rotavirus vaccine contaminated, officials say
-- Federal health authorities recommended Monday that doctors suspend using
Rotarix, one of two vaccines licensed in the United States against rotavirus,
saying the vaccine is contaminated with material from a pig virus. "There
is no evidence at this time that this material poses a safety risk,"
Food and Drug Administration Commissioner Dr. Margaret Hamburg told reporters
in a conference call.
made by GlaxoSmithKline, was approved by the FDA in 2008. The contaminant
material is DNA from porcine circovirus 1, a virus from pigs that is not
known to cause disease in humans or animals, Hamburg said. About 1 million
children in the United States and about 30 million worldwide have gotten
Rotarix vaccine, she said. Rotavirus disease kills more than 500,000 infants
around the world each year, primarily in low- and middle-income countries,
she said. Before rotavirus vaccine became available, the disease was blamed
for more than 50,000 hospitalizations and several dozen deaths per year
in the United States, she said.
FDA learned about the contamination after an academic research team using
a novel technique to look for viruses in a range of vaccines found the material
in GlaxoSmithKline's product and told the company, Hamburg said. The drug
maker confirmed its presence in both the cell bank and the seed from which
the vaccine is derived, suggesting its presence from the early stages of
vaccine development, she said. The FDA then confirmed the drug maker's findings.
emphasized Monday that the pig virus is not known to cause illness in humans,
saying "it is found in everyday meat products and is frequently eaten
with no resulting disease or illness." "No safety issue has been
identified by external agencies or GSK," Thomas Breuer, the drug maker's
chief medical officer, said in a written statement. "GSK is committed
to patient safety and to the highest manufacturing standards for all our
vaccines and medicines. We are already working closely and discussing this
finding with regulatory agencies around the world."
vaccine, RotaTeq, is made by Merck and was approved in 2006. There is no
evidence that the Merck product is affected, Hamburg said. Both vaccines
are given by mouth to infants to prevent rotavirus disease, which is marked
by severe diarrhea and dehydration. Asked whether Merck would be able to
meet the nation's demand, Merck spokeswoman Pam Eisele said, "Obviously,
we will work with the ... FDA to evaluate supply needs." In the next
four to six weeks, the drug agency will convene an advisory committee to
make recommendations and seek input on the use of new techniques for identifying
viruses in vaccine, Hamburg said. "We're not pulling it from the market,
we're just suspending its use during this period while we're collecting
more information," she said. "It should not be in this vaccine
product and we want to understand how it got there. It's not an easy call
and we spent many long hours debating the pros and cons but, because we
have an alternative product and because the background rates of this disease
are not so severe in this country, we felt that the judicious thing to do
was to take a pause, to really ask the critical questions about what this
material was doing in the vaccine, how it got there."
Anthony Fauci, director of the National Institute of Allergy and Infectious
Diseases at the National Institutes of Health, said "a substantial
amount" of the DNA was found in the vaccine. But, he stressed, "there
is no evidence that it causes any disease. ... There is no evidence that
it ever does anything." The research group that discovered the contamination
has asked not to be identified pending its paper's publication in a scientific
journal, Hamburg said. Anyone who has already received a dose of Rotarix
should switch to the Merck product for the next two doses, Hamburg said.
Preliminary testing of the Merck product has found no evidence of the porcine
circovirus 1 DNA, she said. Doctors should be able to tell parents which
of the two products their children received, she said.
stressed that the suspension applies only to the United States. Public health
officials in countries where the incidence of rotavirus is more severe may
decide that the benefits of continuing to use the vaccine outweigh any concerns
raised by the contamination, she said. "Such a decision would be very
understandable," she added.
virus, porcine circovirus 2, also does not cause disease in humans, but
it does cause disease in its pig host, Hamburg said.