NIAID Rotavirus Vaccine Licensed for Commercialization
The National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health (NIH), announced today
a new license agreement aimed at helping to prevent hundreds of
thousands of deaths annually from rotavirus diarrhea in children
living in developing countries. An effective oral rotavirus vaccine created
by NIAID scientists in the mid- to late 1980s and developed further
through a Cooperative Research and Development Agreement with an
industry partner has now been licensed by the NIH Office of Technology
Transfer to BIOVIRx, Inc., of Minneapolis, MN. BIOVIRx, which is
responsible for obtaining requisite marketing approvals for this
product, plans global commercialization of the oral vaccine (RotaShield®).
Rotaviruses are consistently shown to be the leading cause of severe
diarrhea in infants and young children. Worldwide, the wheel-shaped
viruses are estimated to cause more than 135 million episodes of
diarrhea each year in infants and children younger than 5 years
old, resulting in up to 592,000 deaths annually.
Rotaviruses are egalitarian viruses: they readily infect and cause
illness in infants and young children in both developed and developing
countries. The overall consequences of these illnesses, however,
are quite different. Approximately 1,600 rotavirus-related deaths
each day occur predominantly in the developing countries, notes
Albert Z. Kapikian, M.D., who led the NIAID team that developed
the vaccine and serves as head of the epidemiology section in the
Institute's Laboratory of Infectious Diseases.
Symptoms of rotavirus infection develop quickly and in addition
to diarrhea, may include vomiting, fever and dehydration. The resulting
dehydration can be reversed through oral rehydration therapy or,
in more serious cases, through hospitalization and intravenous fluids.
Although effective, these therapies are not readily available or
used in many parts of the developing world. Children in developing
countries are more vulnerable to severe and fatal illness.
Dr. Kapikian has devoted most of his career to working on viruses
that cause gastroenteritis. He and his colleagues discovered the
Norwalk virus, the first virus to be established as an important
cause of diarrhea. Later, he and his colleagues in NIAID developed
the rotavirus vaccine that was tested in the United States and abroad
in collaborative studies.
Wyeth Laboratories, Inc., manufactured the vaccine and carried out
extensive field trials that led to its licensure. In 1998, the Food
and Drug Administration (FDA) approved the vaccine under the trade
name of RotaShield®. Subsequently, it was added to the pediatric
immunization schedule and given to young infants in the United States.
More than 1 million doses were administered before the vaccine
was withdrawn from the market in 1999 because of a link with an
intestinal blockage known as intussusception. After continuing debate
and controversy, the risk of this adverse event was estimated to
be about 1 excess case per 10,000 vaccinated infants and young children.
A recent scientific perspective published by NIH scientists in the
Journal of Infectious Diseases, however, estimated the risk
to be 1 excess case per 32,000 vaccinated infants in the target
population for the vaccine, infants 45 to 210 days old. Moreover,
this perspective reported an overall decrease in intussusception
observed among infants less than 1 year old during the rotavirus
vaccine exposure period. The background rate of intussusception
in the United States is estimated to be 1 case per 3,000 infants
during the first year of life.
NIAID is a component of the National Institutes of Health (NIH),
an agency of the U.S. Department of Health and Human Services. NIAID
supports basic and applied research to prevent, diagnose and treat
infectious diseases such as HIV/AIDS and other sexually transmitted
infections, influenza, tuberculosis, malaria and illness from potential
agents of bioterrorism. NIAID also supports research on transplantation
and immune-related illnesses, including autoimmune disorders, asthma
and allergies. Press releases, fact sheets and other NIAID-related
materials are available on the NIAID Web site at http://www.niaid.nih.gov.
Reference: BR Murphy et al. Reappraisal of the association of intussusception
with the licensed live rotavirus vaccine challenges initial conclusions.
Journal of Infectious Diseases 187:1301-08 (2003).