Transcript Immunization Update 2007

Immunization Update
2007
Donna L. Weaver, RN, MN, Nurse Educator
Centers for Disease Control and Prevention
National Center for Immunization and
Respiratory Diseases
Immunization Services Division
Madison, WI – October 9, 2007
Disclosures
 The speaker has no financial conflict with the
manufacturer of any product named in this
presentation
 The speaker will discuss the use of vaccines
in a manner not approved by the U.S. Food
and Drug Administration (off-label ACIP
recommendations)
 The speaker will discuss products not currently
licensed by the FDA
ACIP Statements Published
Since August 2006
 Rotavirus (8/11/2006)
 General Recommendations (12/1/2006)
 Tdap (adult) (12/15/2006)
 Hepatitis B (adult) (12/8/2006)
 Human papillomavirus (3/23/2007)
 Varicella (6/22/2007)
 Influenza (7/13/2007)
All ACIP statements available at
www.cdc.gov/vaccines/pubs/ACIP-list.htm
General Recommendations
on Immunization
www.cdc.gov/mmwr/PDF/rr/rr5515.pdf
Most recent edition published in MMWR
on December 1, 2006
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Vaccine administration
Vaccine storage and handling
Altered immunocompetence
Special situations
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Allergy to vaccine components
Pregnancy
Vaccines received outside the U.S.
Persons with bleeding disorders
General Recommendations
on Immunization
www.cdc.gov/mmwr/PDF/rr/rr5515.pdf
 New or expanded tables
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minimum intervals and ages
contraindications and precautions
dose and route of administration
needle length and injection sites
vaccine storage temperatures
vaccine recommendations for persons with immune
deficiencies
2007 Childhood Schedule
Birth – 6 years of age
2008 Draft
Birth – 6 years of age
2007 Adolescent Schedule
7 – 18 years of age
2008 Draft
7 – 18 years of age
ACIP Recommends
Rotavirus Vaccination
 Rotavirus Disease Burden in
the U. S.
 Most common cause of
severe gastroenteritis in
infants and young children
worldwide
 Near universal infection by
age 5 years
 Annually responsible for:
• 3,000,000 infections every
year
• >400,000 physician visits
• 200,000 emergency dept
visits
• 55,000-70,000 hospitalizations
• 20-60 deaths
Pentavalent Rotavirus
Vaccine
®
(RotaTeq )
 Approved by FDA in February 2006
 Contains five reassortant rotaviruses developed from
human and bovine parent rotavirus strains
 Vaccine viruses suspended in a solution of buffer
(sodium citrate and phosphate) and stabilizer
 Contains no preservatives or thimerosal
RotaTeq and
Intussusception
®
Intussusception
Prolapse of one section of the bowel into another
section
Most common cause of acute intestinal obstruction in
infantsyounger than 1 year
Can be associated with adenovirus infection and
Meckel’s diverticulum; cause often unknown
Highest incidence at about 6 months of age
(approximately 65 inpatient cases per 100,000 per
year)
RotaTeq Intussusception
Reports Received by VAERS
117 confirmed reports
 38 cases 1-21 days after vaccination
 23 cases 1-7 days after vaccination
 about one third of 38 cases occurred
following the first dose
6 million vaccine doses distributed
*March 2006 through mid-June 2007
Expected and Reported Cases of
Intussusception After RotaTeq
Age Group
(months)
VAERS Cases
Expected
Cases*
6-14
14
30
15-23
14
36
24-35
10
33
Total
38
99
Rotavirus Vaccine and
Intussusception Summary
Observed intussusception rates are not
greater than expected
CDC continues to support the ACIP
recommendation for routine
immunization of all U.S. infants with
three doses of RotaTeq
Ongoing monitoring and recalculation of
estimates
