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| Where can I find information
about vaccine shortages and delays? |
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| Visit CDC's website at www.cdc.gov/vaccines/vac-gen/shortages/default.htm. |
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| Where can I find the most
current vaccine recommendations? |
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| Vaccine recommendations in the U.S. are issued primarily by two national
bodies — the U.S. Public Health Service's Advisory
Committee on Immunization Practices (ACIP) and the American Academy of
Pediatrics (AAP) Committee on Infectious Diseases. To
access the most current ACIP recommendations, go to www.cdc.gov/vaccines/pubs/acip-list.htm for statements in alphabetical
order or www.immunize.org/acip for statements in chronological order.
For the AAP policy statements on immunizations, go to www.immunize.org/aap. |
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| How do I obtain copies of the newest
U.S. recommended immunization schedules for children and for adults? |
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| You can download electronic versions of the schedules from CDC's website
at www.cdc.gov/vaccines/recs/schedules/default.htm.
IAC has also created laminated versions of the child and adolescent
schedule, as well as the adult schedule, which make an
excellent resource for placement in each exam room. Each is based on the
official schedules adopted by ACIP, AAP, AAFP, ACOG,
and ACP. You can find them by going to www.immunize.org/shop. |
| |
| Why do ACIP recommendations not
always agree with package inserts? |
|
| There is usually very close agreement between vaccine package inserts
and ACIP statements. The Food and Drug Administration
(FDA) must approve the package insert, and requires documentation for
all claims and recommendations made in the insert.
Occasionally, ACIP may use different data to formulate its recommendations, or try to add flexibility to its recommendations,
which results in wording different than on the package insert. ACIP
sometimes makes recommendations based on expert opinion
and public health considerations. Published recommendations of national
advisory groups (such as ACIP or AAP's Committee on
Infectious Diseases) should be considered equally as authoritative as
those on the package insert. |
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| What vaccinations are recommended for new immigrants to the United States? |
|
| In 1996 Congress amended the Immigration and Nationality Act and added
vaccination requirements for any person who is
applying for permanent resident status in the United States. Children
and adults must have evidence of having received (or at
least having started the series of) the same vaccines recommended for an American citizen of the same age. Children must be
vaccinated according to the current U.S. childhood schedule. Adults 18
years of age and older must have evidence of
vaccination for tetanus and diphtheria. People born after 1956 must have
evidence of immunity (vaccination or serology) for
measles, mumps, and rubella. All people 12 months of age and older must
have evidence of varicella immunity (vaccination or
history of chickenpox). Children adopted from outside the U.S. and political refugees are recommended to receive age-appropriate vaccination, with catch-up vaccination as appropriate, per
the guidance in ACIP's "General Recommendations on
Immunization" (see www.cdc.gov/vaccines/pubs/acip-list.htm). People
entering the U.S. as visitors are not required to provide
proof of vaccination regardless of the length of stay. |
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| Why are vaccines generally not given to
infants under 6 weeks of age in the U.S.? |
|
| Mainly because little safety or efficacy data exist on doses given
before 6 weeks of age, and the vaccines aren't licensed
for this use. The data that exist suggest that the response to doses
given before 6 weeks is poor; the response to hepatitis
B vaccine is the exception. |
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| What resources does IAC have to help
parents and child caretakers evaluate the immunization needs of children
and
adolescents? |
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| There are several very easy to read pieces that can be downloaded from
the IAC website. This includes "Immunizations for
Babies" found at www.immunize.org/catg.d/p4010.pdf, "When do children
and teens need vaccinations?" found at www.immunize.org/catg.d/p4050.pdf, and "Are you 11-19 years old? Then
you need to be vaccinated against these serious
diseases." found at www.immunize.org/catg.d/p4020.pdf. |
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| What resources are available to help
adult patients evaluate their individual immunization needs? |
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| There are several screening questionnaires that IAC has developed for
patient use. These include an adult assessment piece "Do I Need any Vaccinations Today?", "If You Have HIV Infection, Which Vaccinations Do You Need?", "If You Have Hepatitis C, Which Vaccinations Do You Need?", "Should You Be Vaccinated Against
Hepatitis B? A screening questionnaire for adults", and "Should You Be Vaccinated for
Hepatitis A? A screening questionnaire for adults".
In addition to these printed pieces,
there are several interactive tools on CDC's website. For children, go
to http://www2a.cdc.gov/nip/kidstuff/newscheduler_le and for adults, go to www2.cdc.gov/nip/adultImmSched. |
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| When a 3-month-old infant presents
having had no prior immunizations, would you start the accelerated
schedule? |
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| The accelerated schedule should be used when the child is more than a
month behind schedule, until you get them caught up.
You can give the child the first set of recommended vaccines at age 3
months and then bring him back at age 4 months and give
the second set of vaccinations. At this point the child will be caught
up and can return to the usual schedule. As long as
you observe the minimum intervals between doses and minimum ages for
specific vaccines, this is fine to do. Once you have
them back on schedule, stick with the recommended ages and intervals on
the recommended childhood schedule. It is also
important to educate the parents and talk to them about the importance
of bringing the child in on time. |
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| How can we quickly determine how to
"catch up" children who have fallen behind on their shots? |
|
| As a general rule, infants or children who are more than 1 month or 1
dose behind schedule should be on an accelerated
schedule, which means the intervals between doses should be reduced to
the minimum allowable. Catch-up schedules for children
ages 4 months through 18 years are included with each year's recommended
immunization schedule that is issued by ACIP, AAP,
and American Academy of Family Physicians (AAFP). To obtain a copy, go
to http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm#hcp. |
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| The number of injections recommended to
be given at a single office visit is increasing, and we are running out
of injection
sites. Should we defer certain vaccines? |
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| We strongly recommend that you do not defer any recommended vaccines.
This would be a missed opportunity. No upper limit has
been established regarding the number of vaccines that can be
administered in one visit. ACIP and AAP consistently recommend
administering all vaccines indicated for the patient's age. When giving
several injections at a single visit, separate 2 IM
vaccines by at least 1 inch in the body of the muscle to reduce the
likelihood of local reactions overlapping. Here is a link
to a collection of illustrations (i.e., "site maps") that shows how one
can administer all indicated doses to children: www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/site-map.pdf. |
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| What is the maximum number of IM or SC
doses of vaccines that a child can receive at a single visit? Is it okay
for a child
to receive 3 live vaccines at one visit (e.g., MMR, VAR, and LAIV)? |
|
| All vaccines can be administered at the same visit. There is no limit to
the number of IM or SC injections that can be given
at a single visit. So, an age-appropriate child can get MMR, VAR, and LAIV vaccines during a single visit. If live parenteral
(injected) vaccines (MMR, VAR, MMRV, zoster, and/or yellow fever) and
LAIV are not administered during the same visit, they
should be separated by 4 weeks or more. For details, consult CDC's
"General Recommendations on Immunization" at www.cdc.gov/vaccines/pubs/ACIP-list.htm. |
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| We have some adults who are in need of
multiple vaccines (e.g., influenza, pneumococcal, and a
tetanus-containing vaccine).
When only 2 vaccines are needed, we inject 1 in each arm, but when 3 or
more are recommended, we're not sure whether we
should give all of them or defer 1 or more until a later date. |
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| ACIP recommends giving all indicated vaccines simultaneously (i.e., at
the same visit, NOT in the same syringe). Giving
vaccines together produces seroconversion rates and occurrences of
adverse reactions similar to those observed when the
vaccines are administered separately. Simultaneous administration also
eliminates the possibility that the patient will not
return in a timely manner for the deferred vaccine.
When giving 2 IM injections in the same
limb, the vaccines should be separated by 1 inch or more if possible in
the muscle so
that any local reactions are unlikely to overlap. |
|
| What is meant by "minimum intervals"
between vaccine doses? |
|
| Vaccination schedules are generally determined by clinical trials,
usually prior to licensure of the vaccine. The spacing of
doses in the clinical trial usually becomes the recommended schedule. A
"minimum interval" is shorter than the recommended
interval, and is the shortest time between two doses of a vaccine series
in which an adequate response to the second dose can
be expected. The concern is that a dose given too soon after the
previous dose may reduce the response. The minimum spacing
between doses is generally included in the ACIP recommendation for that
vaccine which can be found at www.cdc.gov/vaccines/pubs/ACIP-list.htm. In addition, an extensive
listing of recommended and minimum intervals and ages for
vaccination can be found at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf. |
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| If two live virus vaccines are
inadvertently given less than 4 weeks apart, what should be done? |
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| If two live virus vaccines are administered less than 4 weeks apart and
not on the same day, the vaccine given second should
be considered invalid and repeated. The repeat dose should be
administered at least 4 weeks after the invalid dose.
