W. Michael Brown, MD, FAAP Director of Pediatrics Associate Director Family Medicine Residency Bayfront Medical Center St. Petersburg, Florida Pertussis Awareness Pertussis Awareness And Prevention And Prevention
Apr 01, 2015
W. Michael Brown, MD, FAAP
Director of Pediatrics
Associate Director Family Medicine Residency
Bayfront Medical Center
St. Petersburg, Florida
Pertussis AwarenessPertussis AwarenessAnd PreventionAnd Prevention
Pertussis Awareness and Prevention: Pertussis Awareness and Prevention: ObjectivesObjectives
• Increase awareness and prevention of pertussis in the United States
• Educate health care professionals on epidemiology and diagnosis of pertussis
• Discuss importance of pertussis immunization
• Discuss important strategies for improving control of pertussis
• Increase awareness and prevention of pertussis in the United States
• Educate health care professionals on epidemiology and diagnosis of pertussis
• Discuss importance of pertussis immunization
• Discuss important strategies for improving control of pertussis
PERTUSSIS (WHOOPING COUGH)PERTUSSIS (WHOOPING COUGH)
• Acute respiratory tract infection by Bordetella pertussis
• highly communicable
• 80% secondary attack rates among susceptible persons
• Significant morbidity and mortality in infants
• Milder nonspecific upper respiratory tract infection in adolescents and adults
• Difficult to diagnose
• Referred to by the Chinese as “the cough of 100 days”
• Acute respiratory tract infection by Bordetella pertussis
• highly communicable
• 80% secondary attack rates among susceptible persons
• Significant morbidity and mortality in infants
• Milder nonspecific upper respiratory tract infection in adolescents and adults
• Difficult to diagnose
• Referred to by the Chinese as “the cough of 100 days”
Prolonged Cough Illness in Adolescents Prolonged Cough Illness in Adolescents and Adults Due to and Adults Due to Bordetella PertussisBordetella Pertussis
Source Locale Year(s) % of cough illnesses
Jackson et al Seattle 1983-87 15%Robertson et al New S Wales 1985-86 26%Mink et al Los Angeles 1986-89 26%Schmitt-Grohé et al Germany 1992-94 32%Wright et al Nashville 1992-94 21%Wirsing v Köenig et al Germany 1992-94 31%Rosenthal et al Chicago 1993-94 26%Jansen et al San Diego 1993-94 17%Nennig et al San Francisco 1994-95 12%Strebel et al Minn-St Paul 1995-96 13%Birbeback et al Denmark 1995-97 17%Vicent et al Korea 1997-98 50%Gilberg et al Paris 1999 52%
Pertussis Disease ManifestationsPertussis Disease Manifestations
• Incubation period -- 7 - 10 days (range 4 - 21)
• Stages• Catarrhal: runny nose,
sneezing, low-grade fever, mild cough
• Paroxysmal: severe spasms of cough, thick mucus, whoops, vomiting, exhaustion
• Convalescent: gradual recovery with less frequent & less severe coughing
Photograph courtesy of the WHO
Why Is Pertussis Increasing?Why Is Pertussis Increasing?
