)
 Interim guidance to be presented at June 2014 ACIP meeting
Identify this picture:
1. Meningococcal
virus
2. Influenza virus
3. Pneumococcal virus
4. My cat’s favorite
toy
0%
1.
0%
2.
0%
3.
0%
4.
Trends in influenza vaccine
 Target the core that stays virtually the same
for most common strains of the flu.
 This could offer immunity to emerging strains
 Vaccine will develop T cells, not B cells
 Research started in 2009
http://inhabitat.com/scientists-unveil-blueprint-for-universal-flu-vaccine/
H7N9
 Avian influenza A (H7N9)
 Since February 2013 ¹
 355 human cases reported with 112 deaths
 All in China except for one single case in Malaysia who
traveled from China
 Vaccine
 Currently nine candidate vaccine viruses available for
research
 Sinovac Biotech has submitted a clinical trial application
with the China Food and Drug Administration to commence
human trials – Accepted January 29, 2014.²
 First global company to successfully develop and launch the
H1N1 vaccine.
¹World Health Organization website. Summary of status of development and availability of A(H7N9) candidate vaccine viruses and potency testing reagents. February 13,
2014.
²Asian Scientist website (www.asianscientist.com). Sinovac Seeks Approval for H7N9 Vaccine Clinical Trials. February 11, 2014.
H9N2
 Avian influenza A (H9N2)
 Since December 2013
 Two cases reported
 China and China Hong Kong Special Administrative
Region
 Mild illnesses belonging to A/chicken/Hong
Kong/Y280/97 genetic lineage
 Vaccine
 Currently nine candidate vaccine viruses available
for research
World Health Organization website. Summary of status of development and availability of A(H9N2) candidate vaccine viruses. February 20, 2014.
Summary
 Vaccines continue to be one of the major
contributors to improved morbidity and
mortality around the world
 Most current vaccines are based on the
antibody or B cell response
 Investigational and future vaccines are being
based on T cell or genome sequencing that
could provide quick responses to pandemics
and multi-strain viruses/bacteria
QUESTIONS?
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