**[FTS-CDC-NIP]{.underline}**

**[Moderator: ]{.underline}[Dale Babcock]{.underline}**

**[January 18, 2007]{.underline}**

**[11]{.underline}[:00 ]{.underline}[a]{.underline}[m CT]{.underline}**

[Coordinator: Welcome and thank you for standing by. At this time, all
participants are on a listen only mode. During the question and answer
session today, you can press star 1 to ask a question. Today\'s
conference is being recorded.]{.underline}

[ At this time, I\'ll turn the call over to Dr. Andrew
Kroger.]{.underline}

[ You may begin, sir.]{.underline}

[Andrew Kroger: Good afternoon and welcome to \"Current Issues and
Immunization\", a CDC net conference. The date is January 18, 2007. I am
Dr. Andrew Kroger in the National Center for Immunization and
Respiratory Diseases and I\'ll be the moderator for today\'s
session.]{.underline}

[ Net conference technology allows us to present material
instantaneously via the internet. To participate in today\'s program,
you need a telephone connection and a separate internet
connection.]{.underline}

[ The learning objectives for the session are, one, list the reason
immunization recommendation made by the advisory committee on
immunization practices or AECIP and two, describe an emerging
immunization issue.]{.underline}

[ We have two parts for today\'s net conference. In part one, Dr. Erik
Mast, Chief of the Prevention branch in the division of Viral Hepatitis
in the National Center for HIV/AIDS, viral Hepatitis, STD and
Tuberculosis prevention, will discuss adult hepatitis B vaccine
recommendations.]{.underline}

[ Next, Dr. Katrina Kretsinger, a medical officer in the Division of
Bacterial Disease in the National Center for Immunization and
Respiratory Diseases, will describe adult\'s tetanus, diphtheria,
acellular (pertussis) vaccine recommendation.]{.underline}

[ A question and answer session will follow.]{.underline}

[ Please make a note of the following instruction. If you have technical
trouble, please dial star 0 on your telephone. If you\'d like to ask a
question, please press star 1 on the phone.]{.underline}

[ CE credit is available only through the CDC-ATSDR Training and
Continuing Education Online System at www.cdc.gov/phtnonline/. You must
have a verification code specific to this program to apply for
continuing education credit. This code will be revealed during the
course of the program. Continuing education credit for this activity
will expire on February 19, 2007.]{.underline}

[ CDC, our planners and our presenters wish to disclose that they have
no financial interest or other relationships with the manufacturers of
commercial products, suppliers of commercial services or commercial
supporters.]{.underline}

[ Presentations will include a discussion of the use of (Tdap) in the
manner recommended by the Advisory Committee on Immunization Practices
or ACIP but not licensed by the Food and Drug
Administration.]{.underline}

[ Presentations will not include a discussion of any unlicensed or
investigational products.]{.underline}

[ Now, Dr. Mask will present a discussion of adult hepatitis B vaccine
recommendation.]{.underline}

[ Eric?]{.underline}

[Eric Mast: Thank you, Andrew. And good afternoon.]{.underline}

[ I plan to present an overview of the new adult hepatitis B vaccine
recommendations from the advisory committee on immunization practices.
This is the second of a two part statement from ACIP. The first part
which provided a recommendation for immunization of infants, children
and adolescents was published in December of 2005.]{.underline}

[ In my presentation, I will discuss background about hepatitis B,
including disease burden in the United States and progress in
implementing the ACIP strategy to eliminate hepatitis B virus
transmission. I will also discuss the rationale for the new
recommendations and provide an overview of these
recommendations.]{.underline}

[ Hepatitis B is a major public health problem in the United States, but
substantial progress has been made in controlling this disease. With the
implementation of the ACIP strategy to eliminate hepatitis B virus
transmission beginning in the early 1990s, new infections have declined
from 200 to 300,000 infections per year in the 1980s to about 51,000 new
infections in 2005. But there continues to be a substantial ongoing
disease burden amongst persons infected in the past. According to data
from the National Health and Nutrition Examination survey, about 5% of
persons in the United States or about 12.5 million persons total have
been infected during their lifetime. And about 10% of these infected
persons have chronic HBV infection. Most of the disease burden
associated with hepatitis B virus infection occurs in persons with
chronic infection and there are about 3,000 to 5,000 deaths per year
from hepatitis B related chronic liver diseases, including cirrhosis and
liver cancer in the United States. ]{.underline}

[Because hepatitis B virus transmission occurs in all age groups,
including infants, young children, adolescents and adults, the ACIP has
developed a four part strategy designed to eliminate transmission of
hepatitis B virus. This strategy includes prevention of perinatal
hepatitis B virus transmission by screening all pregnant women for
hepatitis B surface antigen and providing immunoprophylaxis to infants
born to hepatitis B virus infected mothers beginning at birth. Other
components of the strategy includes universal infant vaccination
beginning at birth, catch up vaccination of all children and adolescents
less than 19 years of age and vaccination of adults in risk
groups.]{.underline}

[ The childhood components of this strategy have been successfully
implemented. In particular, vaccine coverage among 19 to 35 month old
children as measured in the National Immunization Survey has increased
from near zero in 1990 to greater than 90% in 2004 and is now equivalent
to that for other childhood vaccine preventable diseases.]{.underline}