• Ascertainment…awareness and better diagnostic tests
• Incomplete immunization of children
• Variable vaccine efficacy
• Waning immunity• ~ 15 years after active disease• ~ 5-10 years after vaccination
• Under diagnosis, especially in adolescents and adults
• Lack of an adolescent/adult booster vaccine
UNTIL NOW
• Ascertainment…awareness and better diagnostic tests
• Incomplete immunization of children
• Variable vaccine efficacy
• Waning immunity• ~ 15 years after active disease• ~ 5-10 years after vaccination
• Under diagnosis, especially in adolescents and adults
• Lack of an adolescent/adult booster vaccine
UNTIL NOW
DECLINE IN VACCINE-PREVENTABLE DISEASEDECLINE IN VACCINE-PREVENTABLE DISEASE
Disease Maximum Cases %
cases in 2003 change
_____________________________________________________________________________________
Diphtheria 296,939 in 1921 1 99.99%
_____________________________________________________________________________________
Tetanus 1,560 in 1923 20 98.5%
_____________________________________________________________________________________
Pertussis 265,269 in 1934 11647 92.1%
_____________________________________________________________________________________
Measles 894,134 in 1941 56 99.98%
_____________________________________________________________________________________
Paralytic polio 21,269 in 1952 0 100%
3,100 died
_______________________ _____________________________________________________________
Mumps 152,209 in 1968 231 99.80%
_____________________________________________________________________________________
Rubella 57,686 in 1969 7 99.9%
_____________________________________________________________________________________
HIB 20,000 prior to 1985 259 98.7%
_____________________________________________________________________________________
From Centers for Disease Control and Prevention. MMWR 2004
Disease Maximum Cases %
cases in 2003 change
_____________________________________________________________________________________
Diphtheria 296,939 in 1921 1 99.99%
_____________________________________________________________________________________
Tetanus 1,560 in 1923 20 98.5%
_____________________________________________________________________________________
Pertussis 265,269 in 1934 11647 92.1%
_____________________________________________________________________________________
Measles 894,134 in 1941 56 99.98%
_____________________________________________________________________________________
Paralytic polio 21,269 in 1952 0 100%
3,100 died
_______________________ _____________________________________________________________
Mumps 152,209 in 1968 231 99.80%
_____________________________________________________________________________________
Rubella 57,686 in 1969 7 99.9%
_____________________________________________________________________________________
HIB 20,000 prior to 1985 259 98.7%
_____________________________________________________________________________________
From Centers for Disease Control and Prevention. MMWR 2004
Efficacy of Acellular Pertussis VaccinesEfficacy of Acellular Pertussis VaccinesRandomized, Blinded Trials*Randomized, Blinded Trials*
Study Vaccine
Efficacy (%)(Confidence
Interval)†
(WHO)†
StockholmGustafsson L et al. N Engl J Med. 1996;334:349-355.
DAPTACEL™ 85 (81-89)
Connaught DTP 48 (37-58)
ItalyGreco D et al. N Engl J Med. 1996;334(6):341-348.
Infanrix® 84 (76-89)
Connaught DTP 36 (14-52)
*Shows results for vaccines available in the United States for 3-dose infant immunization series; effects of any booster dose are not included.
†The definition closest to the standard WHO case definition (Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999;293-344).
*Shows results for vaccines available in the United States for 3-dose infant immunization series; effects of any booster dose are not included.
†The definition closest to the standard WHO case definition (Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999;293-344).
Source: CDC. Pertussis --- United States, 1997--2000. MMWR 2002;51:73-76.
Reported Pertussis Cases by YearReported Pertussis Cases by YearUnited States, 1922 – 2000United States, 1922 – 2000
Routine pertussisRoutine pertussisimmunization begins immunization begins
Ca
ses
(T
ho
us
and
s)
Ca
ses
(T
ho
us
and
s)
YearYear
00
5050
100100
150150
200200
250250
300300
19221922 19301930 19401940 19501950 19601960 19701970 19801980 19901990 20002000
0
2000
4000
6000
8000
10,000
12,000
14,000
16,000
18,000
20,000
1980 1990 1995 1999 2000 2001 2002 2003 2004
All Patients
25,827
11,647
9,771
7,867
7,580
7,2885,137
4,570
1,730
11,647
25,827
73%5,795
3,355
122%
Children 4 yrs. of age
5,795
3,355
The Growing Disease Reservoir The Growing Disease Reservoir Increases Exposure to PertussisIncreases Exposure to Pertussis
22,000
24,000
26,000
Reports of Pertussis in the U.S.Reports of Pertussis in the U.S.
Centers for Disease Control and Prevention. Centers for Disease Control and Prevention. MMWRMMWR. 2002;51:73-76; . 2002;51:73-76; GGüüririşş et al. et al. Clin Infect DisClin Infect Dis. 1999;28:1230-1237.. 1999;28:1230-1237.
