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Immunization Action Coalition
IAC Express 2007
Issue number 652: March 19, 2007
 
Contents of this Issue
Select a title to jump to the article.
  1. Data collected in first year of postmarketing monitoring does not suggest an association between intussusception and RotaTeq vaccination
  2. CDC's 2005 surveillance of acute viral hepatitis cases indicates dramatic decline from 1995 to 2005
  3. April 21-28 is National Infant Immunization Week; CDC's online resources make it easy to promote
  4. ASTHO updates immunization fact sheets and posts them online
  5. CDC updates its Influenza web section with Spanish-language version of "Key Facts about Influenza and Influenza Vaccine"
  6. Asian Liver Center's free "Know HBV" and "Hepatitis B and Moms-to-Be" brochures now in Korean, Lao, and Tagalog
  7. Points Across IV Health Promotion Conference and Evidence-Based Institute scheduled for May 16-17 in Columbia, MD
 
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 652: March 19, 2007
1.  Data collected in first year of postmarketing monitoring does not suggest an association between intussusception and RotaTeq vaccination

CDC published "Postmarketing Monitoring of Intussusception After RotaTeq Vaccination—United States, February 1, 2006-February 15, 2007" in the March 16 issue of MMWR. Portions of the article are reprinted below. In addition, on March 15, CDC issued a press release, "CDC Releases Safety Data on Rotavirus Vaccine: Reported Intussusception Cases Fall Within Expected Range." It is reprinted below in its entirety.


EXCERPTS FROM MMWR ARTICLE

Rotavirus is the leading cause of severe gastroenteritis in children aged <5 years worldwide. In February 2006, a new rotavirus vaccine, RotaTeq (Merck and Co., West Point, Pennsylvania), was licensed in the United States, and the Advisory Committee on Immunization Practices (ACIP) recommended it for routine vaccination of U.S. infants with 3 doses, administered orally at ages 2, 4, and 6 months. Because a previous rotavirus vaccine, Rotashield (Wyeth Laboratories, Marietta, Pennsylvania), was withdrawn from the U.S. market in 1999 after postmarketing surveillance identified an association with intussusception (a rare type of bowel obstruction), the safety of RotaTeq was evaluated in a prelicensure clinical trial involving 71,725 infants who received either vaccine or placebo. In this controlled trial, no statistically significant elevated risk for intussusception was observed within a 42-day period after RotaTeq vaccination. However, postmarketing monitoring for intussusception after RotaTeq vaccination is necessary because of possible differences in the characteristics of infants who received the vaccine in routine use compared with the infants in the clinical trials. Also, the large numbers of infants being vaccinated provides an opportunity to detect intussusception occurring at a low rate after vaccination. This report presents data from the first year of postmarketing monitoring for intussusception after RotaTeq vaccination in the United States, with particular focus on all intussusception reports received by the Vaccine Adverse Event Reporting System (VAERS) during February 1, 2006-February 15, 2007. As of February 15, 2007, postmarketing surveillance did not suggest association of RotaTeq vaccination with intussusception. CDC reaffirms vaccine policy recommendations to routinely vaccinate U.S. infants with RotaTeq at ages 2, 4, and 6 months. . . .


REPRINT OF CDC'S PRESS RELEASE

The Centers for Disease Control and Prevention (CDC) released today new safety data on a recently licensed rotavirus vaccine given to infants that indicate the vaccine does not pose an elevated risk for intussusception, the most common cause of bowel obstruction in infants.

The vaccine, sold by Merck and Company under the brand name RotaTeq, was licensed by the U.S. Food and Drug Administration (FDA) in February 2006. The Advisory Committee on Immunization Practices (ACIP) recommends RotaTeq for routine vaccination of U.S. infants to protect against rotavirus, which causes severe diarrhea, vomiting, fever, and dehydration (gastroenteritis) in children.

Each year in the United States, rotavirus is responsible for more than 400,000 doctor visits; more than 200,000 emergency room visits; and 55,000 to 70,000 hospitalizations. In developing countries, rotavirus is a major cause of childhood deaths, estimated to cause more than half a million deaths each year in children younger than 5 years of age.

Last month, FDA notified healthcare providers and consumers that it had received reports of intussusception following RotaTeq vaccination. Since then, FDA, ACIP, and CDC have concluded that the number of intussusception reports after administration of RotaTeq has not exceeded the number expected to occur without vaccination and that the vaccine does not appear to be associated with intussusception.

"Monitoring the safety of a new vaccine is very important," said Anne Schuchat, MD, director of CDC's National Center for Immunization and Respiratory Diseases. "The data we have reviewed are reassuring, and we continue to recommend the RotaTeq vaccine. However, we will continue to carefully monitor reports of possible adverse effects associated with the vaccine and will take appropriate action if there proves to be a problem in the future."

