|
IAC Express 2008 |
| Issue number 757: October 6, 2008 |
| |
Contents
of this Issue
Select a title to jump to the article. |
- CDC
presents indications for new DTaP-IPV-Hib combination
vaccine (Pentacel) and provides guidance for use
- CDC presents indications for new DTaP-IPV combination vaccine
(Kinrix) and provides guidance for use
- CDC website spotlights pre-teen and hepatitis B vaccination
in the "CDC Features" section of its homepage
- Current VISs for injectable and nasal-spray influenza
vaccines now available in Hmong, Russian, and Somali
- Important: Be sure to give influenza vaccine throughout the
influenza season--through spring 2009
- CDC
updates its Seasonal Flu web section
- Correction: IAC corrects formatting error in its print piece
"Hepatitis A is a serious liver disease"
- CDC reports on June 2008 importation of canine rabies from
Iraq
- FDA approves a test that identifies seasonal and novel
influenza strains
- Erratum: MMWR corrects a figure published in its article on
influenza vaccination coverage in children ages 6-23 months
- Get Smart About Antibiotics Week is October 6-10; the goal
is to draw attention to the problem of antibiotic resistance
|
| |
| Abbreviations |
|
|
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. |
| |
|
Issue 757: October 6, 2008 |
|
|
|
1. |
CDC presents indications for new DTaP-IPV-Hib combination
vaccine (Pentacel) and provides guidance for use
CDC published "Licensure of a Diphtheria and
Tetanus Toxoids and
Acellular Pertussis Adsorbed, Inactivated Poliovirus, and
Haemophilus b Conjugate Vaccine and Guidance for Use in Infants
and Children" in the October 3 issue of MMWR. It is reprinted
below in its entirety, excluding references.
On June 20, 2008, the Food and Drug Administration (FDA)
licensed a combined diphtheria and tetanus toxoids and acellular
pertussis adsorbed (DTaP), inactivated poliovirus vaccine (IPV),
and Haemophilus influenzae type b conjugate (tetanus toxoid [TT]
conjugate) vaccine, DTaP-IPV/Hib (Pentacel, sanofi pasteur,
Swiftwater, Pennsylvania), for use as a four-dose series in
infants and children at ages 2, 4, 6, and 15-18 months. This
report summarizes the indications for Pentacel and provides
guidance from the Advisory Committee on Immunization Practices
(ACIP) for its use.
ACIP reviewed data on the safety and immunogenicity of DTaP-IPV/Hib (Pentacel). On the basis of these data, expert opinion
of the ACIP Combination Vaccines Workgroup, and feedback from
ACIP liaison organizations including the American Academy of
Pediatrics and the American Academy of Family Physicians, ACIP
endorsed the licensed indications and offered the following
guidance for use of DTaP-IPV/Hib. On June 26, ACIP voted to
include DTaP-IPV/Hib in the federal Vaccines for Children
Program.
Each dose of DTaP-IPV/Hib contains the same diphtheria and
tetanus toxoids and pertussis antigens (inactivated pertussis
toxin [PT], filamentous hemagglutinin [FHA], pertactin, and
fimbriae types 2 and 3) as the FDA-licensed DTaP vaccine
Daptacel (sanofi pasteur, Toronto, Canada) but contains an
increased amount of inactivated PT and FHA. The poliovirus
component of DTaP-IPV/Hib contains the same strains and amount
of inactivated poliovirus types 1, 2, and 3 as the polio vaccine
Poliovax (sanofi pasteur, Toronto, Canada). The Hib component is
identical to ActHib (Haemophilus influenzae type b capsular
polysaccharide [polyribosyl-ribitol-phosphate {PRP}] covalently
bound to tetanus toxoid) (sanofi pasteur, Swiftwater,
Pennsylvania). The DTaP-IPV component is supplied as a sterile
liquid used to reconstitute a lyophilized ActHIB vaccine
component. Components should not be administered separately.
DTaP-IPV/Hib does not contain thimerosal.
In comparative studies, the frequency of solicited local and
systemic adverse events and of serious adverse events after
administration of DTaP-IPV/Hib was similar to that observed
following separately administered DTaP, IPV, and Hib component
vaccines. The immunologic responses after the third dose or the
fourth dose of DTaP-IPV-Hib generally were comparable to those
following separately administered component vaccines, and have
been published. Immune responses following the first and second
doses were not measured.
