Monday, March 22, 2010, 15:54 EDT (03:54 PM EDT)
CDCHAN-00311-2010-03-22-ADV-N
Recommendation to Temporarily Suspend Usage of GlaxoSmithKline Rotarix (Rotavirus) Vaccine
Summary: The U.S.
Food and Drug Administration (FDA) has learned that DNA from porcine circovirus
type 1 (PCV1), a virus not known to cause disease in humans, is present in the Rotarix vaccine. All
available evidence indicates that there has been no increased risk to patients
who have received this vaccine. PCV1 is
not known to cause any disease in animals or humans; therefore, it has not been
routinely tested for in vaccine development.
Rotarix has been extensively studied, before and after approval, and
found to have an excellent safety record (i.e., no unusual adverse events).
However, FDA is recommending that healthcare practitioners temporarily suspend usage
of the Rotarix vaccine for rotavirus immunization in the
Background
FDA has learned that DNA from porcine circovirus type 1 (PCV1) is
present in the Rotarix vaccine. This
finding was reported to FDA by GlaxoSmithKline on March 15th, 2010,
based on work originally performed by an academic research team using a novel
technique to look for viruses.
GlaxoSmithKline then conducted additional studies and confirmed that
PCV1 DNA is present in the finished Rotarix vaccine, as well as in the cell
bank and seed from which the vaccine is derived. This finding suggests that the PCV1 DNA has
likely been present since the early stages of the vaccine's development.
Rotavirus vaccines are given by mouth to young infants to prevent
rotavirus disease, which can cause severe diarrhea and dehydration. Each year, rotavirus disease causes more than
500,000 deaths in infants globally, and more than 50,000 hospitalizations and
several dozen deaths in the
Recommendations
While FDA is learning more about the situation, the agency is
recommending that clinicians temporarily suspend the use of Rotarix. This recommendation applies to all lots of
the Rotarix vaccine. RotaTeq vaccine is
available for rotavirus immunization during this period. For children who have
received one dose of Rotarix, CDC advises that clinicians complete the
series with RotaTeq for the next two doses.
Since RotaTeq was licensed in 2006 and Rotarix in 2008, most
children vaccinated in the
FDA is obtaining additional information about the presence of PCV1
DNA in Rotarix, including whether intact virus (as opposed to DNA components)
is present. FDA is also investigating
how the PCV1 DNA came to be present in the vaccine.
Within the next four to six weeks, FDA will convene an advisory
committee to review the available data and make recommendations on the licensed
rotavirus vaccines. FDA will also seek
input on the use of new techniques for identifying viruses in vaccines. The agency anticipates that following the
advisory committee meeting, based on expert input and additional review, FDA
will make further recommendations on the use of the two licensed rotavirus
vaccines in the
The recommendations detailed above are for the
Clinicians are requested to report any suspected adverse events
following Rotarix vaccination to the Vaccine Adverse Event Reporting System
(VAERS) via phone 800-822-7967 or on-line: http://vaers.hhs.gov.
For More Information:
FDA intends to provide frequent updates to patients, providers,
and the general public as its understanding evolves. Additional information is available at: www.fda.gov.
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- Page last reviewed: April 29, 2011 5:00 PM ET
- Page last updated: April 29, 2011 5:00 PM ET
- Content source: CDC Emergency Risk Communication Branch (ERCB), Division of Emergency Operations (DEO), Office of Public Health Preparedness and Response (OPHPR)
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