Based on ACIP recommendations, CDC policy calls for routine immunization of all U.S. infants with three doses of RotaTeq administered orally at 2, 4, and 6 months.

RotaTeq is the only vaccine approved in the United States for prevention of rotavirus disease. Studies indicate RotaTeq will prevent about 74 percent of all rotavirus cases and about 98 percent of the most severe cases, including 96 percent of cases requiring hospitalization.

Intussusception is a serious, life-threatening condition that occurs when the intestine or bowel becomes blocked. The condition can occur spontaneously in the absence of vaccination. It is most common among infants in the first year of life, causing about 1,400 infant hospitalizations annually. These cases occurred before use of any rotavirus vaccines in the United States.

The reported intussusception cases were detected through routine monitoring of new vaccines using the Vaccine Adverse Event Reporting System (VAERS). Following licensure and general use of all vaccines in the United States, CDC and FDA closely monitor VAERS reports of potential health problems after vaccination submitted by a variety of sources. Reports to VAERS may be submitted by anyone, including healthcare providers, patients, and family members. Physicians and scientists at both agencies review all reports of serious side effects reported to VAERS.

CDC and FDA continue to closely monitor RotaTeq for problems in vaccine recipients. They encourage all healthcare providers and other individuals to report any cases of intussusception or other serious adverse events to VAERS.

Adverse reactions and other potential health problems related to RotaTeq can be reported to VAERS by calling (800) 822-7967 or online at http://www.vaers.hhs.gov


To access a web-text (HTML) version of the complete MMWR article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5610a3.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5610.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html

To access the CDC press release, go to:
http://www.cdc.gov/od/oc/media/pressrel/2007/r070315a.htm

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2 CDC's 2005 surveillance of acute viral hepatitis cases indicates dramatic decline from 1995 to 2005

On March 16, CDC issued a report, "Surveillance for Acute Viral Hepatitis—United States, 2005," in the MMWR Surveillance Summaries. The abstract is reprinted below. In addition, on March 15, CDC issued a press release on the topic; portions of it are reprinted below, following the Surveillance Summary abstract.


ABSTRACT

Problem/Condition: In the United States, acute viral hepatitis most frequently is caused by infection with hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV). These unrelated viruses are transmitted through different routes and have different epidemiologic profiles. Safe and effective vaccines have been available for hepatitis B since 1981, and for hepatitis A, since 1995.

Reporting Period: Cases in 2005, the most recent for which data are available, are compared with those from previous years.

Description of the System: Cases of acute viral hepatitis are reported to CDC via the National Notifiable Diseases Surveillance System.

Results: Since 1995, the incidence of reported acute hepatitis A has declined by 88%, to the lowest rate ever recorded (2005: 1.5/100,000 population). Declines were greater among children and in states where routine vaccination of children was recommended beginning in 1999, compared with the remaining states. The proportion of cases among adults has increased. Since 1990, reported acute hepatitis B incidence has declined by 79%, to the lowest rate ever recorded (2005: 1.8/100,000 population). Declines occurred among all age groups but were greatest among children aged <15 years. Since the late 1980s, acute hepatitis C incidence also has declined. In 2005, as in previous years, the majority of these cases occurred among adults, and injection-drug use was the most common risk factor.

Interpretation: The greater declines in hepatitis A rates among the states and age groups included in the 1999 recommendations for routine childhood hepatitis A vaccination suggest that this strategy reduced rates. Universal hepatitis B vaccination of children has resulted in substantially lower rates among younger age groups. Higher rates of hepatitis B continue among adults, particularly males aged 25-44 years, which emphasize the need to vaccinate adults at risk for HBV infection. The decline in hepatitis C incidence is primarily attributed to a decrease in incidence among injection-drug users (IDUs). The reasons for this decrease are multifactorial and are probably related to risk-reduction practices among IDUs.

Public Health Actions: The recent expansion of recommendations for routine hepatitis A vaccination to include all children in the United States aged 12-23 months is expected to further reduce hepatitis A rates. Ongoing hepatitis B vaccination programs will ultimately eliminate domestic HBV transmission, and increased vaccination of adults who have risk factors will accelerate progress toward elimination. Prevention of hepatitis C relies on identifying and counseling uninfected persons at risk for hepatitis C (e.g., IDUs) regarding ways to protect themselves from infection. . . .


EXCERPTS FROM THE PRESS RELEASE

Acute Viral Hepatitis Cases Down; Hepatitis A and Hepatitis B at Lowest Levels Ever Reported

The three most common forms of acute viral hepatitis in the United States—hepatitis A, B, and C—declined dramatically between 1995 and 2005, with hepatitis A and B at the lowest levels ever recorded since the government began collecting surveillance data more than 40 years ago, according to the Centers for Disease Control and Prevention (CDC). Hepatitis B and C are diseases that can lead to liver cancer and death.

