Questions & Answers
Questions submitted during the
Immunization Update broadcast on August 10, 2006
there any projections to require hepatitis A vaccine for healthcare
No. ACIP does not recommend routine hepatitis A vaccination
of healthcare workers because as an occupation they have not
been shown to be at increased risk. However, many adults have
non-occupational indications such as travel, for which the vaccine
we be vaccinating all persons younger than 18 years of age for
All children should receive hepatitis A vaccine at age 1 year
(i.e., 12–23 months). Vaccination should be completed
according to the licensed schedules and integrated into the
routine childhood vaccination schedule. Children who are not
vaccinated by age 2 years can be vaccinated at subsequent visits.
States, counties, and communities with existing hepatitis A
vaccination programs for children aged 2–18 years are
encouraged to maintain these programs. In these areas, new efforts
focused on routine vaccination of children aged 1 year should
enhance, not replace, ongoing programs directed at a broader
population of children. In areas without existing hepatitis
A vaccination programs, catch-up vaccination of unvaccinated
children aged 2–18 years can be considered. Such programs
might especially be warranted in the context of increasing incidence
or ongoing outbreaks among children or adolescents.
was the age requirement for hepatitis A lowered to one year
The age was lowered to one year based on safety and efficacy
data presented by the vaccine manufacturers to the FDA.
Twinrix be interchanged with hepatitis A and hepatitis B vaccines
if the person is started on the single-antigen vaccines and
then switched to Twinrix and vice versa?
Because the hepatitis B component of Twinrix is equivalent to
a standard adult dose of hepatitis B vaccine, the schedule is
the same whether Twinrix or single-antigen hepatitis B vaccine
hepatitis A vaccine may be used to complete a series begun with
Twinrix and vice versa. A person who receives one dose of Twinrix
may complete the hepatitis A series with two doses of adult
formulation hepatitis A vaccine separated by at least 5 months.
A person who receives two doses of Twinrix may complete the
hepatitis A series with one dose of adult formulation hepatitis
A vaccine or Twinrix 5 months after the second dose. A person
who begins the hepatitis A series with a dose of single-antigen
hepatitis A vaccine may complete the series with two doses of
a person has a documented history of hepatitis A infection,
does the person need hepatitis A vaccine?
No. They are immune. However, if there is any doubt about whether
the infection actually was hepatitis A, then take the conservative
approach and vaccinate. The vaccine will not harm someone who
is already immune.
a child is older than 2 years of age and has received one dose
of hepatitis A vaccine, does ACIP recommend the 2nd dose of
Yes. For long-term protection the person should complete the
series with the second dose.
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is the status of administering the HPV vaccine to males?
The current HPV vaccine, Gardasil, is not FDA approved for use
in males and there are no ACIP off-label recommendations to
vaccinate males. The vaccine manufacturer is conducting clinical
trials with males so at some later time they may apply to FDA
to make the vaccine available to males.
a pregnant woman receives HPV vaccine in the first trimester,
what effect is there on the fetus?
HPV vaccine has not been causally associated with adverse outcomes
of pregnancy or adverse events to the developing fetus. However,
data on vaccination during pregnancy are limited and ACIP has
adopted a conservative approach to the vaccination of pregnant
If a woman is found to be pregnant after initiating the vaccination
series, completion of the series should be delayed until after
the pregnancy. If a dose is administered during pregnancy, there
is no indication for intervention. A vaccine in pregnancy registry
has been established by the manufacturer, and women vaccinated
during pregnancy should be reported to (800) 986-8999. More
information on vaccination during pregnancy is available at
HPV vaccine be administered to teens without parental consent?
Federal law will mandate the recording of certain information
about each vaccination (e.g., manufacturer, lot number), and
the provision of the appropriate Vaccine Information Statement(s);
but there is no federal law requiring a parent/patient signature.
However, providers should check with their state immunization
program to determine whether additional requirements exist under
there any data regarding possible cervical changes that may
occur later in life for young women who have received Gardasil?
This vaccine has just recently been licensed and there are no
long-term post-vaccination data available.
a person who has been diagnosed with one of the HPV vaccine
virus strains still be vaccinated?
Yes, if the female is between 9 and 26 years of age. The vaccine
will not treat an existing infection with one of the vaccine
virus strains. However, in the clinical trials, females with
current or past infection with one or more vaccine-related HPV
types prior to vaccination were protected from the diseases
caused by the other remaining HPV types contained in the vaccine.
I give a dose of HPV vaccine now and the patient does not return
until 4 months later for the second dose, how long should I
wait to administer the third dose?
