Tuesday, September 29, 2009

Cervarix related death in UK

A 14 year old girl in Coventry UK died after receiving a jab of the HPV vaccine Cervarix (GSK). While not acknowledging that the death was directly attributable to safety issues pertaining to Cervarix, the FDA has delayed its review of the safety and efficacy of the GSK vaccine. GSK has meanwhile voluntarily realled the batch of vaccine.

I have posted on the HPV vaccine before. HSA had ahead of the FDA approved the vaccine for girls/women between the ages of 9-26. The discussion then had been the off label use of the vaccine for women outside of this age range.

This latest fatal adverse event will make a signficant dent in GSK's attempt to compete with the Merck vaccine. The GSk vaccine apparently induces a stronger response because it containsthe controversial suqalene adjuvant AS03. Unlike the Merck vaccine which covers 4 strains, the GSK product covers only 2.

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