The main factor behind the declines in new cases of hepatitis A and B were the availability of vaccines and strong federally supported immunization programs. Declines in new cases of hepatitis A were greater among children in the 17 states where routine vaccination of children has been recommended since 1999. The declines in hepatitis B were greatest among children and teens age 15 and younger, likely the result of high vaccination coverage in this age group. The CDC recommends three doses of hepatitis B vaccine beginning at birth. Declines in reported new cases of hepatitis C were likely due to reductions in high-risk behaviors among injection drug users, as well as efforts to diagnose individuals infected with hepatitis C and the promotion of health behaviors to reduce person-to-person transmission of the virus.

Since 1995, new cases of reported acute hepatitis A have declined by 88 percent, to an incidence of 1.5 per 100,000 population, the lowest rate ever reported, according to the Morbidity and Mortality Weekly Report (MMWR) Surveillance Summary, "Surveillance for Acute Viral Hepatitis—United States, 2005."

"The sharp declines in rates of hepatitis A and B are one of the big public health success stories of the last 10 years. The drops in new cases of hepatitis A and hepatitis B are evidence that our prevention strategies have been successful, particularly the widespread use of vaccines for hepatitis A and hepatitis B. In order for these declines to continue, our prevention efforts must be sustained," said Dr. Kevin Fenton, director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. . . .


To access a web-text (HTML) version of the MMWR Surveillance Summary go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5603a1.htm

To access a ready-to-print (PDF) version of it, go to:
http://www.cdc.gov/mmwr/PDF/ss/ss5603.pdf

To access the complete press release, go to:
http://www.cdc.gov/od/oc/media/pressrel/2007/r070315.htm

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3 April 21-28 is National Infant Immunization Week; CDC's online resources make it easy to promote

This year National Infant Immunization Week (NIIW) will again be held in conjunction with the Pan American Health Organization's Vaccination Week in the Americas (VWA), April 21-28. The U.S. will join 39 countries in the Western Hemisphere to concurrently promote the need for routine vaccinations for infants and children during the last week in April.

To assist communities in promoting infant immunization during NIIW, CDC posted the following English- and Spanish-language resources:

  • Print ads
  • Posters
  • Web buttons and banners
  • English- and Spanish-language television public service announcements (PSAs)
  • Spanish-language radio PSA
  • Sample key messages
  • Sample media advisory
  • Sample proclamation stickers
  • Much more

To access these materials and planning tools, go to:
http://www.cdc.gov/nip/events/niiw

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4 ASTHO updates immunization fact sheets and posts them online

The website of the Association of State and Territorial Health Officials (ASTHO) recently posted 12 immunization fact sheets; all have been updated with information for 2007. The 12 documents include maps, charts, and graphs.

To access them, go to: http://www.astho.org/templates/display_pub.php?pub_id=2344&admin=1 You will find most of the documents listed under the  "Immunization" heading and one each under the headings titled "How states are benefiting from preparedness funding" and "Pandemic influenza."

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5 CDC updates its Influenza web section with Spanish-language version of "Key Facts about Influenza and Influenza Vaccine"

CDC recently posted a Spanish-language version of the fact sheet "Key Facts about Influenza and Influenza Vaccine" on its Influenza web section.

To access it, go to:
http://www.cdc.gov/flu/espanol/keyfacts.htm

To access the English-language version, go to:
http://www.cdc.gov/flu/keyfacts.htm

To access a broad range of continually updated information on seasonal influenza, avian influenza, pandemic influenza, and swine influenza, go to: http://www.cdc.gov/flu

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6 Asian Liver Center's free "Know HBV" and "Hepatitis B and Moms-to-Be" brochures now in Korean, Lao, and Tagalog

Two of the Asian Liver Center's brochures, "Know HBV: What every Asian and Pacific Islander should know about hepatitis B and liver cancer" and "Hepatitis B and Moms-to-Be," are now available in Korean, Lao, and Tagalog. Both are also available in English, Chinese, and Vietnamese.

To order them free of charge, go to:
http://liver.stanford.edu/ALC/ALC_order.php

To download them, go to: http://liver.stanford.edu/JRC/JRC_brochures.php and click on the pertinent link(s).

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7 Points Across IV Health Promotion Conference and Evidence-Based Institute scheduled for May 16-17 in Columbia, MD

Sponsored by the Maryland Partnership for Prevention (MPP), "Points Across IV: Proven Strategies for Lasting Success" is scheduled for May 17 in Columbia, MD. In addition, an Evidence-Based Institute pre-conference is planned for May 16. Both meetings will highlight best practices and provide instruction on collecting, interpreting, applying, and reporting health promotion program data.

To access the conference brochure, which includes comprehensive program and registration information, go to: http://www.edcp.org/pdf/Points_Across_Brochure.pdf Registrations must be postmarked or faxed by April 17.

For additional information, call (410) 902-4677.

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Immunization Action Coalition  •  Saint Paul, MN
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.