Indications and Guidance for Use
DTaP-IPV/Hib is licensed for use in children aged 6 weeks
through 4 years. DTaP-IPV/Hib is indicated for use in infants
and children at ages 2, 4, 6, and 15-18 months. DTaP-IPV/Hib is
not licensed for use in children aged >=5 years, and is not
indicated for the booster dose at age 4-6 years. However, DTaP-IPV/Hib that is inadvertently administered to children aged >=5
years should be counted as a valid dose.
For prevention of diphtheria, tetanus, and pertussis, all
children are recommended to receive 4 doses of DTaP, at ages 2,
4, 6, and 15-18 months, and a booster dose at age 4-6 years.
Although an 8-week interval between doses is preferred, if an
accelerated schedule is needed, a minimum interval of 4 weeks
should occur between the first and second doses, and the third
dose should not be administered before age 14 weeks. The fourth
dose of DTaP-IPV/Hib may be administered as early as 12 months
of age if the clinician feels an opportunity to vaccinate may be
missed later and if 6 months has elapsed since the third dose of
DTaP-IPV/Hib.
Data are limited on the safety and immunogenicity of
interchanging DTaP vaccines from different manufacturers. ACIP
recommends that, whenever feasible, the same manufacturer's DTaP
product should be used for the pertussis series; however, that
vaccination should not be deferred if the specific DTaP vaccine
brand previously administered is unavailable or unknown.
For prevention of poliomyelitis, all children are recommended to
receive 4 doses of IPV, at ages 2, 4, 6-18 months, and 4-6
years. DTaP-IPV/Hib may be used for 1 or more doses of the IPV
series, including in children who have received 1 or more doses
of another licensed IPV vaccine and who also are scheduled to
receive DTaP and Hib vaccination. When an accelerated or catch-up schedule is needed, IPV doses may be administered at 4-week
intervals and the fourth dose counted as valid if administered
as early as age 18 weeks when the proper spacing of prior doses
is maintained. Therefore, DTaP-IPV/Hib (Pentacel) doses
administered at 2, 4, 6, and 12-18 months would provide 4 valid
doses of IPV under these circumstances.
The recommended vaccination schedule for Hib-TT vaccines (e.g.,
Pentacel) consists of a 3-dose primary series at ages 2, 4, and
6 months, and a booster dose at age 12-15 months. Intervals
between doses of the primary series as short as 1 month are
acceptable but not optimal. Minimum intervals for the booster
dose vary by age at first vaccination and have been published.
DTaP-IPV/Hib may be administered at 12 months and counted as a
valid Hib-TT dose if the minimum intervals are followed;
however, the safety and efficacy of DTaP-IPV/Hib in this
circumstance have not been evaluated. DTaP-IPV/Hib may be
administered at separate injection sites with other vaccines
administered at age 12-18 months, such as hepatitis A, hepatitis
B, pneumococcal conjugate, measles, mumps, and rubella (MMR),
and varicella vaccines.
Special Considerations
Certain American Indian/Alaska Native (AI/AN) children are at
increased risk for Hib disease, particularly in the first 6
months of life. Furthermore, the immunologic response to
different Hib conjugate vaccine preparations can vary. Compared
with other Hib conjugate vaccines (e.g., Hib-TT), administration
of polyribosylribitol phosphate-meningococcal outer membrane
protein (PRP-OMP)-containing Hib vaccine preparations leads to a
more rapid seroconversion to protective antibody concentrations
within the first 6 months of life. Although for subsequent
doses, PRP-OMP and other Hib conjugate vaccines appear to have
equal efficacy, failure to use PRP-OMP vaccines for the first
dose has been 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. In
addition, stocking of both PRP-OMP and other Hib conjugate
vaccine preparations in the same clinic might lead to
inadvertent administration of another vaccine for the first Hib
dose. For this reason, clinics that serve predominantly AI/AN
children might elect to stock and use only PRP-OMP-containing
Hib vaccines.
Different lot numbers for the different components of DTaP-IPV/Hib are included on the DTaP-IPV vial and on the Hib powder
vial. Providers should record lot numbers separately for the
DTaP-IPV and Hib components.
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a5.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5739.pdf
Back to top |
| |
|
|
2. |
CDC presents indications for new DTaP-IPV combination vaccine
(Kinrix) and provides guidance for use
CDC published "Licensure of a Diphtheria and
Tetanus Toxoids and
Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
and Guidance for Use as a Booster Dose" in the October 3 issue
of MMWR. It is reprinted below in its entirety, excluding
references.
