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| As appeared in the February 2012 issue of Needle Tips |
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Click here for PDF version |
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Human papillomavirus (HPV) vaccine |
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| Q: |
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Please describe the
new recommendations for the use of HPV4 vaccine in males and
explain how these new recommendations differ from the previous
ones. |
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| A: |
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ACIP recommends
routine vaccination of males age 11–12 years with HPV4 (Gardasil,
Merck) administered as a 3-dose series. The vaccination series
can be started beginning at age 9 years. Vaccination with HPV4
is recommended for males age 13 through 21
years who have not been vaccinated previously or who have not
completed the 3-dose series. Males age 22 through 26 years may be vaccinated with HPV4. |
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| ACIP recommends that immunocompromised males who have not been
vaccinated previously or who have not completed the 3-dose
series receive routine vaccination with HPV4 through age 26
years. |
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| Men who have sex with men (MSM) are at higher risk for
infection with HPV types 6, 11, 16, and 18 and associated
conditions,
including genital warts and anal cancer. ACIP recommends that MSM who have not been vaccinated previously or who have not
completed the 3-dose series receive routine vaccination with
HPV4 through age 26 years. |
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| Previously, ACIP had issued permissive recommendations for
HPV4 use in males age 9–26 years for the prevention of genital
warts. |
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| To obtain a copy of the new recommendations, which were
published in MMWR in December 2011, see
www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a3.htm. |
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| Q: |
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Is it recommended that patients age
26 years start the HPV vaccination series even though they will be
older than 26 when they complete it? |
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| A: |
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Yes. HPV vaccine is recommended
for all women through age 26 years and also may be given to
men through that age. So, the 3- dose series can be started at
age 26 even if it will not be completed at age 26. The series
should be completed regardless of the age of the patient
(i.e., even if the patient is older than 26). In certain
situations, some clinicians choose to start the 3-dose HPV
series in patients who are older than 26 years. This, however,
is an off-label use. |
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| Q: |
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Will patients who have already had
genital warts benefit from receiving Gardasil? |
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| A: |
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A history of genital warts or
clinically evident genital warts indicates infection with HPV,
most often type 6 or 11. However, people with this history
might not have been infected with both HPV 6 and 11 or with
HPV 16 or 18. Vaccination will provide protection against
infection with HPV vaccine types the patient has not already
acquired. Gardasil (HPV4) protects against HPV vaccine types
6, 11, 16, and 18; Cervarix (HPV2; GlaxoSmithKline) protects
against HPV 16 and 18. Providers should advise their
patients/clients that results from clinical trials do not
indicate the vaccine will have any therapeutic effect on
existing HPV infection or genital warts. |
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| Q: |
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If a patient has been sexually
active for a number of years, is it still recommended to give HPV
vaccine or to complete the HPV vaccine series? |
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| A: |
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Yes. You should not withhold
HPV vaccine from people who are already sexually active.
Ideally, patients should be vaccinated before onset of sexual
activity; however, patients who have already been infected
with one or more HPV types still get protection from other HPV
types in the vaccine that have not been acquired. |
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| Q: |
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If a patient's
vaccination history indicates she received the third dose of HPV
vaccine earlier than the recommended minimum interval of 24 weeks,
should she be given a fourth dose? |
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| A: |
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Maybe. If the 3-dose series was
given with minimum intervals of at least 4 weeks between dose
#1 and dose #2 AND at least 12 weeks between dose #2 and dose
#3, do not repeat any doses. If the third dose was given at
less than 12 weeks from dose #2, repeat dose #3 at least 12
weeks after the invalid dose. |
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| Q: |
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Will VFC cover HPV vaccination for
males? |
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| A: |
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Yes. VFC funding will cover
HPV4 (Gardasil) vaccination for VFC-eligible males age 9
through 18 years. |
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| Q: |
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If HPV vaccine is
given subcutaneously (SC) instead of intramuscularly (IM), does
the dose need to be repeated? |
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| A: |
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No, the dose does not need to
be repeated. Vaccines should always be administered by the
route recommended by the manufacturer; however, if a vaccine
is inadvertently administered SC instead of IM, or IM instead
of SC, ACIP recommends that the dose be counted as valid with
two exceptions: Hepatitis B or rabies vaccine administered by
a route other than IM should be repeated. |
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| Q: |
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Would you please provide
details about the new ACIP recommendations for the use of
hepatitis B vaccine in adult diabetic patients? |
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| A: |
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In December 2011, CDC
published new ACIP recommendations that hepatitis B vaccine be
given to adults with diabetes. The vaccine series is