National Immunization Program, Bacterial Vaccine Preventable Diseases Branch. National Immunization Program, Bacterial Vaccine Preventable Diseases Branch. Pertussis Surveillance Report, August 6, 2004Pertussis Surveillance Report, August 6, 2004
00
500500
10001000
15001500
20002000
25002500
30003000
35003500
<1 yr<1 yr 1-4 yrs1-4 yrs 5-9 yrs5-9 yrs 10-19 yrs10-19 yrs 20+ yrs20+ yrs
Av
era
ge
Nu
mb
er
Av
era
ge
Nu
mb
er
of
Ca
ses
/ Y
ear
of
Ca
ses
/ Y
ear
1990-1993 1990-1993 1994-1996 1994-1996 1997-2000 1997-2000 2001-20032001-2003
552%552%
490%490%
……there are between there are between ~800,000 and 3.3 million ~800,000 and 3.3 million cases per year in the United States.cases per year in the United States.
Estimated Duration of Immunity After Infection or Vaccination
Source of Immunity Duration Reference
Natural infection 15 years Wirsing Von Konig, 1995
Whole-cell vaccine
UK 6 years Jenkinson, 1988
Finland 6 years He, 1994
Germany > 6 years Lugauer, 2002
Acellular vaccine
Italy 6 years Salmaso, 2001
Germany > 6 years Lugauer, 2002
Wirsing Von Konig et al. Lancet ID 2002:2:774-750
Consequences of Waning ImmunityConsequences of Waning Immunity
• Increased transmission of pertussis disease to unimmunized and underimmunized infants and children1
• Considerable pertussis-related morbidity and economic cost in families2
• Increased incidence of pertussis disease among adolescents and adults1,3
• Increased transmission of pertussis disease to unimmunized and underimmunized infants and children1
• Considerable pertussis-related morbidity and economic cost in families2
• Increased incidence of pertussis disease among adolescents and adults1,3
1. Edwards KM et al. In: Plotkin SA et al, eds. 1. Edwards KM et al. In: Plotkin SA et al, eds. VaccinesVaccines. 1999;293-344. . 1999;293-344. 2. Lee LH et al. 2. Lee LH et al. Arch Fam MedArch Fam Med. 2000;9:989-996.. 2000;9:989-996.3. Centers for Disease Control and Prevention. 3. Centers for Disease Control and Prevention. MMWRMMWR. 2002;51:73-76. . 2002;51:73-76.
Reported Pertussis Cases Are the Reported Pertussis Cases Are the Tip of the IcebergTip of the Iceberg
Not Reported
Under- reporting
Atypical forms
Wide disease variability
Inconsistent case definitions
Underdiagnosis
Low physician awareness
Underconsultation
Reported
• Nationwide, an estimated Nationwide, an estimated 12%12% of pertussis cases are actually reported of pertussis cases are actually reported• Underreporting may be greatest among adolescents and adultsUnderreporting may be greatest among adolescents and adults
Güriş et al. Clin Infect Dis. 1999;28:1230. 16
Pertussis Cases Reported in 2002Pertussis Cases Reported in 2002Each Dot Represents One CaseEach Dot Represents One Case
The total number of cases and incidence rate for each state represent provisional numbers, which may change as states report more cases for 2002Source: Bacterial Vaccine Preventable Diseases Branch, National Immunization Program, CDC.
Sharp demarcation at state borders illustrates inconsistent reporting.
75% Of Suspected Sources For Infant Pertussis 75% Of Suspected Sources For Infant Pertussis Cases Were Family MembersCases Were Family Members
47% Mom or Dad
Mom32%
Dad15%
Sibling20%
Grandparent8%
Other25%
20% Other Adults
33% Other Children
Bisgard, K. et al. Ped Infect Dis J. 2004;23:985-989.
The Cycle of Pertussis Susceptibility The Cycle of Pertussis Susceptibility Promotes Transmission & DiseasePromotes Transmission & Disease
Primary vaccination:
Protected
Booster vaccination: Prolonged protection
No additional booster: Immunity
wanes
Unvaccinated orpartially vaccinated infants: Susceptible
Susceptible adolescents and
adults: Reservoir of B pertussis
Break the Pertussis Cycle: Vaccinate
• Reduce morbidity in all age groups
• Reduce reservoir of Pertussis disease
• Prevent transmission of Pertussis disease between adolescents and adults, and from adolescents and adults to infants
Supported by multiple publications. See notes
Pertussis: Clinical PresentationPertussis: Clinical Presentation In Infants In Infants
Severe vs Mild PertussisSevere vs Mild Pertussis
1. Scott PT et al. Am Fam Physician. 1997;56:1121-1128. 2. Strebel P. Infect Med. 1996;13:S33-S41. 3. Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999;293-344.
