Federal drug regulators have asked
US paediatricians to stop giving children a diarrhoea vaccine until federal
scientists can figure out why the product contains apparently harmless but
extraneous pieces of a pig virus.
The vaccine, called Rotarix, is
manufactured by GlaxoSmithKline and is intended to prevent severe cases of
rotavirus infections, a diarrheal illness that can cause dehydration in infants
and young children.
Kiran Kumar, Medical Officer of
Health, said Cayman’s public health system did not use Rotarix of Glaxo, but
used an alternative vaccine, Merck’s Rotateq, instead.
Rotarix is available in the Cayman
Islands. Paediatricians contacted by the Caymanian Compass on Tuesday said they
have not been notified by the local health authorities to cease administering
the vaccine to children in Cayman.
For now, the decision is unlikely
to disrupt routine immunisations in children since a second vaccine, made by
Merck and called RotaTeq, remains available. RotaTeq was approved for use in
the US in 2006 and is still the more popular vaccine. Rotarix was approved in
2008 and has been used to vaccinate about one million children.
The vaccines are usually provided
by mouth to children at two and three months of age.
“This was a difficult decision for
us because there is no evidence at this time that there is a risk to children,”
said Dr. Margaret Hamburg, the Food and Drug Administration commissioner.
Neither doctors nor parents need
worry about potential illnesses in children who were vaccinated with Rotarix,
Dr. Hamburg said, because the viral particles have been present in the vaccine
from the earliest stages of its development.
Extensive testing before and after
approval has shown the vaccine to be safe, she said.
“We’re not taking this vaccine off
the market,” Dr. Hamburg said. “We’re simply asking that there be a pause in
Thomas Breuer, chief medical
officer of GlaxoSmithKline Biologicals, said, “No safety issue has been
identified by external agencies or GSK.” The company said it would continue producing
the vaccine with the extraneous virus, which originated in pigs, until it could
figure out a way to fix the process.
Vaccines for rotavirus have a
difficult history. The first such vaccine, called RotaShield, was approved for
use in the United States in 1998 and withdrawn a year later after it was linked
with rare cases of intussusception,
Before widespread vaccinations,
rotavirus infections in the United States caused 50,000 hospitalisations
annually but only a few dozen deaths. Adequate medical care almost always saves
dehydrated children. In the developing world, an estimated 500,000 children die
each year from poorly treated rotavirus infections.
Additional local reporting by Norma Connolly