HHS NEWS

U.S. Department of Health and Human Services


P-98-24                     FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE       Lenore Gelb:         301-827-6242
August 31, 1998             
                            Consumer Inquiries:  800-532-4440

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".

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