Vaccine Update - Ungerboeck Software International

4/22/2013
Vaccine Update
Part 1
William Atkinson, MD, MPH*
Older Adolescent and Adult
Immunization Conference
Lansing, Michigan
April 22, 2013
*Representing the Immunization Action
Coalition, Saint Paul, MN
Disclosures
William Atkinson has no financial
conflict or interest with the
manufacturer of any product named
during this presentation
The speaker will discuss the use of
Tdap, PCV13 and HPV vaccines in a
manner not approved by the Food and
Drug Administration (FDA) but
recommended by ACIP
The speaker will not discuss vaccines
not licensed by the FDA
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Disclosures
The recommendations to be discussed
are primarily those of the Advisory
Committee on Immunization Practices
(ACIP)
• composed of 15 experts in clinical
medicine and public health who are not
government employees
• provides guidance on the use of vaccines
and other biologic products to the
Department of Health and Human
Resources, CDC, and the U.S. Public
Health Service
www.cdc.gov/vaccines/recs/acip/
What’s New in Adult Immunization
2013 schedules
Influenza vaccine
Tdap in pregnancy
PPSV23/PCV13
Meningococcal vaccines
HPV vaccines
Zoster vaccine
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4/22/2013
2013 Immunization Schedules
Published in MMWR on February 1, 2013
Childhood, adolescent and adult
schedules published together for the first
time
Childhood and adolescent schedules
merged (separate schedules since 2007)
Footnotes consolidated
Download schedules from CDC website
www.cdc.gov/vaccines/schedules/
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4/22/2013
Changes to the 2013 Adult
Immunization Schedule
Addition of information on 13-valent
pneumococcal conjugate vaccine (PCV13)
Clarification of number of doses of
pneumococcal polysaccharide
Tdap for persons 65 years and older*
Tdap during each pregnancy regardless
of interval since last Td/Tdap**
Information about quadrivalent influenza
vaccine
*off-label recommendation for Adacel brand Tdap
**off-label recommendation for both Tdap vaccines
2013 Adult Schedules
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2013 Adult Schedules
2013 Adult Schedules
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2013 Adult Schedules
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2013-2014 Influenza Vaccine
(Northern Hemisphere)
Vaccine Composition
• A/California/7/2009 (H1N1)-like
• A/Victoria/361/2011(H3N2)-like
• NEW! B/Massachusetts/2/2012-like (B/Yamagata
lineage)
• NEW! B/Brisbane/60/2008-like (B/Victoria lineage) for
quadrivalent vaccine
2 types of vaccine will be available
• IIV: Inactivated, trivalent or quadivalent, multiple
presentations
• LAIV: Live, attenuated, trivalent or quadrivalent
Quadrivalent Influenza Vaccine
Influenza vaccine has been trivalent
H3N2, H1N1, B) since the 1978-79
season
2 “lineages” (Victoria and Yamagata) of
influenza B circulate; choice of which
virus to include is difficult
QIV will contain both B virus lineages
Quadrivalent IIV and LAIV will be
available during 2013-14 season
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Non Egg-based Inactivated
Influenza Vaccine
Prior to the 2013-2014 influenza season
all influenza vaccines available in the
United States were produced in
embryonated hen’s eggs
Cell culture and recombinant IIV will be
available for the first time in the 2013-
2014 season
Flublok (Protein Sciences), trivalent,
recombinant, for persons 18 through 49 years
Flucelvax (Novartis), trivalent, canine kidney
cell culture, for persons 18 years and older
Health Care Personnel and
Influenza Vaccination
Influenza Vaccination Rates
(internet panel, Nov 2012)
Occupation Rate
Pharmacists 88.7%
Physicians 83.8%
Nurses 81.5%
Other 76.7%
2020 Healthy
