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Updated
ACIP General Recommendations on Immunization
Summary of Major Changes
·
No vaccination schedules
·
4- day "grace period"
for timing and spacing of vaccines
·
Guidance for non-simultaneous
administration of live vaccines
·
Guidance for non-standard route
or site of administration
·
Vaccination of internationally
adopted children
·
Aspiration before injection
·
Management of preterm infants
whose mothers' HBsAg status is unknown
No Vaccination Schedules
Unlike previous
versions of the General Recommendations, this revision does not
include vaccination schedules. Beginning in 1995, the Recommended Childhood
Immunization Schedule has been published annually by Advisory Committee on
Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and
the American Academy of Family Physicians (AAFP). The 2002 schedule is
available on the National Immunization Program website at http://www.cdc.gov/nip/recs/child-schedule.htm
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4-Day Grace Period for Timing and
Spacing of Vaccines
Since 1994, ACIP has
recommended that doses of vaccine separated by less than the recommended
minimum interval should not be considered part of a primary series. ACIP
continues to recommend that vaccine doses should not be given at intervals
less than the minimum intervals or earlier than the minimum age. An extensive
listing of recommended and minimum interval and ages for vaccination is
included in the document. In an effort to increase the flexibility of the
complicated childhood immunization schedule, ACIP now recommends that vaccine
doses administered up to four 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.
This 4-day "grace
period" should NOT be used when scheduling future vaccination visits. It
should be used primarily when reviewing vaccination records. The 4-day
"grace period" may also be useful in situations where a child
visits a provider a few days earlier than a scheduled vaccination
appointment. For example, if a child comes to the office or clinic for an ear
check 27 days after his or her second DTaP dose, the provider could
administer the third DTaP at that visit rather than having the child return
for vaccination the next day.
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Non-Simultaneous Administration of
Live Vaccines
Since 1983, ACIP has
recommended that whenever possible, live-virus vaccines not administered on
the same day should be administered at least 30 days apart, because of
concern that the vaccine given first could interfere with response to the
vaccine given second. These concerns were based on two 1965 studies that
indicated thet recent measles vaccination reduced the response to smallpox
vaccine. A study recently published in Morbidity and Mortality Weekly Report
(MMWR 2001;50:1058-61) found that children who received varicella vaccine
less than 30 days after MMR vaccination had a 2.5-fold increased risk of
breakthrough varicella (i.e., varicella disease in a vaccinated person)
compared with those who received varicella vaccine before, simultaneous with,
or more than 30 days after MMR.
Until now, ACIP has not
provided guidance on the course of action if two live-virus vaccines were
given less than 30 days apart. In the revised General Recommendations,
ACIP recommends that if two live parenteral vaccines are given less than 28
days apart, the vaccine given second should not be counted as valid and
should be repeated at least 4 weeks later. One exception to this
recommendation is that yellow fever vaccine may be given at any time after
measles vaccine.
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Non-Standard Route or Site of
Administration
In the 1994 revision of
the General Recommendations, ACIP recommended that any vaccination
using less than a standard dose or a nonstandard route or site of
administration should not be counted, and the person should be revaccinated
according to age. This recommendation was intended to discourage
inappropriate vaccination practices, such as administration of half doses (a
practice mostly associated with whole cell DTP vaccine), or inappropriate
routes of vaccination (particularly the gluteus). This recommendation also
led to repetition of some vaccine doses given by routes other than those
recommended by the manufacturer, but whose route of administration probably
had no significant effect on immunogenicity (for example, administration of
MMR by the intramuscular route rather than the recommended subcutaneous
route). In the revised General Recommendations, ACIP continues to
strongly discourage variation from the recommended route, site, or dose of
any vaccine. However, ACIP now recommends repeating doses only in cases where
a reduction in immunogenicity has been demonstrated: rabies and hepatitis B
vaccines administered in the gluteus, and hepatitis B vaccine administered by
any route other than intramuscular injection (i.e., intradermal or
subcutaneous injection).
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Vaccination of Internationally
Adopted Children
Since 1994, ACIP has
recommended that vaccines administered outside the United States could be
accepted as valid if they were documented by a written, dated record. There
is conflicting information regarding the accuracy of vaccination records for
internationally adopted children, particularly those adopted from orphanages
in China, Russia, and other eastern European countries, and it is difficult
to determine if a child is protected on the basis of their country of origin
and their records alone. ACIP continues to recommend that vaccines received
outside the United States can usually be accepted if there is written, dated
documentation and the age, spacing and timing is comparable with that
recommended in the United States. But it is especially important for the
provider to carefully review the records of children adopted from orphanages,
due to potential issues of authenticity. If there is any doubt about the
validity of a vaccination record (for instance, doses dated before the
child's birth or a record of receiving MMR or Hib vaccine, which are not commonly
used in less developed countries), age-appropriate revaccination is generally
recommended. Serologic testing may be considered if the parent or provider
does not wish to repeat all doses, particularly for DTaP if three or more
doses are documented. The General Recommendations provides guidance on
selection and interpretation of these serologic tests.
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Aspiration Before Injection
Previous versions of
the General Recommendations have recommended aspiration (i.e., gently
pulling back on the plunger to check for blood before injection) prior to
injection, particularly before intramuscular injection. No data exist to
document the necessity of this procedure. The 2002 General Recommendations
on Immunization does not recommend aspiration before injection.
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Management of Preterm Infants
Whose Mothers' HBsAg Status is Unknown
Neither the current
ACIP statement nor the 2002 schedule addresses hepatitis B post-exposure
management of preterm (<2 kg) infants whose mothers' HBsAg status is
unknown.
The revised General
Recommendations recommends that preterm infants whose mothers are HBsAg
positive OR whose HBsAg status is unknown should be given both hepatitis B
vaccine and HBIG within 12 hours of birth. For all preterm infants, the
birth dose of hepatitis B vaccine should not be counted, and the infant
should receive 3 additional doses at 1, 2, and 6 months of age.
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