1. Scott PT et al. Am Fam Physician. 1997;56:1121-1128. 2. Strebel P. Infect Med. 1996;13:S33-S41. 3. Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999;293-344.
SevereSevere** MildMild
• More common in infantsMore common in infants
• Occurs in nonimmune Occurs in nonimmune individualsindividuals
• Paroxysmal cough (Paroxysmal cough (>>21 days’ 21 days’ duration) with heavy inspiration duration) with heavy inspiration (whoops) accompanied by (whoops) accompanied by vomiting and gaggingvomiting and gagging
• Characteristic symptoms Characteristic symptoms (eg, whoop) often absent(eg, whoop) often absent11
• An important mechanism of An important mechanism of transmission to infantstransmission to infants
• Estimated to represent 21% to Estimated to represent 21% to 26% of acute cough illness in 26% of acute cough illness in adultsadults2,32,3
• Often unrecognized, Often unrecognized, underdiagnosedunderdiagnosed
* World Health Organization (WHO) definition.* World Health Organization (WHO) definition.
Common Clinical Manifestations of Common Clinical Manifestations of Adolescent-Adult PertussisAdolescent-Adult Pertussis
• Cough 97% 3 weeks, 52% 9 weeks
• Paroxysms 3 weeks in 73%
• Whoop in 69%
• Post-tussive emesis in 65%
• Teens missed average 5 days of school; Adults missed average 7 days of work
• Average 14 days of disrupted sleep
De Serres et al. J Infect Dis. 2000;182:174–9.De Serres et al. J Infect Dis. 2000;182:174–9.
PERTUSSIS DEATHS BY AGE, UNITED STATES PERTUSSIS DEATHS BY AGE, UNITED STATES (1980-1999)(1980-1999)
Pertussis Complications By AgePertussis Complications By Age
Diagnostic Laboratory Findings In PertussisDiagnostic Laboratory Findings In Pertussis
• Marked lymphocytosis with leukocyte counts often exceeding 50,000 cells/mm3
• Generally afebrile with no elevation of ESR or other acute phase reactions
• CXR with a “shaggy heart” produced by bilateral perihilar infiltrates, edema, and atelectasis
• Culture of posterior NP swab may take 2 weeks, but negative cultures are common especially after 4 weeks of illness
• Direct immunofluorescent assay of NP secretions had variable sensitivity and low specificity
• Serologic tests to measure immunglobin antibody to pertusis toxin (IgG, IgM, IgA).
• DNA by PCR of NP secretions is the most sensitive and rapid test but may not always be available
*Most cases of Pertussis are diagnosed clinically!
Period Of Communicability Of PertussisPeriod Of Communicability Of Pertussis
-2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12
Weeks of cough
Catarrhal stage
Paroxysmal stage
Convalescent stage
Cough onset
Period of communicability
• Persons with pertussis are most infectious during the catarrhal period starting Persons with pertussis are most infectious during the catarrhal period starting as early as one day of cough as early as one day of cough
• Some individuals, such as infants who remain culture-positive for several Some individuals, such as infants who remain culture-positive for several weeks, may be infectious for a longer periodweeks, may be infectious for a longer period
Diagnostic Laboratory Findings in PertussisDiagnostic Laboratory Findings in Pertussis
Adapted from Mortimer EA. In: Krugman’s Infectious Diseases of Children. 10th ed. Mosby Year Book, Inc; 1998:335-349. Adapted from Mortimer EA. In: Krugman’s Infectious Diseases of Children. 10th ed. Mosby Year Book, Inc; 1998:335-349.
