BUENOS
AIRES, Argentina – Authorities are inquiring a possible association
between the deaths of 14 kids and an experimental vaccine administered
to them in a clinical trial, conducted by GlaxoSmithKline (GSK).
They are investigating whether the deaths are linked to the
Synflorix vaccine, said an agency official. The drug, made to fight
against pneumonia, ear infections and several other pneumococcal
diseases by the London-based GSK, the world’s second-largest drug maker.
A U.S. spokeswoman for Glaxo, Sarah Alspach, said “the company is
not attributing the deaths to the experimental vaccine, which is being
tested in three Latin American countries and in other countries around
the world.”
“We rely on their safety review,” Alspach said. “Safety is our
primary concern, always, with the development of any new treatment.”
More than 19,000 babies have taken at least one shot of Synflorix, which Glaxo decided to test on 24,000 infants, she said.
Ana
Maria Marchesse witnessed “poor ethical management” of patient
recruitment, a member of national food and drug administration, told
The Associated Press.
“Parents were unaware that this was a trial vaccine, and most of the
parents who signed consent forms were illiterate,” said Marchesse.
“In few cases, they first gave children the vaccine and then gave
parents a 13-page consent form to sign that I had to read three times
to understand,” she added.
Glaxo’s enrolled thousands of babies for trial in Argentina. Alspach
said 12 kids died in Panama, and another two died in Chile. The death
rate in neonates with pneumonia is 4 – 5 out of 1000 births in these
countries.
Data from various studies show the drug is as safe and tolerable as competitor Wyeth’s best-seller Prevnar.
Still, the Argentine province of Santiago del Estero is trying to
find out the reason of the deaths of the seven children there, local
Health Minister Franklin Moyano told state news media.
“While legal authorities investigate, we’re in an observation phase
to see if everything happened as expected, or if there were deviations
that caused damage, in this case the death of seven kids,” he said.