[ In addition, vaccine coverage among adolescents has increased,
primarily as a result of implementation of school entry vaccination
requirements. Elementary school vaccination requirements are now in
place in 45 states and middle school requirements are in place in 37
states.]{.underline}

[ Coincident with the successful implementation of routine infant
vaccination and catch up vaccination of adolescents, acute hepatitis B
rates among those children less than 12 years of age and among
adolescents, 12 to 19 years of age have declined 96% since 1990. Disease
rates among adults have also declined 76% during this time period.
However, currently, the incidence of acute hepatitis B remains highest
among adults, who accounted for more than 95% of an estimated 51,000 new
infections in 2005.]{.underline}

[ The highest incidence of acute hepatitis B in 2005 was among adults
aged 25 to 45 years and adult males had higher rates of acute hepatitis
B than adult females in all age groups.]{.underline}

[ Most of the infections occurring in adults are occurring among persons
in well-defined risk groups. During 2001 to 2005, data from the Sentinel
Counties Study of viral hepatitis indicates that 63% of newly acquired
cases of acute hepatitis B were associated with high risk sexual
activity, with 39% of cases among high risk heterosexuals and 24% of
cases among men who have sex with men. In addition, 16% of cases were
associated with injection drug use. Other known exposures, including
household contacts, institutionalizations, hemodialysis, blood
transfusion, and occupational exposure, together accounted for 5% of
cases and 16% denied a specific risk factor for
transmission.]{.underline}

[ There has been some success in vaccinating adults at risk for HBV
infection as indicated by this vaccine coverage data from the 2004
National Health Interview Survey. In particular, higher age specific
hepatitis B vaccine coverage was found among adult risk groups than in
the general adult population. However, overall vaccine coverage among
the adult risk group is low, and ongoing hepatitis B virus transmission
continues to occur primarily among unvaccinated adults with risk factors
for transmission.]{.underline}

[ Ultimately, hepatitis B incidence among adults is expected to decline
during the next decade, as success of highly immunized children and
cohorts of highly immunized children and adolescents reach adulthood.
However, the ongoing high disease burden of new hepatitis B virus
infections among adults at risk for hepatitis B virus infection provides
a rationale for the ACIP to re-examine strategies for vaccination of
adults.]{.underline}

[ Since 1982, ACIP has recommended hepatitis B vaccination for adults at
risk for HBV infection. However, these recommendations have not been
effectively implemented. At present, many health care settings do not
vaccinate adults at risk and as a result, a substantial number of adults
at risk for HBV infection are not vaccinated. As a result of the current
low vaccination coverage among adults, a substantial burden of new
infections continues to occur.]{.underline}

[ One strategy that has been demonstrated to be particularly effective
at increasing vaccine coverage among adults at risk for HBV infection is
to offer vaccination to all adults as a part of routine prevention
services in settings in which a high proportion of persons have risk for
HBV infection. During 2001 to 2004, in a study of a 760 adults with
reported cases of acute hepatitis B, who participated in CDC\'s Sentinel
County Study of viral hepatitis, 39% reported a history of STD
treatment, 40% reported a history of incarceration, and 22% reported a
history of drug treatment. Overall, 61% of persons with acute hepatitis
B would have had at least one opportunity to be vaccinated either during
STD or drug treatment or during incarceration.]{.underline}

[ A number of adults\' hepatitis B vaccine demonstration projects have
been conducted in settings serving adults at risk. In these
demonstration projects, first dose (acceptance) rates of 60 to 85% have
been achieved in STD clinics, drug abuse treatment and prevention
settings, HIV testing and counseling settings and correctional
facilities. In addition, third dose completion rates of 20 to 30% have
been achieved in outpatient settings and completion rates of 50 to 90%
have been achieved in correctional facilities where inmates had at least
four months of incarceration. Although these third dose completion rates
are not optimum, concerns about the completion of the three dose
hepatitis B vaccine series should not prevent starting the series,
because each dose confers some protection. Approximately 30% to 55% of
adults have seroprotective levels of antibody to hepatitis B surface
after the first dose, 75% have protection after two doses and greater
than 90% have protection after three doses. These demonstration projects
have also established the feasibility of providing hepatitis B vaccine
as a part of comprehensive STD, HIV/AIDS, and hepatitis prevention
services. ]{.underline}

[And they have also identified components needed for implementation of
successful adult hepatitis B vaccination programs. These components
include institutional commitment to adult hepatitis B vaccination,
trained and knowledgeable staff, patients who were informed about
hepatitis B and the benefits of vaccination, infrastructure that ensures
vaccine administration is accessible, convenient and flexible for
patients, protocols and standing orders, integrated delivery of vaccine
with other services, protected patient confidentiality and funding for
hepatitis B vaccine.]{.underline}

[ There have also been studies that have demonstrated that adult
hepatitis B vaccination in settings serving adults at risk is highly
cost-effective. In these studies, hepatitis B vaccination was estimated
to be cost-saving from societal perspective for prison inmates and the
cost per year of life you save for STD clinic clients and for clients of
HIV testing sites was \$3,500 per life you save and \$4,400 per life you
save, respectively.]{.underline}

