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| Can combination vaccines be used with children
who have fallen behind with their vaccinations? If so, what schedule should we
follow? |
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| Combination vaccines can be used for
children who have fallen behind. In this case, the minimum intervals
between doses would be the greatest interval between any of the
individual antigens. For example, the minimum interval between Hib dose
#2 and Hib dose #3 is 4 weeks and the minimum interval between HepB dose
#2 and HepB dose #3 is 8 weeks. When the two antigens are combined, as
in Comvax, the minimum interval between Comvax dose #2 and Comvax dose
#3 would be 8 weeks, which is the greatest of the minimum intervals of
the two vaccines if given separately. Likewise, the minimum age for the
3rd dose of Comvax is the oldest minimum age of the two antigens (i.e.,
age 24 weeks). |
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| Can we switch back and forth from
monovalent vaccines at one visit to combination vaccines at another
visit? For example, if a child is given monovalent DTaP, IPV, Hib, and
Hep B during her 2-month visit, could we give her either DTaP-IPV/Hib
(Pentacel) or DTaP-HepB-IPV (Pediarix) at her 4-month visit? |
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| Switching between combination and
single-antigen vaccines poses no problem as long as you maintain the
recommended minimum intervals for all vaccines. |
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| How should we record combination
vaccines on paper records (e.g., parent-maintained records,
non-computerized office systems)? |
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| You should record the generic abbreviation
for the type of vaccine given (e.g., DTaP-IPV-HepB) in each of the
sections that correspond to the separate antigens listed on the record
(e.g., DTaP section, polio section, hepatitis B section). If possible,
avoid using trade names (who remembers which antigens were in Acel-Imune?). |
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| Why does the nomenclature for
combination vaccines contain either hyphens or, sometimes, a forward
slash? |
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| The hyphen (-) is intended to indicate
that the antigens are mixed together by the manufacturer before the
product is sold and the forward slash (/) indicates that the two
products are to be reconstituted by the user. |
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| How can we obtain a VIS for
combination vaccines? |
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| With some exceptions, there aren't VISs
for combination vaccines. Instead, providers should provide a separate
VIS for each vaccine component in the combination (e.g., HepB-Hib, or
DTaP-IPV-HepB). The exceptions are for DTaP, Tdap, Td, and MMR vaccines,
which all have a VIS that covers all separate components of the vaccine,
and a combined VIS that can substitute for any or all of the routine
vaccines given from birth-6 months (DTaP, IPV, Hib, PCV, hepatitis B,
and rotavirus vaccines). |
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| DTaP-IPV-HepB (Pediarix by GlaxoSmithKline) |
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| What is the dosing schedule for the
DTaP-IPV-HepB combination vaccine (Pediarix by GSK)? |
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| Pediarix contains the vaccine components
DTaP, IPV, and hepatitis B. The primary series is 3 doses (0.5 mL) given
intramuscularly at 2, 4, and 6 months of age. It should not be given to
infants younger than 6 weeks of age nor to children 7 years or older. |
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| Can Pediarix be given to infants born
to mothers who are HBsAg-positive? |
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| Yes, although the package inserts states
that Pediarix should only be given to infants born to mothers who are
HBsAg-negative, the ACIP voted on February 26, 2003, to expand its
recommendations for use to also include infants born to mothers whose
HBsAg status is positive or unknown beginning no earlier than age 6
weeks. In expanding the use of Pediarix beyond FDA-prescribing
information, ACIP remained consistent with its 1997 vote, which
permitted the use of Comvax (Merck's Hib-hepatitis B combination
vaccine) to complete the hepatitis B vaccine series in infants born to
HBsAg-positive mothers and mothers whose HBsAg status is unknown. |
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| Can Pediarix be used in infants and
children who have fallen behind? |
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| Yes. As with any combination vaccine, it
may be used when any of the components are indicated and none are
contraindicated. Providers must observe spacing intervals such that the
minimum interval between doses is equal to the greatest interval of any of
the individual antigens. The vaccine may only be used in children younger
than age 7 years. |
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| Our nurses have been routinely giving
DTaP-HepB-IPV (Pediarix; GSK) to toddlers who were overdue for their
third doses of DTaP, IPV, and HepB. Recently someone told me that
Pediarix is only intended for use at 2, 4, and 6 months of age. Did we
err? |
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| No, you did not err. Pediarix is
licensed for use in children ages 6 weeks through 6 years for doses 1,
2, and 3 of the DTaP primary series. This would not constitute a vaccine
error, as long as you observe the recommended minimum intervals for all
the vaccine components (i.e., DTaP, IPV, and HepB). |
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| We have been giving DTaP-HepB-IPV
(Pediarix) to children who are overdue for DTaP #4, IPV #3, and HepB #3.