Alternatively, one can perform serologic testing to check for immunity,
but this option may be more costly. |
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| We gave a dose of vaccine too soon after
the previous dose. When can we give another (valid) dose? |
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| ACIP allows a grace period of 4 days (i.e., vaccine doses administered
up to 4 days before the recommended minimum interval
or age can be counted as valid). However, if a dose was administered 5
or more days earlier than the recommended minimum
interval between doses, it is not valid and must be repeated. The repeat dose should be spaced after the invalid dose by the
recommended minimum interval.
Likewise, doses administered 5 or more
days before the minimum age should be repeated on or after the patient
reaches the
minimum age and 4 or more weeks after the invalid dose.
Avoid such errors by knowing the minimum
intervals and ages for routinely given vaccines. You can look up such
information www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf. |
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| What should we do if we give a dose of
vaccine at less than the minimum interval since the previous dose? |
|
| If vaccines are given too close together (or to a child younger than the
minimum recommended age), it can result in a less
than optimal immune response. However, in most instances, a difference
of a few days is unlikely to have a negative effect on
immune response. With the exception of rabies vaccine, CDC recommends
that vaccine doses given 4 or fewer days before the
minimum interval or age be counted as valid, unless local or state
requirements specify otherwise. If the dose needs to be
repeated, the repeat dose should be spaced after the invalid dose by the
recommended minimum interval. You can look up
minimum ages and intervals here: www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf |
|
| We sometimes have differences of opinion
among our staff in determining the minimum interval or age for
administering
vaccines. Recommendations are sometimes written in months, weeks, or
days. Can you help clarify? |
|
| This is a common source of frustration. Customarily, if the dosing
interval is 4 months or more, it is common to use calendar
months (e.g., 6 months from October 1 is April 1). If the interval is
less than 4 months, it is common to convert months into
days or weeks (e.g., 1 month = 4 weeks = 28 days). |
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| What is the 4-day "grace period" for
vaccine administration and when can I use it? |
|
| Since 2002, in an effort to increase the
flexibility of the complicated childhood and adult immunization
schedules, ACIP recommends that vaccine doses administered up to 4 days
before the minimum interval or age can be counted as valid. ACIP
believes that administering a dose a few days earlier than the minimum
interval or age is unlikely to have a significant negative effect on the
immune response to that dose.
The 4-day "grace period" should not be
used when scheduling future vaccination visits, and should not be
applied to the 28-day interval between live parenteral vaccines not
administered at the same visit. It should be used primarily when
reviewing vaccination records (for example, when evaluating a
vaccination record prior to entry to daycare or school).
Use of the grace period may create a
conflict with state daycare or school entry vaccination requirements. In
particular,
many states require MMR be given on or after the first birthday. ACIP
recommends that providers comply with state and local
immunization requirements when scheduling and administering vaccines. |
|
| A 3-year-old who was otherwise on
schedule received some of her 15-month vaccinations (MMR, DTaP, IPV)
twice due to a change in health plans. Can these doses be counted toward
kindergarten vaccinations? |
|
| Whether these doses count as part of the child's
series depends on the intervals between these doses and the ones that preceded
them. If the second MMR was separated from the previous one by at least 4 weeks,
it can be counted as the second MMR. No additional doses are indicated.
(Exception: the 4th dose of IPV is recommended after the 4th birthday. In this
case, the child would need a fifth dose of IPV on or after her fourth birthday.)
The fifth dose of DTaP should not be given earlier than age 4 years. Assuming
this dose of DTaP was the fifth the child received, it was given much too early
and should not be counted. The DTaP should be repeated on or after the child's
fourth birthday. |
|
| Is it necessary to start a vaccine
series over if a patient doesn't come back for a dose at the recommended
time, even if there's been a year or more delay? |
|
| For routinely administered vaccines,
there is no vaccine series that needs to be restarted because of an
interval that is longer than recommended. In certain circumstances, oral
typhoid vaccine (which is sometimes given for international travel)
needs to be restarted if the vaccine series isn't completed within the
recommended time frame. |
|
| If I give a pneumococcal
polysaccharide vaccine to my patient now, how long must I wait before
giving the influenza or Td vaccine? |
|
| Influenza vaccine and Td (or Tdap) may
be given at the same time or at any time before or after a dose of
pneumococcal polysaccharide vaccine. There are no minimum interval
requirements between the doses of any inactivated vaccines. |
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| Is it necessary to routinely obtain a
pregnancy test before administering any vaccines to young women? |
|
| No. Pregnancy tests are not routinely recommended. However, females of
childbearing age should be asked about the possibility
of their being pregnant prior to being given any vaccine for which
pregnancy is a contraindication or precaution. The
patient's answer should be documented in the medical record. If the
patient is uncertain if she is pregnant, a test should be
performed before administering live virus vaccines (e.g.,
measles-mumps-rubella [MMR], varicella [VAR], LAIV [live attenuated
influenza vaccine, i.e., FluMist]). |
|
| For which vaccines is an egg allergy a
contraindication? What about MMR vaccine? |
|
| Influenza and yellow fever vaccines are the only vaccines that are
contraindicated for people who have a history of a severe
(anaphylactic) allergy to eggs. Allergy to eggs is no longer considered
a contraindication for giving MMR vaccine. Though
measles and mumps vaccines are grown in chick embryo tissue culture,
several studies have documented the safety of these
vaccines in children with severe egg allergy. In 1994, ACIP's General
Recommendations for Immunization listed egg allergy as
a contraindication for administering MMR. That was changed, however, and
by 1998 when ACIP's most recent recommendations for
MMR were published, egg allergy was no longer listed as a
contraindication. That remains true today: Neither AAP's Committee
on Infectious Diseases ("Red Book Committee") nor ACIP consider egg
allergy a contraindication to MMR vaccine. You can always
check for contraindications for any vaccine in CDC's Guide to Vaccine
Contraindications and Precautions at www.cdc.gov/vaccines/recs/vac-admin/downloads/contraindications-guide-508.pdf. |
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| What should we ask a patient when
screening to determine a gelatin allergy? |
|
| Begin by asking a general question about whether the person has an
allergy to any food, medication, or vaccine. If they
report an allergy to gelatin or foods that contain gelatin, you could
follow up by asking if they can eat Jell-O™ and
gelatin-type products. Gelatin allergies are extremely rare. Only
severe, life-threatening (anaphylactic) allergy is a
contraindication to vaccination. |
|
| What is a latex allergy and why should
we be concerned? |
|
| Latex is a product of the rubber tree – Hevea basiliensis. It is
processed and used in various products (e.g., medical
gloves), including some that come in contact with vaccines. Latex may be
present in syringe plungers, vial stoppers, or in
the tip caps on prefilled syringes. Some people develop sensitivities to
latex, particularly if they have had significant
cumulative latex exposure, such as from repeated surgeries early in life
or employment in the healthcare industry. The most
common type of latex sensitivity is contact-type allergy; however, on
rare occasions, severe (anaphylactic) allergy occurs.
People with a history of anaphylactic reactions to latex should
generally not be given vaccines that have been in contact
with natural rubber, either in the vial or in the syringe. People with
latex allergies that are not anaphylactic in nature
may be vaccinated as usual. |
| |
| What precautions should we take for
patients that have a latex allergy? |
|
| Although rare, people having had a severe, anaphylactic reaction to
latex should generally not be given vaccines that have
been in contact with natural rubber, unless the benefit of vaccination
outweighs the risk of a potential allergic reaction.
People with latex allergies that are not anaphylactic may be vaccinated
as usual; this would include a contact-type allergy,
such as what occurs with prolonged contact with latex-containing gloves. |
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| Do any or all stoppers still contain
latex? |
|
| Not all stoppers in vaccine vials contain latex. Manufacturers are
beginning to switch to synthetic rubber-like materials
that do not contain rubber latex or dry natural rubber. The best
approach is to check the package insert, which will indicate
if the packaging contains latex. Also, remember that prefilled syringes
could contain natural rubber in the plunger, in the
needle cover, or in the tip cap. This information is also supplied in
the package insert. |
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| Which vaccines are supplied in vials or
syringes containing latex? |
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| You can find information on latex in vaccine packaging in Appendix B of
CDC's Epidemiology and Prevention of Vaccine-Preventable Diseases (the "Pink Book") at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/latex-table.pdf. |
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| If we have a patient who has a
severe latex allergy, why shouldn't we just remove the stopper from the
vial before
withdrawing the vaccine in order to prevent a latex reaction? |
|
| We do not recommend removing the stopper from a vaccine vial before
administering a vaccine to a person who has a severe
life-threatening allergy to latex. The vaccine has already been exposed
to the rubber stopper in the vial, which might be
just enough of an exposure to cause a reaction. These people should not
be given the vaccine. |
|
| What are the special recommendations for
administering intramuscular injections in people with clotting
disorders? |
|
| This issue is discussed in the ACIP "General Recommendations on Immunization".
Intramuscular (IM) injections should be scheduled shortly after
antihemophilia therapy or prior to a dose of anticoagulant.