10
30
50
1-21-2 2-52-5 5-12+5-12+
Time After Onset of Symptoms (weeks)Time After Onset of Symptoms (weeks)
CatarrhalCatarrhal ParoxysmalStage
ParoxysmalStage
ConvalescentConvalescent
Lym
ph
ocy
te C
ou
nt
(th
ou
san
ds
)L
ymp
ho
cyte
Co
un
t (t
ho
usa
nd
s)
Po
siti
ve
Cu
ltu
reP
osi
tiv
eC
ult
ure
DiagnosisDiagnosis
•Culture 1-3 weeks cough
•PCR 1-4
•Serology 3 weeks or longer
• IFA never
•Culture 1-3 weeks cough
•PCR 1-4
•Serology 3 weeks or longer
• IFA never
TREAMENT OF PERTUSSISTREAMENT OF PERTUSSIS
• Infants younger than 6 months generally require hospitalization
• Antibiotic Therapy:
• Erythromycin 40 to 50 mg/kg/day given QID x 14 days
• Azythromycin 10 to 12 mg/kg/day given Qday X 5 days
• Clarithromycin 15 to 20 mg/kg/day given BID X 7 days
• Bactrim or Septra 8 mg TMP/ 40 mg SMX per kg per day in two divided doses for 14 days if allergic to macrolides
• *Treatment with antibiotics does not effect duration or severity of clinical course
• Cough suppressants
MMWR Jan. 2005
• Infants younger than 6 months generally require hospitalization
• Antibiotic Therapy:
• Erythromycin 40 to 50 mg/kg/day given QID x 14 days
• Azythromycin 10 to 12 mg/kg/day given Qday X 5 days
• Clarithromycin 15 to 20 mg/kg/day given BID X 7 days
• Bactrim or Septra 8 mg TMP/ 40 mg SMX per kg per day in two divided doses for 14 days if allergic to macrolides
• *Treatment with antibiotics does not effect duration or severity of clinical course
• Cough suppressants
MMWR Jan. 2005
• Pertussis toxin (PT), also knownas “lymphocytosis-promoting factor” (systemic action)
• Filamentous hemagglutinin (FHA)
• Pertactin (PRN) or 69 kD* protein
• Fimbrial agglutinogens (FIM)(1-4 serotypes)
• Pertussis toxin (PT), also knownas “lymphocytosis-promoting factor” (systemic action)
• Filamentous hemagglutinin (FHA)
• Pertactin (PRN) or 69 kD* protein
• Fimbrial agglutinogens (FIM)(1-4 serotypes)
FIM
PT
PRN
FHA
Antigenic Components of Antigenic Components of B pertussisB pertussis
*kD = kilodalton. *kD = kilodalton. Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999;293-344. Edwards KM et al. In: Plotkin SA et al, eds. Vaccines. 1999;293-344.
Currently licensed in US
Tripedia® Infanrix®* Daptacel™ Boostrix™ Adacel®
Indicated Age Group
Infants/Children†
Infants/Children†
Infants/Children† Adolescents
‡ (10-18 years)
Adults/Adolescents
‡ (11-64 years)
AntigenicComponents§
PT (µg)FHA (µg) PRN (µg)FIM 2 + 3 (µg) D (Lf) T (Lf)
23.423.4——6.75
25258—2510
10535
155
88
2.5—2.55
2.553525
Diphtheria, Tetanus, andDiphtheria, Tetanus, andAcellular Pertussis VaccinesAcellular Pertussis Vaccines
Comparison of Tdap VaccinesComparison of Tdap Vaccines
Adacel Boostrix
Company Sanofi GSK
Age 11-64 10-18
Efficacy 21d 85% 84%
7d 78% 71%
Components 4 (fimbrae) 3
Diphtheria LF 2 2.5
Adacel Boostrix
Company Sanofi GSK
Age 11-64 10-18
Efficacy 21d 85% 84%
7d 78% 71%
Components 4 (fimbrae) 3
Diphtheria LF 2 2.5
The Adacel Program in NewfoundlandThe Adacel Program in Newfoundland
• Replaced Td in 1999 school year
• Adacel delivered in a Grade 9 (14 year olds) school-based program
• Approximately 25,000 doses given by June 2004
Incidence of Pertussis in Newfoundland, 1993-2003
1993 94 95 96 97 98 99 2000 01 02 03
Time Periods
Inc
ide
nc
e p
er
10
0,0
00
Po
pu
lati
on
0
10
20
30
40
50
60 Introduction of adolescent dTaP5
CCDR Notifiable Disease Annual Summaries
70
****
**** Pertussis outbreak confined to persons not immunized with dTaP5
Pertussis Incidence and Vaccine Use, 1993 Pertussis Incidence and Vaccine Use, 1993 – – 20042004Canada’s Northwest TerritoriesCanada’s Northwest Territories
Kandola, K. Abstract in Kandola, K. Abstract in Can J Infect Dis Med Microbiol.Can J Infect Dis Med Microbiol. 2004;15:351. Manuscript in preparation. 2004;15:351. Manuscript in preparation.