People Goal
is 90%
• Lowest among assistants/ aides (43.4%) and
administrative/non-clinical support staff (54.5%)
Source: www.cdc.gov/flu/pdf/fluvaxview/hcp-ips-nov2012.pdf
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H7N9 Avian Influenza
First human infections - 91 cases and
17 deaths* most from Shanghai and all
from China
All cases believed to have had contact
with birds
No evidence of person-to-person
transmission
Cull of birds in Shanghai commenced
on April 5
*as of April 19, 2013
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Pertussis in the U.S. 2012
Nationwide – provisional 2012
• 41,880 reported cases
More than twice as many cases as in 2011
year (2011=18,719)
Several outbreaks or increased activity in
several states in 2012
17 deaths reported (14 among infants less
than 3 months of age)
• CDC unpublished data, http://www.cdc.gov/pertussis/outbreaks.html
• MMWR 61 (37) ND-516
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Pertussis-Containing Vaccines
DTaP (pediatric)
• Approved for ages 6 weeks through 6 years
Tdap (adolescents and adults)
• Boostrix (GlaxoSmithKline) - approved for
persons 10 years of age and older
• Adacel (sanofi pasteur) - approved for
persons ages 11 through 64 years
• Neither approved by FDA for persons
7 through 9 years of age
• Both approved as a single booster dose
Pertussis Vaccine Effectiveness
DTaP
• Very good short-term protection
• Effectiveness wanes over time
• Even modest waning, with high exposure, can result
in
• Infection of vaccinated children
• Increase rates of disease in communities
Tdap
• Despite high adolescent vaccination rates, a lot of
disease in this age group
• Effectiveness and duration of protection being
evaluated
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Adolescent Tdap Recommendations
Routinely recommended at 11 - 12 years
of age
Catch up 13 through 18 years who have
not been vaccinated with Tdap
Children 7 through 10 years who are not
“fully vaccinated against pertussis”*
• “fully vaccinated against pertussis” is
• 5 doses of DTaP, or
• 4 doses of DTaP if the fourth dose was
administered on or after the fourth birthday
*Off-label recommendation. MMWR 2011; 60 (No. 1):13-5
Adult Tdap Recommendations
Administer Tdap to unvaccinated
adults 19 years and older including
adults over 65 years of age*
Tdap should be administered as soon
as feasible to unvaccinated
• Healthcare personnel with direct patient
contact
• Close contacts of infants younger than 12
months of age, including unvaccinated
postpartum women
*Off-label recommendation for Adacel. MMWR 2011; 60 (No.41):1);1424-1426
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Tdap –Additional Information
There is no minimum interval between
the last dose of tetanus toxoidcontaining
vaccine and a dose of Tdap
If possible, Boostrix should be used for
adults 65 years of age and older
• Administer Adacel* if Boostrix is not available
*Off-label recommendation. MMWR 2011; 60 (No.1):13-5
Tdap and Pregnant Women
Administer a dose of Tdap vaccine to
during each pregnancy irrespective of
the woman’s prior history of receiving
Tdap*
To maximize passive transfer of
antibody to the fetus optimum timing of
Tdap is between 27 and 36 weeks
gestation
Tdap may be administered earlier in
pregnancy if necessary (e.g. wound
management)
*Off-label recommendation. MMWR 2013:62( (No.7): 131-135
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Pertactin-negative Bordatella
pertussis
12 pertactin-negative variants reported
from 1 hospital in Philadelphia
Pertactin included in 2 of 3 DTaP
products and both Tdap products
available in the U.S.
Currently no evidence that pertactinnegative
B. pertussis strains have been
responsible for outbreaks in the U.S. or
elsewhere
N Engl J Med 2013;368:583-4.
