Home
|
About IAC
|
Contact
|
A-Z Index
|
Donate
|
Shop
|
SUBSCRIBE
Immunization Action Coalition
IAC Express 2008
Issue number 757: October 6, 2008
 
Contents of this Issue
Select a title to jump to the article.
  1. CDC presents indications for new DTaP-IPV-Hib combination vaccine (Pentacel) and provides guidance for use
  2. CDC presents indications for new DTaP-IPV combination vaccine (Kinrix) and provides guidance for use
  3. CDC website spotlights pre-teen and hepatitis B vaccination in the "CDC Features" section of its homepage
  4. Current VISs for injectable and nasal-spray influenza vaccines now available in Hmong, Russian, and Somali
  5. Important: Be sure to give influenza vaccine throughout the influenza season--through spring 2009
  6. CDC updates its Seasonal Flu web section
  7. Correction: IAC corrects formatting error in its print piece "Hepatitis A is a serious liver disease"
  8. CDC reports on June 2008 importation of canine rabies from Iraq
  9. FDA approves a test that identifies seasonal and novel influenza strains
  10. Erratum: MMWR corrects a figure published in its article on influenza vaccination coverage in children ages 6-23 months
  11. 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
   
Immunization Action Coalition  •  2550 University Avenue West  •  Suite 415 North  •  Saint Paul, Minnesota  •  55114
tel 651-647-9009  •  fax 651-647-9131
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.