Adacel Adacel begunbegun
Switch to Switch to PentacelPentacel
00
22
44
66
88
1010
1212
1993-19961993-1996 1997-20001997-2000 2001-20022001-2002 2003-20042003-2004
Time PeriodsTime Periods
Av
era
ge
Yea
rly
Av
era
ge
Yea
rly
Ca
ses
/ 1
0,0
00
Ca
ses
/ 1
0,0
00
United States Licensure Trial:United States Licensure Trial:Summary of ImmunogenicitySummary of Immunogenicity
Pre Post PostPre
Diphtheria Tetanus
Data reported for sera collected one month after vaccination.Data on file, Td 506, Aventis Pasteur Limited, Toronto, Canada.
Diphtheria and Tetanus Seroprotection ≥0.1 IU/mL With Adacel™ vs Td
0
20
40
60
80
100
Sero
pro
tecti
on
Rate
(%
)
Tdap Adolescents(N = 1175)
Td Adolescents (N = 787)
Tdap Adults (N = 1698)
Td Adults (N = 561)
Diphtheria and Tetanus Seroprotection ≥0.1 IU/mL With Adacel™ vs Td
0
20
40
60
80
100
Sero
pro
tecti
on
Rate
(%
)
Tdap Adolescents(N = 1175)
Td Adolescents (N = 787)
Tdap Adults (N = 1698)
Td Adults (N = 561)
Incidence of Systemic Reactions With Adacel™ vs Td
0
20
40
60
80
Perc
en
tag
e (
%)
Tdap Adol (N = 1175)
Td Adol (N = 787)
Tdap Adults (N = 1698)
Td Adults (N = 561)
Incidence of Systemic Reactions With Adacel™ vs Td
0
20
40
60
80
Perc
en
tag
e (
%)
Tdap Adol (N = 1175)
Td Adol (N = 787)
Tdap Adults (N = 1698)
Td Adults (N = 561)
Fever Headache GeneralizedBody Ache
Tiredness Sore JointsChills
United States Licensure Trial:United States Licensure Trial:Summary of Solicited Systemic ReactionsSummary of Solicited Systemic Reactions
Data collected from days 0-14.Data on file, Td 506, Aventis Pasteur Limited, Toronto, Canada.
United States Licensure Trial:United States Licensure Trial:Summary of Solicited Local ReactionsSummary of Solicited Local Reactions
No significant difference was observed between Tdap and Td recipients for any safety parameters measured with the exception of pain in adolescents which was marginally more frequent in Tdap recipients.Data collected from days 0-3.*≥35 mm; †Severe local pain: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
Incidence of Injection Site Erythema, Swelling, and Pain With Adacel™ vs Td
0
20
40
60
80
Perc
en
tag
e (
%)
Tdap Adol (N = 1175)
Td Adol (N = 787)
Tdap Adults(N = 1698)
Td Adults (N = 561)
Incidence of Injection Site Erythema, Swelling, and Pain With Adacel™ vs Td
0
20
40
60
80
Perc
en
tag
e (
%)
Tdap Adol (N = 1175)
Td Adol (N = 787)
Tdap Adults(N = 1698)
Td Adults (N = 561)
Severe Erythema*
Erythema Severe Swelling*
Swelling Severe Local Pain†
Local Pain
Data on file, Td 506, Aventis Pasteur Limited, Toronto, Canada.
Adolescents = 11-17 years. Adults = 18-64 years.
