|
IAC Express 2007 |
| Issue number 652: March 19, 2007 |
| |
Contents
of this Issue
Select a title to jump to the article. |
- Data
collected in first year of postmarketing monitoring does not suggest an
association between intussusception and RotaTeq vaccination
- CDC's
2005 surveillance of acute viral hepatitis cases indicates dramatic
decline from 1995 to 2005
- April
21-28 is National Infant Immunization Week; CDC's online resources make it
easy to promote
- ASTHO
updates immunization fact sheets and posts them online
- CDC
updates its Influenza web section with Spanish-language version of "Key
Facts about Influenza and Influenza Vaccine"
- Asian
Liver Center's free "Know HBV" and "Hepatitis B and Moms-to-Be" brochures
now in Korean, Lao, and Tagalog
- 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
Back to top |
| |
|
|
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
Back to top |
| |
|
|
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
Back to top |
| |
|
|
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."
Back to top |
| |
|
|
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
Back to top |
| |
|
|
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).
Back to top |
| |
|
|
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.
Back to top |
| |
|
|
