There is no joy in this report.
Somewhere, a family is grieving the loss of a child. The FDA has announced today that a death by intussusception has been reported by Merck, maker of Dr. Paul Offit's RotoTeq vaccine. You may recall that the last Rotovirus vaccine was pulled a decade ago for the same reason. The only reports we can find so far are from stock market sites.
Here's one from Street Account. The death was disclosed in a letter posted on the FDA site, and dated today. In the letter, the FDA says that it received Merck's April 14 supplement to its BLA for RotaTeq, to include changes to the post-marketing experience section of the label to include a post-marketing report of a death due to intussusception that has occurred after vaccination with RotaTeq. StreetAccount notes that in a February 2007 update, the FDA announced that there had been 28 post-marketing reports of intussusception with RotaTeq, but said that there had been no deaths and that the incidence rate did not exceed the number expected based on background rates in the unvaccinated population. Sanofi is Merck's partner on RotaTeq, which competes with GSK/AVAN's Rotarix.
From TradeTheNews.com: Merck & Co Inc Update: FDA reports a death after vaccination with Rotateq - death from intussusception (bowel obstruction) will be added to prescribing information for doctors.
In additional news, the FDA has sent a letter to Merck ordering the company to clean up violations at its PA vaccine plant: The nine-page warning letter gives Merck 15 days to tell the FDA how it will correct the violations. Otherwise, the FDA says it could suspend the plant's manufacturing license and seize products.
Read more HERE.