FDA Advisory Committee Rejects Combination Vaccine

March 12, 2001

ATLANTA, Ga-An advisory committee has narrowly rejected to recommend a combination vaccine for children after questioning the vaccination's immunogenicity.

Infanrix, manufactured by GlaxoSmithKline, was voted down by a 6-5 vote. There was one abstention.

The vaccine is designed to guard against five common childhood diseases: diphtheria, whooping cough, tetanus, hepatitis B, and polio. The panel said the vaccine would not be recommended to the FDA because they questioned its effectiveness in creating a protective immune response.

The advisory panel's decision is not final; although, it is strongly considered by the FDA when approving new drugs.

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