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IAC Express 2007 |
| Issue number 702: December 10, 2007 |
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Contents
of this Issue
Select a title to jump to the article. |
- CDC
issues interim recommendations for the use of Hib vaccines in light of the
recall of certain lots of PedvaxHIB and Comvax
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| Abbreviations |
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AAFP, American Academy of Family Physicians; AAP,
American Academy of Pediatrics; ACIP, Advisory Committee on Immunization
Practices; AMA, American Medical Association; CDC, Centers for Disease
Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization
Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NCIRD,
National Center for Immunization and Respiratory Diseases; NIVS, National
Influenza Vaccine Summit; VIS, Vaccine Information Statement; VPD,
vaccine-preventable disease; WHO, World Health Organization. |
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Issue 702: December 10, 2007 |
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1. |
CDC issues interim
recommendations for the use of Hib vaccines in light of the recall of certain
lots of PedvaxHIB and Comvax
CDC published "Interim
Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate
Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedvaxHIB
and Comvax)" in the December 19 issue of MMWR Dispatch. CDC publishes the
web-based MMWR Dispatch only for the immediate release of important public
health information. The article will be published in a print issue of MMWR in
the future.
The December 19 MMWR Dispatch is reprinted below in its entirety, excluding
references.
On December 13, 2007, Merck & Co., Inc. (West Point, Pennsylvania)
announced a voluntary recall of certain lots of two Haemophilus
influenzae type b (Hib) conjugate vaccines, PedvaxHIB (monovalent
Hib vaccine) and Comvax (Hib/hepatitis B vaccine). Providers should
return unused vaccine from these recalled lots using procedures
outlined on the Merck website at
http://www.merckvaccines.com/PCHRecall.pdf
Additional information
regarding the affected lots is available online from the Food and
Drug Administration (FDA) at
http://www.fda.gov/consumer/updates/hib121307.html Merck has
suspended production of its Hib conjugate vaccines and does not
expect to resume distribution of these vaccines until the fourth
quarter of 2008. The recall of PedvaxHIB and Comvax and suspension
of production are expected to result in short-term disruption to
the Hib vaccine supply in the United States.
Merck issued this voluntary recall as a precautionary measure
because the company cannot assure the sterility of equipment used
during manufacture of these lots. However, the potency of the
vaccine in the recalled lots was not affected, and Merck reported
that no contamination of vaccine has been detected. Therefore,
children who received Hib conjugate vaccine from the recalled lots
do not need revaccination or any special follow-up.
Two other Hib conjugate vaccines manufactured by sanofi pasteur
(Swiftwater, Pennsylvania) and currently licensed and available for
use in the United States, ActHIB (monovalent Hib vaccine) and
TriHIBit (diphtheria and tetanus toxoids and acellular pertussis
[DTaP]/Hib vaccine), are unaffected by the recall. However, sanofi
pasteur likely will not be able to immediately provide adequate Hib
vaccine to vaccinate fully all children for whom the vaccine is
recommended.
The recommended vaccination schedule for all available Hib-containing vaccines consists of a primary series (consisting of 2
or 3 doses, depending on the formulation) administered beginning at
age 2 months and a booster dose at age 12-15 months. Because of the
short-term reduction in available doses of Hib-containing vaccines,
CDC, in consultation with the Advisory Committee on Immunization
Practices (ACIP), the American Academy of Family Physicians, and
the American Academy of Pediatrics, recommends that providers
temporarily defer administering the routine Hib vaccine booster
dose administered at age 12-15 months except to children in
specific groups at high risk, which are described in this report.
Providers should register and track children for whom the booster
dose is deferred to facilitate recalling them for vaccination when
supply improves.
Sustained high levels of coverage with Hib conjugate vaccine have
resulted in a substantial decline in the incidence of Hib disease
in the United States. In 2006, the incidence of Hib disease in
children aged <5 years was 0.21 per 100,000, representing a greater
than 99% reduction in disease compared with incidence in the
prevaccine era. Population immunity is a result of direct
protection of children by vaccination with Hib vaccine and herd
immunity resulting from prevention of nasopharyngeal carriage and
interruption of Hib transmission. Short-term deferral of the
booster dose among children aged 12-15 months is not likely to
result in an increased risk for Hib disease because of continued
protection of children with the primary series and the low level of
nasopharyngeal carriage and transmission achieved in the United
States by the Hib immunization program.
