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FDA Asks Docs to Suspend Using Glaxo Rotavirus Vaccine
Date:3/22/2010

e said.

Follow-up FDA analysis has confirmed the presence of PCV1 in Rotarix, Hamburg added. "FDA is investigating how the PCV1 DNA came to be present in the vaccine," she said.

The other vaccine available to protect against rotavirus is RotaTeq, also delivered by mouth and made by Merck. RotaTeq was licensed by the FDA in 2006 so most children vaccinated in the United States received RotaTeq, Hamburg said.

RotaTeq is made using a different method, she noted. "Preliminary tests on the RotaTeq vaccine by an academic research team and FDA have not shown the presence of PCV1 DNA," Hamburg said.

RotaTeq requires three doses while Rotarix requires two. That means that children who have already gotten one shot of Rotarix should now get two shots of RotaTeq to be fully vaccinated, Hamburg said.

She stressed that the the FDA recommendation applies only to the United States. Other countries where rotavirus is more common and severe may choose to continue recommending Rotarix. "Such a decision would be very understandable," she said.

In several weeks, the FDA is having an expert advisory committee meeting to make additional recommendations on the use of rotavirus vaccines, Hamburg said.

Thomas Breuer, head of global clinical R&D and chief medical officer of biologicals at GlaxoSmithKline, said in a statement that, "no safety issue has been identified by external agencies or GSK. 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."

"GSK is now reviewing how best to replace, in a timely way, the cell bank and virus seeds used as base production material. In the meantime, and in accordance with the regulators, the company will continue to manufacture Rotarix to the existing approved production and quality standards to meet public hea
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