E-DRUG: U.S. FDA approves diarrhea vaccine
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FDA Press release
August 31, 1998
NEW ORAL ROTAVIRUS VACCINE HELPS PREVENT SEVERE CHILDHOOD DIARRHEA AND
VOMITING
The Food and Drug Administration today announced it has licensed the
first vaccine to help prevent rotaviral disease. Rotavirus infections
are the most common cause of severe diarrhea and vomiting in infants in
the United States.
In this country, approximately 80% of children develop symptoms of
rotavirus infection before they are five years old, with the most
severe cases occurring before the age of three. About 55,000 infants
and children are hospitalized because of severe diarrhea and
dehydration due to rotaviral disease, and about 20-40 of these children
die each year. Worldwide, approximately 870,000 deaths annually are
attributed to rotaviral disease, with the vast majority of these deaths
in developing countries.
The vaccine is approved for the immunization of infants in a three dose
schedule at ages 2, 4, and 6 months, when most other childhood vaccines
are given. The vaccine is given orally. If a child is over six months
old, it is not currently recommended that the vaccination schedule be
started.
"This new vaccine can prevent the most serious effects of rotaviruses
in most infants," said Acting FDA Commissioner Michael A Friedman, M.D.
"And even when symptoms of infection do appear, they are milder and
don't last as long."
The vaccine was studied in nearly 7,000 infants, including
approximately 2,000 who were given the vaccine in placebo-controlled
trials both in the U.S. and abroad. In these controlled trials, the
vaccine prevented at least half of all cases of rotavirus disease and
at least 70% of the severe cases.
The most common adverse reactions included moderate fever, increased
irritability, and decreased appetite and activity, all within five days
of vaccination.
Immunization with the rotavirus vaccine is not recommended for adults.
Although adults get rotavirus infections as well, most adults do not
become sick or have only mild illness.
The rotavirus vaccine is manufactured by Wyeth Ayerst Laboratories,
Marietta, PA, and will be marketed with the trade name "Rotashield".