Pneumococcal Conjugate Vaccine
(PCV13) and Adults
In 2011 FDA approved PCV13 for use
among adults 50 years of age and older
Immunogenicity of PCV13 was found to
be non-inferior to PPSV23
Indicated for use of PCV13
• prevention of pneumococcal disease,
including pneumonia and invasive disease
caused by the 13 Streptococcus pneumoniae
serotypes in PCV13
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Summary of February 2012 ACIP
Deliberations: PCV13 for Adults
ACIP deferred universal
recommendation for all adults
pending the further collection of
data
• efficacy of PCV13 against pneumonia
(CAPITA trial, results in 2013)
• indirect (herd) effects of PCV13 use
in children
Incidence of IPD in Adults 18-64 Years With
Selected Underlying Conditions - 2009
200
180
20 fold increased risk
173
186
160
Cases per 100,000 persons
140
120
100
80
60
40
20
0
8
26 28
3-7 fold increased risk
32
41
HEALTHY CVD DIABETES PULMONARY KIDNEY LIVER ALCOHOL HIV/AIDS HEMATOLGICAL
CANCER
52
59
Active Bacterial Core Surveillance, 2009. Unpublished data
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ACIP Recommendations for PCV13 for
Immunocompromised Adults - Rationale
Extremely high burden of disease among
immunocompromised adults
Benefits outweigh any risks for use of PCV13
in some adults
Indirect effects of PCV13 use in children not
likely to eliminate IPD due to PCV13
serotypes in adults
PCV13 use alone may not provide adequate
coverage of serotypes causing disease in
adults
Combined use of PCV13 and PPSV23 more
effective than either vaccine alone
MMWR 2012;61(No. 40):816-9
Administering PCV13 and
PPSV23 Vaccines
PCV13 and PPSV23 should not be
administered simultaneously
Administer PCV13 before PPSV23,
whenever possible
PPSV23 recommendations and
indications for those at highest risk for
invasive pneumococcal disease remain
unchanged from earlier
recommendations
MMWR 2012;61(No. 40):816-9
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ACIP Pneumococcal Recommendations
Administer PCV13 and PPSV23 vaccines for
certain high risk adults 19 years of age and older
with:
• Nephrotic syndrome and
renal disease
• HIV infection
• Leukemia ,multiple myeloma,
lymphoma, general malignancy
• Hodgkin disease
• Solid organ transplant
• Iatrogenic immunosupression
• Functional or anatomic asplenia
Immunocompromising
conditions
• Cochlear implants
• CSF leak
MMWR 2012;61(No. 40):816-9
Immunocompetent
Recommendations for PCV13 and PPSV23 in
Pneumococcal Vaccine-Naïve Adults
Administer:
• single dose of PCV13
• dose of PPSV23 at least 8 weeks later
Adults 19-64 years with functional and
anatomic asplenia or immunocompromising
conditions, administer:
• second dose of PPSV23 five (5) years after
the first PPSV23 dose
MMWR 2012;61(No. 40):816-9
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Recommendations for Use of PCV13 in
Adults Previously Vaccinated with PPSV23
Adults 19 years and older with high-risk
conditions previously vaccinated with
PPSV23, administer:
• single dose of PCV13 at least one year after
PPSV23
Adults age 64 and younger with
functional/anatomic asplenia or
immunocompromising conditions,
administer a dose of PPSV23 at least
• five (5) years after the first PPSV23 dose
AND
• eight (8) weeks after PCV13
MMWR 2012;61(No. 40):816-9
Recommendations for Use of PCV13 in
Adults Previously Vaccinated with PPSV23
Revaccination with PPSV23 after 5
years does not apply to those ages 19-
64 with CSF leaks or cochlear implant
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MMWR 2012;61(No, 40):816-19
PPSV23 at 65 Years or Age
All adults are eligible for a dose of
PPSV23 at 65 years of age regardless
of previous pneumococcal vaccination
Administer a dose of PPSV23 to those
not vaccinated at/after age 65. Ensure:
• 8 weeks from a dose of PCV13 and/or
• 5 years since last PPSV23 dose
Adults vaccinated with PPSV23 at/after
age 65 require no further doses of
