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| Where can I find
information about vaccine shortages and delays? |
 |
| Visit CDC's website at
www.cdc.gov/vaccines/vac-gen/shortages/default.htm. |
|
| Where can I find the most
current vaccine recommendations? |
|
| 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. |
|
| How do I obtain copies of the newest
U.S. recommended immunization schedules for children and for adults? |
|
| 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. |
|
| 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, if the disease being prevented is communicable in a school setting. 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. |
|
| What resources does IAC have to help
parents and child caretakers evaluate the immunization needs of children
and adolescents? |
|
| There are several very easy to read pieces that can be downloaded from
the IAC website. This includes "Vaccinations for Infants and Children,
Age 0—10 Years", "When
do children and teens need vaccinations?", "Vaccinations
for Preteens and Teens, Age 11—19 Years". |
|
| What resources are available to help
adult patients evaluate their individual immunization needs? |
|
| There are several screening questionnaires that IAC has developed for
patient use. These include an adult assessment piece "Do I need any vaccinations today?",
"Vaccinations
for Adults with HIV", "Vaccinations
for Adults with Hepatitis C Infection", "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. |
|
| When a 3-month-old infant presents
having had no prior immunizations, would you start the accelerated
schedule? |
|
| 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. |
|
| 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/schedules/child-schedule.htm#hcp. |
|
| How many vaccines can be given during an
office visit? |
|
| No upper limit exists for the number of vaccines that can be
administered during one visit. ACIP and AAP consistently recommend that
all needed vaccines be
administered during an office visit. |
|
| 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? |
|
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 two IM
vaccines by at least 1 inch in the body of the muscle to reduce the
likelihood of local
reactions overlapping. Here are some helpful site maps for different
ages so you can record where shots were given:
http://eziz.org/assets/docs/IMM-718.pdf
https://kids.phila.gov/Docs/Imm_teen_site_map.pdf
http://www.eziz.org/assets/docs/IMM-718A.pdf |
|
| 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. |
|
| 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. |
|
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 two 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. |
|
| If all needed vaccines aren't
administered during the same visit, does one need to wait a certain
period of time before administering the other needed
vaccines? |
|
| All inactivated vaccines can be given on the same day, or on any day
before or after giving other inactivated or live vaccines. However, if
two live
vaccines are not given on the same day, they need to be spaced at least
4 weeks apart. |
|
| 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. |
|
| If two live virus vaccines are
inadvertently given less than 4 weeks apart, what should be done? |
|
| 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. |
|
| We gave a dose of vaccine too soon after
the previous dose. When can we give another (valid) dose? |
|
| 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.
If the first dose in a series is given >5 days before the recommended
minimum age, the dose should be repeated on or after the date when the
child reaches at
least the minimum age. If the vaccine is a live vaccine, ensuring that a
minimum interval of 28 days has elapsed from the invalid dose is
recommended. 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. |
|
| 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, 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 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 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). |
|
| 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. |
|
|
|
|
|
| Do we have to check vital signs
before giving vaccines? |
|
| No. ACIP does not recommend routinely
checking a patient's temperature or other vital signs before
vaccination. Requiring these extra steps can be a barrier to
immunization. |
|
| 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]). |
|
| Should I vaccinate a child who has
recently been exposed to an infectious disease? What about a child who
is convalescing from illness? |
|
| Neither of these situations is a
contraindication or precaution to vaccination. |
|
| For which vaccines is an egg allergy
a contraindication? |
|
| 1) Yellow fever is contraindicated for
people who have a history of a severe (anaphylactic) allergy to eggs.
2) People who have experienced a serious systemic or anaphylactic
reaction (e.g., hives, swelling of the lips or tongue, acute respiratory
distress, or collapse) after eating eggs should consult a specialist for
appropriate evaluation to help determine if influenza vaccine should be
administered.