recommended for unvaccinated adults with diabetes age 59 years
and younger. At the discretion of the treating clinician, the
vaccine may also be administered to unvaccinated adults with
diabetes age 60 years and older. |
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| The recommendations were
prompted by a number of outbreaks of hepatitis B virus
infection in settings that provide assisted blood glucose
monitoring for people with diabetes. |
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| Administration of the
hepatitis B vaccine series should be completed as soon as
feasible after diabetes is diagnosed. No serologic testing or
additional hepatitis B vaccination is recommended for adults
who received a complete series of hepatitis B vaccinations at
any time in the past. |
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| Hepatitis B vaccine may be
administered during healthcare visits scheduled for other
purposes, as long as minimum intervals between doses are
observed. No maximum interval between doses exists that would
make the hepatitis B vaccination series ineffective or that
would require restarting the series. |
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| You can read the details of
this recommendation and the rationale behind it in MMWR at
www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm. |
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| Q: |
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Is it true that ACIP no longer
specifies a time interval between administering doses of Td and
Tdap to teens and adults? |
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| A: |
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In January 2011, CDC issued
updated ACIP recommendations (www.cdc.gov/mmwr/preview/mmwrhtml/mm6001a4.htm?s_cid=mm6001a4)
on the use of Tdap vaccine. They clearly state that pertussis
vaccination, when indicated, should not be delayed and that
Tdap should be administered regardless of the interval since
the last tetanus- or diphtheria-toxoid-containing vaccine was
given. This means that if Td was administered inadvertently
when Tdap was indicated, the dose of Tdap can be given on the
same day the dose of Td was given. |
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| Q: |
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If a teen or adult patient received
a dose of Td vaccine 2 years ago, should I wait approximately 8
more years before administering a dose of Tdap to the patient? |
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| A: |
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No. ACIP recommends that people
age 11 through 64 who have not yet received Tdap receive their
one-time Tdap dose now. ACIP specifies no waiting interval
between administering Td and Tdap to anyone in this age group.
Adults age 65 years and older do not need to delay Tdap
vaccination following Td either. |
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| Q: |
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If a teen or adult
mistakenly received a dose of Td when they should have received
Tdap, what is the optimal time to give the missing Tdap dose?
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| A: |
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| As soon as
possible, even if it is the same day. |
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| Q: |
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Is there any reason
not to administer Tdap vaccine to adults age 65 and older who want
the vaccine but are not in contact with an infant? It seems like
it would be a good idea to vaccinate them to protect them, their
family, and their community from pertussis. |
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No medical reason exists for
withholding Tdap from adults age 65 and older unless they have
a medical contraindication. |
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| Q: |
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We intend to start vaccinating
family contacts of pregnant women with Tdap to protect the
newborn. Can you tell me how long it takes for the Tdap vaccine to
provide protection? |
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| A: |
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To best protect infants, CDC
recommends that teens and adults who haven't been vaccinated
receive Tdap 2 weeks or more before having contact with an
infant. |
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| Q: |
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Since we know that
children with functional or anatomic asplenia are at high risk for
contracting Neisseria meningitidis, why aren't they
included in the latest recommendations to vaccinate certain
high-risk children against meningococcal disease beginning at age
9 months? |
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| A: |
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Though what you say is true,
these children are also at higher risk of Streptococcus
pneumoniae. Data show that the MCV4-D vaccine (Menactra;
sanofi pasteur) may interfere with the immunologic response to
PCV13 if these two vaccines are given too close together.
Therefore, ACIP recommends that MCV4 vaccination be delayed
until age 2 years to ensure that these children get
age-appropriate vaccination with PCV13, and to improve the
likelihood that these children are not vaccinated
simultaneously with PCV13 and MCV4. |
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| Q: |
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Can we vaccinate a
2-year-old boy with functional or anatomic asplenia who has not
completed a series of PCV13? |
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| A: |
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You should first be certain that
he is up to date with PCV13 vaccine before you vaccinate him
with MCV4. If you are going to give him MCV4-D (Menactra;
sanofi pasteur), you need to wait at least 4 weeks after he
completes the PCV13 series before giving him the MCV4-D. There
is no similar space consideration if MCV4-CRM (Menveo;
Novartis) is used; it may be given simultaneously with PCV13
or at any interval since receipt of PCV13. |
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| Q: |
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When people are in
their 80s, is it still recommended for them to get the shingles
vaccine? I've heard it doesn't work as well in the elderly. |
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ACIP recommends the vaccine for
everyone age 60 and older, even though the vaccine's efficacy
decreases with the recipient's age. The clinical trials found
approximately an 18% efficacy rate in people age 80 and older
as compared with 64% efficacy in people age 60 through 69
years (see pages 13–14 at
www.cdc.gov/mmwr/PDF/rr/rr5705.pdf).