Is this an acceptable practice? |
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| No. Pediarix is intended to be used only
for doses 1, 2, or 3 of the DTaP primary series; consequently using
Pediarix for DTaP #4 is off-label and not recommended. You should take
measures to prevent this error in the future. The DTaP, IPV, and HepB
doses given in this scenario do not need to be repeated as long as you
met the recommended minimum intervals for each vaccine component (DTaP,
IPV, HepB). If you did meet the minimum intervals, the doses should be
counted as valid. |
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| Please describe the new combination
vaccine Pentacel and how it should be used. |
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| FDA licensed Pentacel on June 20, 2008. It is
approved for use as a 4-dose series in infants and children at ages 2, 4, 6, and
15-18 months. It should not be used for any dose in the primary series for
children age 5 years or older or as the booster dose for children ages 4-6
years. The DTaP-IPV component is supplied as a sterile liquid, which is used to
reconstitute lyophilized (freeze-dried) ActHIB vaccine. The two components of
the vaccine should be stored together in the carton to reduce vaccine
administration errors. The DTaP-IPV component should never be administered
alone. |
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| Can we give Pentacel to a child who has
previously received separate injections of one or more of these antigens? |
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| Yes, as long as minimum intervals are
maintained. |
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| We inadvertently gave a child only the DTaP-IPV
component of Pentacel (DTaP-IPV/Hib; sanofi pasteur), not realizing that this
component was intended to reconstitute the Hib component. Does this count as a
valid dose of DTaP and IPV? Can we mix the unused Hib component with sterile
water and give it separately? |
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| Use of DTaP-IPV solution as the diluent
for the Hib component is specifically written both on the Pentacel box
AND on the DTaP-IPV vial label. In answer to your first question, the
DTaP-IPV component will count as valid doses of DTaP and IPV vaccines,
but take measures to prevent this error in the future. In answer to your
second question, NO, you cannot mix the Hib component with sterile
water. ActHib must ONLY be reconstituted with either the DTaP-IPV
solution supplied with Pentacel, or with a specific ActHib diluent. If
you have ActHib but neither diluent, you must contact the manufacturer
(sanofi pasteur) and obtain ActHib diluent. |
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| Can we give Pentacel if we don't know the type of
DTaP vaccine the child previously received? |
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| Yes. CDC recommends that whenever
feasible, only one manufacturer's DTaP product be used for the entire
pertussis series, but that vaccinations should not be deferred if the
DTaP product previously given is unavailable or unknown. |
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| When we give the combination DTaP-IPV/Hib vaccine (Pentacel by sanofi) for the primary series to a child at ages 2, 4, 6, and 15–18 months, the child receives a total of 4 doses of IPV. Does the child still need a booster dose of IPV before entering kindergarten? |
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| Yes. In summer 2009, ACIP updated its recommendations for use of inactivated poliovirus vaccines (IPV), partly in response to the availability of newer combination vaccines (e.g., Pentacel) that include an IPV component. ACIP now recommends that children receive at least 1 dose of IPV at age 4 through 6 years, even if they have previously received 4 doses. The interval between the next-to-last and last dose should be at least 6 months. (Note: This updated recommendation applies to all IPV-containing vaccines, including combination vaccines as well as IPV given as a single product.) This means that some children may receive a total of 5 doses, a practice ACIP considers acceptable. This is similar to the recommendation for the last dose in the DTaP series. To view the updated polio vaccine recommendations, go to www.cdc.gov/mmwr/preview/mmwrhtml/mm5830a3.htm. |
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| Can Kinrix (DTaP-IPV; GSK) be used at
kindergarten entry if the previous brand of DTaP is unknown? |
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| Yes. Though it is preferable to use the
same manufacturer's DTaP vaccine for all of the doses in the series, you
can give Kinrix as the fifth dose of DTaP and fourth dose of IPV at age 4
through 6 years if the previous brand is unknown or if Kinrix is the only
product stocked. |
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| We mistakenly gave Kinrix (DTaP-IPV) to
a child age 3 years 10 months. We later realized that he had a prior
history of receiving 4 doses of DTaP and IPV. Can the dose of Kinrix count
as his 4 through 6 year booster? |
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Use of the vaccine in a child
younger than age 4 is off-label and is not recommended. You should take
measures to prevent this error in the future. The minimum age for the
fifth dose of the DTaP series is 4 years, and the minimum age for the
final dose of IPV is also 4 years, so this dose of Kinrix is not valid.