PPSV23
MMWR 2012;61(No. 40):816-9
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End of Part 1
Vaccine Update
Part 2
William Atkinson, MD, MPH*
Older Adolescent and Adult
Immunization Conference
Lansing, Michigan
April 22, 2013
*Representing the Immunization Action
Coalition, Saint Paul, MN
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Meningococcal Disease Incidence,
United States, 1970-2011
2
Rate per 100,000
1.5
1
0.5
0
1970
1972
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
*2010
Year
1970-1996 NNDSS data, 1997-2011 ABCs data estimated to U.S. population with 18% correction for under reporting
*In 2010, estimated case counts from ABCs were lower than cases reported to NNDSS and may not be representative
Meningococcal Vaccines
Vaccine Type Age
Menomune PS 2 yrs and older
Menactra Conj 9 mos – 55 yrs
Menveo Conj 2 – 55 years
MenHibrix Conj 6 wks – 18 mos
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4/22/2013
Meningococcal Vaccine
Recommendations
Routine vaccination of adolescents at
11-12 years with booster dose at 16
years
Routine vaccination persons 2 months
and older at increased risk of
meningococcal disease
• Medical conditions (asplenia, complement deficiency)
• Previously unvaccinated first-year college students
living in a resident hall

4/22/2013
Meningococcal Vaccine
Recommendations
ACIP does not recommend routine
meningococcal vaccination of infants
Infants at increased risk for meningococcal
disease should be vaccinated with 4 doses of
HibMenCY
• persistent complement pathway deficiencies
• anatomic or functional asplenia including
sickle cell disease
HibMenCY can be used in infants ages 2
through 18 months who are in communities
with serogroup C and Y meningococcal
disease outbreaks
MMWR 2013;62 (RR-2):1-27
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Pop Quiz
Child receives a dose of MPSV4 at
10 years of age because of
international travel and a dose of
MCV4 at 12 years of age. Does the
child need the “booster” dose of
MCV4 at 16 years of age?
Answer:
Pop Quiz
Child receives a dose of MPSV4 at
10 years of age because of
international travel and a dose of
MCV4 at 12 years of age. Does the
child need the “booster” dose of
MCV4 at 16 years of age?
Answer: No
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Pop Quiz
Any dose of meningococcal vaccine
administered before age 10 should be
disregarded
Doses at 10 years and older can be
counted as part of the adolescent
series if:
• separated by at least 8 weeks, AND
• second dose is a conjugate vaccine
Clinicians may choose to give another
dose of MCV4 to college students living
in residential facilities (and age

4/22/2013
HPV-Associated Cancers in
the United States
33,369 HPV-associated cancers diagnosed
annually (2004-2008)
• 12,080 men
• 21,290 women
Site
Total Cancers
Attributable to
HPV
Cervix 12,170 96%
Anus 6230 93%
Vagina 2680 64%
Oropharynx 27,480 63%
Vulva 4490 51%
Penis 1570 36%
American Cancer Society. www.cancer.org/acs/groups/. Gillison ML, et al.
Cancer. 2008;113(10 Suppl) 3036-3046; MMWR 2012;61:268-261
HPV Immunization Rates*, NIS-Teen, 2011
Females13-17 Years of Age
HPV Vaccine U.S. MI
1 or more doses 53.0% 55.5%
3 dose series
completion **
70.7% 61.6%
*Percentages 1 or more human papillomavirus vaccine doses, either HPV4
or HPV2 reported among females only (n=9,220)
** Percentage of females who received 3 doses among those who had at
least 1 HPV dose and at least 24 weeks between the first dose and
interview date
MMWR 2012; 61 (No. 34): 671- 677
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Actual and Potentially Achievable Vaccination
Coverage if Missed Opportunities Were
Eliminated: NIS-Teen, 2011
100
Percent Vaccinated
80
60
40
20
91.5 90.9
85.3
89.5
70.5
53
Healthy People 2020 Objectives
Actual
Potentially Achievable
0
Td/Tdap MenACWY HPV-1
Vaccine
HPV-1 coverage is among females only.
