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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 |
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| 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. 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 persons 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). Persons 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.?
|
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| 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 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. |
|
| 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 "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 |
|
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?" (www.immunize.org/catg.d/p4036.pdf), "If You Have
HIV Infection, Which Vaccinations Do You Need?" (www.immunize.org/catg.d/p4041.pdf), "If You Have Hepatitis
C, Which Vaccinations Do You Need?" (www.immunize.org/catg.d/p4042.pdf), "Should You Be Vaccinated
Against Hepatitis B? A screening questionnaire for adults" (www.immunize.org/catg.d/p2191.pdf), and "Should
You Be Vaccinated for Hepatitis A? A screening questionnaire for adults" (www.immunize.org/catg.d/2190hepa.pdf).
In addition to these printed pieces, there are several interactive tools on CDC's website. For children, go
to
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. |
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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
www.cdc.gov/nip/recs/child-schedule.htm#catchup |
|
| 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 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. |
|
| 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/mmwr/PDF/rr/rr5515.pdf |
|
| 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 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. |
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| 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. |
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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
here. |
|
| 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 statement for that vaccine. In addition, an extensive listing of recommended and minimum
intervals
and ages for vaccination can be found in Table 1 of the ACIP's "General Recommendations on
Immunization" (see
www.cdc.gov/vaccines/pubs/ACIP-list.htm). |
|
| 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 doses of MMR and IPV were separated from the previous ones by at least
4 weeks, they can be counted as the second MMR and fourth IPV. No additional doses are
indicated. (Exception: some states require a dose of polio vaccine on or after the fourth birthday for school entry. 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. |
|
| 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. |
|
| 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? |
|
| Some vaccine vial stoppers are made with natural rubber, which may contain latex as well as other
impurities from the original latex material. Latex and other impurities may therefore be present in very small quantities
in the vaccine, or on the needle as it passes through the stopper. Persons 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. Persons 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? |
|
| The most common type of latex sensitivity is contact-type allergy, such as with persons who have
prolonged contact with latex-containing gloves. Some syringes plungers and vial stoppers are made with natural
rubber, which may contain latex as well as other impurities from the original latex material. Latex and other
impurities may therefore be present in very small quantities in the vaccine, or on the needle as it passes through
the
stopper. Although rare, persons 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. Persons with latex allergies that are not anaphylactic may be vaccinated
as usual. |
|
| 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 or in the needle cover. 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 Guide to Vaccine
Contraindications and Precautions at
www.cdc.gov/vaccines/recs/vac-admin/downloads/contraindications-guide-508.pdf. |
|
| If we have a patient who has 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 persons 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"
(www.cdc.gov/vaccines/pubs/acip-list.htm). Intramuscular (IM) injections should be scheduled shortly after antihemophilia therapy
or just 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). |
|
| I need both Tdap and MMR vaccines but
my doctor won't give them to me unless I stop breastfeeding. Is this
really necessary? |
|
| No. 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/standingorders |
|
| 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. |
|
| 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" at
www.immunize.org/catg.d/p3082a.pdf and "Medical Management of Vaccine
Reactions in Adult Patients"
at
www.immunize.org/catg.d/p3082.pdf]
|
Since 2005, VAERS has received an
increased number of reports of syncope. 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 52% of fainting episodes
occurred within 5 minutes of
vaccination and 70% occurred within 15 minutes. Vaccine providers should
strongly consider
observing vaccinated people for 15 minutes after vaccination, in
accordance with ACIP General
Recommendations (see
www.cdc.gov/mmwr/PDF/rr/rr5515.pdf). 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. |
|
| 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 needlestick 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 must be administered within 8 hours. |
|
| When you inject a vaccine, why is it not necessary to aspirate? |
|
| 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, 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"
(www.cdc.gov/vaccines/pubs/acip-list.htm). |
|
|
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. Using
larger than recommended dosages can be hazardous because of excessive
local or systemic concentrations of antigens or other
vaccine constituents.