People who have documented immunoglobulin E (IgE)-mediated
hypersensitivity to eggs, including those who have had occupational
asthma or other allergic responses to egg protein, might also be at
increased risk for allergic reactions to influenza vaccine. Protocols
have been published for safely administering influenza vaccine to people
with egg allergies.
Some people who report allergy to egg might not be egg allergic. If a
person can eat lightly cooked eggs (e.g., scrambled eggs), they are
unlikely to have an egg allergy. However, people who can tolerate egg in
baked products (e.g., cake) might still have an egg allergy. If the
person develops hives only after ingesting eggs, CDC recommends (1) they
receive TIV (not LAIV), (2) the vaccine be administered by a healthcare
provider familiar with the potential manifestations of egg allergy, and
(3) the vaccine recipient be observed for at least 30 minutes after
receipt of the vaccine for signs of a reaction.
For more details about giving influenza vaccine to people with a history
of egg allergy, see
Prevention and Control of Influenza with Vaccines: Recommendations of
the Advisory Committee on Immunization Practices (ACIP)—United States,
2012–13. You may find the IAC handout "Influenza
Vaccination of People with a History of Egg Allergy" helpful.
NOTE: A new influenza vaccine [Flucelvax; Novartis] was licensed
in November 2012. It is produced using cultured animal cells, instead of
fertilized chicken eggs, and is approved to prevent seasonal influenza
in people age 18 years and older. Novartis plans to begin distribution
of this product in the 2013–14 influenza season. |
|
| Isn't egg allergy a contraindication
for MMR? |
|
| 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. |
| |
| 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. |
|
| 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. |
|
| Which vaccines are supplied in vials or
syringes containing latex? |
|
| 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. |
| |
| 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 ACIP's "General Recommendations on
Immunization"
www.immunize.org/askexperts/experts_inf.asp#contraindications
(pages 29-30). 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 can be given to
breastfeeding women? |
|
| All vaccines except smallpox can be given to breastfeeding women.
Breastfeeding is a precaution for yellow fever vaccine. Women who are
breastfeeding
should be advised to postpone travel to yellow fever endemic or epidemic
regions; however, if travel cannot be postponed, the woman should
receive yellow
fever vaccine. |
|
| 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. |
|
|
|
|
|
| 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. |
|
|
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. ACIP's 2011
General Recommendations on Immunization state: "Evidence does not
support use of antipyretics before or at the time of vaccination;
however, they can be used for the treatment of fever and local
discomfort that might occur following vaccination. Studies of children
with previous febrile seizures have not demonstrated antipyretics to
be effective in the prevention of febrile seizures." For more
information on this issue, see
www.cdc.gov/mmwr/pdf/rr/rr6002.pdf (page 16). |
|
| 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.
|
CDC has posted frequently asked
questions on this topic at
http://www.cdc.gov/vaccinesafety/Concerns/syncope_faqs.html. |
|
| 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.
|
If the wrong diluent is used, the vaccination will always need to be
repeated. If an inactivated vaccine is reconstituted with the wrong
diluent and is
administered, the dose is invalid and should be repeated ASAP. If a live
vaccine is reconstituted with the wrong diluent and is administered, the
dose is
invalid and if it can't be repeated on the same clinic day, it needs to
be repeated no earlier than four weeks after the invalid dose. This
spacing is due
to the effects of generating a partial immune response that could
suppress the live replication of subsequent doses, even of the same live
vaccine. |
|
| I know that it is advisable
to clean the vaccine vial stopper with an alcohol wipe after removing
the protective cap from a vaccine or diluent vial. Do you
have to wait for the alcohol to dry before you insert the needle in to
the stopper? |
|
| The stopper of a single-dose vial is often assumed to be sterile.