For both IM and subcutaneous (SC) injections, a fine needle (23 gauge or
smaller) should be used and firm pressure applied to
the site, without rubbing, for at least 2 minutes. Providers should not
administer a vaccine by a route that is not approved
by the FDA for that particular vaccine (e.g., administration of IM
vaccines by the SC route). |
| |
| Which vaccines are contraindicated if a
child is breastfeeding? |
|
| Breastfeeding is not a contraindication to the administration of any
routinely recommended vaccine, either to the mother or
to the child. Providers also often miss opportunities to vaccinate by
assuming contraindications when none exist. Only follow
true contraindications and precautions to vaccinations. |
|
| What percentage of vaccine recipients
will experience an anaphylactic reaction? |
|
| It is estimated that for every million
doses administered, about one (~0.0001%) will result in an anaphylactic
reaction following vaccination. With proper screening, most providers
who administer thousands of vaccines in their lifetimes will never see
an anaphylactic reaction. |
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|
| Where can I obtain standing orders for
vaccination? |
|
| The Immunization Action Coalition (IAC) has developed suggested standing
orders for all vaccines commonly given to children and adults. They are
based on CDC's Advisory Committee on Immunization Practices (ACIP)
recommendations and are reviewed for technical accuracy by CDC staff.
You can find the standing orders and protocols for medical management of
vaccine reactions at www.immunize.org/standing-orders. |
|
| Is it necessary to wear gloves when we
administer vaccinations? |
|
| No. Occupational Safety and Health Administration (OSHA) regulations do
not require the wearing of gloves when administering vaccinations,
unless the person administering the vaccine is likely to come into
contact with potentially infectious body fluids or has an open lesion on
their hand. If a healthcare worker chooses to wear gloves, he or she
must change them between each patient encounter. |
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|
On October 17, 2009, The Lancet published a study that found that
infants who received 3 doses of acetaminophen following immunization had
reduced immune responses to certain vaccines. Based on these findings,
should we stop recommending acetaminophen for fever or discomfort after
infant immunizations? |
|
|
Evidence from this study discourages the prophylactic use of paracetamol
(acetaminophen) prior to or immediately following vaccination.
Acetaminophen can be used to treat pain or fever if it should occur
following vaccination. In the upcoming 2010 General Recommendations on
Immunization, CDC will remove all recommendations for prophylactic use
of acetaminophen or other analgesics BEFORE or AT THE TIME OF
vaccination. AAP removed such recommendations beginning with the 2009
Red Book. |
|
| What guidance is there for
preventing patients from fainting after vaccination? |
|
All providers who administer vaccinations should be aware of the
potential for syncope (fainting) after vaccination and take appropriate
measures to prevent it. Thus, clinicians should (1) make sure that
people who are being vaccinated are always seated; (2) be aware of
symptoms that precede fainting (weakness, dizziness, pallor, etc.); and
(3) take appropriate measures to prevent injuries if such symptoms
occur. [Note: IAC has two pertinent educational pieces for healthcare
professionals: "Medical Management of Vaccine Reactions in Children and
Teens" and "Medical Management of
Vaccine Reactions in Adult Patients".
|
Since 2005, VAERS has received an increasing number of reports of
syncope, coinciding with the licensure of three vaccines for adolescents
– HPV, meningococcal conjugate, and Tdap. Fainting among girls and young
women ages 11-18 accounted for most of the increase. Serious injuries
have occurred, including one fatality from intracranial hemorrhage
caused by head trauma. The May 2, 2008, MMWR included a summary of
findings on the increase in fainting after vaccination (see www.cdc.gov/mmwr/preview/mmwrhtml/mm5717a2.htm).
In people for whom vaccination time and fainting time were reported, it
was discovered that 80% occurred within 15 minutes of receiving the
vaccine. Vaccine providers should strongly consider observing vaccinated
people for 15 minutes after vaccination in accordance with ACIP General
Recommendations (see www.cdc.gov/vaccines/pubs/acip-list.htm). This is
particularly important when vaccinating adolescents and young adults. |
|
| Are vaccine diluents interchangeable? |
|
| As a general rule vaccine diluents are not interchangeable. One
exception is that the diluent for MMR can be used to reconstitute
varicella vaccine, and vice versa. The diluent for both vaccines is
sterile water for injection, and is produced by the same company. No
other diluent can be used for MMR and varicella vaccines, and these
diluents must not be used to reconstitute any other lyophilized vaccine. |
|
| When a vaccine vial is new
and the cap has just been removed, is the rubber stopper sterile, or
should it be cleansed with alcohol before inserting the needle? |
|
| The rubber stopper is not sterile. When you remove the protective cap
from a vaccine or diluent vial, you should always clean the stopper with
an alcohol wipe. This practice is covered in CDC's online vaccine
storage and handling toolkit. To access the kit, go to http://www2a.cdc.gov/vaccines.ed/shtoolkit.
(under revision) |
|
| Is it recommended to change needles
after a vaccine dose has been drawn into a syringe? |
|
| No. Also, it is unnecessary to change the needle if it has passed
through two stoppers, which is done when a lyophilized vaccine is
reconstituted. Changing needles is a waste of resources and increases
the risk of needle stick injury. |
|
| When patients need multiple vaccines
(e.g., influenza and pneumococcal), can we just combine them in the same
syringe? |
|
| Absolutely not. No vaccines should ever be mixed in the same syringe
unless the combination has been specifically approved by the FDA. At
present, only the combined DTaP and Hib vaccine (TriHIBit by sanofi) has
been approved for mixing in the same syringe and only for the fourth
dose. |
|
| Is it okay to draw up vaccines at the
beginning of the shift? If it isn't, how much in advance can this be
done? |
|
| The ACIP discourages the practice of prefilling vaccine into syringes,
primarily because of the increased possibility of administration and
dosing errors. An exception may be considered when only a single type of
vaccine is to be administered during a clinic (e.g., influenza). Another
reason to discourage the practice in general is that some vaccines have
a very limited shelf life after reconstitution. In particular,
varicella, zoster, and meningococcal polysaccharide vaccines must all be administered within 30 minutes of reconstitution, and MMR and MenACWY (Menveo;
Novartis) must be administered within 8 hours. |
|
| Do you need to aspirate before giving a
vaccination? |
|
| No. ACIP does not recommend aspiration when administering vaccines
because no data exist to justify the need for this practice. IM
injections are not given in areas where large vessels are present. Given
the size of the needle and the angle at which you inject the vaccine, it
is difficult to cannulate a vessel without rupturing it and even more
difficult to actually deliver the vaccine intravenously. We are aware of
no reports of a vaccine being administered intravenously and causing
harm in the absence of aspiration. |
|
| While giving an injection, a nurse had
blood return in the syringe upon aspirating. What should she have done
with the vaccine? |
|
| Although aspiration is no longer recommended, if you do aspirate and get
a flash of blood, then the procedure is to withdraw the needle and start
over. The syringe, needle, and contaminated dose of vaccine should be
discarded in a sharps container, and a new syringe and needle should be
used to draw up and administer another dose of vaccine. This is a waste
of expensive vaccine that could be avoided by simply not aspirating. |
|
| If some portion of a vaccine (e.g.,
influenza) leaks out of the syringe while it is injected into a patient,
does the dose need to be repeated and if so, when? |
|
| When this happens, it is difficult to judge how much vaccine the person
received. This would be a nonstandard dose and should not be counted.
You should go ahead and re-immunize the individual at that time. |
|
| What should we do if a dose of expired
vaccine is given to a patient? |
|
| The dose should be repeated. If the expired dose is a live virus
vaccine, you should wait at least 4 weeks after the previous (expired)
dose was given before repeating it. If the expired dose is not a live
vaccine, the dose should be repeated as soon as possible. If you prefer,
you can perform serologic testing to check for immunity for certain
vaccinations (e.g., measles, rubella, hepatitis A, polio, diphtheria,
and tetanus). |
|
| Why are some vaccinations given
subcutaneously while others must be given intramuscularly? |
|
| In general, vaccines containing adjuvants (a component that enhances the
antigenic response) are administered IM to avoid irritation, induration,
skin discoloration, inflammation, and granuloma formation if injected
into subcutaneous tissue. This includes most of the inactivated
vaccines, with a few exceptions (e.g., IPV and pneumococcal vaccines may
be given either SC or IM). Vaccine efficacy may also be reduced if not
given by the recommended route. |
|
| What should we do if we give an
injection by the wrong route (e.g., IM instead of SC)? |
|
| Vaccines should always be given by the route recommended by the
manufacturer because data regarding safety and efficacy of alternate
routes are limited. If this does inadvertently happen, ACIP recommends
that vaccines given by the wrong route be counted as valid with two
exceptions: hepatitis B or rabies vaccine given by any route other than
IM should not be counted as valid and should be repeated. This and other
information on vaccine administration is discussed in the ACIP "General Recommendations on Immunization". |
|
| One of our staff gave a dose of
pediatric hepatitis A vaccine to an adult patient by mistake. How do we
remedy this error? |
|
| In general, if you give less than a full age-appropriate dose of any
vaccine, the dose is invalid. You should revaccinate the person with the
appropriate dose as soon as feasible.