[ Although universal vaccination of adults in settings serving adults at
risk is a highly effective strategy, there\'s also a need for
vaccination strategies that reach adults in primary care and specialty
medical settings, because not all adults with risk factors for HBV
infection visits settings serving adults at high risk. For example, an
estimated 80 to 95% of STDs are diagnosed in settings other than STD
clinics. In primary care and specialty medical settings that serve
general adult populations, risk-targeted vaccination is the most
efficient approach to prevent HBV infection. There are several reasons
for this First, whereas about 84% of persons with acute hepatitis B
report behaviors or characteristics placing them in a group recommended
for hepatitis B vaccination, only about 15 to 20% of all adults report
risk for HBV infection. Second, risk identification is already
recommended by several medical advisory groups to identify persons who
need other prevention intervention, such as HIV screening, STD screening
and drug treatment.]{.underline}

[ And, in addition, risk targeted vaccination was demonstrated to be
substantially more cost-effective than vaccination of all adults in one
published study of the cost-effectiveness of adults hepatitis B
vaccination.]{.underline}

[ Although, risk targeted vaccination is the most efficient approach to
prevent HBV infection in adults, risk targeted approaches can miss
at-risk persons for a couple of reasons. First, patients might be
reluctant to report risk behaviors, especially when they are not
relevant to the clinical encounter. In addition, despite recommendations
of the American Medical Association and the US Preventive Services Task
Force to screen patients for sex and drug related behaviors, surveys of
physicians and patients conducted during 1995 to 1999, indicated that
less than 50% of patients were asked about sexual and drug related risk
behaviors. These findings provide the rationale that all patients need
to be educated about the health benefits of hepatitis B vaccination,
including risk factors for HBV infection and the importance of
vaccination for persons with risky behaviors. This type of education
might stimulate patients to request vaccination without acknowledging a
specific risk factor.]{.underline}

[ Next, I will discuss an overview of the new ACIP recommendations for
adult hepatitis B vaccination.]{.underline}

[ In this statement, ACIP recommends hepatitis B vaccination for all
unvaccinated adults at risk for HBV infection as well as all adults
seeking protection from HBV infection. And specifically, the
recommendation states that acknowledgement of a specific risk factor is
not a requirement for vaccination. In addition, ACIP recommends that
vaccination strategies appropriate for the medical practice setting be
implemented to ensure that all adults at risk for HBV infection are
offered hepatitis B vaccine.]{.underline}

[ The unvaccinated adults at risk for HBV infection that ACIP recommends
receive hepatitis B vaccine include persons at risk for sexual
transmission, persons at risk for transmission by percutaneous or
mucosal exposure to blood, as well as others.]{.underline}

[ Persons at risk for sexual transmission includes sex partners of
hepatitis B-surface-antigen-positive persons, sexually active persons
who are not in a long term mutually monogamous relationship, such as
persons who have more than one sex partner in the previous six months,
persons seeking evaluation or treatment for a sexually transmitted
disease and men who have sex with men.]{.underline}

[ Persons at risk for transmission by percutaneous or mucosal exposure
to blood include injection drug users, household contacts of
surface-antigen-positive persons, residents and staff of institutions
for developmentally disabled persons, healthcare and public safety
workers and dialysis patients and others with end stage kidney
disease.]{.underline}

[ And other persons recommended to receive hepatitis B vaccine include
international travelers to regions with hepatitis B-surface-antigen
prevalence greater and equal to 2%, persons with chronic liver disease,
persons with HIV infection and all other persons seeking protection from
HBV infection.]{.underline}

[ The ACIP statement also provides recommended implementation strategies
for three types of settings in which adults at risk for HBV infection
receive medical care. This includes settings in which a high proportion
of adults have risk factors for HBV infection, primary care and
specialty medical settings and occupational health
settings.]{.underline}

[ The settings in which a high proportion of persons at risk for HBV
infection include STD treatment facilities, HIV testing and treatment
facilities, drug abuse treatment and prevention settings, correctional
facilities, facilities targeting services to either men who have sex
with men or injection drug users, chronic hemodialysis facilities and
end stage renal disease programs and institutions in non-residential day
care facilities for developmentally disabled persons.]{.underline}

[ In these settings in which a high proportion of persons have risk for
HBV infection, ACIP recommends implementing standing orders to
administer hepatitis B vaccine to all unvaccinated adults. In these
standing orders, all unvaccinated adults should be assumed to be at
risk. And hepatitis B vaccine should be provided as a component of STD,
HIV/AIDS and other viral hepatitis prevention services. In addition,
when feasible, hepatitis B vaccine should be provided in outreach
settings, such as needle exchange program, HIV testing sites and
homeless shelters.]{.underline}

[ In primary and specialty medical settings, ACIP recommends
implementing standing orders to identify and vaccinate eligible adults.
In these standing orders, information about the health of hepatitis B
vaccine should be provided to all adults including risk factors for HBV
infection and persons for whom hepatitis B vaccine is recommended. It is
also recommended that a risk history should be obtained to help patients
assess their need for hepatitis B vaccination. This risk history should
have particular emphasis on risk for sexual transmission and risk for
percutaneous or mucosal exposure to blood. And hepatitis B vaccine
should be administered to all adults who report risks for HBV infection
and all adults seeking protection from HBV infection without
acknowledging a specific risk factor for infection.]{.underline}

[ In occupational health programs, ACIP recommends implementing
protocols and procedures to identify all staff, whose work related
activities involve exposure to blood or other potentially infectious
body fluids. Information also should be provided to educate staff to
encourage vaccination and ACIP recommends implementing active follow up
with reminders to track completion of the vaccine series.]{.underline}