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. 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. |
|
| 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 one exception: hepatitis B 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 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" (www.cdc.gov/vaccines/pubs/acip-list.htm). |
|
|
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" (www.cdc.gov/vaccines/pubs/acip-list.htm). |
|
|
|
|
|
| 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 (through
April); (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. |
| |
| Do persons 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
persons 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 (HSCT)? |
|
Antibody titers to vaccine-preventable diseases decline during the 1–4 years after HSCT, if the recipient is
not revaccinated. HSCT recipients are at increased risk for certain vaccine-preventable diseases, including
those caused by encapsulated bacteria. In short, all HSCT recipients should begin revaccination with
inactivated vaccines 12 months after HSCT, except inactivated influenza vaccine which should begin at least 6
months following the transplant and annually thereafter. PPV should be administered at 12 and 24 months after
HSCT, and 2 doses of PCV (with 8 weeks between doses) can be considered, especially for children younger than
age 60 months. A 3-dose series of Hib vaccine should also be given at 12, 14, and 24 months
following
transplantation for persons of any age. Immunocompetent persons 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" (www.cdc.gov/vaccines/pubs/acip-list.htm). |
|
| 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. |
|
| With what frequency should splenectomized patients receive Hib, pneumococcal,
and meningococcal vaccines? |
|
| Persons with anatomic or functional asplenia (including sickle cell disease) are at increased risk of
infection with encapsulated bacteria, especially with
S. pneumoniae (pneumococcus), N.
meningitidis (meningococcus), and Hib. If unvaccinated, these persons should receive age-appropriate Hib, pneumococcal, and
meningococcal vaccines. Although Hib vaccine is not routinely recommended for persons 5 years of age and older,
studies suggest good immunogenicity in patients who have sickle cell disease or have had splenectomies.
Therefore, healthcare providers may choose to administer Hib vaccine to older children and adults with chronic
conditions associated with an increased risk for Hib disease. |
|
| 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, 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 PCV7: 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 persons 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, 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" at
www.cdc.gov/mmwr/PDF/rr/rr5515.pdf |
|
| 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" (www.cdc.gov/vaccines/pubs/acip-list.htm). |
| |
| 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.cispimmunize.org/pro/pdf/RefusaltoVaccinate_revised%204-11-06.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 health care 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). |
|
| 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 manufacturer or state/local
health department 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, 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 standard fluid-filled, minimum-maximum, or continuous chart recorder
thermometer. 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" (www.cdc.gov/vaccines/pubs/acip-list.htm) and on the CDC website at
www2a.cdc.gov/vaccines/ed/shtoolkit/pages/storage_equipment.htm#Thermometers |
|
| 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 www.cdc.gov/nip/vfc/st_immz_proj/faqs_storage-h.htm#4.
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
www2a.cdc.gov/vaccines/ed/shtoolkit. 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
https://www2a.cdc.gov/nchstp_od/PIWeb/niporderform.asp |
|
| 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, 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 visibly 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 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.vaccineinformation.org/concern.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 (www.cispimmunize.org), the CDC (www.cdc.gov/vaccinesafety), Every Child
by Two (www.ecbt.org), Immunization Action Coalition (www.immunize.org/safety), the National Network
for Immunization Information (www.immunizationinfo.org/vaccine_safety_issues.cfm), the Institute of
Medicine (www.iom.edu/?id=4705&redirect=0), and the Vaccine Education Center, Children's Hospital of
Philadelphia (www.chop.edu/consumer/jsp/division/generic.jsp?id=75694). |
|
|
|
|
|
| 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 April 2008, 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
(www.immunize.org/coordinators).
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 persons 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
persons, 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 persons 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 30 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 |
|
| 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 30 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's Desk Reference. |
|
| 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 video "Immunization Techniques: Safe, Effective, Caring."
You can order this from IAC or from the California Distance Learning Health Network
(http://cdlhn.com/default.htm). 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/shop/toolkit_iztechdvd.asp |
|
| 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 (www.immunize.org/coordinators). |
|
| 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 |
|
| 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.cispimmunize.org; Immunization Action Coalition
at www.immunize.org/free; 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/vpd-vac/default.htm#shortages |
|
|
|
|
|
| Where can I find information about
vaccine shortages and delays? |
|
| Visit CDC's website at
www.cdc.gov/vaccines/vac-gen/shortages/default.htm |
|
| 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 using authorized and signed standing orders. In these situations, the 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.elsevier.com or call (800) 545-2522. |
|
| 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 persons using a Mantoux (PPD) skin test, 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 (www.immunize.org/coordinators). 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/faq-elig.htm 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 6/09 |
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