The minimum interval between the second and third doses of HPV
vaccine is 12 weeks regardless of the length of the interval
between the first and second doses. The minimum interval between
the first two doses is 4 weeks, but there is no maximum interval.
is HPV vaccine not recommended for women older than 26 years?
The vaccine is approved only for use in females 9 through 26
years of age because there are no safety or efficacy data for
older women. Studies are currently being conducted in women
27 years of age and older.
is the HPV transmitted?
Transmission of genital HPV is predominantly associated with
sexual activity; viable HPV and microtrauma to skin or mucous
membranes are likely required. Transmission can occur from asymptomatic
and subclinical patients. Infectiousness after treatment of
warts or cervical cell abnormalities is unknown. Transmission
by fomites has never been documented.
Although rare, genital HPV infection with low-risk types can
be transmitted from mother to baby during delivery and causes
respiratory tract warts in the baby, known as recurrent respiratory
following website provides more information on HPV and HPV transmission,
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immunity to influenza wanes, why does a child need only one
dose instead of two doses if they were vaccinated in a previous
The first dose of influenza vaccine given to a child younger
than 9 years of age is a "priming" dose. It offers
little protection. It is the second dose that offers the protection.
There is no need for priming in subsequent years, so only one
dose is recommended. Persons 9 years of age and older are assumed
to have been exposed to influenza viruses, and will have been
primed by that exposure. Therefore, they do not need a second
dose of vaccine in one year, even if they are receiving it for
the first time. Booster doses are not recommended for anyone
because data do not indicate that booster doses increase protection.
there an influenza vaccine available for persons with a severe
allergy to eggs?
No. Persons who have a severe life-threatening allergy to eggs
should be evaluated by an allergist who may be able to desensitize
them so that they can receive the vaccine. If not, then the
other option for these persons is an antiviral.
should we do if we discover that adults were given influenza
vaccine with a 5/8” needle?
Although it is likely that these adults did not get the full
dose of vaccine into their muscle, ACIP does not recommend revaccination.
These persons likely received some benefit from the vaccine,
but for optimal immune response the correct needle length should
be used, http://www.cdc.gov/mmwr/PDF/rr/rr5102.pdf
it OK to pre-draw influenza vaccine for a large clinic?
The National Center for Immunization and Respiratory Diseases
and the vaccine manufacturers strongly discourage prefilling
syringes with vaccine prior to usage. With the exception of
manufacturer-prefilled syringes, syringes used to administer
vaccines are meant for administration, not storage. However,
if you must prefill syringes for a large clinic, please review
guidelines in the “Vaccine Storage & Handling Toolkit”,
(Chapter 11, pages 6-8). Any non-manufacturer prefilled syringes
should be discarded at the end of the clinic day.
you are vaccinating a child between the ages of 5 and 8 years
with influenza vaccine for the first time, can you use one dose
of LAIV and one dose of TIV?
Yes. If the child is healthy you can give one dose of LAIV and
one dose of TIV. If LAIV is administered first, wait at least
6 weeks to administer the TIV dose. If TIV is administered first,
wait at least 4 weeks to administer the LAIV dose.
long after vaccination with LAIV should a person wait to become
ACIP has not directly addressed this situation. However, with
other live virus vaccines the recommendation is to wait at least
4 weeks before becoming pregnant.
LAIV going to be recommended for children 6 months to 5 years
In July, 2006 the vaccine manufacturer submitted an application
to FDA to approve the use of CAIV-T (Flu-Mist) in persons 6
months through 49 years of age. FDA review of the data is pending,
isn’t a second dose of influenza recommended later in
the season to boost immunity?
There is no evidence this is an effective strategy for preventing
is the basis for the recommendation that LAIV should only be
given to healthy person up through 49 years of age?
LAIV is only recommended for healthy, nonpregnant persons 5
years through 49 years of age because this is the population
in which the clinical trials were conducted. FDA licensed the
vaccine for use based on the manufacturer’s clinical trials
data. There are no ACIP off-label recommendations to administer
LAIV to any other age groups.
have patients with hypertension who are at risk for stroke.
Should they be prioritized to receive influenza vaccine?
Influenza vaccine is recommended for everyone 50 years of age
and older. For persons younger than 50 years of age, isolated
hypertension is not considered a risk factor for influenza.
However, it is important to screen these persons carefully.
They may have another chronic illness such as chronic cardiac
disease or diabetes that does put them at high risk for influenza
someone receives LAIV, is it possible to have a false-positive
culture later on?
Yes. LAIV contains live viruses so a false-positive antigen
test is possible for anywhere from 1-2 weeks after vaccination.
the definition of healthcare worker evolving? Previously that
designation referred to hands-on providers. Now, however, other
employees in a healthcare setting are also being considered.
