CDC’s
Advisory Committee Recommends New Vaccine
to Prevent Rotavirus
February
21, 2006
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The
Advisory Committee on Immunization Practices
(ACIP) to the Centers for Disease Control
and Prevention (CDC) in their meeting in
Atlanta today voted to recommend a newly
licensed vaccine to protect against rotavirus,
a viral infection that can cause severe
diarrhea, vomiting, fever and dehydration
(gastroenteritis) in infants and young children.
The
ACIP recommendation is for infants to receive
three doses of the oral vaccine at two,
four, and six months of age. Children should
receive the first dose of the vaccine by
12 weeks of age and should receive all doses
of the vaccine by 32 weeks of age. There
is insufficient data on safety and efficacy
outside of these age ranges. The new vaccine,
RotaTeq™ (marketed
by Merck and Company), is the only vaccine
approved in the United States for prevention
of rotavirus gastroenteritis (vomiting and
diarrhea).
“Rotavirus is the leading cause of
severe gastroenteritis in infants and young
children worldwide” said Dr. Anne Schuchat,
director of CDC’s National Immunization
Program. “Nearly every child in the
United States is infected with rotavirus by
age five and most will develop gastroenteritis,
leading to a large number of physician visits,
emergency room visits, and hospitalizations,
with a few deaths. Therefore, this vaccine
will help reduce one of our most common and
potentially severe childhood illnesses.”
Each year, rotavirus is responsible for
more than 400,000 doctor visits, more than
200,000 emergency room visits, 55,000 to 70,000
hospitalizations, and between 20 and 60 deaths
in US children younger than 5 years of age,
leading to about $300 million in direct medical
costs and $900 million in total societal costs.
In developing countries, rotavirus is a major
cause of childhood deaths, causing more than
half a million deaths each year in children
younger than five years of age.
Rotavirus vaccine will not prevent gastroenteritis
caused by other viruses, but is very effective
against rotavirus disease. Studies indicate
the vaccine will prevent about 74 percent
of all rotavirus cases and about 98 percent
of the most severe cases, including 96 percent
of rotavirus cases requiring hospitalization.
In trials, the vaccine prevented 59 percent
of all causes of gastroenteritis hospitalizations,
which highlights the important role of rotavirus
in severe childhood gastroenteritis.
In
1999, RotaShield®,
a different rotavirus vaccine was withdrawn
from the market after it was found to be
associated with a rare type of bowel obstruction
called intussusception. The
risk of intussusception for RotaTeq™,
the new vaccine, was evaluated in a large
scale trial of over 70,000 children. In
that study, there was no association found between
the RotaTeq™ and an increased risk
of intussusception and it did not cause
fever to the extent caused by RotaShield®.
“This is a different vaccine than the
vaccine removed from the market because of
problems with bowel obstructions,” said Dr. Schuchat. “It
is made differently and was not associated
with intussusception in a large clinical trial. Nevertheless,
we will continue to very closely monitor this
vaccine to ensure there are no problems. At
the same time it’s important to remember
that the known benefits of the vaccine far
outweigh any known risks.”
CDC
will conduct a large study to rapidly detect
any association between RotaTeq™ and
intussusception as well as other potential
adverse events through its Vaccine Safety
Datalink Program that evaluates vaccine safety
in approximately 90,000 infants every year.
CDC and the Food and Drug Administration (FDA)
will also regularly monitor reports of intussusception
and other serious adverse events reported
to the Vaccine Adverse Event Reporting System
(VAERS). Merck has also committed to conducting
a post-licensure study of approximately
44,000 children. In addition, the manufacturer
will report cases of intussusception to
FDA within 15 days of receiving them.
Recommendations
of the ACIP become recommendations of CDC
once they are accepted by the director of
CDC and the Secretary of Health and Human
Services (HHS) and are published in the
Morbidity and Mortality Weekly Report (MMWR).
For
more information on rotavirus and the rotavirus
vaccine, visit www.cdc.gov.
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