For detailed information, see CDC's useful table "Recommended and Minimum
Ages and Intervals Between Doses of Routinely Recommended Vaccines" at
www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf. |
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| If Kinrix is inadvertently given to a
child age 15 through 18 months, as the fourth DTaP dose and the third IPV
dose, does the Kinrix dose have to be repeated? |
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| Since Kinrix is licensed and recommended
only for children ages 4 through 6 years, you should take measures to
prevent this error in the future. However, you can count this as a valid
dose for DTaP and IPV as long as you met the minimum interval between
administering dose #3 and dose #4 of DTaP (6 months) and dose #2 and dose
#3 of IPV (4 weeks). |
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| Please tell us about the combination
vaccine Kinrix and the recommendations for its use. |
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| On June 24, 2008, FDA licensed Kinrix, a
combination DTaP and IPV vaccine. It is approved for use as the fifth dose
of DTaP and the fourth dose of IPV in children ages 4 through 6 years who
received DTaP (Infanrix) and/or DTaP-HepB-IPV (Pediarix) as the first
three doses and DTaP (Infanrix) as the fourth dose. It should not be given
to children younger than age 4 years. |
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| If an 8-year-old child who needed IPV
and Td vaccines was mistakenly given a dose of DTaP-IPV (Kinrix; GSK),
will that count as a valid dose of polio and Td vaccine? |
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| Kinrix is licensed and recommended only
for use in children ages 4 through 6 years, so you should take measures to
prevent this error in the future. However, you can count the IPV dose as
valid as long as it has met the minimum interval (4 weeks between doses
except for the final dose in the series, which should be 6 months from the
previous dose). With regard to the mistaken administration of the DTaP in
a child older than age 6 years, the dose can be counted and does not need
to be repeated with Td. |
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| I would like more information about
Twinrix, the combination hepatitis A and B vaccine. |
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| Twinrix (GlaxoSmithKline) is an inactivated
combination vaccine containing both hepatitis A virus
(HAV) and HBV antigens. The vaccine contains 720 EL.U. of hepatitis A antigen
(half of the Havrix
adult dose) and 20µg of hepatitis B antigen (the full Engerix-B adult dose). In
the U.S., Twinrix
is licensed for use in people who are age 18 years or older. It can be
administered to people who
are at risk for both hepatitis A and hepatitis B, such as certain international
travelers, men who
have sex with men, illegal drug users, or to people who simply want to be
immune to both diseases.
Primary immunization consists of 3 doses given intramuscularly on a 0, 1, and 6
month schedule. Twinrix cannot be
used for postexposure
prophylaxis. |
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| We heard that there is an alternative schedule
for the adult HepA-HepB (Twinrix; GSK) vaccine that gives the patient protection
sooner than the standard schedule does. Can you tell us more? |
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| Yes. Licensed for use in people age 18
and older, the combined HepA-HepB vaccine is normally given as a 3-dose
series at intervals of 0, 1, and 6 months. However, if someone needs
protection sooner (e.g., imminent foreign travel), you can give it as a
4-dose series at intervals of 0, 7, and 21-30 days, followed by a dose
at 12 months. |
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| I have seen adults who have had 1 or 2 doses of
Twinrix, but we only carry single-antigen vaccine in our practice. How should we
complete their vaccination series with single-antigen vaccines? |
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Twinrix is licensed as a 3-dose series
for people age 18 years and older. If Twinrix is not available or if
you choose not to use Twinrix to complete the Twinrix series, you should
do the following: If 1 dose of Twinrix was given, complete the series
with 2 adult doses of hepatitis B vaccine and 2 adult doses of hepatitis
A vaccine. If 2 doses of Twinrix were given, complete the schedule with
1 adult dose of hepatitis A vaccine and 1 adult dose of hepatitis B
vaccine.