We are getting away from “workers” and moving to
“providers.” This means not only people who have
close contact with patients or give vaccines, but also other
personnel, including anyyone who works in a healthcare facility
or provides any type of care (dieticians, clerks, janitorial
staff, etc.). Which definition applies depends on the disease.
For example, with respiratory or airborne infections, it doesn’t
matter if the employee is hands-on or in direct contact with
the patient. In this case, the definition should be wide enough
to include anyone who shares the air in the facility.
can I find the influenza declination form?
This form (which may be signed by healthcare providers to document
that they understand the consequences of declining influenza
vaccination) is available from the Immunization Action Coalition
did the influenza recommendation for pregnant women change from
the 2nd & 3rd trimester to any trimester?
This recommendation changed in 2004 (http://www.cdc.gov/mmwr/PDF/rr/rr5306.pdf).
The risk to the fetus is theoretical and the main reason for
avoiding the first trimester seemed to be associated with the
fact that most spontaneous abortions occur in the first trimester
and that the vaccine might be blamed if given in the first trimester.
Ultimately the risk of influenza infection was felt to outweigh
any theoretical risk from vaccination.
is the difference between whole virus influenza vaccine and
split-virus influenza vaccine?
You might say split-virus is analogous to whole-virus as skim
milk is to whole milk. The virus is basically stripped down
to the specific protein subunits that will induce an immune
response, thus decreasing the risks of adverse reactions associated
with whole viruses.
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review the mumps vaccination recommendations in response to
the recent Midwest outbreak.
Updated mumps vaccination recommendations are available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5522a4.htm?s_cid=mm5522a4_e.
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should I tell providers who insist on starting the rotavirus
vaccine series at the 4 month visit?
FDA did not approve – and ACIP does not recommend starting
– rotavirus vaccination after a child reaches 13 weeks
of age. There are no safety data for administering the first
dose of rotavirus vaccine beyond 12 weeks of age.
are the guidelines for providing rotavirus vaccine to premature
Practitioners should consider the potential risks and benefits
when vaccinating premature infants (<37 weeks gestation)
against rotavirus. Limited data suggest that premature infants
are at increased risk for hospitalization from viral gastroenteritis
during their first year of life. In clinical trials, the safety
and efficacy of rotavirus vaccine appeared to be similar for
premature and term infants, although relatively few preterm
infants were evaluated.
The lower level of maternal antibody to rotaviruses in very
low birthweight, premature infants theoretically could increase
the risk for adverse reactions from rotavirus vaccine. ACIP
supports vaccination of prematurely born infants if they are
aged at least 6 weeks, are being or have been discharged from
the hospital nursery, and are clinically stable. Until further
data are available, ACIP considers that the benefits of rotavirus
vaccine vaccination of premature infants outweigh the theoretical
risks. Remember that premature infants should be vaccinated
according to chronological age; the age is not adjusted.
the first dose of rotavirus vaccine is administered to a 16-week
old, should the other two doses be administered?
Rotavirus vaccination should not be initiated for infants aged
13 weeks and older because there are insufficient data on safety
of the first dose in older infants. However, ACIP recommends
that when the first dose is inadvertently administered off-label
at 13 weeks of age or older, the rest of the series should be
completed as per the schedule, because the timing of the first
dose should not affect the safety and efficacy of the second
and third doses. Vaccine should not be administered after 32
weeks of age because of insufficient data on the safety and
efficacy of rotavirus vaccine in infants after this age.
do you do if a child receives the first two doses of rotavirus
schedule, but doesn’t return on time for the 3rd
dose at the recommended interval? Do you have to start over
when they do come back?
No you do not start the series over. There are minimum intervals
between vaccine doses, but there are no maximum intervals. You
just pick up where the child left off and complete the series,
as long as you do not exceed the maximum age,
which is 32 weeks. No doses should be administered once the
child reaches 33 weeks of age, even if this means the child
will not complete the series.
the rotavirus vaccine is removed from the package and is lying
in a tray, is it still viable? The package insert states that
it should be protected from light.
Rotavirus vaccine is a live attenuated virus vaccine. Do not
remove the foil package from the refrigerator until you are
ready to administer the vaccine. If you are preparing several
immunizations for the child, keep the rotavirus vaccine in the
foil package to protect it from light until you are at the patient’s
side and ready to administer the vaccine. Then remove the plastic
tube from the foil pack and administer the vaccine.
should rotavirus vaccine plastic tubes or used tissues (if a
child regurgitates some of the vaccine) be disposed of?