In general, with increasing age at vaccination, the vaccine
was more effective in reducing the severity of zoster and
post-herpetic neuralgia than in reducing the occurrence of
zoster itself. |
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| Q: |
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Occasionally we have
asplenic adult patients who want to get the Hib vaccine. We know
it's given only to infants and young children, but what about
using it in this situation?
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| A: |
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Although the vaccine is not
routinely recommended for adults, CDC states in the General
Recommendations on Immunization: "No efficacy data are
available on which to base a recommendation for use of Hib
vaccine for older children and adults with the chronic
conditions that are associated with an increased risk for Hib
disease. Administering 1 dose of Hib vaccine to these patients
who have not previously received Hib vaccine is not
contraindicated." For additional information, consult page 22
of the General Recommendations, published January 2011, at
www.cdc.gov/mmwr/pdf/rr/rr6002.pdf. |
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General vaccine
questions |
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| Q: |
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ACIP and CDC's
Vaccine Storage and Handling Guide say that refrigerated vaccines
should be stored between 35°–46°F, but some
vaccine package inserts list 36°–46°F as the proper range. Should
I use 35°F or 36°F as the low boundary of the range? |
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On the Celsius scale, the
appropriate storage range for refrigerated vaccines is
2°C–8°C. Because 2°C converts to 35.6°F,
some manufacturers have rounded the Fahrenheit reading to
36°F. However, 35°F is still considered acceptable for storage
of
any refrigerated vaccine. Providers should make an effort to
store vaccines toward the midpoint of the range (approximately
40°F or 5°C) rather than at either end of the scale. |
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What should I do if my
thermometer indicates my refrigerated vaccine has been stored
between 32°–34°F? Since the vaccine
wasn't "frozen," will it be OK to use? And what about people who
received the vaccine before we discovered the temperature
excursion—will we need to revaccinate them? |
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This is a complex
question that requires case-by-case review. First, while
you're assessing the situation, return the vaccine
to proper storage temperatures and mark it "Do Not Use." Then,
contact your state or local immunization program or the
appropriate vaccine manufacturer(s) to discuss the potential
usability of the vaccine. They will need to consider several
variables related to vaccine storage conditions. For example,
their guidance will be affected by the accuracy of the
thermometer, whether the thermometer probe was in a liquid or
was reading the temperature of the air, the type of vaccine
involved, the length of time of the excursion, etc. |
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In general, if it can be
reliably determined that the vaccine in question was not
stored below 32°F and the manufacturer's
stability data concurs, most immunization programs and vaccine
manufacturers would not recommend wasting the vaccine or
revaccinating recipients. |
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| Q: |
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Does the federal law
that requires providing patients with VISs apply when
administering influenza vaccine to employees and
volunteers in hospitals or other workplaces? |
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Yes. Employees and
volunteers are considered patients, and you need to provide
them with a VIS. |
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| If a vaccine is covered under
the National Childhood Vaccine Injury Act—and almost all
vaccines routinely administered to adults are (with the
exception of PPSV and zoster)—it is mandatory under federal
law to give the VIS for that vaccine to the vaccinee.
Therefore, when you give influenza vaccine to employees and
staff, you are required by law to provide them with a VIS. |
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| You can find more details
about the requirements for using VISs at
www.cdc.gov/vaccines/pubs/vis/downloads/vis-Instructions.pdf.
For VISs in multiple languages, go to
www.immunize.org/vis. |
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| Q: |
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If you place a needle
on a pre-filled syringe and then don't administer the vaccine, how
long can you store the pre-filled syringe with the needle
attached? |
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In general, a vaccine
should not be prepared until the provider is ready to
administer it to a patient. This is because once the syringe
cap is removed or a needle is attached, the sterile seal is
broken. However, if a sterile seal has been broken, staff
should be sure to maintain the syringe at the appropriate
temperature and either use it or discard it at the end of the
clinic day. |
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| CDC's Pink Book has a new
chapter about vaccine storage and handling at
www.cdc.gov/vaccines/pubs/pinkbook/downloads/vac-storage.pdf. |
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Click here for PDF version |
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