Another way to consider this is as
follows:
A dose of Twinrix contains a standard adult dose of hepatitis B vaccine
and a pediatric dose of
hepatitis A vaccine. Thus, a dose of Twinrix can be substituted for any
dose of the hepatitis B
series but not for any dose of the hepatitis A series.
| • |
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Any combination of 3 doses of adult
hepatitis B or 3 doses of Twinrix = a complete series of hepatitis B
vaccine |
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One dose of Twinrix
+ 2 doses of adult hepatitis A = a complete series of
hepatitis A vaccine |
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Two doses of Twinrix + 1
dose of adult hepatitis A = a complete series of
hepatitis A vaccine |
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| We're thinking of using Twinrix and we're
wondering whether we can use it for doses #1 and #3 only and use single antigen
hepatitis B vaccine for dose #2? |
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| No. Twinrix contains 50% less hepatitis
A antigen component than Havrix, GSK's monovalent hepatitis A vaccine
[720 vs. 1440 El. U.], so the patient would not receive the recommended
dose of hepatitis A vaccine antigen. For this reason, 3 doses of Twinrix
must comprise the series. |
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| A 4-month-old needs both Hib and
hepatitis B vaccines today. Can I use Comvax even if the child has not
previously received this combination product? |
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| Yes. Comvax can be used when either or
both antigens are indicated and neither antigen is contraindicated.
Comvax would not be used after the fifth birthday because Hib vaccine is
not routinely recommended beyond this age. Comvax should also not be
used in infants less than 6 weeks of age. |
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| How should the combined MMR and
varicella vaccine (ProQuad) be used? |
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ProQuad was licensed in September
2005 for use in children ages 12 months through 12 years. It combines the
MMR and varicella vaccines and therefore can be used in place of the
individual MMR and varicella vaccines given at ages 12-15 months and 4-6
years. For more information, consult the package insert at
www.fda.gov/cber/label/mmrvmer090605LB.pdf |
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| Please review the specifics of the
latest CDC recommendations for the use of the combination measles, mumps,
rubella, and varicella (MMRV) vaccine. |
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| On May 7, 2010, CDC issued new
recommendations for the use of combination MMRV vaccine. Prior to issuing
these
recommendations, ACIP reviewed results of post-licensure studies that
suggest that, during the 5-12 day post-vaccination
period, approximately one additional febrile seizure occurred among every
2,600 children ages 12 through 23 months vaccinated
with a first dose of MMRV vaccine compared with children in the same age
group vaccinated with separate first doses of MMR
vaccine and varicella vaccine administered during a single office visit. |
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The summary of the recommendations for use
of MMRV vaccine are as follows:
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The routinely
recommended ages for measles, mumps, rubella, and varicella
vaccination continue to be age 12 through 15 months for the first
dose and age 4 through 6 years for the second dose. |
| • |
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For the first dose of
measles, mumps, rubella, and varicella vaccines at age 12 through
47 months, providers may use either measles, mumps, and rubella
(MMR) vaccine and varicella vaccine or MMRV vaccine. Providers who
are considering administering MMRV vaccine should discuss the
benefits and risks of both vaccination options with the parents or
caregivers. Unless the parent or caregiver expresses a preference
for MMRV vaccine, CDC recommends that providers administer MMR
vaccine and varicella vaccine for the first dose in this age
group. |
| • |
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For the second dose of measles,
mumps, rubella, and varicella vaccines at any age (15 months
through 12 years) and for the first dose at age 48 months and
older, use of MMRV vaccine generally is preferred over separate
injections of its equivalent component vaccines (i.e., MMR vaccine
and varicella vaccine). |
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A personal or family (i.e.,
sibling or parent) history of seizures of any etiology (i.e.,
cause) is a precaution for MMRV vaccination, and such children
generally should be vaccinated with MMR vaccine and varicella
vaccine. |
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The complete recommendations for the use of
MMRV vaccine are available on CDC's website at
http://www.cdc.gov/mmwr/pdf/rr/rr5903.pdf |
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| In addition, CDC has issued a new VIS for
MMRV, dated 5/21/10, which is available at
http://www.immunize.org/vis and
http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-mmrv.pdf As with
all other VISs, it should be given to the parent or vaccine recipient
prior to vaccination to facilitate discussion about the vaccine between
the patient and provider. |
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| If we don't have the combination MMRV
vaccine in stock, can I make my own by mixing MMR and Varivax in the same
syringe? |
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| Absolutely not. Vaccines should never be
mixed except when specifically approved by FDA and packaged for that
specific purpose. |
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| Reviewed on 4/11 |
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