[ In summary, substantial progress has been made in eliminating
hepatitis B virus transmission in the United States since 1991. Overall
childhood hepatitis B rates have declined by more than 95% and adult
hepatitis B rates have declined by more than 75%. However, a substantial
burden of new infections continues to occur in the United States, with
51,000 new infections in 2005, more than 95% of which occurred among
adults. Ultimately, these infections among adults are expected to be
eliminated as highly immunized cohorts of children and adolescents reach
adulthood. In the meantime, elimination of HBV transmission can be
accelerated by increasing hepatitis B vaccination coverage among at risk
adults. These new recommendations provide the adult risk groups for whom
hepatitis B vaccine is recommended, as well as settings specific
implementation strategies to assure that at risk adults are offered
hepatitis B vaccine.]{.underline}

[ And finally, to assist providers with implementing these
recommendations, the Division of Viral Hepatitis has launched a new
website at http://www.cdc.gov/hepatitis. This website provides
information and resources targeted to each of the different settings in
which adult hepatitis B vaccine is recommended. Thank you very much for
your attention and also for your ongoing efforts to eliminate hepatitis
B virus transmission.]{.underline}

[(Andrew Kroger): Thank you, Eric.]{.underline}

[ Now, Dr. Katrina Kretsinger will describe new recommendations for the
use of tetanus, diphtheria, acellular pertussis vaccine in adults,
Katrina?]{.underline}

[(Katrina Kretsinger): Thank you, Andrew.]{.underline}

[ Hello and thank you all for attending the session on the use of Tdap
among adults.]{.underline}

[ Pertussis also known as whooping cough is a poorly controlled vaccine
preventable disease, in fact, the most poorly controlled bacterial
disease for which routine children immunization is recommended. The
incidents of reported pertussis has been increasing over the past 20
years. In 2005, over 25,000 cases were reported in the United States - a
40 year high. Adults are among the age groups vulnerable to pertussis
and 27% of the 2005 cases were among adults. Immunity induced by
childhood pertussis vaccination with DTaP waned after approximately five
to 10 years leaving adolescents and adults vulnerable to infection.
However, a new tool is available to combat pertussis. The first US
pertussis vaccines for adults and adolescents were licensed in 2005.
These vaccines are known as Tdap.]{.underline}

[ In this presentation, I will first discuss the epidemiology and
clinical characteristics of adult pertussis. Since this is a new
vaccine, I\'ll spend a little bit of time discussing product information
including Tdap (immunogenicity) and safety. Finally, I will present
recommendations for adult Tdap use.]{.underline}

[ Pertussis is under-reported among adults, probably because it is often
considered a childhood disease and not recognized by clinicians. And
also because it can be difficult to diagnose. The burden of adult
disease is substantial with almost 8,000 cases of adult pertussis
reported in the US in 2005. However, the burden of true disease is
estimated from prospective trials to be much higher with approximately
600,000 cases per year among adults aged 19 to 64 years. Adult pertussis
is costly. The estimated societal cost per individual case is estimated
to be \$773. Furthermore, controlling pertussis outbreaks can place a
large burden on public health departments because control measures
include labor intensive contact tracing and prophylactic post exposure
antibiotics.]{.underline}

[ This figure shows the trends in reported pertussis since the 1920s.
The number of cases dropped in the early part of the century and
particularly after the introduction of universal childhood pertussis
vaccination in the late 1940s. After reaching a low of 1,010 cases in
1976, reported cases had increased, in particular over the past decade.
The inset figure shows the age distribution of reported cases. Please
note that the proportion of case among adolescents and adults has been
increasing.]{.underline}

[ Adult pertussis presents with an upper respiratory illness lasting for
approximately one to two weeks followed by a cough illness. In studies
of reported cases, the median duration of cough illness is over two
months. Anti-microbials do not modify the course of illness after cough
is established, but they will decrease infectivity of patients if given
early. Pertussis can result in repeated medical visits and time lost
from work. The societal cost per adult cases is approximately \$773.
Finally, high risk groups for pertussis infection are not well-defined.
Pertussis can affect all segments of the adult population.]{.underline}

[ The following clinical characteristics were reported in a study of
Massachusetts adults with reported pertussis. Between 84 and 86%
reported paroxysms of coughing which means that coughs stack up, making
it difficult for the patient to catch their breath. Over half reported a
cough duration of over nine weeks and 86% reported difficulty breathing.
Other symptoms, however, which are considered characteristic of
pertussis, post-tussive of vomiting and whoop, were present in less than
half of the adult patients. Thus, adult pertussis may not have a classic
presentation and may not be recognized. Also note that radiographically
confirmed pneumonia was reported in 2 to 5% of the patients, rib
fracture 4%, and hospitalization 3%.]{.underline}

[ Infants less than 12 months of age are at greatest risk for death and
complications from pertussis. From 2000 to 2004, infants counted for 92
of 100 US pertussis death and the risk of death is highest among the
youngest infants, who may not yet have had the opportunity to receive
three doses of DTaP. Over 60% of infants with pertussis are
hospitalized. Adults are known to transmit pertussis to infants. In a
recent study of infant pertussis, among 264 known source cases, 55% were
identified as a mother, father, grandparents and 51% were adults over 19
years of age.]{.underline}