There are, however, two exceptions to the general rule: 1) If a patient
sneezes after receiving nasal-spray live attenuated influenza vaccine,
count the dose as valid. 2) If an infant regurgitates, spits, or vomits
during or after receiving oral rotavirus vaccine, count the dose as
valid.
If you give more than an age-appropriate dose, count the dose as valid
and notify the patient/parent about the error. Avoid such errors by
checking the vaccine vial label 3 TIMES! |
|
| Which vaccines may be given
simultaneously? |
|
| All vaccines used for routine vaccination in the United States may be
given simultaneously (i.e., at the same visit, not in the same syringe).
There is no evidence that simultaneous administration of vaccines either
reduces vaccine effectiveness or increases the risk of adverse events.
If you miss giving recommended vaccines at the same visit, any
inactivated vaccine (e.g., DTaP, Tdap, HPV) can be administered any time
before or after a different inactivated or live vaccine (e.g., MMR, VAR, LAIV). Any 2 live vaccines not given at the same time must be given at
least 4 weeks apart. |
|
| What does "simultaneous
administration of vaccines" mean? Does it mean the same day, hour, or
what? |
|
| Simultaneous means the same day—the same
clinic day. If someone receives a vaccine in the morning and then
another that same afternoon, it would be considered simultaneous
administration. |
|
| One of our nurses accidentally gave
Zostavax IM instead of SC. What do we need to do? |
|
| You can count the dose as valid. ACIP
recommends that vaccines given by the wrong route be counted as valid
with two exceptions: hepatitis B or rabies administered by any route
other than intramuscular should not be counted as valid and should be
repeated. Vaccines should always be given by the route recommended by
the manufacturer, but errors do occur. Your practice should put
procedures in place to ensure that you give vaccines by the recommended
route. |
|
| What length of needle should be used
to give infants IM injections? One of our clinical coordinators says a
1" needle and another says a 5/8" needle. |
|
| ACIP recommends that a 5/8" needle may
be used to administer IM injections in a newborn or premature infant
only if the skin is stretched tight and the subcutaneous tissues are not
bunched. For infants age 1 month or older, IM injections should be given
in the anterolateral thigh with 1" needle. For a detailed discussion of
needle length and injection sites, refer to the ACIP's "General Recommendations on Immunization". |
|
| If I have to give more than 1
injection in a muscle, are certain vaccines best given together? |
|
| Since DTaP and pneumococcal conjugate
are the vaccines most likely to cause a local reaction, it's practical
to give DTaP and PCV in separate limbs (if possible), so there is no
confusion about which vaccine caused the reaction. |
|
| When giving two IM injections in the
same limb, what is the minimum spacing between the two injection sites? |
|
| The vaccines should be separated by at
least one inch in the body of the muscle so that any local reactions are
unlikely to overlap. |
|
| Is it safe to give a vaccine directly
into an area where there is a tattoo? |
|
| Both IM and SC vaccines may be given
through a tattoo. |
|
| Does ACIP recommend that providers
observe patients for a period of time after a vaccination? |
|
| The ACIP recommends that providers
strongly consider observing patients for 15 minutes after vaccination,
if possible, due to the slight risk of syncope, particularly when
vaccinating adolescents and young adults. This issue is discussed in the
ACIP's "General Recommendations on Immunization". |
|
|
|
|
|
| Which vaccines are contraindicated if
a child is breast-feeding? |
|
| Breast-feeding is not a contraindication
to the administration of any routinely recommended vaccine, either to
the mother or to the child. |
|
| Which vaccines are contraindicated if
a child's mother or other household member is pregnant? |
|
| Having a pregnant woman in a household,
including the child's mother, is not a contraindication to
administration of any routinely recommended vaccine. |
|
| For how long should a woman of
child-bearing age avoid pregnancy after receiving a live attenuated
vaccine? |
|
| Due to theoretical risks to the
developing fetus, ACIP recommends that women avoid pregnancy for four
weeks after receiving a live attenuated vaccine (e.g., MMR, varicella,
LAIV). This interval may be shorter than that recommended by the
manufacturer. |
|
| Is there a risk for a pregnant staff
person administering live-virus vaccines? |
|
| A pregnant woman may administer any
vaccine except smallpox vaccine. |
|
| Which vaccines are recommended to be
given postpartum to mothers of newborns before hospital discharge? |
|
| The following vaccines are recommended
for new mothers before they leave the hospital: (1) women who have not
previously been vaccinated with Tdap need 1 dose to protect their
newborn; (2) women who did not receive influenza vaccination during
pregnancy need to be vaccinated if it is still influenza vaccination
season (October through March); (3) women who tested susceptible to
rubella on prenatal testing need MMR vaccine if they don't have a
documented dose of MMR in their medical record; (4) women who are not
immune to chickenpox need 2 doses of varicella vaccine, dose #1 before
hospital discharge and dose #2 given 4-8 weeks after dose #1. |
|
| Is there any reason to delay or
adjust the immunization schedule for children with Down syndrome? |
|
| No. Children with Down syndrome should
receive all indicated vaccines on the recommended schedule. These
children are often at greater risk for complications from
vaccine-preventable diseases than are children without Down syndrome. |
| |
| Do people who received chemotherapy
need their vaccines repeated? |
|
| Vaccines received before starting
chemotherapy do not need to be repeated after chemotherapy is completed.
Chemotherapy does not negate vaccine-induced immunity. However,
revaccination is recommended for people who are recipients of a
hematopoietic stem cell transplant (HSCT), such as a bone marrow
transplant, because immunity present before the transplant is lost and
may not be replaced by donor cells. |
|
| Which vaccinations should be given to
a patient who is a recipient of hematopoietic stem cell transplantation
(HCT)? |
|
| Antibody titers to
vaccine-preventable diseases decline during the 1-4 years after HCT, if
the recipient is not revaccinated. HCT recipients are at increased risk
for certain vaccine-preventable diseases, including those caused by
encapsulated bacteria. In short, all HCT recipients should begin
revaccination with inactivated vaccines 6 months after HCT Three doses
of PCV13 should be given 6 months following transplant followed by a
dose of PPSV23. A 3-dose series of Hib vaccine should also be given
beginning at 6 months following transplant. A one month interval between
these doses is reasonable. Immunocompetent people should receive MMR 24
months after transplant. For a complete discussion of the indications
and schedule of vaccination, refer to the ACIP's "General Recommendations on Immunization". |
|
| Should vaccines be withheld for
patients on steroids? |
|
| Steroid therapies that are short term
(less than 2 weeks); alternate-day; physiologic replacement; topical
(skin or eyes); aerosol; or given by intra-articular, bursal, or tendon
injection are not considered contraindications to the use of live virus
vaccines. The immunosuppressive effects of corticosteroid treatment
vary, but many clinicians consider a dose equivalent to either 2 mg/kg
of body weight or a total of 20 mg per day of prednisone for 2 or more
weeks as sufficiently immunosuppressive to raise concern about the
safety of vaccination with live virus vaccines (e.g., MMR, varicella,
LAIV, yellow fever). Providers should wait at least 1 month after
discontinuation of therapy or reduction of dose before administering a
live virus vaccine to patients who have received high systemically
absorbed doses of corticosteroids for 2 weeks or more. Inactivated
vaccines and toxoids can be administered to all immunocompromised
patients in usual doses and schedules, although the response to these
vaccines may be suboptimal. |
|
| What vaccines are indicated for
someone who has had a splenectomy, and is there concern that they may
have a less than optimum response to vaccines? |
|
Regarding which vaccines are indicated:
People who do not have a functioning spleen or who have had a
splenectomy do not handle encapsulated bacteria well and, therefore, are
at increased risk for infection with encapsulated bacteria, especially
Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus
influenzae type b. They should be vaccinated with age-appropriate
pneumococcal, meningococcal, and possibly Hib vaccines.
Regarding immune response to vaccines:
Immunosuppression is not an issue unless the patient has other health
issues or treatments that are suppressing the immune system. Their
response to vaccination should not be affected by the lack of a
functioning spleen.
|
In addition to receiving their routine
vaccinations, children and adults without a functioning spleen who are
age 2 years and older should receive 1 dose of pneumococcal
polysaccharide vaccine (PPSV) and 1 dose of quadrivalent meningococcal
conjugate vaccine (MCV4). However, if the person is age 56 years or
older, give meningococcal polysaccharide vaccine (MPSV4). If the person
is a child age 2 through 4 years who has recently been vaccinated with
pneumococcal conjugate vaccine (PCV13), wait at least 2 months following
PCV before giving PPSV. Although Haemophilus influenzae type b (Hib)
vaccine generally is not recommended for people age 5 years and older,
studies suggest good immunogenicity in patients who have had a
splenectomy. Giving 1 pediatric dose of Hib vaccine to these patients
who have not previously received Hib vaccine is not contraindicated.
