Components of Extraneous Virus Detected in Rotarix Vaccine;

No Known Safety Risk

FDA Recommends Clinicians Temporarily Suspend Use of Vaccine

as Agency Learns More

FDA is recommending that healthcare practitioners temporarily suspend use of the

Rotarix vaccine for rotavirus immunization in the United States while the agency

learns more about components of an extraneous virus detected in the vaccine. 

There is no evidence at this time that this finding poses a safety risk.

team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1)

in Rotarix, which is manufactured by GlaxoSmithKline.  PCV1 is not known to

cause illness in humans or other animals.  In addition, Rotarix has been studied

extensively, before and after approval, and found to have an excellent safety record.

Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic

team’s findings and confirmed that viral components have been present since the

early stages of the vaccine’s development, including during clinical studies.  Preliminary

testing by both the academic researchers and FDA scientists of another licensed vaccine

against rotavirus infection, RotaTeq, has not detected components of PCV1.

"We are making clinicians aware of information recently received by FDA about the

Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs.

“There is no evidence at this time that there is a safety concern.  FDA is recommending

that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. 

We will keep the public and the clinical community updated on our findings.”

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease,

which can cause severe diarrhea and dehydration and is estimated to be responsible for

the deaths of more than 500,000 infants around the world each year, primarily in low-

and middle-income countries.  Before the introduction of a rotavirus vaccine, rotavirus

resulted in more than 50,000 hospitalizations and several dozen deaths in the United

States each year.  FDA licensed RotaTeq in 2006 and Rotarix in 2008.  Most children

vaccinated in the United States received RotaTeq.

“In many countries, rotavirus causes so much severe illness and death that the known

benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the

vaccine,” said Dr. Thomas Frieden, Director of the Centers for Disease Control and

Prevention.  “We anticipate that many countries will decide to continue vaccinating

with Rotarix while more information becomes known.”

FDA will continue to gather more information about the PCV1 components in Rotarix,

including whether intact virus, as opposed to DNA fragments, is present.  The agency

is assessing current vaccine testing methods.  In four to six weeks, FDA will convene

an expert advisory committee and make additional recommendations on the use of

rotavirus vaccines.

FDA will provide updates to patients, providers, and the general public as more

information becomes available.  The agency will also continue to communicate with

the World Health Organization and counterpart regulatory agencies in other countries.