MMWR 2007;56(No. 10):218-22. March 16, 2007
Rotavirus Vaccine
ACIP Recommendations
www.cdc.gov/nip/publications/acip-list.htm#rota
 Routine immunization of all infants without
contraindications
 3 oral doses at 2, 4, and 6 months of age
 Minimum age of first doses is 6 weeks
 First dose should be administered between 6
and 12 weeks of age (until age 13 weeks)
Rotavirus Vaccine
ACIP Recommendations
 Vaccination should not be initiated for infants
older than 12 weeks of age (? Increased risk of IS)
 Minimum interval between subsequent doses is 4
weeks
 No maximum interval between doses
 All 3 doses of vaccine should be administered by 32 weeks
of age
 Vaccine should NOT be administered after 32 weeks of age
Rotavirus Vaccine
ACIP Recommendations
 Administer simultaneously with all other indicated
vaccines
 Breastfeeding infants should be vaccinated on usual
schedule
 Vaccinate infants who have recovered from documented
rotavirus infection
 Do not repeat dose if infant spits out or regurgitates
vaccine - administer remaining doses on schedule
Pentavalent Rotavirus Vaccine
 Contraindications
 Severe allergic reaction to a vaccine component or
following a prior dose of vaccine
 Precautions*
 Altered immunocompetence
 Recent receipt of blood product
 Acute, moderate to severe gastroenteritis or other
acute illness
 Pre-existing chronic GI disease
 Infants with history of intussusception
*the decision to vaccinate if a precaution is present should be
made on a case-by-case risk and benefit basis
Pentavalent Rotavirus Vaccine
Special Situations
 Preterm infants (<37 weeks gestation)
 Recommend immunization if at least 6 weeks of
age, clinically stable, and are being or have been
discharged from nursery
 Recent administration of antibody
containing blood products
 Defer for 6 weeks unless deferral would delay
first dose beyond 12 weeks of age
Pentavalent Rotavirus Vaccine
Special Situations
 Infants living in households with
immunocompromised persons
 Small risk of transmitting vaccine virus to
household member
 Without vaccination the infant will be infected with
wild-type rotavirus and expose household contacts
 Can be vaccinated because theoretical benefits
outweigh risks
Updated ACIP Varicella
Vaccine Recommendations
www.cdc.gov/mmwr/pdf/rr/rr5604.pdf
 Routine vaccination at 12 to 15 months of age
 Routine second dose at 4 to 6 years of age
 Two doses recommended for all persons
older than 4 to 6 years who do not have
evidence of varicella immunity
 Second dose recommended for persons of
ANY age who have only received one dose
Source: MMWR 2007;56(RR-4)
Varicella Vaccine
Minimum Interval Between Doses
Age
12 months through
12 years of age
13 years of age or
older
Source: MMWR 2007;56(RR-4)
Interval
3 months
4 weeks
Varicella Immunity
 Written documentation of age-appropriate
vaccination
 1 dose for preschool-aged children
 2 doses for school-aged children,
adolescents and adults
 Born in the United States before 1980
EXCEPT healthcare personnel,
immunocompromised persons and
pregnant women
Source: MMWR 2007;56(RR-4)
Varicella Immunity
 Laboratory evidence of immunity or
laboratory confirmation of varicella disease
 Healthcare provider diagnosis or verification
of a history of varicella disease
 History of herpes zoster (shingles) based on
healthcare provider diagnosis
Source: MMWR 2007;56(RR-4)
Varicella FAQ
Question:
If a person who received ONE dose of varicella
vaccine subsequently develops “breakthrough”
chickenpox (or shingles) does the person need a
second dose of vaccine?
Answer:
Not if you are sure that the illness the person had
was really chickenpox. If there is doubt about the
diagnosis, give the second dose.