[ Health care personnel are a group of adults at an increased risk of
pertussis exposure and infection and they can transmit infection to
vulnerable patients including infants. Pertussis outbreaks have been
reported in pediatric and adult in-patient wards, maternity units and
obstetric units. Infection control activities related to these outbreaks
are exceedingly resource-intensive, disruptive and costly with the
average cost ranging from 74 to \$174,000 in four recent
outbreaks.]{.underline}

[ In 2005, a new tool to combat pertussis became available when the
first US vaccines against pertussis were licensed for adolescents and
adults. These vaccines are combined with tetanus and reduced diphtheria
toxoid and are known as Tdap. Please note that there are no
pertussis-only vaccines available in the United States. Tdap is licensed
for a single use only and not for sequential uses for repeated doses as
a booster. Studies on sequential use have not yet been conducted. Two
Tdap vaccines were licensed in 2005, but only one is licensed for adults
and neither product is licensed for older adults aged greater than or
equal to 65 years.]{.underline}

[ The licensed Tdap products include Boostrix which is indicated for
adolescents age 10 to 18 years and Adacel, which is shown in yellow in
the right column, which can be used both for adolescents and adults with
an age indication of 11 to 64 years. As I mentioned before, no
prelicensure studies were conducted on older adults. Both products are
indicated for active booster immunization for prevention of tetanus,
diphtheria and pertussis as a single dose. Since only Adacel is licensed
for adults, most of my comments during this talk will concern Adacel
only. ]{.underline}

[ For Adacel, the composition of the tetanus and diphtheria toxoid is
equivalent to that of Td, which is the adult tetanus, diphtheria vaccine
which has been a historic standard of care. The acellular pertussis
(antigens) are the same as (Daptacel), the pediatric Dtap vaccine except
that that the detoxified pertussis toxin is present in a lower
quantity.]{.underline}

[ Because no serologic correlate of protection exists for pertussis, the
efficacy of Tdap against pertussis for licensure was inferred from
immunogenicity data using a serologic bridge. Immune responses in adult
after one dose of Adacel were not inferior to immune responses in
infants after three doses of Daptacel during pertussis efficacy trials
and adult booster responses after Tdap were found to be
acceptable.]{.underline}

[ For tetanus and diphtheria, efficacy was also inferred from
immunogenicity. A serologic correlate of protection of 0.1 international
unit per ml is well accepted for both. Adult immune responses after Tdap
were not inferior to Td, the existing standard of care, with a
seroprotective rate for tetanus of 100% and diphtheria of 94%. Booster
responses were acceptable.]{.underline}

[ A prospective clinical efficacy trial known as the APERT trial was
conducted among almost 2,800 subjects using a different formulation of
acellular pertussis vaccine. These results were not considered in
licensing Tdap but it did demonstrate a clinical efficacy of
92%.]{.underline}

[ The primary adult safety study conducted in the United States with a
randomized observer-blinded controlled study of almost 1,700 adults aged
18 to 64 years who received a single dose of Adacel and 561 who received
Td. ]{.underline}

[ Pain at the injection site was the most frequently reported local
adverse event among adults in both vaccination groups. These rates were
comparable among the Tdap and Td groups at 65.7 and 62.9%, respectively.
Severe pain was reported much less frequently, about 1% in both groups.
In summary, the rates of pain, erythema, swelling and fever were
non-inferior among the Adacel recipients compared to the Td recipients.
44 serious adverse events within six months after vaccination were
reported among 1.9% of vaccinees in both groups. Among these, two
neuropathic events were assessed by the investigators as possibly
related to vaccination and symptoms did resolve completely. No Arthus,
full arm swelling or Guillain-Barré Syndrome was reported.]{.underline}

[ The primary objective of the adult pertussis vaccination is to protect
the vaccinated adults against pertussis. The secondary objective is to
reduce the reservoir of pertussis in the population and thereby to
decrease the exposure of persons at increased risk for complicated
infection such as infants and to reduce the cost and disruption of
pertussis in health care settings.]{.underline}

[ The Advisory Committee on Immunization Practices reviewed evidence for
the use of Tdap in 2005 and 2006. In June 2005, immediately following
licensure, they voted to recommend Tdap for routine adolescent use and
in October for routine adult vaccination and for adults in close contact
with infants. In February of last year, ACIP voted to recommend Tdap for
health care personnel. And finally, in June, ACIP voted on
recommendations for the use of Tdap among pregnant women.]{.underline}

[ Routine adult Tdap use. First I\'d like to discuss routine use. The
routine recommendations apply to adults 19 to 64 years of age, who have
not previously received a dose of Tdap. As you\'ll recall, Tdap is
licensed for single use only. After receipt of Tdap, subsequent doses of
boosters should be with Td according to previously published guidance.
Adacel is the only Tdap licensed for adults.]{.underline}

[ The core recommendation for adult Tdap use is that all adults should
receive a single dose of Tdap to replace the single dose of Td for
active booster immunization against tetanus, diphtheria and pertussis if
they received their last dose of Td 10 years or more earlier. This is a
simple replacement of Td with Tdap whenever TD is next due and applies
to all adults up to the age of 64 years. If Tdap and another vaccine are
both indicated, they should be administered during the same
visit.]{.underline}

