March 23, 2010 — 9:12am ET | By George Miller
Contamination has led to a temporary halt in the use of a childhood vaccine and to a separate drug recall expansion.
GlaxoSmithKline's oral rotavirus vaccine Rotarix has been temporarily shelved in the U.S. due to a pig-virus contamination. Researchers stumbled on DNA from porcine circovirus type 1--believed nonthreatening to humans--while using new molecular detection techniques. More work is being done to determine whether the whole virus or just DNA pieces are present.
Additional testing has confirmed presence of the matter in the cell bank and seed from which the vaccine is derived, in addition to the vaccine itself. So the vaccine has been contaminated since its early stages of development.
GSK says it is now reviewing how best to replace the cell bank and virus seeds used in making the vaccine, but it will continue Rotarix production using current methods. The FDA, for its part, says it is assessing current vaccine testing methods.
Separately, The Medicines Company has added four lots to the 11 lot recall initiated last December for IV blood pressure medication Cleviprex. Members of the quality team spotted particle contamination during an inspection, prompting the recall. The visible contamination comprises sub-visible stainless steel particles, the company says.
The contamination could "theoretically" reduce blood flow in capillaries, damage tissues, or cause inflammatory reactions, according to the recall notice. The company asks that treatments from the affected lots be returned via wholesaler or distributor.
Click on title above for working links to the below articles;
- here's the Cleviprex recall announcement
- see the FDA's Rotarix announcement
- here's GSK's statement
- see this Rotarix recall article
FDA tells doctors to temporarily halt Rotarix shots
Read more: http://www.fiercepharmamanufacturing.com/story/pig-virus-halts-gsk-rotarix-use/2010-03-23?utm_medium=nl&utm_source=internal#ixzz0j1ZvfWEu