Source: NIS Teen 2011; Slide courtesy Shannon Stokley (CDC/NCIRD/ISD)
Pediatrics 2013;131:645–651
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ACIP HPV Recommendations
2 products: HPV2 (Cervarix) and HPV4
(Gardasil)
• Approved for ages: 9 through 26 years*
Both products are a 3 dose series
Schedule*:
• Administer the 2nd dose 1-2 months after
dose 1
• Administer the 3rd dose 6 months (24
weeks) after dose 1 and at least 12 weeks
after dose 2
*Off-label recommendation. Cervarix FDA approved 9 – 25 yrs. MMWR; (59)20; 626-629
ACIP HPV Vaccination
Recommendations
Males
Routine: 11 or 12 years
Catch-up:
13 through 21 yrs All
22 through 26 years
Immunocompromised
HIV infected
MSM
Healthy men: 22 -26
years may be vaccinated
Administer HPV4 only
Females
Routine: 11 or 12 years
Catch-up: 13 through 26
years
Administer HPV4 or HPV2
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4/22/2013
Strategies for Increasing HPV
Vaccination Rates in Clinical Practices
Recommend HPV vaccine!
• Include HPV vaccine when discussing other
needed vaccines
Integrate standard procedures
supporting vaccination
• Assess for needed vaccines at every clinical
encounter
• Immunize at every opportunity
• Standing orders
Reminder and recall
Tools for improving uptake of HPV:
www.cdc.gov/vaccines/teens
66
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Long-Term Effectiveness of
Varicella Vaccine
7585 vaccinated in 1995; 2826 received a
second dose in 2006-09
Overall vaccine efficacy 90%
No evidence of waning immunity
No cases of breakthrough varicella after
second dose
Rate of zoster lower among vaccinated
children than among unvaccinated
children
Baxter R et al. Pediatrics 2013;131(5). May 2013
67
Baxter R et al. Pediatrics 2013;131(5). May 2013 68
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Herpes Zoster Vaccine
(Zostavax)
Administered to persons who had
chickenpox to reduce the risk of subsequent
development of zoster and postherpetic
neuralgia
Contains live varicella vaccine virus in much
larger amount (14x) than standard varicella
vaccine (Varivax)
Reduces the risk of zoster ~50% in persons
60 years and older
Reduces the risk of zoster ~70% in persons
50-59 years
NEJM 2005;352(22):2271-84 and zoster package insert (2012)
Zoster Vaccine
In 2011 the Food and Drug Administration
approved a label change for zoster
vaccine to include persons 50 through 59
years of age
ACIP declined to recommend vaccination
of persons younger than 60 years
because of inadequate supply and lower
risk of zoster in this age group
Zoster vaccine is neither licensed nor
recommended for persons younger than
50 years
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4/22/2013
ACIP Recommendations for
Zoster Vaccine
Adults 60 years and older should
receive a single dose of zoster vaccine
Need for booster dose or doses not
known at this time
A history of herpes zoster should not
influence the decision to vaccinate
MMWR 2008;57(RR-5)
2013 Adult Schedules
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73
Zoster Vaccine
It is not necessary to inquire about
chickenpox or test for varicella
immunity before administering zoster
vaccine
Persons 60 years of age and older can
be assumed to be immune* regardless
of their recollection of chickenpox
MMWR 2008;57(RR-5)
*for the purpose of establishing eligibility for zoster vaccine
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Zostavax package insert, June 2011
75
Zoster and Pneumococcal
Polysaccharide (PPSV) Vaccines
Zoster package insert: “consider
administration of the two vaccines
separated by at least 4 weeks”
Based on a study that showed the titer
against VZV was lower in persons who
received zoster and PPSV at the same
visit compared to persons who received
these vaccines 4 weeks apart
Zostavax package insert, June 2011
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4/22/2013
Zoster and PPSV Vaccines
Study examined the incidence of zoster
(per 1000 person-years) among
persons in a large HMO 60 years and
older who received zoster and PPSV
vaccines on the same day or PPSV 30
to 365 days before zoster vaccine
• same day 4.55
• different visits 4.51
Vaccine 2011;29:3628-32
Zoster and PPSV Vaccines
CDC has not changed its
recommendation for either vaccine
Zoster and PPSV should be
administered at the same visit if
the person is eligible for both
vaccines
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Zoster Vaccine Contraindications