The vaccines affected by the recall, PedvaxHIB and Comvax, contain
Hib capsular polysaccharide (i.e., polyribosylribitol phosphate
[PRP]) covalently linked to a meningococcal outer membrane protein
(OMP) carrier. The two unaffected vaccines, ActHIB and TriHIBit,
are PRP-tetanus toxoid (PRP-TT) conjugate Hib vaccines. PedvaxHIB
and Comvax are recommended as a 2-dose primary series (at ages 2
and 4 months), whereas ActHIB is recommended as a 3-dose primary
series (at ages 2, 4, and 6 months). ActHIB and PedvaxHIB also are
licensed for the 12-15 month booster dose. TriHIBit is licensed
only for the 12-15 month booster dose. Children who are not at
increased risk for Hib disease, as described in this report, and
who received PRP-OMP vaccines for only the first or second dose of
their routine primary series may be administered PRP-TT to complete
the primary series. In these children, a total of 3 doses will
complete the primary series. Children who are behind schedule
should complete the primary series according to age-appropriate
recommendations.
Certain children are at increased risk for Hib disease, including
children with asplenia, sickle cell disease, human immunodeficiency
virus infection and certain other immunodeficiency syndromes, and
malignant neoplasms. CDC recommends that providers continue to
vaccinate these children with available Hib conjugate vaccines
according to the routinely recommended schedules, including the
12-15 month booster dose. PedvaxHIB (if available), ActHIB, and
TriHIBit may be used for the booster doses for these children
during this shortage. Hib vaccines also are recommended for use in
prophylaxis for susceptible close contacts of patients with Hib
disease. CDC recommends that providers continue to vaccinate close
contacts according to published guidelines.
American Indian/Alaska Native (AI/AN) children also are at
increased risk for Hib disease, particularly in the first 6 months
of life. Before the use of Hib conjugate vaccines, the incidence of
Hib disease among young AI/AN children in AI/AN communities was
approximately 10 times higher than among children of comparable age
in the general population. Compared with PRP-TT conjugate vaccines,
the administration of PRP-OMP vaccines leads to a more rapid
seroconversion to protective antibody concentrations within the
first 6 months of life. Failure to use PRP-OMP vaccines for the
first dose is associated with excess cases of Hib disease in AI/AN
infants living in communities where Hib transmission is ongoing and
exposure to colonized persons is likely. Although PRP-OMP and PRP-TT vaccines are equally effective after completion of the primary
series, availability of more than one Hib vaccine in a clinic could
lead to administration of the wrong vaccine for the first dose in
these populations. For these reasons, CDC recommends that providers
who currently use PRP-OMP-containing Hib vaccines (PedvaxHIB and
Comvax) to serve predominantly AI/AN children in AI/AN communities
continue to stock and use only PRP-OMP-containing Hib vaccines not
affected by the recall and vaccinate according to the routinely
recommended schedules, including the 12-15 month booster dose. In
its vaccine stockpile, CDC has PRP-OMP-containing Hib vaccines not
affected by the recall and will prioritize distribution of
available PRP-OMP vaccines for use in AI/AN communities. AI/AN
children not in AI/AN communities or who already receive PRP-TT
conjugate vaccines should continue to be vaccinated with available
vaccines according to the routinely recommended schedules,
including the 12-15 month booster dose.
Limitations of the vaccine supply underscore the importance of
surveillance for Hib disease in children and serotyping of H.
influenzae isolates. ACIP recommends that public health
practitioners conduct thorough and timely investigations of all
cases of Hib disease. To maximize the amount of available vaccine,
providers should order only the number of doses of vaccine required
to meet immediate needs (i.e., a supply for up to 4 weeks) and
should refrain from attempting to build an inventory of Hib
vaccine. CDC, ACIP, and other partners will continue to monitor the
supply of available Hib vaccines and the epidemiology of Hib
disease and provide updates when available. FDA and CDC will
continue to monitor the safety of Hib vaccines. Any adverse events
that are potentially vaccine-related should be reported to the
Vaccine Adverse Event Reporting System (VAERS) by telephone ([800]
822-7967) or online (http://www.vaers.hhs.gov). Additional
information regarding Hib vaccine is available at
http://www.cdc.gov/vaccines/vpd-vac/hib/default.htm Updates on
vaccine supply are available at
http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm#chart
To access a web-text (HTML) version of the complete article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d1219a1.htm
To access a ready-to-print (PDF) version of this issue of MMWR, go
to:
http://www.cdc.gov/mmwr/PDF/wk/mm56d1219.pdf
To receive a FREE electronic subscription to MMWR (which includes
new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html
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