Ideally, PPSV, meningococcal, and Hib vaccines should be administered at
least 2 weeks before a scheduled splenectomy, if possible. If vaccines
are not administered before surgery, they should be administered as soon
as the person's condition stabilizes post-operatively. |
|
| Should you administer vaccine to a child
who is taking antibiotics? |
|
| Treatment with antibiotics is not a valid reason to defer vaccination.
If the child or adult is otherwise well, or has only a
minor illness, vaccines should be administered. But if the person has a
moderate or severe acute illness (regardless of
antibiotic use) one should defer vaccination until the person's
condition has improved. |
|
| What vaccines can a patient with severe
combined immunodeficiency disease (SCID) receive? |
|
| Patients with SCID may be given inactivated vaccines (e.g., DTaP, Hib,
hepatitis B, IPV, injectable influenza, and, if
indicated, pneumococcal and hepatitis A). They should not be given live
virus vaccines (e.g., intranasal influenza, MMR, oral
polio, rotavirus, and varicella). |
|
| We frequently see patients who are
febrile or have an acute illness and are due for vaccinations. We're
never quite sure if
we should withhold the vaccines or not. What do you advise? |
|
| A "moderate or severe acute illness" is a precaution for administering
any vaccine. A mild acute illness (e.g., diarrhea or
mild upper-respiratory tract infection) with or without fever is not.
The concern in vaccinating someone with moderate or
severe illness is that a fever following the vaccine could complicate
management of the concurrent illness (that is, it could
be difficult to determine if the fever was from the vaccine or due to
the concurrent illness). In deciding whether to
vaccinate a patient with moderate or severe illness, the clinician needs
to determine if forgoing vaccination will increase
the patient's risk to vaccine-preventable diseases, as is the case if
the patient is unlikely to return for vaccination or to
seek vaccination elsewhere. |
|
|
|
|
|
| Where can I find a list of
vaccines currently licensed for use in the U.S.? |
|
| CDC maintains a sortable list of vaccine names at
www.cdc.gov/vaccines/about/terms/USVaccines.html. |
| |
| When we are giving multiple injections
in a limb, what is the best way to accurately document the injection
site? It is not
unusual for us to give 4-6 injections to each infant/child that we see,
and I want to ensure that we are doing this safely
and documenting it adequately. |
|
| One way to handle this is to indicate if the vaccination was given
either in the "upper" or "lower" portion of the injection
area selected (e.g., DTaP: right thigh, upper; Hib: right thigh, lower;
or PCV13: left thigh, upper; HepB: left thigh,
lower). It is helpful if everyone in your office or clinic uses the same
sites for each vaccine. Use of a standardized site
map can facilitate this. Site maps for administering vaccines to
children are available at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/site-map.pdf.
Site maps for administering vaccines to adults are at www.eziz.org/PDF/IMM-718adult.pdf. |
| |
| We frequently see patients who do not
have records of past vaccination (e.g., new immigrants) or who insist
they or their
children are up to date. Should we go ahead and give vaccinations anyway
or is there a concern for "over immunization?" |
|
Vaccination providers frequently encounter people who do not have
adequate documentation of vaccinations. Providers should
only accept written, dated records as evidence of vaccination. With the
exception of influenza vaccine and pneumococcal
polysaccharide vaccine (PPSV) given to adults, self-reported doses of
vaccine without written documentation should not be
accepted. An attempt to locate missing records should be made whenever
possible-by contacting previous healthcare providers,
reviewing state or local immunization information systems, and searching
for a personally held record. However, if records
cannot be located or will definitely not be available anywhere because
of the patient's circumstances, children without
adequate documentation should be considered susceptible and should be started on the age-appropriate vaccination schedule.
Serologic testing for immunity is an alternative to vaccination for
certain antigens (e.g., measles, rubella, hepatitis A,
polio, diphtheria, and tetanus).
|
In general, although it is not ideal,
receiving extra doses of vaccine poses no medical problem. Receiving
excessive doses of
tetanus toxoid (e.g., DTP, DTaP, DT, Tdap, or Td) can increase the risk
of a local adverse reaction, however. For details,
consult CDC's "General Recommendations on Immunization". |
|
| We sometimes encounter patients with
foreign vaccination records. Sometimes we suspect the record isn't
valid. What should we do? |
|
| If a provider suspects an invalid
vaccination record in any person vaccinated outside the U.S., one of two
approaches can be taken. Repeating the vaccinations is an acceptable
option. Doing so is usually safe and avoids the need to obtain and
interpret serologic tests. If avoiding unnecessary injections is
desired, judicious use of serologic testing might be helpful in
determining which immunizations are needed. This may be particularly
helpful in determining tetanus and diphtheria antitoxin levels for
children whose records indicate 3 or more doses of DTP or DTaP. This
issue is discussed in the ACIP's "General Recommendations on Immunization". |
| |
| Where can I find names of vaccines
used outside the U.S.? |
|
| Appendix B of the CDC publication
Epidemiology and Prevention of Vaccine-Preventable Diseases ("The Pink
Book") contains a list of vaccines used outside the U.S. You'll find
Appendix B at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/foreign-products-tables.pdf. |
|
| Since the Health Insurance
Portability and Accountability Act (HIPAA) went into effect, we are
unsure if we can share immunization information on our pediatric
patients with staff in schools or daycare facilities. |
|
| Healthcare providers (or other covered
entities) may share immunization information with schools or daycare
facilities, without authorization, if permitted or required by state
law. These state laws would not be preempted by the HIPAA Privacy Rule
[45 CFR 160.203(c)]. |
|
| If a patient or parent refuses
recommended vaccinations, is it necessary for them to sign a refusal
form, or is the provider's documentation sufficient? |
|
| The American Academy of Pediatrics
states that healthcare providers may decide it is in their best interest
to formally document a parent's refusal to accept vaccination for their
(minor) child. To read a discussion on this topic and to access a
prototype refusal form, go to www.aap.org/immunization/pediatricians/pdf/RefusaltoVaccinate.pdf. |
|
| Is a parent signature required for
vaccination? |
|
| Federal law does not require parent
signatures, but state or local requirements may apply. Providers should
check with their state immunization program to determine whether
additional requirements exist under state law. For information on state
contacts, go to www.immunize.org/coordinators. |
|
| If my state has a registry, do I
still need to give patients vaccine record cards? |
|
| Yes. Patient-held cards are an extremely
important part of a person's medical history. The person may move to an
area without a registry, and the personal record may be the only
vaccination record available. In addition, even within a state, all
healthcare providers may not participate in the registry, and the
personal record card would be needed. |
|
|
|
|
|
| When is a "dormitory style" refrigerator
not adequate for storing vaccines? |
|
| This type of unit is not acceptable for storing varicella, MMRV, LAIV,
or zoster vaccines because the freezer compartment
cannot maintain 5°F (-15°C) or colder consistently. A dormitory
refrigerator may be used for storing small amounts of
vaccines that require only refrigeration if the unit can maintain a
consistent temperature of 35-46°F (2-8°C). However
dormitory refrigerators should NOT be used for permanent storage of
vaccines. |
|
| Can we store vaccine in the same unit
where we store employees' lunches? |
|
| No, don't use the same unit. Frequent opening of the refrigerator's door
to retrieve food items can adversely affect the
internal temperature of the unit and potentially damage the vaccines. |
|
| Is it okay to store blood products in
the same unit as vaccines? |
|
| CDC's vaccine storage and handling toolkit states "If possible, other
medications and other biologic products should not be
stored inside the vaccine storage unit. If there is no other choice,
these products must be stored below the vaccines on a
different shelf. This prevents contamination of the vaccines should the
other products spill." |
|
| There is a vent in our refrigerator that
brings in cold air from the freezer. Vaccines stored near this vent are
colder to
the touch. Could this be a problem? |
|
| Yes. Vaccines that are stored in a household refrigerator with a
separate freezer compartment should be moved away from the
vent located in the refrigerator compartment as the cold air from the
freezer can cause your vaccines to freeze. Inactivated
vaccines must be kept at 35-46°F (2-8°C) and not frozen. |
| |
| One morning, our
refrigerator thermometer registered 32 degrees F. The vaccine didn't
look frozen so we kept using it. Was this okay? |
|
| No. If you find that a
vaccine has been exposed to an inappropriate temperature, determine the
reason for the temperature alteration, mark the vaccine "Do Not Use,"
and contact the state or local health department or manufacturer to
determine if the vaccine can be used. |
| |
| For an extended period, the
temperature in the vaccine-storage refrigerator in our practice was too
cold. We assume all the vaccines given during that period are considered
invalid. How should we schedule the revaccinations? |
|
| If administered vaccine is found to be
stored at an inappropriate temperature, the provider should contact the
state health department to determine if the vaccine dose is invalid. If
the vaccine dose is determined to be invalid, another dose should be
given. This applies to inactivated or live vaccines. If the damaged
vaccine was a live virus vaccine (e.g., MMR, VAR), you should wait at
least 4 weeks after the previous (damaged) dose was given before
repeating it. If the damaged vaccine was an inactivated vaccine, you can
give the repeat dose on the same day you gave the damaged dose or at any
other time. If you prefer, you can perform serologic testing to check
for immunity for certain vaccinations (e.g., measles, rubella, hepatitis
A, polio, diphtheria, varicella, and tetanus). |
| |
| We have a large quantity of vaccines,
and space is always an issue. Since you cannot put vaccines in the
vegetable bins, can we remove them and then put vaccines in that space? |
|
| Vaccines should not be stored in
vegetable bins or the space occupied by vegetable bins because this area
is commonly closer to the motor of the unit and temperatures may be less
stable. We recommend that you remove the vegetable bins and put bottles
of water in that space to help maintain a constant temperature in your
refrigerator. Vaccines should be placed in the center of the
refrigerator, away from the walls and floor of the unit in open
containers so air can circulate around the vaccines. You also do not
want the top shelf in the refrigerator too close to the vents that come
from the freezer because this can expose your vaccines to freezing
temperatures. |
|
| What type of thermometer is good for
measuring temperatures in a vaccine storage unit? |
|
| ACIP recommends either a continuous
chart recorder thermometer, minimum-maximum, or standard fluid-filled.
