New Generation Vaccine?

GlaxoSmithKline is touting new, late-stage data that demonstrates how its experimental pediatric vaccine Synflorix effectively protects children from pneumococcal disease. Glaxo filed Synflorix for review by the EMEA at the beginning of the year. The new data illustrates its protection against 10 strains of streptococcus pneumoniae, which includes bacteria that causes meningitis, pneumonia and ear infections. If Glaxo prevails in its quest for regulatory approval, Synflorix will go up against Wyeth’s Prevnar, which targets seven of the 10 strains.

“The data presented today are extremely encouraging and represent a major step forward to a pneumococcal conjugate vaccine formulation, specifically designed to address the global epidemiology of pneumococcal disease in both developed and developing countries,” says Jean Stéphenne, president of GlaxoSmithKline Biologicals.

Encouraging? Maybe they missed the part where babies have died during the trials. Or maybe they find those babies simply..expendable? Informed Consent, what happened to that? Read excerpts below…

Authorities in Argentina are investigating whether there is a link between the deaths of 14 children and an experimental vaccine.

The children took Synflorix as part of a clinical trial run by the British pharmaceutical company Glaxo-SmithKline.

Synflorix is also being tested in Panama, Chile and some European countries, but it is not being tested in Britain.

The company is still enrolling participants. But officials at Argentina’s food and drug administration said the agency had ‘received complaints about irregularities in the recruitment of patients’ for the drug trial and on July 31 asked that recruitment be suspended.
GSK stopped recruiting the following day, saying it had already gathered the necessary number of participants.
Ana Maria Marchesse, who heads one of two groups that notified the national food and drug administration, said that she had witnessed ‘poor ethical management’ of patient recruitment, with participants being unaware they were being given an experimental drug.

Data from other studies shows that the vaccine is about as safe and tolerable as competitor Wyeth’s Prevnar, a vaccine widely used against pneumococcal disease, Miss Alpsach added.

However, the Argentinian province of Santiago del Estero is conducting a separate inquiry into the deaths of the seven children there, local health minister Franklin Moyano said.




In Argentina…Did Glaxo know that many of those who signed consent forms were illiterate? They also gave the vaccine first, then a consent form afterwards. When asked to have recruitment suspended for safety reasons, they just happen to have enough ‘guinea pigs’…
I don’t know about you, but something sure smells funny to me..

 Remember the name, Synflorix, as it may be knocking on your doctor’s door soon. It is expected to go up against the present Prevnar vaccine that targets only 7 strains. Wyeth, they hope to have their new version, that targets 13 strains, out by 2009.








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