To: Don W Stone who wrote (358 ) 5/11/1998 11:36:00 PM From: Cacaito Respond to of 507
Safety Experience with a Monocomponent Acellular Pertussis Vaccine: No Reported Hypotonic-Hyporesponsive Episodes in more than 72,000 infants. Presented by J. Taranger, B. Trollfors et all, At the Pediatric Academic Societies Annual Meeting New Orleans, LA May 4, 1998 Results: 1. Previous multicomponent vaccines (Regular Whole cell pertussis) incidence in Sweden was 1 in 3,000. This is cases requiring hospitalizations. 2. Certiva monocomponent vaccine: 0 cases after more than 300,000 doses in more than 100,000 children in Sweden and Denmark. 3. This was based on passive reporting and review of hospitalizations. My comments: I am very favorably impressed with the data. I was in New Orleans for the meeting ( I was presenting my fellowship paper and very honor to present in a meeting of this caliber). I went to the poster presentation and met Dr Taranger, he is very passionate with the subject, but a very strong scientific mind. I was sad that his paper was not in a platform session like other vaccines (Aviron's influenza and RSV, and Rotavirus from another company) cause I think it was very important. But it gave me the opportunity to met Dr Taranger one to one. Most important data was the fact that there was no pertussis vaccine program in Sweeden for 17 years due to their previous whole cell program failure. They thought they will wait only 5 years for a new vaccine. But Certiva effectiveness was proven in a practically virgin population except for the high endemic incidence of pertussis. Part of the decision to developed a monocomponent vaccine was due to the fact that babies protection received from mothers was more effective when antitoxoids antibodies were present. I think Sturza is not right in the scientific aspect of this vaccine. I think Sturza is not right calling prognosis of poor chances of FDA approval. Caveat: I am not a shareholder yet. Observer status only.