In addition, the thermometer should have a certificate that indicates a
second calibration. While all thermometers are calibrated during
manufacturing, certified calibrated thermometers undergo a second
individual calibration against a reference standard from an appropriate
agency. They are then given a certificate indicating successful
completion of this process. Be sure to look for a thermometer with a
"traceable certificate," usually to a National Institute of Standards
and Technology (NIST) or American Society for Testing and Materials
(ASTM) standard. The certificate is provided with the instrument when
purchased and is different from the manufacturer's warranty. These
thermometers may cost a bit more than the average hardware store
thermometer, but it is better to invest in a more reliable model than to
risk damaging thousands of dollars worth of vaccine because of
inaccurate readings. This topic is discussed in the ACIP's "General Recommendations on Immunization" and on the CDC website at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/C/storage-handling.pdf. |
|
| How can I find an appropriate
thermometer for monitoring my vaccines? |
|
| While not endorsing any particular
product or vendor, CDC has compiled a partial list of appropriate
thermometers at www2a.cdc.gov/vaccines/ed/shtoolkit/default.htm (under revision).
Some of the vendors listed may also offer products that are not
certified; buyers should make inquiries about the specific models they
wish to purchase. Be sure to look for a thermometer with a "traceable
certificate," usually to a National Institute of Standards and
Technology (NIST) or American Society for Testing and Materials (ASTM)
standard. These thermometers may cost a bit more than the average
hardware store thermometer, but it is better to invest in a more
reliable model than to risk damaging thousands of dollars worth of
vaccine because of inaccurate readings. |
|
| How often should temperatures be
checked and recorded on our vaccine storage unit's log? |
|
| It is important that you check and
record the temperatures of both the refrigerator and freezer units at
the beginning and end of the day. You should also record the room
temperature on your log. |
|
| We are carefully logging our vaccine
storage unit's temperatures each day. Is there anything else that could
go wrong? |
|
| Congratulations on all your hard work.
You would be surprised at the number of people who, just like you, do a
careful job of recording temperatures but then they fail to act on them
when the temperatures go out of range. Always take immediate action when
you notice an out-of-range temperature. You may need to move the
vaccines temporarily to a more reliable storage unit and determine the
source of the problem. It may be something quite fixable (e.g.,
excessive lint or dust on the coils) and you will be back in business
after you determine that the temperature is back in range after a few
hours. Above all, don't chart an out-of-range temperature and not act on
it! |
|
| Why is it recommended that we keep
temperature logs for 3 years or longer? |
|
| It is important that you keep
your temperature logs for at least 3 years. As the refrigerator ages,
you can track recurring
problems. If temperatures have been documented out of range, you can
determine how long this has been happening and take
appropriate action. Some states and localities may require providers to
keep these logs for a longer period and some may also
require providers to submit completed vaccine storage logs in order to
receive vaccine from their program. |
|
| I've heard there is a vaccine storage
and handling toolkit available from CDC. How do I get it? |
|
| You can access the toolkit on CDC's
website at http://www2a.cdc.gov/vaccines/ed/shtoolkit (under revision). The
toolkit contains 2 videos on CD-ROM (How to Protect Your Vaccine Supply
and Top 10 Storage and Handling Errors); an interactive game; and
resources including forms, checklists, posters, and contact information.
Single copies of the CD-ROM can be ordered from CDC at wwwn.cdc.gov/pubs/ncird.aspx. |
|
| How long is a vaccine viable if it
has been stored in the refrigerator in a syringe? |
|
| Disposable syringes are meant for
administration of immunobiologics, not for storage. CDC recommends that
vaccines that have been drawn into syringes be discarded at the end of
the clinic day. |
|
| What should we do if a dose of
expired vaccine is given to a patient? |
|
| The dose should be repeated. If the
expired dose is a live virus vaccine, you must wait at least 4 weeks
after the previous (expired) dose was given before repeating it. If the
expired dose is not a live vaccine, the dose should be repeated as soon
as possible. If you prefer, you can perform serologic testing to check
for immunity for certain vaccinations (e.g., measles, rubella, hepatitis
A, polio, diphtheria, and tetanus). |
|
| I've heard that multidose vaccine
vials should be disposed of after being open for 30 days. Is this true? |
|
| No. Multidose vials of vaccine that do
not require reconstitution may be used through the expiration date
printed on the label or box as long as the vaccine is not contaminated. |
|
| When the expiration date of a vaccine
indicates a month and year, does the vaccine expire on the first or last
day of the month? |
|
| Vaccine may be used through the last day
of the month indicated on the expiration date. After that, do not use
it. Monitor your vaccine supply carefully so that vaccines do not
expire. |
|
|
|
|
|
| Some parents are requesting that we
space out their infant's vaccinations because they are concerned that
receiving multiple
vaccinations at a single office visit might overwhelm the infant's
immune system. What do you think about using alternative
schedules? |
|
| Vaccine recommendations are determined after extensive studies in large
clinical trials. They include studies on how vaccine
recipients respond to multiple vaccines given simultaneously. The
overall aim is to provide early protection for infants and
children against vaccine-preventable diseases that could endanger their
health and life. No scientific evidence exists to
support that delaying vaccinations or separating them into individual
antigens is beneficial for children. Rather, this
practice prolongs susceptibility to disease, which could result in a
greater likelihood of the child becoming sick with a
serious or life-threatening disease. There could also be added expense
(e.g., multiple office visits), additional time off
from work for parents, and increased likelihood that the child will fail
to get all necessary vaccinations. |
|
| Many of my patients are reading The
Vaccine Book, in which the author, Dr. Robert W. Sears, cites studies
that he interprets as showing that the amount of aluminum found in
certain vaccines might be unsafe. He thinks it is better to separate
aluminum-containing vaccines, rather than give them according to the
recommended U.S. immunization schedule. I would love any information you
have about this. |
|
| Paul Offit, MD, and Charlotte Moser, BS, of the
Vaccine Education Center (VEC) at the Children's Hospital of Philadelphia,
published an article, "The Problem with Dr. Bob's Alternative Vaccine Schedule,"
in the January 2009 issue of Pediatrics. It
includes a section about aluminum. You can read it in its entirety at http://pediatrics.aappublications.org/cgi/content/full/123/1/e164.
Here are some additional sources of related
information: |
|
| Here are two sources of related
information:
|
|
| Does the thimerosal in some of the
injectable influenza vaccines pose a risk? |
|
| Thimerosal, a very effective preservative, has
been used to prevent bacterial contamination in vaccine vials for more than 50
years. It contains a type of mercury known as ethylmercury, which is different
from the type of mercury found in fish and seafood (methylmercury). At very high
levels, methylmercury can be toxic to people, especially to the neurological
development of infants. |
|
| In recent years, several large
scientific studies have determined that thimerosal in vaccines does not
lead to neurologic problems, such as autism. Nonetheless, because we
generally try to reduce people's exposure to mercury if at all possible,
vaccine manufacturers have voluntarily changed their production methods
to produce vaccines that are now free of thimerosal or have only trace
amounts. They have done this because it is possible to do, not because
there was any evidence that the thimerosal was harmful. |
| |
| A patient has expressed concern that
some vaccines have been produced in fetal tissue. How can I address this
concern? |
|
| The production of a few vaccines,
including those for varicella, rubella, and hepatitis A, involves
growing the viruses in human cell culture. Two human cell lines provide
the cell cultures needed for producing vaccines; these lines were
developed from two legally aborted fetuses in the 1960s. These cell
lines are maintained to have an indefinite life span. No fetal tissue
has been added since the cell lines were originally created. |
|
| Some parents are concerned about this
issue because of misinformation they have encountered on the Internet.
Two such untrue statements are that ongoing abortions are needed to
manufacture vaccines and vaccines are contaminated with fetal tissue.
