US panel rejects GSK pentavalent vaccine

GlaxoSmithKline's pentavalent vaccine for the prevention of diphtheria,tetanus, pertussis, hepatitis B and polio, Infanrix DTaP-HepB-IPV, has failed to win a recommendation for approval from a US Food and Drug Administration advisory committee. The panel was not convinced that the components of the vaccine were as effective in combination as they were when given separately and voted six-five against GSK. One member of the panel abstained.

The vaccine would have formed part of the Infanrix group of vaccines, which recorded sales of L171 million ($250.9 million) last year, and would have been the first product in the USA to target the five diseases with just one injection.

Studies of over 7,000 infants who received more than 20,000 doses of Infanrix DTPa-HepB-IPV showed the vaccine spurred an immune response at least as strong as that seen with individual vaccines, according to GSK, but panel members thought that the most relevant study was too small to clearly show that the combination vaccine worked as well as individual shots. They also expressed concern that 41% of infants given the combination vaccine developed fevers, compared with 29.6% who received separate shots.