Varicella Vaccine Supply
 Merck is having difficulty with their varicella
vaccine virus bulk production
 Duration of the problem is not known
 Should not affect the supply of single antigen
varicella vaccine
 Will affect the supply of MMRV vaccine at least
through remainder of 2007
Zoster Vaccine for Adults
Zos (Zostavax®)
 Live attenuated vaccine
 Single subQ dose
 Approved for persons 60 years of age and
older
ACIP Recommendations for
Zoster Vaccine
www.cdc.gov/vaccines/recs/provisional/downloads/zoster-11-20-06.pdf
 Adults 60 years and older should receive a
single dose of zoster vaccine
 Routine vaccination of persons younger than
60 years is NOT recommended
 A history of herpes zoster should not influence
the decision to vaccinate
*Provisional recommendations, October 2006
http://www.cdc.gov/nip/recs/provisional_recs/zoster-11-20-06.pdf
Zoster Vaccine
 Don’t Ask (about a history of varicella)
 Screening for a history of varicella disease is
not necessary or recommended to administer
zoster vaccine to a person 60 years of age or
older
 Persons 60 years of age and older can be
assumed to be immune regardless of their
recollection of chickenpox (so don’t ask)
Zoster Vaccine
 Don’t Test (it will just cause you trouble)
 If tested and seronegative the person should
receive 2 doses of single antigen varicella
vaccine (Varivax®) separated by at least 4 weeks
 Zoster vaccine is not indicated for a person
whose immunity is based on vaccination
Zoster Vaccine
Contraindications and Precautions
 Severe allergic reaction to vaccine
component or following a prior dose
 Immunosuppression
 Moderate or severe acute illness
 Pregnancy
Human Papillomavirus
(HPV)
 Genital HPV is the most prevalent sexually
transmitted infection in the US
 Estimated 80% of sexually active persons will have
been infected by age 50
 ~20 million infected
 6 million new infections/year
 Vast majority of infections are transient and
asymptomatic
 Persistent infection may lead to anogenital
cancers
Cates, STD 26:Supp 1-7 (1999); Meyers et al. Am J
Epidemiol 151: 1158-1171 (2000)
HPV-Associated Disease
Type
Women
Men
70% of Cervical Cancer
70% of Anal Cancer
16/18 70% of Anal/genital
Transmission to women
Cancer
6/11
90% of Genital Warts
90% of RRP lesions
90% of Genital Warts
90% of RRP lesions
Transmission to women
HPV Vaccine - Gardasil®
Approved for females 9 through 26 years
of age
3 doses at 0, 2, and 6 months
Minimum intervals:
 4 weeks between doses 1 and 2
 12 weeks between doses 2 and 3
Intramuscular injection
Routine HPV Vaccination Recommendations
www.cdc.gov/mmwr/PDF/rr/rr5602.pdf
 ACIP recommends routine vaccination of
females 11-12 years of age with three doses
of quadrivalent HPV vaccine
 The vaccination series can be started as
young as 9 years of age at the clinician’s
discretion
 “Catch-up” vaccination through age 26 years
HPV Vaccination Schedule
Routine schedule is 0, 2, 6 months
Intramuscular injection in the deltoid
Minimum intervals
 4 weeks between doses 1 and 2
 12 weeks between doses 2 and 3
Minimum age is 9 years
Maximum age is 26 years
MMWR 2006;56(No. RR-2):1-23. March 23, 2007
Incomplete Schedules and
Duration of Immunity
The efficacy of less than three doses of
HPV vaccine is not known
The duration of immunity after a complete
3-dose schedule is not known
 Available evidence indicates protection for at
least 5 years
 Multiple studies are in progress to monitor the
duration of immunity
HPV Vaccine
HPV vaccine should not be administered to
males
 No safety or efficacy data
 Off-label use not recommended
Studies of vaccine efficacy in males in
progress now
Long term follow-up studies in progress to
examine duration of immunity
HPV Vaccine
 HPV vaccine is not approved for women older
than 26 years or males
 Efficacy data is not yet available for these
groups
 ACIP does NOT recommend off-label in either
women older than 26 years or in males
Correct and consistent condom use
may have a protective effect on HPV
acquisition, reduce the risk for HPVassociated diseases, and mitigate the
adverse consequences of infection
with HPV.