Parents can read the facts and several thought-provoking articles about
this issue at www.immunize.org/concerns/religious.asp and then make an informed
decision. |
|
| A Catholic bishop's statement that
Catholic parents have no general obligation to refuse permission for
these vaccines can be accessed at www.cdc.gov/vaccines/vac-gen/laws/rubella-cathnews.htm |
|
| Where can I find more information to
help address my patients' concerns about vaccine safety? |
|
| There are many excellent
websites that have information about vaccine safety, including the American Academy of Pediatrics, the CDC, Every Child by Two, Immunization Action Coalition, the National Network for Immunization Information, the Institute of Medicine, and the Vaccine Education Center, Children's Hospital of Philadelphia. |
|
| We understand that it is advisable to
observe patients for 15 minutes after vaccination--can the patient sit
in the waiting room for 15 minutes before leaving or do they have to be
observed by a nurse? |
|
| Although syncope can occur in anyone, it
is more common among adolescents and young adults. It can result in
serious injury, and the 15-minute guideline is therefore advised. There
are no specific guidelines as to who should watch the patient. The main
goal is to avoid a situation where the patient suffers injury from a
fall. |
|
|
|
|
|
| Please explain the federal requirements
imposed on all healthcare providers under the National Childhood Vaccine
Injury Act
that administer vaccines? |
|
The National Childhood Vaccine Injury Act (NCVIA), enacted in 1986, set
forth 3 basic requirements for all vaccination
providers, which are:
-
Providers must give the patient (or parent/legal
representative of a minor) a copy of the relevant federal "Vaccine Information
Statement" (VIS) for the vaccine they are about to receive.
-
Providers must record certain information about the vaccine(s)
administered in the patient's medical record or a
permanent office log.
-
Providers must document any adverse event following the vaccination
that the patient experiences and that becomes known
to the provider, whether or not it is felt to be caused by the vaccine,
and submit the report to the Vaccine Adverse Event
Reporting System (VAERS).
|
|
| Which vaccines are covered by NCVIA? |
|
| As of November 2010, NCVIA requirements apply to diphtheria, tetanus,
pertussis, measles, mumps, rubella, polio, hepatitis A,
hepatitis B, Haemophilus influenzae type b (Hib), varicella, influenza,
pneumococcal conjugate, meningococcal, rotavirus, and
human papillomavirus (HPV) vaccine. |
|
| Where can I get instructions on how,
why, and when to use the federally-mandated VISs? |
|
| Instructions on the use of VISs and many additional items are available
on the CDC website at www.cdc.gov/vaccines/pubs/vis/default.htm or from your state immunization program. You can
also visit IAC's website at www.immunize.org/vis for links to many
important documents about the use of VISs. |
|
| When are Vaccine Information Statements
(VISs) released for new vaccines? |
|
| An interim Vaccine Information Statement (VIS) can sometimes be released
soon after licensure of the vaccine or after the
official vote by ACIP is taken. The interim VIS is not replaced with a
final version until the ACIP recommendations have been
published and the new VIS has been developed according to
legally-mandated procedures. |
|
| Is it required to use a VIS in an
emergency room when we give Td/Tdap to a patient? |
|
| Yes. The National Childhood Vaccine Injury Act requires that a VIS be
given to people of any age before they receive a dose
of any vaccine included in the Act. Tetanus and diphtheria toxoids (and
pertussis vaccine) are included in the Act. If the
patient is unaccompanied and unable to clearly read and understand the information in the VIS (e.g., unconscious), this
should be noted in the patient's chart. |
|
| Our large pediatric practice is
struggling with the requirement to provide VISs to the parents of every
child we vaccinate.
We think we have a solution and would like your opinion of it. We would
like to create a re-usable packet of laminated VIS
sheets (fastened together on a ring). We plan to place a packet in each
exam room for parents to read prior to vaccine
administration. On the bottom of each sheet would be a statement, "If
you would like a copy of this sheet to take home,
please ask our staff." This will ensure that parents are given the VIS
sheets to read prior to vaccine administration. It
will also help save paper; our experience is that many parents throw out
the VIS documents or leave them behind in the
waiting room. |
|
| Many clinicians are looking for ways to reduce paper overload, so this
is a common question. Your solution will meet the
spirit of the federal law, as long as you make sure to encourage the
patient (or parent) to take home a paper copy of the VIS
and to refer to it if needed (e.g., if they need to know what to do if
there is an adverse event or how to contact VAERS).
Patients can also download VISs onto mobile devices. For more
information about this technology, go to www.cdc.gov/vaccines/pubs/vis/vis-downloads.htm. |
|
| We operate an acute care hospital and
commonly give vaccinations to our employees and patients. Are we
required to use
Vaccine Information Statements (VISs), or does that apply only to
patients seen in outpatient settings? |
|
| VISs must be given to all people, including adults, before administering
HPV, Td, Tdap, MMR, varicella, hepatitis A,
hepatitis B, meningococcal, influenza, or polio vaccine. This includes
Td, Tdap, MMR, varicella, hepatitis A, hepatitis B,
influenza, and others. Current VISs are available from the CDC's website
at www.cdc.gov/vaccines/pubs/vis and from the
Immunization Action Coalition's (IAC) website at www.immunize.org/vis.
You'll also find many VIS translations on IAC's site. |
|
| When using VISs and providing vaccines,
is a parent/guardian signature required? |
|
| No. There is no federal requirement for signed consent for any dose of
vaccine. The federal requirement is to provide all
adult patients or parents/legal representatives of minor children with
the appropriate VIS for each dose of vaccine
administered. Federal law also requires that you record the date you
gave the VIS to the patient or minor child's
parent/legal representative and the edition date of the VIS, among other
items, in the patient's medical record. Some
clinics, agencies, and/or state immunization programs may have
requirements for signatures. Contact information for your
state health department is available at www.immunize.org/coordinators. |
|
| I'm unclear about when to use the
multi-vaccine VIS versus the individual VISs. |
|
| The multi-vaccine VIS is a 4-page alternative VIS that you can use in
place of the individual VISs for any or all of the 6
vaccines routinely given to infants (i.e., DTaP, IPV, Hib, PCV, HepB,
and rotavirus). It is not designed to be used with
adolescents or adults (risk factors that apply only to older people are
not included on this VIS). Use of this VIS saves
paper and staff time. When giving the multi-vaccine VIS to a parent,
check the boxes on the first page that correspond to the
vaccines you plan to administer at the current visit. The multi-vaccine
VIS, as well as all other VISs in English and more
than 35 languages, are available on IAC's website at www.immunize.org/vis.
English-language VISs are available on CDC's
website at www.cdc.gov/vaccines/pubs/vis. |
|
| Where can I get VISs for some of the
newer combination vaccines? |
|
| CDC currently has no plans to develop
VISs for Pediarix, Comvax, Twinrix, TriHIBit, Kinrix, or Pentacel. When
administering these combination vaccines, use the VISs for all component
vaccines. For certain combination vaccines given to children, you can
use the multi-vaccine VIS and check the appropriate box(es), just as you
would if you were administering the individual vaccines.
A VIS was developed for MMRV vaccine
because of its unique adverse reaction profile. |
|
| By law, when vaccinating adults or
children, when and to whom is it required to give Vaccine Information
Statements (VISs)? |
|
| The National Childhood Vaccine Injury
Act requires that a VIS must be given to parents, legal representatives,
or adult patients before administering the vaccine. A VIS must be
provided prior to each dose, not just the first. Providers should be
sure they are using the most current version of each VIS. Current VISs
and their dates are available from on the CDC's website at www.cdc.gov/vaccines/pubs/vis/default.htm#download and from IAC's
website at www.immunize.org/vis. |
|
| Where can I get foreign language
VISs? |
|
| CDC publishes VISs in English only; all
translations have been developed by others. To access all currently
available VISs in more than 35 languages and some alternative formats
(audio/video), go to IAC's website at www.immunize.org/vis. |
|
| What is the Vaccine Adverse Event
Reporting System (VAERS)? |
|
| As the name implies, VAERS is a
nationwide system for monitoring adverse events following vaccination.