Adequacy, Efficacy, & Safety Data for Tdap Adequacy, Efficacy, & Safety Data for Tdap VaccinesVaccines
• Age Indications: Adacel 11- 64 years, Boostrix 10-18 years
• Both vaccines met all agreed non-inferiority criteria
• For Diphtheria and Tetanus antigens, at least as immunogenic as US – licensed Td vaccines
• Pertussis booster response induced an immune response at least as immunogenic as Daptacel and Infanrix
• Can be used concomitantly with other vaccines
• Safety profile comparable to US-licensed Td Vaccine
• Age Indications: Adacel 11- 64 years, Boostrix 10-18 years
• Both vaccines met all agreed non-inferiority criteria
• For Diphtheria and Tetanus antigens, at least as immunogenic as US – licensed Td vaccines
• Pertussis booster response induced an immune response at least as immunogenic as Daptacel and Infanrix
• Can be used concomitantly with other vaccines
• Safety profile comparable to US-licensed Td Vaccine
FDA Vaccine Advisory CommitteeFDA Vaccine Advisory Committee
• Unanimous vote March 2005– Adacel safe and effective age 11-64 years of age– Boostrix safe and effective 10-18 years of age
• Licensure… May, June 2005
• CDC ACIP
• July 2005 11-12 yr Universal Immunization, catch up 5 yrs from last Td Oct 2005 Universal Adult Immunization,10 yrs from Td
• Unanimous vote March 2005– Adacel safe and effective age 11-64 years of age– Boostrix safe and effective 10-18 years of age
• Licensure… May, June 2005
• CDC ACIP
• July 2005 11-12 yr Universal Immunization, catch up 5 yrs from last Td Oct 2005 Universal Adult Immunization,10 yrs from Td
Rationale for Vaccinating Adolescents Rationale for Vaccinating Adolescents and Adults: and Adults: Bordetella PertussisBordetella Pertussis Reservoirs Reservoirs
1. Sheretz et al. Emerg Infect Dis. 2001;7:241-244. 2. Izurieta et al. Clin Infect Dis. 1996;22:503-507.3. Postels-Multani et al. Infection. 1995;23:139-142.4. Crowcroft et al. Arch Dis Child. 2003;88:802-806.
Adolescents and Adults Are Primary Sources for Infant TransmissionAdolescents and Adults Are Primary Sources for Infant Transmission
Health Care ProvidersHealth Care ProvidersMost hospital outbreaks of Most hospital outbreaks of pertussis disease involve pertussis disease involve transmission from health transmission from health care workers to pediatric care workers to pediatric patientspatients11
Adults/ParentsAdults/ParentsIn Chicago, young In Chicago, young mothers with a cough mothers with a cough >7 days were shown to >7 days were shown to be a significant source of be a significant source of pertussis disease pertussis disease transmission transmission to their young infantsto their young infants22
GrandparentsGrandparentsIn 15% of families, an In 15% of families, an adult patient was adult patient was identified as the identified as the source of infection for source of infection for other household other household members. Fifteen members. Fifteen percent of these percent of these adults were adults were grandparents or great-grandparents or great-grandparents of an grandparents of an affected childaffected child33
Adolescents/SiblingsAdolescents/SiblingsFor 27% of infants For 27% of infants hospitalized with pertussis hospitalized with pertussis disease in London disease in London between 1998 and 2000, between 1998 and 2000, an older, fully vaccinated an older, fully vaccinated sibling was the source of sibling was the source of infectioninfection44
Advisory Committee On Immunization Practices (ACIP) Recommendations For Tdap Vaccine In Adolescents
• Recommendations of the ACIP (CDC) for the use of Tdap vaccines:
• Adolescents 11 to 12 years of age be given Tdap in place of the Td booster currently being used
• Tdap vaccine should be given to adolescents 13 to 18 years who missed the 11 to 12 year dose of Td
• Adolescents 11 to 18 years of age who have already been vaccinated with Td are encouraged to receive a dose of Tdap to further protect against pertussis
• Adolescents can and should receive Tdap and the meningococcal conjugate vaccine (menactra) at the same visit
ACIP Recommendations for Tdap Vaccine Use in ACIP Recommendations for Tdap Vaccine Use in AdultsAdults
• Adults who have not received a Td immunization during the last 10 years should receive a single dose of Tdap Vaccine
• Those not previously given Tdap vaccine may be given Tdap vaccine at shorter intervals (< 10 years) following last Td immunizations in settings of wound management and increased risk (including pertussis outbreaks and contact with infants
• Adults who anticipate having close contact with infants (ie: parents, healthcare workers and daycare workers) should receive a single dose of Tdap vaccine to protect against pertussis if they have not received Tdap vaccine. Ideally these adults should receive Tdap vaccine at least one month before beginning close contact with infants
