FDA panel rejects combination vaccine

ATLANTA, Georgia (CNN) -- An advisory committee to the U.S. Food and Drug Administration narrowly refused to recommend a combination vaccine manufactured by GlaxoSmithKline, the company said Wednesday.

The panel voted 6-5 with one abstention against Infanrix, a vaccine designed to guard against five common childhood diseases: diphtheria, whooping cough, tetanus, hepatitis B and polio.

The panel questioned the vaccine's immunogenicity, or effectiveness in creating a protective immune response.

In a statement, the drug maker said it will review the panel's discussions. Officials said they are "confident in the vaccine's safety and immunogenicity" and "look forward to working with the FDA to bring Infanrix to market as soon as possible."

Trials of the new vaccine have been promising, according to Dr. Joel Ward of the Center for Vaccine Research at the University of California, Los Angeles.

"We found this new five-combination vaccine was just as effective and just as safe as the existing vaccines," he said.

The advisory committee's decision is not final, but is strongly considered by the FDA when deciding on a drug approval.

A combination vaccine like Infanrix could help assure children get the shots they need when they need them.

A recent study by the Centers for Disease Control and Prevention found that one child in five gets at least one extra vaccine each year, while one-third miss at least one vital shot. Missing a vaccine or getting it at the wrong time could expose a child to illness.

A combination vaccine would have another benefit: fewer painful shots for kids.

A spokesperson for GlaxoSmithKline said the company is confident Infanrix will ultimately be approved.

CNN Medical Correspondent Rhonda Rowland contributed to this report.

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Centers for Disease Control and Prevention - National Immunization Program
American Academy of Pediatrics - Child Health & Safety Information
Immunization Action Coalition and the Hepatitis B Coalition

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