Promising data for GSK's otitis media vaccine
The CNN.com story was one of many in the past few days reporting favorably on GSK's vaccine against S. pneumoniae and H. influenza, the two leading causes of acute middle ear infections...
Licensure, however, is likely still a long way off: GSK plans to seek EU approval is 2007, with US approval coming at an unspecified date thereafter.
"The vaccine, called Streptorix, is currently being tested in ongoing Phase III clinical studies.The paper referenced has the catchy title "Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pnemoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study". (Lancet, 4 March 2006 (367):740-748.)Researchers at the University of Defence in the Czech Republic tested the vaccine on nearly 5,000 infants and children under the age of five and said the vaccine reduced the frequency of infection by 65.5 percent.
'This study showed a statistically significant and clinically relevant reduction in episodes of acute otitis media," Dr. Roman Prymula, who headed the Phase III study, reported in the March 4 edition of Lancet.'"
Licensure, however, is likely still a long way off: GSK plans to seek EU approval is 2007, with US approval coming at an unspecified date thereafter.
Labels: GSK, New vaccine targets, Otitis Media