[ Intervals less than 10 years since the last TD may be used to protect
against pertussis, particularly in settings with increased risk for
pertussis. The benefit of using of a single dose of Tdap in an interval
less than 10 years to protect against pertussis generally outweighs the
risk for local and systemic reactions after vaccination. The safety of
intervals as short as approximately two years are supported by data from
a Canadian study of approximately 7,000 children and adolescents.
Although less well studied, intervals shorter than two years may also be
used.]{.underline}

[ I\'d like to turn now to two high risk sub-groups, adults in contact
with infants and health care personnel. Adults who have or who
anticipate having close contact with an infant less than 12 months of
age, for example parents, grandparents of less than 65 years, child care
providers and health care personnel should receive a single dose of Tdap
at intervals shorter than 10 years since the last Td to protect against
pertussis, if they had not previously received Tdap. Ideally, these
adults should receive Tdap at least two weeks before beginning close
contact with an infant. An interval as short as two years from the last
dose of Td is suggested but shorter intervals may be used. Infants
should be vaccinated on time with pediatric DTaP. When possible, women
should receive Tdap prior to conception. It is estimated that
approximately half of all pregnancies in the United States are
unplanned. Any woman of childbearing age, who might become pregnant is
encouraged to receive a single dose of Tdap if she had not previously
received Tdap. Women, including those who are breastfeeding, should
receive a dose of Tdap in immediate post partum period if they had not
previously received Tdap. The post partum Tdap should be given before
discharge from the hospital or the birthing center.]{.underline}

[ The recommendations for the use of Tdap among health care personnel
are supported by members of the health care infection control practices
advisory committee or HICPAC. Health care personnel in hospitals or
ambulatory care settings with direct patient contact should receive a
single dose of Tdap if they have not previously received Tdap. Although
Td boosters are now routinely recommended at an interval of 10 years, an
interval as short as two years from the last dose of Td is recommended
for the Tdap use. Recommendations apply to physicians at a primary care
provider, nurse\'s aides, respiratory therapists, radiology technicians,
students, dentists, social workers, chaplains, volunteers, dietary
clerical workers. Vaccinating health care workers with Tdap will protect
them against pertussis and is expected to reduce transmission to
patients, other health care personnel, household members and persons in
the community. Priority should be given to vaccination of health care
personnel who have direct contact with infants aged less than 12 months.
Hospitals and ambulatory care facilities should provide Tdap for health
care personnel and use approaches that maximize vaccination rates, such
as education, convenient access and the provision of Tdap at no
charge.]{.underline}

[ For the sake of completeness and to provide a comparison, I\'ve
included the core adolescent recommendations on this slide. Basically,
these recommendations state that adolescents aged 11 to 18 years to
receive a single dose of Tdap instead of Td, if they have not yet
received Td or Tdap. And the preferred age is 11 to 12 years.
Adolescents who have already received TD but not Tdap are encouraged to
receive a single dose of Tdap and a five year interval between Td and
Tdap is encouraged to reduce the risk for local and systemic reaction.
Please note there\'s an important distinction between the adolescent and
the adult recommendations. For both groups, short intervals since
receipt of last Td may be used. But only for adolescents with a five
year interval are encouraged. For adults, the safety of intervals as
short as two years is emphasized.]{.underline}

[ On this slide, I\'ve summarized the major contraindications and
precautions for Tdap and for DTaP as a comparison. For Tdap, like DTaP,
a serious allergic reaction to a vaccine component or encephalopathy
within seven days from receipt of a pertussis vaccine, but no alternate
explanation or contraindication. Progressive neurological conditions are
a contraindication to receipt of childhood DTaP and a precaution for
receipt of Tdap among adolescents. However, for adults
stably-progressive neurologic condition such as dementia are more
common. Progressive conditions do not constitute a precaution but rather
unstable neurologic conditions do. A history of Guillain-Barré Syndrome
less than six weeks after a tetanus vaccine is also considered a
precaution to receiving Tdap. Finally, certain adverse events after a
childhood DT or DTaP vaccine are considered precautions to receipt of
pediatric DTaP, but are not considered precautions for adult Tdap. These
are listed in the footnotes.]{.underline}

[ Moving on to special situations. In pertussis outbreak settings, Tdap
may be used at shorter intervals since the most recent Td. A history of
pertussis does not alter the routine recommendation for Tdap use. For
wound management, Tdap is preferred to Td if tetanus prophylaxis is
indicated using the standard algorithm. And finally, for adults with an
incomplete history of childhood diphtheria, tetanus and pertussis
vaccination, a primary three dose series is indicated. Tdap may be used
as one of the doses and Td should be used for the remaining
two.]{.underline}

[ Of the two licensed Tdap products, only Adacel is licensed and
recommended for use in adults. Boostrix is licensed for persons aged 10
to 18 years and should not be administered to the adults. Pediatric DTaP
is not indicated for persons seven years old or older. The packaging of
Daptacel and Adacel appear very similar and shown here are photographs
of the packaging in question. If Boostrix for pediatric DTaP is
administered to an adult, this dose should count as a Tdap dose and the
patient should not receive an additional dose of Tdap. The patient
should be informed of any inadvertent vaccine
administration.]{.underline}

