FDA Recommends Temporary Halt to Use of Rotarix

The FDA is recommending that physicians temporarily suspend use of GlaxoSmithKline's Rotarix rotavirus vaccine because DNA from porcine circovirus 1, or PCV1, has been detected in the vaccine.

FDA commissioner Margaret Hamburg, M.D., said during a March 22 conference call that PCV1 is not known to cause disease in animals or humans. She said the Rotarix rotavirus vaccine, which was approved in 2008, has an excellent safety record, and the recommendation to suspend its use was made out of an abundance of caution.

"This was a difficult decision for us to make because there is no evidence at this time that there is a risk to patients who have received this vaccine," she said, "and we know there are real benefits for children to be vaccinated against rotavirus."

Melinda Wharton, M.D., acting director of the CDC’s National Center for Immunization and Respiratory Diseases, said about 500,000 children die worldwide each year because of rotavirus. The disease caused more than 50,000 hospitalizations and dozens of deaths each year in the United States before vaccines were approved.

It is unclear how PCV1 got into the Rotarix vaccine. It also is unclear whether the material is a DNA fragment or an intact virus. Hamburg said the material was found in the vaccine, cell bank and the viral seed from which the vaccine is derived. That means the material has been present since Rotarix's early development stages, including during clinical trials.

Thomas Breuer, head of global clinical research and development and chief medical officer of GSK Biologicals, said in a March 22 news release that GlaxoSmithKline, or GSK, is determining how to replace 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 health needs worldwide," Breuer said.

GSK said the European Medicines Agency and the World Health Organization, or WHO, are not recommending any changes to the way physicians in Europe and the developing world use Rotarix.

Rotarix has not been recalled in the United States, and physicians are encouraged to continue properly storing -- but not using -- their supplies of the product during the investigation, Wharton said. She said that an advisory committee would meet and make recommendations on how to proceed with the product within four to six weeks.

Hamburg said no significant shortage of rotavirus vaccine is expected. She added that children who have received one dose of Rotarix, of its two-dose regimen, should complete the series with two doses of Merck and Co. Inc.'s three-dose RotaTeq series.

"We are definitely encouraging ongoing rotavirus vaccinations," Hamburg said.

No medical follow up is warranted for children who have been vaccinated with Rotarix, she added.