On June 24, 2008, the Food and Drug Administration licensed a
combined diphtheria and tetanus toxoids and acellular pertussis
adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine, DTaP-IPV (Kinrix, GlaxoSmithKline Biologicals, Rixensart, Belgium).
Kinrix is licensed for use as the fifth dose of the DTaP vaccine
series and the fourth dose of the IPV series in children aged 4-6 years whose previous DTaP vaccine doses were DTaP (Infanrix,
GlaxoSmithKline) and/or DTaP-Hepatitis B-IPV (Pediarix,
GlaxoSmithKline) for the first 3 doses and DTaP (Infanrix) for
the fourth dose. DTaP-IPV administered to children aged 4-6
years would reduce by one the number of injections needed to
complete DTaP and IPV immunization. This report summarizes the
indications for Kinrix and provides guidance from the Advisory
Committee on Immunization Practices (ACIP) for its use.
ACIP reviewed data on the safety and immunogenicity of DTaP-IPV
(Kinrix). On the basis of these data, expert opinion of the ACIP
Combination Vaccines Workgroup, and feedback from ACIP liaison
organizations including the American Academy of Pediatrics and
the American Academy of Family Physicians, ACIP endorsed the
licensed indications and offered the following guidance for use
of DTaP-IPV. On June 26, ACIP voted to include DTaP-IPV in the
federal Vaccines for Children Program.
The individual antigens (diphtheria, tetanus, and pertussis
toxoids, filamentous hemagglutinin, pertactin, and poliovirus
types 1, 2, and 3) contained in combined DTaP-IPV are identical
to the antigens contained in GlaxoSmithKline's DTaP (Infanrix)
and DTaP-Hepatitis B-IPV (Pediarix) and have been described
previously. DTaP-IPV contains no preservatives. DTaP-IPV is
administered as an intramuscular injection, preferably into the
deltoid region. Two clinical trials conducted in U.S. children
aged 4-6 years showed that combined DTaP-IPV and separately
administered DTaP and IPV vaccines had comparable safety and
reactogenicity profiles, with or without a co-administered
second dose of measles, mumps, and rubella (MMR) vaccine. The
immunogenicity of all antigens was similar between the treatment
groups, with or without a co-administered second dose of MMR
vaccine.
Indications and Guidance for Use
DTaP-IPV (Kinrix) is indicated for use as the fifth dose of DTaP
and fourth dose of IPV in children aged 4-6 years who received
DTaP (Infanrix) and/or DTaP-Hepatitis B-IPV (Pediarix) as the
first 3 doses and DTaP (Infanrix) as the fourth dose. This
vaccine should not be administered to children aged <4 years or >=7 years; however, if DTaP-IPV (Kinrix) is inadvertently
administered for an earlier dose of the DTaP and/or IPV series,
the dose should be counted as valid and does not need to be
repeated provided minimum interval requirements have been met.
Data are limited on the safety and immunogenicity of
interchanging DTaP vaccines from different manufacturers. ACIP
recommends that, whenever feasible, the same manufacturer's DTaP
vaccines should be used for each dose in the series; however,
vaccination should not be deferred because the type of DTaP
previously administered is unavailable or unknown.
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a4.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5739.pdf
Back to top |
| |
|
|
3. |
CDC website spotlights pre-teen and hepatitis B vaccination
in the "CDC Features" section of its homepage
The CDC website's homepage (http://www.cdc.gov)
is currently
offering the public information about pre-teen and hepatitis B
vaccination. The information is included on the "CDC Features"
banner, which appears at the top of the homepage. Note: Topics
included on the banner change frequently; if you do not see the
vaccination topics mentioned above on the banner, you can access
them from the URLs below.
The CDC Feature titled "Pre-teens Need Vaccines Too!" is
intended for parents of pre-teens. To access it directly, go to:
http://www.cdc.gov/Features/PreteenVaccines
The CDC Feature titled "Hepatitis B: Make Sure Your Child is
Fully Vaccinated" is intended for parents of children ages 0-18
years. To access it directly, go to:
http://www.cdc.gov/Features/HepatitisB
Back to top |
| |
|
|
4. |
Current VISs for injectable and nasal-spray influenza
vaccines now available in Hmong, Russian, and Somali
Dated 7/24/08, the current VISs for trivalent
inactivated
influenza vaccine (TIV; injectable) and live attenuated
influenza vaccine (LAIV; nasal spray) are now available in
Hmong, Russian, and Somali. IAC gratefully acknowledges the
Minnesota Department of Health for the translations.