• Adults who have not received a Td immunization during the last 10 years should receive a single dose of Tdap Vaccine
• Those not previously given Tdap vaccine may be given Tdap vaccine at shorter intervals (< 10 years) following last Td immunizations in settings of wound management and increased risk (including pertussis outbreaks and contact with infants
• Adults who anticipate having close contact with infants (ie: parents, healthcare workers and daycare workers) should receive a single dose of Tdap vaccine to protect against pertussis if they have not received Tdap vaccine. Ideally these adults should receive Tdap vaccine at least one month before beginning close contact with infants
Other ACIP Recommendations for Adult Tdap UseOther ACIP Recommendations for Adult Tdap Use
• Women should receive Tdap vaccine immediately post partum if not previously immunized
• Women are encouraged to receive Tdap vaccine before conception
• Tdap vaccine is encouraged over Td vaccine in the wound care setting for those who have not previously received Tdap vaccine
• Pregnancy is not a contraindication to Tdap and may be considered in the 2nd and 3rd trimester
• Women should receive Tdap vaccine immediately post partum if not previously immunized
• Women are encouraged to receive Tdap vaccine before conception
• Tdap vaccine is encouraged over Td vaccine in the wound care setting for those who have not previously received Tdap vaccine
• Pregnancy is not a contraindication to Tdap and may be considered in the 2nd and 3rd trimester
ACIP Recommendations for Tdap ACIP Recommendations for Tdap Use In Healthcare WorkersUse In Healthcare Workers
• There are 8-10 million workers employed in hospital and ambulatory settings.
• The risk of contracting pertussis from healthcare workers is nearly 2 times greater than the general population.
• For each decade the immunization of healthcare workers could prevent as many as 100, 000 cases of pertussis and save up to $151 million in direct and indirect costs.
• Therefore it is recommended that all healthcare workers and anyone who works in a healthcare setting receive Tdap.
• There are 8-10 million workers employed in hospital and ambulatory settings.
• The risk of contracting pertussis from healthcare workers is nearly 2 times greater than the general population.
• For each decade the immunization of healthcare workers could prevent as many as 100, 000 cases of pertussis and save up to $151 million in direct and indirect costs.
• Therefore it is recommended that all healthcare workers and anyone who works in a healthcare setting receive Tdap.
Strategies to Control Pertussis…Strategies to Control Pertussis…
• Improve immunization coverage
• Ensure immunization of all appropriate infants
• Prevent mild disease
• Improve surveillance and reporting
• Implement Tdap vaccines for adolescents and adults
• Eliminate reservoirs of infection in general population
• Reduce transmission to vulnerable infants
SUMMARYSUMMARY
• Epidemiology of pertussis disease has changed with the spectrum of illness shifting to a milder form in all age groups
• B. pertussis infections in the adolescent and adult populations are common and endemic accounting for more of the disease seen today
• Immunity after natural infection or vaccinations is not life long and wanes rapidly after 5 – 8 years
• Pertussis acounts for up to 25% of acute cough illnesses in the adolescent and adult populations
• The adolescent and adult populations serve as a major resevoir of disease transmission to the young infant population
• Immunizing the infant population on time and implementing a booster vaccine program in the adolescent and adult populations will have the greatest impact on decreasing the amount of disease seen
• Epidemiology of pertussis disease has changed with the spectrum of illness shifting to a milder form in all age groups
• B. pertussis infections in the adolescent and adult populations are common and endemic accounting for more of the disease seen today
• Immunity after natural infection or vaccinations is not life long and wanes rapidly after 5 – 8 years
• Pertussis acounts for up to 25% of acute cough illnesses in the adolescent and adult populations
• The adolescent and adult populations serve as a major resevoir of disease transmission to the young infant population
• Immunizing the infant population on time and implementing a booster vaccine program in the adolescent and adult populations will have the greatest impact on decreasing the amount of disease seen
……a universal program of adolescent and adult boosters a universal program of adolescent and adult boosters would decrease the circulation of would decrease the circulation of B pertussisB pertussis… and … and possibly could lead to the elimination of the organism…possibly could lead to the elimination of the organism…
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