FDA Advisory Committee Rejects Combination Vaccine

Article

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.

Related Videos
Patient Safety: Infection Control Today's Trending Topic for March
Infection Control Today® (ICT®) talks with John Kimsey, vice president of processing optimization and customer success for Steris.
Picture at AORN’s International Surgical Conference & Expo 2024
Infection Control Today and Contagion are collaborating for Rare Disease Month.
Rare Disease Month: An Infection Control Today® and Contagion® collaboration.
Vaccine conspiracy theory vector illustration word cloud  (Adobe Stock 460719898 by Colored Lights)
Rare Disease Month: An Infection Control Today® and Contagion® collaboration.
Infection Control Today Topic of the Month: Mental Health
Infection Control Today's topic of the month: Mental Health
Related Content