TIV vaccine VIS
To access the Hmong version of the TIV vaccine VIS, go to:
http://www.immunize.org/vis/hm_flu04.pdf
To access the Russian version of the TIV vaccine VIS, go to:
http://www.immunize.org/vis/ru_flu05.pdf
To access the Somali version of the TIV vaccine VIS, go to:
http://www.immunize.org/vis/so_flu05.pdf
To access the English version of the TIV vaccine VIS, go to:
http://www.immunize.org/vis/2flu.pdf
NOTE: The VIS for TIV vaccine comes in additional languages,
including Spanish. To access them, go to: http://www.immunize.org/vis/vis_flu_inactive.asp Click on the
link to the pertinent language.
LAIV vaccine VIS
To access the Hmong version of the LAIV vaccine VIS, go to:
http://www.immunize.org/vis/hmLAIV04.pdf
To access the Russian version of the LAIV vaccine VIS, go to:
http://www.immunize.org/vis/ru_LAIV05.pdf
To access the Somali version of the LAIV vaccine VIS, go to:
http://www.immunize.org/vis/so_LAIV05.pdf
To access the English version of the LAIV vaccine VIS, go to:
http://www.immunize.org/vis/liveflu.pdf
NOTE: The VIS for LAIV vaccine comes in additional languages,
including Spanish. To access them, go to:
http://www.immunize.org/vis/vis_flu_live.asp Click on the link
to the pertinent language.
For information about the use of VISs, and for VISs in more than
35 languages, visit IAC's VIS web section at
http://www.immunize.org/vis
For general information about VISs from CDC's website go to:
http://www.cdc.gov/vaccines/pubs/vis
Back to top |
| |
|
|
5. |
Important: Be sure to give influenza vaccine throughout the
influenza season--through spring 2009.
Influenza vaccine for the 2008-09 influenza
season is available.
Vaccination should continue through the spring months of 2009.
Visit the following websites often to find the information you
need to keep vaccinating. Both are continually updated with the
latest resources.
The National Influenza Vaccine Summit website at
http://www.preventinfluenza.org
CDC's Seasonal Flu web section at http://www.cdc.gov/flu
Back to top |
| |
|
|
6. |
CDC updates its Seasonal Flu web section
CDC recently added the following resources to its
Seasonal Flu
web section:
"Questions & Answers about the 2008-2009 Flu Season: 2008-09
Influenza (Flu) Season":
http://www.cdc.gov/flu/2008-09_flu_qa.htm
"Seasonal Flu and Staph Infections":
http://www.cdc.gov/flu/professionals/flustaph.htm
To access a broad range of continually updated information on
seasonal influenza, avian influenza, pandemic influenza, swine
influenza, and canine influenza, go to: http://www.cdc.gov/flu
Back to top |
| |
|
|
7. |
Correction: IAC corrects formatting error in its print piece
"Hepatitis A is a serious liver disease"
In the September 29 issue of IAC Express, we
informed readers
that we revised our print brochure "Hepatitis A is a serious
liver disease. Vaccination can protect you!" The revised piece
had a formatting error, which we have now corrected. The error
concerned only the formatting of the revised piece, not the
content. If you printed the revised brochure, you may want to
discard the printed copies and print the newly formatted
brochure. The brochure is designed to be printed on two sides of
a single piece of paper and folded in thirds.
To access the newly formatted piece "Hepatitis A is a serious
liver disease. Vaccination can protect you!" go to:
http://www.immunize.org/catg.d/p4080.pdf
IAC's Print Materials web section offers healthcare
professionals and the public more than 175 FREE, English-language materials (many available also in translation), which
we encourage website users to print, copy, and distribute
widely. To access all of IAC's free print materials, go to:
http://www.immunize.org/printmaterials
Back to top |
| |
|
|
8. |
CDC reports on June 2008 importation of canine rabies from
Iraq
CDC published "Rabies in a Dog Imported from
Iraq--New Jersey,
June 2008" in the October 3 issue of MMWR. A summary made
available to the press is reprinted below in its entirety.