This statement is required by section 317 of the
Public Health Service Act, 42 U.S.C., 243
Cervical Cancer Screening
 Cervical cancer screening – no change
 30% of cervical cancers caused by HPV
types not prevented by the quadrivalent
HPV vaccine
 Vaccinated females could subsequently be
infected with non-vaccine HPV types
 Sexually active females could have been
infected prior to vaccination
 Providers should educate women about the
importance of cervical cancer screening
HPV Vaccine
Special Situations*
 Females 26 years of age or younger with an
equivocal or abnormal Pap test, positive HPV
DNA, or genital warts may be vaccinated
 Vaccine will have no effect on existing disease
or infection
 Females 26 years of age or younger who are
lactating/breastfeeding or are
immunocompromised may be vaccinated
 Not recommended for pregnant women
HPV Vaccine
Contraindications & Precautions
Severe allergic reaction to a vaccine
component or following a prior dose
Moderate or severe acute illnesses (defer
until illness improves)
Preventing Adverse Reactions
 Syncope (vasovagal response or fainting)
 Can result in injury
 More common in adolescents and adults
 Have older children, adolescents, and adults seated
during vaccination
 Consider 15 min. observation after vaccination
Source of Infection for
Infants With Pertussis
 Household contact – 71%
 Parent – 55%
(mother 37%, father 18%)
 Sibling – 16%
 Non-household contact – 29%
 Aunt/uncle – 10%
 Friend/cousin - 10%
 Grandparent – 6%
N=44 infants <6 months of age. Pediatr Infect Dis J 2007;26(4):293-9.
Tdap Vaccines
 Boostrix (GlaxoSmithKline)
 Approved for persons 10-18 years of age
 Adacel (sanofi pasteur)
 Approved for persons 11-64 years of age
 No brand preference (except as dictated by age group
being vaccinated; off-label use NOT recommended)
 Licensed only for a single dose
 Tdap not approved or recommended for children 7-9
years of age or adults 65 years or older (use Td)
DTaP and Tdap
Administration Errors
 Occur because both
types of vaccine stored
in the same refrigerator,
and similarity of
appearance of
packaging
 DTaP (pediatric) given to a
person 7 years of age or
older
 Tdap (adolescent/adult)
given to child younger
than 7 years
DTaP and Tdap Administration
Errors
www.cdc.gov/mmwr/PDF/rr/rr5503.pdf (Page 27)
Error
Action
DTaP given to person >7
years
Count dose as valid
Tdap given to child <7
years as DTaP #1, 2, or 3
Do not count dose;
give DTaP now
Tdap given to child <7
years as DTaP #4 or 5
Count dose as valid
Produced by
California
Immunization
Branch
Available at http://www.dhs.ca.gov/ps/dcdc/izgroup/pdf/IMM-508.pdf
Influenza Vaccine
2007-2008
www.cdc.gov/flu/
 Anticipating >132 million doses to be
available from four manufacturers
 H1N1 strain changed from 2006-2007
formulation
 No new recommendations for adults
 In January 2007 FDA approved a
refrigerator-stable formulation of LAIV
Timing of Influenza
Vaccination
 Immunization providers should begin offering
vaccine soon after it becomes available and if
possible by October
 Providers should offer vaccine during routine
healthcare visits or during hospitalizations
whenever vaccine is available
Source: MMWR 2007;56 (RR-6)
Timing of Influenza
Vaccination
 Consider scheduling organized vaccination
campaigns after at least mid-October
 Scheduling campaigns after mid-October will
minimize the need for cancellations because
vaccine is unavailable
 Continue to offer influenza vaccine in
December, especially to healthcare personnel
and those at high risk of complications
 Continue to vaccinate throughout influenza
season (December-March)
Source: MMWR 2007;56 (RR-6)
Influenza Vaccine Manufacturers for the
2007-08 Influenza Season
Manufacturer
Sanofi pasteur, Inc.
Novartis Vaccine
(formerly Chiron Corporation)
Vaccine
Fluzone®,
Inactivated
TIV
Fluvirin™
Inactivated
TIV
MedImmune Vaccines, Inc
FluMist™
LAIV
CSL Biotherapies
Afluria
Inactivated
TIV
®
Formulation
Thimerosal preservative
Age indication
Multi-dose vial
Yes
>6 months
None
6--35 months
None
> 36 months
Multi-dose vial
Yes
> 4 years
Single-dose prefilled
0.5 mL syringe
Preservative free
(?1 mcg mercury/0.5mL
dose)
> 4 years
Single-dose sprayer
None
Healthy persons 2--49 years
Single-dose prefilled
0.5 mL syringe
None
> 18 years
Multi-dose vial
Yes
> 18 years
Single-dose prefilled
0.25mL syringe
Single-dose prefilled
0.5mL syringe or vial
®
GlaxoSmithKline Biologicals
(subsidiary of GlaxoSmithKline PLC)
Fluarix
Inactivated
TIV
Single-dose prefilled
0.5 mL syringe
Preservative free
(?1 mcg mercury/0.5mL
dose)
> 18 years
ID Biomedical Corporation
(subsidiary of GlaxoSmithKline PLC)
FluLaval™
Inactivated
TIV
Multi-dose vial
Yes
> 18 years
2007-2008 Influenza
Vaccine Recommendations
 Children 6 months through 8 years of age who received
only 1 dose in their first year of vaccination should receive
2 doses the next year. If they skip one or more years with
no flu vaccine, then only one dose is necessary.