However, not all vaccine manufacturers guarantee the tops of unused
vials are sterile, and
the manner in which the cover over the stopper is removed can
potentially contaminate the stopper. Therefore, using friction and a
sterile alcohol pad to
swab the stopper may help to assure aseptic technique in preparing the
single-dose vial prior to inserting a sterile syringe. Alcohol
evaporates quickly and
will dry while the needle is being prepared for insertion into the vial. |
|
| In cleaning the vaccine vial stopper, is
it okay to use a non-sterile cotton ball or do we need to use a
pre-packaged sterile alcohol prep pad? |
|
| Using a pre-packaged sterile alcohol prep pad is recommended to maintain
aseptic technique. Not only are cotton balls not sterile, but neither is
a bottle of
sterile alcohol, once it's opened. |
|
| 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. If the reconstituted vaccine is not used within
the designated
time period, it must be discarded. A chart of the time allowed between
reconstitution and use, "Vaccines with Diluents: How to Use Them," is
available at
www.immunize.org/catg.d/p3040.pdf. For more information on prefilling
syringes, please read
www.immunize.org/technically-speaking/20110901.asp. |
|
| 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? |
|
| 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. CDC's Pink Book has a new chapter about vaccine storage and
handling at
www.cdc.gov/vaccines/pubs/pinkbook/downloads/vac-storage.pdf. |
|
| 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. There are
data that show that
aspiration is more painful for the vaccine recipient. 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. |
|
| When reconstituting a vaccine with the
manufacturer-supplied diluent, should the clinic nurse administer
exactly 0.5 mL and then discard the rest? |
|
| No. The nurse should administer the entire volume supplied. The package
inserts include this information. |
|
| 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. |
|
| A child wiggled when we were injecting a
dose of vaccine, and approximately half the dose was lost. Should we
revaccinate the child? If so, when? |
|
| When injectable vaccine volume is lost (patient moves, syringe leaks),
it may be difficult to judge how much vaccine the patient actually
received. In
general, you should treat this as a nonstandard injectable dose and
should not count it. If it was an inactivated vaccine, you should
re-immunize the person
as soon as possible. If it was a live vaccine, you can give another dose
if you detect the error on the same clinic day; otherwise you should
wait 28 days to
give the next dose. However, if part of a dose of an oral vaccine
(rotavirus) was spit out, count the dose and do not administer a second
dose. |
|
| 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 three exceptions: hepatitis B
or rabies
vaccine given by any route other than IM and HPV given by SC rather than
IM route 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.
|
*There are 3 NONROUTINE exceptions to the 'simultaneous' rule: a) If you
need to give *both* PCV13 and PPSV23 to a high-risk patient, these 2
vaccines should
not be given simultaneously. Give PCV13 first and then wait 8 weeks
before giving PPSV23. If PPSV has already been given, wait 8 weeks (for
a child) or 1
year (for an adult age 19+) before giving PCV13 to avoid interference between the 2 vaccines. b) When a child with anatomic or functional
asplenia needs
meningococcal vaccine, he should first be caught up with PCV13 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. c) Varicella and
smallpox vaccines
should not be given together, which is a situation that will almost
never come up anyway. |
|
| 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 three exceptions: hepatitis B
or rabies
vaccine given by any route other than IM and HPV given by SC rather than
IM route 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 we have to give multiple
injections, can we give two in the same limb? |
|
| If a patient requires more than one vaccine, ACIP and AAP consistently
recommend administering all needed vaccines during a single office visit
(unless there
are contraindications or precautions). If you have the option of giving
the vaccines in different anatomic sites, do so. If you need to give
multiple
injections in the same limb, separate two intramuscular injections by 1
inch or more in the body of the muscle, if possible, to reduce the
likelihood of
local reactions overlapping. Likewise, separate two subcutaneous
injections by 1 inch or more in the fatty tissue. |
|
| 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. |
|
| We run a student health center and are
wondering what the position is on discarding empty vaccine vials. Do
they need to go in a sharps container after they
are drawn up or can they go in the trash? |
|
| Empty or expired vaccine vials are
considered medical waste and should be disposed of according to state regulations. |
|
|
|
|
|
| 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. |
|
| Is it acceptable practice to administer
MMR, Tdap, and influenza vaccines to a postpartum mom at the same time
as administering RhoGam? |
|
| Yes. Receipt of RhoGam is not a reason to delay vaccination. See page 9
of CDC's General Recommendations on Immunization at
www.cdc.gov/mmwr/pdf/rr/rr6002.pdf. |
|
| 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 did not receive Tdap for their current
pregnancy,
regardless of their previous history, need a 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," pages 22-23. |
|
| Should vaccines be withheld for patients
on steroids? |
|
| Steroid treatment, and possible immunosuppression, is only a concern
with live vaccines. 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 vaccines (PCV13 and PPSV23), 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 (PPSV23) and for adults, 1 dose of
pneumococcal conjugate vaccine (PCV13), 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 8 weeks following PCV13 before
giving PPSV23.