Canine rabies can be imported into the United States from
abroad. Travelers should be aware of the risk of rabies exposure
when traveling to countries where rabies is common in dogs and
should not import animals to the United States without properly
vaccinating them against rabies and adhering to animal
importation laws. Dog-to-dog transmission of rabies has been
eliminated in the United States. However, canine rabies virus
variants can still be imported by unvaccinated dogs from
countries where it is common in animals, specifically Asia,
Africa, the Middle East, and parts of Latin America. Rabies
between canine variants are responsible for most of the 55,000
human deaths from rabies reported globally each year. While
traveling in areas where rabies is common, travelers should not
pet stray animals, nor is it advisable to adopt stray animals
without a veterinarian's health assessment. Adopted animals
should be properly vaccinated before importation to the United
States.
To access a web-text (HTML) version of the MMWR article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a3.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5739.pdf
Back to top |
| |
|
|
9. |
FDA approves a test that identifies seasonal and novel
influenza strains
On September 30, the Department of Health and
Human Services
(HHS) issued a press release announcing that FDA has approved a
test that can identify commonly circulating influenza viruses,
as well as influenza A(H5N1) viruses. Results can be available
within four hours and the system can test multiple samples at
once.
To access the HHS press release, go to:
http://www.hhs.gov/news/press/2008pres/09/20080930a.html
Back to top |
| |
|
|
10. |
Erratum: MMWR corrects a figure published in its article on
influenza vaccination coverage in children ages 6-23 months
CDC published "Erratum: Vol. 57, No. 38" in the
October 3 issue
of MMWR. It is reprinted below in its entirety, with the
exception of one figure.
In the report, "Influenza Vaccination Coverage Among Children
Aged 6-23 Months--United States, 2006-07 Influenza Season," an
error occurred in Figure 1 on page 1043. The corrected figure
follows. (IAC Express editor's note: IAC Express is unable to
duplicate images such as Figure 1; to access the corrected
Figure 1, click on the URLs below.)
To access a web-text (HTML) version of the erratum, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a9.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5739.pdf
Back to top |
| |
|
|
11. |
Get Smart About Antibiotics Week is October 6-10; the goal
is to draw attention to the problem of antibiotic resistance
CDC published "Notice to Readers: Get Smart About
Antibiotics
Week--October 6-10, 2008" in the October 3 issue of MMWR. It is
reprinted below in its entirety. On October 2, CDC issued a
related press release, "It's Time to Get Smart about the Use of
Antibiotics: CDC campaign aims to draw attention to the
increasing problem of antibiotic resistance." Links to the
English- and Spanish-language versions of the press release are
given at the end of this IAC Express article.
October 6-10 is Get Smart About Antibiotics Week. The theme of
this observance is "The power to prevent resistance is in your
hands."
Inappropriate use of antibiotics to treat upper respiratory
infections (URIs) can result in unnecessary risk for adverse
events and contribute to the likelihood of antibiotic
resistance. Adverse events related to antibiotics (usually
allergies or drug intolerance) resulted in an estimated 142,500
emergency department visits annually in the United States during
2004-2006. In addition, inappropriate and excessive
antimicrobial use can increase a community's risk for
antibiotic-resistant bacterial infections that might lead to
severe or prolonged illness, hospitalization, and sometimes
death. Educating clinicians and the public regarding appropriate
use of antibiotics might help reduce adverse drug events,
including antibiotic resistance.
As part of Get Smart About Antibiotics Week, healthcare
providers are urged to take the following actions to help reduce
antibiotic resistance and other adverse drug events:
- Know when antibiotics are indicated, and avoid prescribing
antibiotics for URIs such as pharyngitis, bronchitis,
sinusitis, and the common cold, which are primarily caused by
viruses.
- Instead of prescribing antibiotics for URIs, identify and
validate patient concerns and recommend symptomatic therapy.
Additional information about Get Smart About Antibiotics Week is
available at http://www.cdc.gov/getsmart
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5739a6.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5739.pdf
To receive a FREE electronic subscription to MMWR (which
includes new ACIP recommendations), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html
To access the English-language CDC press release, go to:
http://www.cdc.gov/media/pressrel/2008/r081002.htm
To access the Spanish-language CDC press release, go to:
http://www.cdc.gov/media/pressrel/2008/rs081002.htm
Back to top |
| |
|
|