The two doses should be separated by 4 weeks
of which
vaccine (TIV or LAIV) is used
Source: regardless
MMWR 2007;56
(RR-6)
Trivalent Inactivated Influenza Vaccine
(TIV) Schedule
Age Group
6-35 mos
Dose
0.25 mL
# Doses
1 or 2*
3-8 yrs
0.50 mL
1 or 2*
9 years or older 0.50 mL
*separated by 4 weeks
Source: MMWR 2007;56 (RR-6)
1
Live Attenuated Influenza Vaccine
(LAIV) Indications
 Approved only for healthy persons 2 years
through 49 years of age who are not pregnant
 healthcare personnel
 persons in close contact with high-risk groups
 persons who want to reduce their risk of
influenza
Source: MMWR 2007;56 (RR-6)
Live Attenuated Influenza
Vaccine (LAIV) Schedule
Age Group
Dose
# Doses
5 thru 8 yrs
0.2 mL
(0.1 mL/nostril)
2*
- no previous
influenza vaccination
- previous
influenza vaccination
for
ALL ages
9 thru 49 years of age
*separated by at least 4 weeks
Source: MMWR 2007;56 (RR-6)
1 or 2*
1
Use of LAIV Among Close
Contacts of High Risk Persons
 Inactivated influenza vaccine is preferred for close
contacts of severely immunosuppressed persons who
require care in a protective environment
 Persons who receive LAIV should refrain from contact
with severely immunosuppressed persons for 7 days
after vaccination
 Persons who receive LAIV do not need to be excluded
from visitation of patients who are not severely
immunosuppressed
Source: MMWR 2007;56 (RR-6)
Administration of LAIV
 Severely immunosuppressed persons should
not administer LAIV
 Other persons at increased risk for influenza
complications* may administer LAIV
 Gloves and masks are not required
*e.g., pregnant women, persons with asthma and
persons 50 years of age or older
Influenza Vaccine
Storage and Handling
 Both TIV and LAIV should be stored at
o
o
refrigerator temperature (35 - 46 F) at all
times
 Neither vaccine should be exposed to
freezing temperature
H5N1 Avian Influenza
www.pandemicflu.gov/
H5N1 Avian Influenza
 Human Cases
 12 countries
 328 cases
 200 deaths
Alternative Schedule for
Hepatitis A/Hepatitis B
Combination (Twinrix®)
 Approved for persons >18 years
 Routine schedule
 0, 1, and 6 months
 Alternative schedule
 0, 7, 21-30 days and a month 12 booster dose
Healthcare Workers Need the
Following Immunizations
• Varicella
• MMR
• Annual influenza
• Hepatitis B - exposure risk
• Td (one-time Tdap) – 10-year booster
Are YOU up to date?
http://www.cdc.gov/vaccines/
Vaccines in the Pipeline
 Cytomegalovirus
 Pentacel (sp)
 DTaP-IPV-Hib combination
 Cervarix (GSK)
 Bivalent HPV 16/18
 Respiratory syncytial virus
 Human immunodeficiency
virus
 Herpes simplex virus
 Hepatitis C virus
 Rotarix (GSK)
 Monovalent rotavirus
vaccine
 Staphylococcus aureus
 Group B streptococcus
 Mycobacterium tuberculosis
 Malaria
National Center for Immunization
and Respiratory Diseases
Contact Information
Hotline
800.CDC.INFO
Email
[email protected]
Website
www.cdc.gov/vaccines
Vaccine Safety
www.cdc.gov/nip/vacsafe/concerns/gen/of-interest.htm