[ Recommendations for pregnant women are still provisional. The core
recommendation is that a pregnant woman who have not received Tdap
should receive a routine post-partum dose of Tdap after delivery before
discharge from the hospital. Td is recommended if tetanus and diphtheria
protection are required during pregnancy. In some circumstances, a woman
may choose to defer Td and receive Tdap post partum. Finally, pregnancy
is not a contraindication for Tdap and in some circumstances, providers
may choose to administer Tdap for pertussis protection during
pregnancy.]{.underline}

[ Tdap is not licensed for use among older adults over 65 years and
older and Tdap use among older adults was not studied during
prelicensure trials. An older adult should receive a dose of Td every 10
years for protection against tetanus and diphtheria and as indicated for
wound management.]{.underline}

[ ACIP recommendations for the use of Tdap are available on three
separate documents which are available on the web addresses provided on
the slide.]{.underline}

[ I would like to acknowledge the following individuals at CDC who
provided assistance with adult recommendations. In addition, I would
like to thank the members of the ACIP pertussis working
group.]{.underline}

[ Thank you for your attention.]{.underline}

[ Andrew?]{.underline}

[Andrew Kroger): Thank you, Katrina.]{.underline}

[ We now like to invite our listeners to call in and ask questions. Be
sure to restrict your questions to the contents discussed today and
please tell us your name and where you are from. I\'m going to
temporarily now turn the mike over to our operator.]{.underline}

[Coordinator: Thank you.]{.underline}

[ We will now begin the question and answer session. If you would like
to ask a question, press star 1. You will be prompted to record your
name. Again, press star 1 to ask a question. And it\'ll be just a moment
for our first question.]{.underline}

[Andrew Kroger: While we are waiting for the first question, I would
like to provide some continuing education credit
information.]{.underline}

[ For CE credit, go to www.cdc.gov/phtnonline/. The course number for
our net conference is EV0378 and the verification code is CR177F.
Remember that CE credit expires on February 19th, 2007.]{.underline}

[ So now I\'m happy to take the first question.]{.underline}

[Question 1: . I just wondered if the slides will be made available to
us.]{.underline}

[Answer 1: They will be available. They will be available on the same
website on which you registered, which is cdc.gov/nip/ed/ciinc. Ciinc
stands for "Current Issues in Immunization NetConference, ciinc. The
slides should be up in a couple of days and we will also be archiving a
script for the net conference. That should be up in a week or two as
well as the audio replay.]{.underline}

[Question 2: Hi. I was wondering, the hepatitis B series for the adults.
We work in occupation medicine setting and what is the current
recommendation for if they do not show immunity after the third
shot?]{.underline}

[Answer 2: Right. In the occupational health setting, it is recommended
that persons at high risk of exposure to blood borne pathogens have post
vaccination testing to see if they\'re protected. And in order for them
to be protected, they need to have an anti-HBS antigen of greater than
or equal to 10 milli-international units per milliliter.]{.underline}

[ And it\'s recommended that testing be done within one to two months
after the third dose of the series. If they don\'t have protection,
it\'s recommended that they get additional doses of vaccine. And they
can either get up to three doses of hepatitis B vaccine, either one dose
and testing again after one dose or up to three additional doses of
vaccine.]{.underline}

[Question 2 follow-up: That\'s what we\'re trying to figure out which
way to go with that.]{.underline}

[Answer 2 follow-up: That will, basically, depend on the feasibility in
your particular setting. If it\'s easy to get people back after the
first dose and test them, that\'s certainly a way to go. If it\'s easier
to give those three doses before testing, that is also an approach that
can be used.]{.underline}

[Question 3: My question is regarding the Tdap. Is there a
recommendation regarding pre-hospital emergency workers such as
paramedics?]{.underline}

[Answer 3: They, actually, would fall under the routine adult
recommendation or possibly within the health care worker recommendation
as well. They don\'t technically work in a hospital or in ambulatory
care setting, which is the way the health care recommendation is defined
for the workers who are recommended \-- health care workers who are
recommended to get Tdap at an earlier setting. However, we would still
encourage any health care worker including people who work in an EMT
setting to receive Tdap in an interval that\'s earlier than when the
next Td would otherwise be due.]{.underline}

[ For that situation, I didn\'t go into detail on this particular
presentation, but those fall into a group that we encourage earlier
vaccination as well. ]{.underline}

[Question 4: Do you happen to know how long it might be before we can
see update on the infection guidelines for health care workers that
would include the Tdap information? That really helps us because we
follow those guidelines as our standard in our facility. I know it\'s
been published and we can use that now, but that would make it easier
for what\'s actually in that document.]{.underline}

[Answer 4: We, in the actual published recommendation, did put in
wordings specifically that have been reviewed and are supported by
HICPAC, so to the extent that, you know, having the HICPAC endorsement
is important or helpful in terms of the occupational health guidelines,
They are present in the now published adult Tdap recommendations. I
don\'t know when the next hospital infection guidelines \-- overall
general guidelines will be published and I apologize.]{.underline}

[Question 5: Do you happen to know \-- we\'ve still had some issues with
availability (of Tddap) and is that cleared up?]{.underline}

[Answer 5: According to the manufacturers, it has cleared up. During the
period of time when there was a shortage, they were distributing doses
to everybody who was ordering products but in some reduced quantity from
the order. And my understanding is that they are now filling all the
orders that they are receiving.]{.underline}