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, PPSV23, 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. Here
are some helpful site maps for different ages so you can record where
shots were given:
http://eziz.org/assets/docs/IMM-718.pdf
https://kids.phila.gov/Docs/Imm_teen_site_map.pdf
http://www.eziz.org/assets/docs/IMM-718A.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),
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? |
|
| There is no national law requiring such documentation. Several major
medical organizations, including the American Academy of Pediatrics,
have stated 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, see
"Decision to not vaccinate my child" that can be accessed at
www.immunize.org/catg.d/p4059.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. |
|
|
|
|
|
| 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:
|
|
| 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? |
|
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. |
|
|
|
|
|
| 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 January 2013, 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. |
|
| Does the federal law that requires
providing patients with VISs apply when administering influenza vaccine
to employees and volunteers in hospitals or other workplaces? |
|
| Yes. Employees and volunteers are
considered patients, and you need to provide them with a VIS. 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.
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. |
|
| 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
website at
www.immunize.org/vis. |
|
| 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. |
|
| Can we start vaccinating on the basis of
a provisional ACIP recommendation? Or do we need to wait until the
recommendation is made final by publication in MMWR? |
|
| Consider a provisional recommendation as you would a final
recommendation. The basic recommendation will not change. Getting a
recommendation officially approved and published can be a lengthy process. It is more a matter of internal government procedures than
anything of significance to a practitioner. |
|
| If a new version of a VIS becomes
available, is it legal for us to use up the outdated VISs or do we have
to discard them and provide the most up-to-date version? |
|
| When a new or updated VIS is released, CDC posts information on its
website that indicates if healthcare providers can use up their stock of
the old version of the VIS or should discard the old version and begin
using the new VIS right away. The answer generally depends on how
significantly the VIS was changed. You can tell what has been changed
recently by going to the CDC website at
www.cdc.gov/vaccines/pubs/vis/vis-news.htm.
To determine whether you need to use the new one versus the old, you can
have CDC email you an update by subscribing to CDC's free email
subscription service at
www.cdc.gov/emailupdates. After you've signed
up, you'll be taken to a page with lots of options. Once there, check
the Vaccine Information Statements box under the section titled
"Vaccines & Immunizations." |
|
| 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 links to 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's Desk 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.
VAERS looks for trends, so such information is helpful. 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. |
|
|
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|
| 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.
|
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| • |
|
ACIP's "General
Recommendations on Immunization" To obtain a ready-to-print
(PDF) version, go to
www.cdc.gov/mmwr/PDF/rr/rr6002.pdf. |
|
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| • |
|
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. |
|
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| • |
|
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/index.html |
|
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|
| • |
|
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/index.htm. |
|
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|
| • |
|
"Ask the Experts"
To read IAC's collection of challenging questions answered by
CDC experts, go to
www.immunize.org/askexperts. |
|
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| • |
|
"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;
American Academy of Pediatrics;
Immunization
Action Coalition;
National Network for Immunization Information; and
Vaccine Education Center at Children's Hospital of Philadelphia. |
|
| 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 anti-tuberculous 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/index.html. |
|
| 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 (this link
didn't connect and Teresa couldn't find the info on the VFC website)
www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/06-module-2.pdf
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. |
|
| Reviewed on 1/13 |
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