Severe allergic reaction to a vaccine
component or following a prior dose
Pregnancy or planned pregnancy
within 4 weeks
Immunosuppression
MMWR 2008;57(RR-5)
Zoster Vaccine Contraindications
Immunosuppression
Leukemia, lymphoma or other malignant
neoplasm affecting the bone marrow or
lymphatic system
• persons whose leukemia or lymphoma is in
remission and who have not received
chemotherapy or radiation for at least 3
months can be vaccinated
AIDS or other clinical manifestation of HIV
infection
• includes persons with CD4+ T-lymphocyte
values less than 200 per mm3 or less than
15% of total lymphocytes
MMWR 2008;57(RR-5)
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4/22/2013
Zoster Vaccine Contraindications
Immunosuppression
High-dose corticosteroid therapy
• 20 milligrams or more per day of prednisone
or equivalent lasting 2 or more weeks
• Vaccination should be deferred for at least
1 month after discontinuation of therapy
MMWR 2008;57(RR-5)
Zoster Vaccine Contraindications
Immunosuppression
Hematopoietic cell transplant recipients
• experience is limited
• assess the immune status of the recipient on a
case-by-case basis
• if a decision is made to vaccinate, the vaccine
should be administered at least 24 months after
transplantation
MMWR 2008;57(RR-5)
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Zoster Vaccine Contraindications
Immunosuppression
Recombinant human immune mediators
and immune modulators
Preferable to administer zoster vaccine
before treatment
Assess the immune status of the recipient
on a case-by-case basis
Vaccination should be deferred for at least
1 month after discontinuation of treatment
MMWR 2008;57(RR-5)
Zoster Vaccine Precautions
Moderate or severe acute illness
Current treatment with an antiviral drug
active against herpes viruses
• discontinue at least 24 hours before
administration of zoster vaccine
• should not be taken for at least 14 days after
vaccination
Recent receipt of a blood product is
NOT a precaution
MMWR 2008;57(RR-5)
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4/22/2013
A Common Question from
Healthcare Providers
“I have a patient with 2 documented
doses of [MMR, varicella] vaccine but
their serologic test for [measles,
mumps, rubella, varicella] is negative.
How many doses of [MMR, varicella]
vaccine should I give?”
Resolution of the Problem
Serologic testing of persons with
documented MMR or varicella
vaccination is NOT RECOMMENDED
Documentation of 2 doses of MMR or
varicella supersedes the results of
subsequent serologic testing for any of
the antigens
MMWR 2011; 60(RR-7):1-45
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4/22/2013
The Future
Revaccination with Tdap among
nonpregnant persons
Expansion of PCV13 vaccination of
adults
HPV vaccines with additional
oncogenic types
More vaccine safety concerns
Continued attempts to weaken school
entry requirements
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4/22/2013
www.immunize.org
CDC Vaccines and Immunization
Contact Information
Telephone
(for patients and parents)
Email
(for providers)
800.CDC.INFO
nipinfo@cdc.gov
Website
ww.cdc.gov/vaccines/
Vaccine Safety www.cdc.gov/vaccinesafety/
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4/22/2013
2012 Recommended Childhood
Immunization Schedules
• www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html
2013 Schedule - 1 Through 18 Years
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2013 Schedule - 1 Through 18 Years
2013 Schedule - 1 Through 18 Years
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4/22/2013
2013 Schedule - 1 Through 18 Years
2012-2013 Influenza Season
Moderately severe season with peak in
late December and early January
Influenza A (H3N2) was dominant virus
2009 H1N1 pandemic virus still
circulated but less common
Good match of vaccine to circulating
viruses
110 influenza-related pediatric deaths
(as of March 23)
48

4/22/2013
Meningococcal Vaccination of
Persons 56 Years and Older
For meningococcal vaccine-naïve persons
56 or older years who anticipate requiring
a single dose of meningococcal vaccine
(e.g., travelers and persons at risk as a
result of a community outbreak), MPSV4
is preferred
For persons now 56 years or older who
were vaccinated previously with
MenACWY and are recommended for
revaccination or for whom multiple doses
are anticipated MenACWY is preferred*
*Off-label recommendation. MMWR 2013;62 (RR-2):15
49