[Question 6: Do you have any data on how many of the cases of hepatitis
B are occupational? We haven\'t seen any data like that in a long time.
Is it zero or are there still some?]{.underline}

[Answer 6: It\'s rare to have an occupationally acquired infection.
Rates of hepatitis B that are occupationally acquired used to be several
fold higher than in the general adult population and in the mid 1990s,
rates declined below the general population and now substantially below
the general population. But in terms of actual numbers, I don\'t have
those.]{.underline}

[Question 7: My question is in reference to the Tdap. I wanted to know
if Vaccines for Children will be providing that for those adolescents
ages 16 to 18 and then also, what is the cost for those that are over
that particular age like 19 and above?]{.underline}

[Answer 7: My understanding is the VFC, the vaccine for children program
will supply vaccines for eligible children up to the age of 18. The out
of pocket cost of product, in my understanding, is that it\'s
approximately \$35 per dose, which is approximately \$20 more than the
Td cost. As always, the financing and availability of adult vaccines is
a little more problematic than it is for children and I believe the 19
year old would fall into that category.]{.underline}

[Question 8: Okay. I noticed in the graph that the pertussis rate was
pretty flat for at least 20 years, like between 1980 and 2000 and then
it rose, why weren\'t we having more cases during that
period?]{.underline}

[Answer 8: The short answer is that we don\'t really know. First of all,
there\'s no question that there is a lot of disease right now, what we
don\'t really know is how much disease there was, especially among
adults and adolescents, earlier, that was not being detected because of
the absence of laboratory testing. We might have otherwise picked up
those cases or clinician awareness cases among adults and
adolescents.]{.underline}

[ So, there\'s a number of hypothesis that have been entertained, which
may explain what could account for the increased number of cases. And
none of them have really been shown \-- have been proven: such as
speculation about whether some of the lots of vaccine that were
distributed were sub-potent. We don\'t have any evidence in the United
States. That was the case although there is pretty good data in Canada
to suggest that may have been the case.]{.underline}

[ But in addition to the increase of case among adults and adolescents
which are probably more subject to the vagaries of reporting and
recognition, we\'ve also seen a rise in the number of cases among
infants. We believe that our reporting for infants is considerably
better than it is for adults and adolescents and since those cases have
also increased, we do believe that, at least some portion of the
increase is real and we don\'t really understand or have a very good
explanation with which to work.]{.underline}

[Question 9: I work in a small \-- acute care hospital and our OB
physicians are reluctant to administer the Tdap during the pre-natal
period and have some concerns also about giving during the immediate
post partum period. What would you recommend would be the best time to
administer this vaccine in a patient at risk?]{.underline}

[Answer 9: Prior to pregnancy. In fact, for any woman of childbearing
age, as well as in the immediate post partum period, the urgency is much
greater, obviously. Women who have recently delivered an infant are
actually going to be in contact with an infant who is vulnerable to
pertussis and can suffer debilatory consequences of infant pertussis. If
you had to prioritize between the two groups, the post partum dose is
probably more important. Although we\'d like to see both.]{.underline}

[Question 10: My question is regarding DTaP.. If a child is seven years
old then this would be unusual, but for some reason has not received the
DTaP and they're between seven and 11 years, is there any flexibility in
giving the pertussis to them, the adolescent/adult pertussis to
them?]{.underline}

[Answer 10: Yeah. The troubling question for this gap of seven, eight,
nine year olds, we don\'t have a pertussis vaccine which is currently
licensed by FDA. You know, as a representative of CDC and ACIP, I could
only repeat what the specific ACIP recommendations are, which is that
children that age group not receive Tdap, however, one thing you should
realize, is that Boostrix is licensed for children at 10 years of age.
That\'s which is different from Adacel where the lowest age indication
of 11 years of age. However, ultimately, the decision is at the
discretion of the provider.]{.underline}

[Andrew Kroger: For CE credits, please go to www.cdc.gov/phtnonline. The
course number for net conference is EV0378 and the verification code is
CR177F. Remember that CE credit expires on February 19th,
2007.]{.underline}

[ Once you become familiar with the online system, you will find it easy
to use and a good way to keep track of CE credit earned from the CDC
training programs. If you\'re having any difficulty or are new to the
system, you can get assistance by phoning 1-800-41-TRAIN, that\'s
404-639-1292 and that\'s during business hours from 8:00 am to 4:30 pm
eastern time. To get help by way of email, contact
ce@cdc.gov.]{.underline}

[ If you were unable to ask your question today or if you have other
questions related to this net conference or in general, you can contact
us at our email question and answer service at the address
nipinfo@cdc.gov. If the question is related to net conference, please
write the word net conference in the subject line. We do look forward to
receiving our feedback as well.]{.underline}

[ Another way you can ask us a question to call the CDC hotline at
1-800-CDCINFO. This is a general hotline service that handles
immunization related questions, in addition to other public health
related question. The hotline is staffed 24 hours a day, seven days a
week.]{.underline}

[ I\'d like to thank everyone for joining us today, with special thanks
to our subject matter experts, Dr. Eric Mast and Dr. Katrina
Kretsinger.]{.underline}

[ Thank you very much and good-bye.]{.underline}

[Coordinator: Thank you and that does conclude today\'s conference. We
do thank you for your participation. At this time, you may disconnect
your lines.]{.underline}

[END]{.underline}