Dispose of the plastic tubes or any other articles that may
have virus on them as medical waste in a biohazard container.
do you remove the cap from the rotavirus plastic tube?
There are instructions on the manufacturer’s website,
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an adult has a history of pertussis infection as a child, is
Tdap vaccine recommended for this person?
Immunity from infection wanes just as immunity from immunization
Adults with a history of pertussis generally should receive
Tdap according to routine recommendations, http://www.cdc.gov/nip/vaccine/tdap/tdap_adult_recs.pdf.
there anything written that says you can give Tdap at a shorter
than 5-year interval in the case of an outbreak?
Yes. "Vaccine providers can administer Tdap to adolescents
aged 11–18 years at an interval less than 5 years after
Td, particularly when the benefit of providing protection against
pertussis is likely to be increased. The safety of an interval
as short as approximately 2 years between Td and Tdap is supported
by a Canadian study among children and adolescents (see Spacing
and Sequence Administration of Vaccines Containing Tetanus Toxoid,
Diphtheria Toxoid, and Pertussis Antigens). . ." (Adolescent
"Tdap may be given at an interval shorter than 10 years
since receipt of the last dose of tetanus toxoid-containing
vaccine to protect against pertussis. The safety of an interval
as short as approximately 2 years between administration of
Td and Tdap is supported by a Canadian study of children and
adolescents. The dose of Tdap replaces the next scheduled booster
dose of Td." (Provisional Adult Recommendations: http://www.cdc.gov/nip/vaccine/tdap/tdap_adult_recs.pdf).
a healthcare worker receives Tdap and then is exposed to someone
with pertussis, do you treat the healthcare worker prophylactically
or consider the person immune.
You would follow the post-exposure prophylaxis (PEP) protocol.
There have been no changes in pertussis PEP with the licensure
of Tdap. The vaccine is too new to make any changes until we
have more data and know how Tdap may affect pertussis epidemiology
in the U.S.
recently had a pertussis outbreak with six confirmed cases ages
4 months, 7 months, 4 years, 13 years, 14 years, and 19 years.
The 4-year-old had received all of his vaccines on time. Do
you have any idea why he would have developed pertussis?
Just as with any medication, no vaccine is 100% effective. There
are multiple factors that could have been at play here. Not
every individual responds the same to every vaccine. Perhaps
one or more doses of the vaccine were not stored or administered
properly. Perhaps the child had a large exposure (time or proximity
or number of exposures).
we administer Tdap now or should we wait for the ACIP adult
recommendations to be published in the MMWR?
The Tdap vaccines are approved for use now by the FDA. You are
not required to wait for the ACIP recommendations to be published.
a woman received Td during pregnancy, do you then routinely
give Tdap postpartum or wait until another Td is indicated?
Pregnant women who previously have not received a dose of Tdap
(including women who are breastfeeding) should receive Tdap
after delivery, before discharge from the hospital or birthing
center, if 2 years or more have elapsed since the last Td. Shorter
intervals can be used (see "Special Situations" in
the ACIP's provisional recommendations:http://www.cdc.gov/nip/recs/provisional_recs/tdap-preg.pdf).
If Tdap cannot be administered before discharge, it should be
given as soon as feasible. The dose of Tdap replaces the next
decennial dose of Td.
a child 7 through 9 years of age has an incomplete history or
no history of DTaP, DT, or Td can you use Tdap?
There is no Tdap vaccine approved by FDA or the ACIP for use
in children 7 through 9 years of age. Td should be used. Appendix
E of the ACIP Tdap Adolescent recommendations provides guidance
in completing the series for children 7 through 10 years of
a child 10 years of age or older receives DTaP instead of Tdap,
should the dose be repeated?
No. If pediatric DTaP is inadvertently administered to an adolescent,
the dose should be counted as the adolescent Tdap booster. The
adolescent should receive the next dose of a vaccine containing
tetanus and diphtheria toxoids 10 years after the inadvertent
pediatric DTaP dose. http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf
you clarify the timeline for giving Tdap vaccine after someone
has received the Td vaccine?
The recommended interval between Td and Tdap for adolescents
is 5 years and for adults it is 10 years. However, if there
is a risk of pertussis or if the person will have contact with
an infant younger than 12 months of age, then there is NO minimum
interval. It is a risk (increased local reaction) vs. benefit
(prevention of pertussis infection) situation that must be assessed
by the provider. There are data suggesting that it is safe to
give these two vaccines as close as 2 years apart, but they
can be given even closer if the benefit outweighs the risk.
The bottom line is that there is no minimum interval written
Tdap vaccine replace the Td booster that is routinely recommended
every 10 years?
