Rotavirus vaccine suspended after virus is detected

Mary Glode, MD, a pediatric infectious disease specialist in Denver, has been answering calls from physicians concerned that the Food and Drug Administration's suspension of a rotavirus vaccine was the result of a major safety issue.

It wasn't, said Dr. Glode, a professor of pediatrics and head of pediatric infectious diseases at the University of Colorado School of Medicine, and a member of the American Academy of Pediatrics Committee on Infectious Diseases. "We tell them that we're going to wait around with everyone else for more information."

The FDA recommended March 22 that physicians stop administering the oral GlaxoSmithKline vaccine Rotarix until further research is conducted on a virus found in the vaccine. The virus, porcine circovirus type 1, is not known to cause illness in humans.

The FDA said doctors can still use Merck's RotaTeq rotavirus vaccine.

"Rotarix was extensively studied before and after approval, and was found to have an excellent safety record. However, finding this material was unexpected, and the FDA believes it's prudent to carefully assess the situation," said Jill S. Burkoff, consumer safety officer in the FDA's Center for Biologics Evaluation and Research.

FDA researchers are investigating whether the PCV1 components are an intact virus, which could possibly replicate within the host cell, or just DNA fragments. An advisory committee convened by the FDA also will assess vaccine testing methods, as well as new and more advanced screening tools.

An independent U.S. academic research team detected PCV1 components in Rotarix. Follow-up tests by GSK and FDA scientists confirmed viral components of PCV1 have been present in the vaccine since the early stages of development, including during clinical studies, the FDA said.

Before RotaTeq was licensed in 2006 and Rotarix in 2008, rotavirus led to more than 50,000 hospitalizations and several dozen deaths in the U.S. each year, the FDA said. Worldwide, the disease is responsible for more than 500,000 infant deaths annually.

The Centers for Disease Control and Prevention recommends children receive the first oral dose of rotavirus vaccine at age 2 months and the second dose at 4 months. Merck's RotaTeq requires a third dose, at 6 months.

Children who received one dose of Rotarix should be given RotaTeq for the next two doses, the CDC said.