VAERS is operated jointly by the FDA and the CDC, and became fully
operational in November 1990. |
|
| How do I report an adverse event to
VAERS? |
|
| A standardized form is used to report to
VAERS. The report forms and instructions, or a copy of the Vaccine
Injury Table, may be obtained directly from VAERS by calling (800)
822-7967. The forms may also be obtained from your state immunization
program, the FDA Drug Bulletin, the AAP's Red Book, and the
Physician'sDesk Reference. |
|
| If a patient faints following
vaccination, should we submit a report to the federal Vaccine Adverse
Event Reporting System (VAERS)? |
|
| Yes. Any occurrence of medical
significance warrants a VAERS report. You can obtain more information
about VAERS at http://vaers.hhs.gov or by calling (800) 822-7967. |
|
| How do I decide whether to report an
adverse event to the Vaccine Adverse Events Reporting System (VAERS)? |
|
| All significant health events that may
have been related to a dose of vaccine, particularly those that lead to
hospitalization, disability, or death, should be reported to VAERS. The
healthcare provider doesn't need to be certain the event was vaccine
related in order to report it. It is not necessary to report minor
adverse reactions, such as local reactions or low-grade fever. |
|
|
|
|
|
| How can we quickly locate the most
important recent publications (e.g., FDA licensures) and announcements
about immunization issues? |
|
| Visit www.immunize.org/newreleases for IAC's chronological list of these
events. Also, be sure to sign up for IAC Express to
receive weekly email updates and links to newly released publications by
going to www.immunize.org/subscribe. |
|
| We want to make sure that all our
staff who administer vaccines are well trained. Is there a good tool we
can use as a refresher? |
|
| One of the best resources available today is the DVD "Immunization
Techniques: Best Practices with Infants, Children, and
Adults." You can order this from IAC. Other good materials in print are
available from IAC, including "How to Administer IM
and SC Injections" which can be found at www.immunize.org/handouts. |
|
| What are the best places to get
answers to my questions about immunization? |
|
| There are many excellent sources of
information available for health professionals as well as the public.
You can get a personal response to your questions regarding vaccines and
practice issues by contacting immunization staff at your local or state health department.
You'll find answers to almost all
questions about vaccines and the diseases they prevent by reading the
appropriate ACIP
statement. Although these may appear to be overwhelming documents, they
are all organized in much the same manner and are
easy to navigate and understand. Every office or clinic providing
vaccinations should have a copy of all relevant ACIP
statements for easy reference. IAC maintains an online library of ACIP
statements at www.immunize.org/acip. You can also
download them from CDC's website at www.cdc.gov/vaccines/pubs/acip-list.htm. |
|
| What are some of the most commonly
used references for information about immunization for healthcare
professionals who want to get answers on their own? |
|
The following are some basic resources
for anyone providing immunization services.
|
| ACIP's "General
Recommendations on Immunization" To obtain a ready-to-print (PDF)
version, go to www.cdc.gov/mmwr/PDF/rr/rr5515.pdf. |
|
| All ACIP
recommendations can be accessed on CDC's website at www.cdc.gov/vaccines/pubs/ACIP-list.htm or from IAC's website
at www.immunize.org/acip. |
|
| The American Academy of
Pediatrics' vaccine policy statements can be found on IAC's
website at www.immunize.org/aap. |
|
| CDC's "Pink Book" To read
or download this book as a whole or by chapter, go to www.cdc.gov/vaccines/pubs/pinkbook. |
|
| CDC's immunization
schedules for infants, children, adolescents, and adults To access
the schedule(s) of your choice, including catch-up schedules that
contain minimum intervals, go to www.cdc.gov/vaccines/recs/schedules. |
|
| "Ask the Experts" To read
IAC's collection of challenging questions answered by CDC experts,
go to www.immunize.org/askexperts. |
|
| "Immunization
Techniques: Best Practices for Infants, Teens, and Adults" This
DVD was developed by the California Department of Health Services
and is available for sale on IAC's website at www.immunize.org/shop. |
|
|
| Where can I get immunization
education materials to hand out to my patients? |
|
| Many excellent websites offer
easy-to-access, patient-friendly materials on vaccines and
vaccine-preventable diseases. Here are just a few: the Centers for
Disease Control and Prevention at www.cdc.gov/vaccines/spec-grps/parents.htm; American Academy of
Pediatrics at www.aap.org/immunization; Immunization Action Coalition at www.immunize.org/handouts; National Network for Immunization
Information at www.immunizationinfo.org; and Vaccine Education Center at Children's
Hospital of Philadelphia at www.vaccine.chop.edu. |
|
| Where can I find the most up-to-date
information about vaccine shortages? |
|
| The vaccine shortage/supply situation
changes frequently. The most current information can be found at www.cdc.gov/vaccines/vac-gen/shortages/default.htm. |
|
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|
|
|
| Can vaccinations be given without a
physician's order? |
|
| Vaccines must always be dispensed with a prescription or order from a
physician or other healthcare provider authorized by
the state to prescribe medications. However, there are situations where
vaccines can be administered under a standing order
or vaccine protocol that is not patient-specific. In these situations, a physician or other healthcare provider does not need
to be physically present for the vaccine to be administered. Several
studies have shown that the use of standing orders can
improve vaccination rates, and ACIP recommends the use of standing
orders programs in both outpatient and inpatient settings.
A comprehensive set of standing orders for most all vaccines given to
children and adults can be found at www.immunize.org/standingorders. |
|
| How can I find out if our state
or locality has an automated immunization information system (IIS) in
which I might
participate? |
|
| Many states have made significant progress in the development of
automated immunization information systems (IISs). Much of
this information is available from the American Immunization Registry
Association (AIRA) at www.immregistries.org AIRA
provides a forum through which IIS programs, as well as interested organizations, individuals, and communities combine
efforts and share knowledge that promotes IIS activities as a resource
for both IISs and immunization programs. To view the
current status of IIS development in your state, simply go to AIRA's
Registry Profiles and click on a state on the map to
bring up a list of IISs in that state. Clicking on an IIS will display
all sorts of information about that IIS, including
programmatic and technical contact information. If you would like to
participate, contact your state health department
immunization program. Phone numbers are available at www.immunize.org/coordinators. |
|
| Where can I get the most
up-to-date information on vaccination recommendations for people who
travel outside the U.S.? |
|
| You can get this information from CDC's Travel Health website at wwwn.cdc.gov/travel/default.aspx CDC also publishes Health
Information for International Travel (a.k.a. "Yellow Book") every two
years as a reference for those who advise international
travelers of health risks. The Yellow Book is written primarily for
healthcare providers, although others might find it
useful. To order a copy of the Yellow Book from Elsevier Publishing,
visit their website at www.elsevierhealth.com or call
(800) 545-2522 and ask for ISBN# 978-0-7020-3481-7. |
|
| Who is responsible for reporting
cases of vaccine-preventable diseases to the state? Which cases are
reportable? |
|
| Reporting requirements vary from state
to state but, in general, the responsibility for submitting a disease
report is with the provider who diagnoses the disease. Most states
prefer to receive reports of suspected as well as confirmed diseases,
particularly for diseases in which prompt containment activities are
needed to prevent further spread of the disease (e.g., measles,
pertussis). While some diseases (e.g., measles, pertussis) are
reportable in all states, some diseases are not. Your state health
department can supply a list of reportable diseases and specific
reporting procedures. |
|
| Why aren't people in the United
States vaccinated with BCG? |
|
| BCG vaccine is used in countries of high
endemicity to help prevent tuberculosis disease. A more effective
strategy for the prevention of tuberculosis in countries where the
endemicity is low is to identify infected people through tuberculin skin
test screening, and eliminate the infection with antituberculous drugs.
This is the strategy used in the United States. |
|
| What is the Vaccines for Children (VFC)
program? |
|
| VFC is a program designed to reduce or
eliminate vaccine cost as a barrier to childhood vaccination. The
program purchases vaccines from manufacturers at federal contract prices
and provides them at no cost to participating public and private
healthcare providers for use in children through age 18 years who are
eligible for Medicaid, are uninsured, or are American Indian or Native
American. Children whose health insurance benefit plan does not cover a
particular VFC vaccine are also able to receive VFC vaccine at a
Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC).
If you are interested in becoming a VFC provider, you should contact
your state immunization program. For more information on the VFC program
in general, go to the CDC's website at www.cdc.gov/vaccines/programs/vfc. |
|
| If a child isn't covered by health
insurance but the parent plans to get insurance, is the child eligible
for VFC vaccine? |
|
| If the child has no health insurance on
the day he or she presents at a medical practice or health department
for immunization, the child is VFC eligible because he or she is
uninsured. A child must be screened for VFC eligibility at each visit,
even though the eligibility form needs to be updated only when the
child's eligibility status changes. |
|
| Do I need to verify my patient's
residency status before using VFC vaccine? |
|
| No. The CDC website www.cdc.gov/vaccines/programs/vfc/projects/faqs-doc.htm#elig states
that the only criteria are age (age 18 years or younger) and the four
eligibility criteria listed previously. No other factors (e.g.,
residency status) can be considered when screening for eligibility
requirements for the VFC program. |
|
| Where can I get the most up-to-date
information on vaccination recommendations for people who travel outside
the U.S.? |
|
| You can get this
information from CDC's Travel Health website at wwwn.cdc.gov/travel/default.aspx CDC also publishes Health
Information for International Travel (a.k.a. "Yellow Book") every two
years as a reference for those who advise international travelers of
health risks. The Yellow Book is written primarily for healthcare
providers, although others might find it useful. To order a copy of the
Yellow Book from Elsevier Publishing, visit their website at www.elsevierhealth.com or call (800) 545-2522 and ask for ISBN#
978-0-7020-3481-7. |
|
| Reviewed on 11/10 |
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