It is too early to know that. At this time Tdap is only approved
for one dose.
there a combination meningitis and tetanus vaccine?
There is no combination meningococcal/tetanus vaccine. If you
are referring to Hib meningitis, there is a combination Hib-DTaP
vaccine known as TriHIBit.
an 11-year old received DT instead of Td, what do you do about
the Tdap dose?
Wait at least 2 years if possible to give the Tdap dose. However,
if the patient is at increased risk of pertussis (e.g., pertussis
outbreak, international travel, an infant younger than 12 months
of age in the household) then there is no minimum interval.
The patient should be warned that they could experience a stronger
than normal local adverse reaction.
can I find the poster “Check You Vials: Is it Tdap, DTaP,
This poster was developed by the California Immunization Program
and is available from them at http://www.dhs.ca.gov/ps/dcdc/izgroup/pdf/IMM-508.pdf.
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you vaccinate someone who has already had the chickenpox?
If a person has acceptable evidence of prior varicella zoster
virus (VZV) infection, then vaccination is not necessary. Acceptable
evidence of prior VZV infections includes:
- Laboratory evidence of immunity or laboratory confirmation
- Born in the US before 1980 (not acceptable for healthcare
workers or pregnant women);
- A healthcare provider diagnosis of varicella or healthcare
provider verification of history of varicella disease; or
- History of herpes zoster based on healthcare provider diagnosis.
If there is any doubt, vaccinate. If the person is already immune,
vaccination will not harm them. You will find a complete list
for acceptable varicella immunity at http://www.cdc.gov/nip/vaccine/varicella/varicella_acip_recs_prov_june_2006.pdf.
are the minimum intervals between doses of varicella vaccine
for various age groups?
For persons 12 months through 12 years of age the minimum interval
between two doses of varicella vaccine is 12 weeks. However,
if you discover on record review that the second dose was administered
at least 4 weeks (28 days) after the first dose, the dose does
not have to be repeated.
For persons 13 years of age and older the minimum interval between
two doses of varicella vaccine is 4 weeks (28 days).
we draw titers on healthcare workers after varicella vaccination
to verify immunity?
Routine serologic testing for varicella immunity after administration
of two doses of vaccine is not considered necessary because
99% of persons become seropositive after the second dose. Seroconversion,
however, does not always result in full protection against disease.
Institutional guidelines are needed for management of exposed
vaccinees who do not have detectable antibody and for those
who develop clinical varicella. A potentially effective strategy
to identify persons who remain at risk for varicella is to test
vaccinated persons for serologic evidence of immunity immediately
after they are exposed to VZV. Prompt, sensitive, and specific
serologic results can be obtained at reasonable cost with a
commercially available latex agglutination (LA) test. Many other
methods also have been used to detect antibody to VZV. The LA
test can be completed in 15 minutes. Persons with detectable
antibody are unlikely to become infected with varicella. Persons
who do not have detectable antibody can be retested in 5–6
days. If an anamnestic response occurs, these persons are unlikely
to contract the disease. HCWs who do not have antibody when
retested may be furloughed. Alternatively, the clinical status
of these persons may be monitored daily and they can be furloughed
at the onset of manifestations of varicella.
a child had one dose of varicella vaccine and develops breakthrough
infection, is the second varicella vaccine doses necessary?
No, not if the rash illness is definitely known to be wild-type
varicella infection. However, if there is any doubt, take the
conservative approach and administer the second dose.
MMRV be used if a person (adolescent or adult) presents with
no evidence of immunity to measles, mumps, rubella, and varicella?
No. MMRV vaccine is not approved for use in anyone 13 years
of age or older.
persons 13 years of age and older who previously received two
doses of varicella vaccine now need a booster dose?
No. Once a person receives two valid doses of varicella vaccine,
there are no recommendations to give any further doses.
MMRV be used for the second varicella dose in persons 12 months
through 12 years of age?
Yes, as long as none of the components are contraindicated.
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a person has had a case of shingles, do you recommend the vaccine?
The vaccine was not studied in persons who have already had
shingles, and there are no recommendations to vaccinate them
at this time. ACIP should be voting on recommendations for zoster
vaccine in October, 2006.
In general persons develop shingles only once because this infection
boosts their immunity. Zoster vaccine is expected to provide
that boost of immunity to persons who have not had shingles,
thus allowing them to avoid the pain and unpleasantness of a
someone younger than 60 years of age receive the zoster vaccine?
FDA has only approved the vaccine for persons 60 years of age
and older because that is the population in which the vaccine
was studied. ACIP is expected to vote on zoster vaccine recommendations
in October, 2006.
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