Source: DGNews  |  Posted 1 year ago

ROCKVILLE, Md -- March 22, 2010 -- The US Food and Drug Administration (FDA) is recommending that healthcare practitioners temporarily suspend use of the rotavirus vaccine (Rotarix) 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.

The European Medicines Agency (EMEA) is also aware of this new information relating to the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine. The Committee has therefore requested the manufacturer, GlaxoSmithKline, to provide further information as a matter of urgency.

Using a novel technique, researchers have found DNA from porcine circovirus 1 (PCV1) in the vaccine. 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.

“There is no evidence at this time that there is a safety concern,” said Margaret A. Hamburg, Commissioner for Food and Drug, FDA, Rockville, Maryland. “The 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.”

“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 Thomas Frieden, MD, Centers for Disease Control and Prevention, Atlanta, Georgia. “We anticipate that many countries will decide to continue vaccinating with Rotarix while more information becomes known.”

The 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 4 to 6 weeks, the FDA will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

SOURCE: US Food and Drug Administration