Argentine authorities are exploring a possible link between the deaths of 14 children and an experimental vaccine they were taking in a clinical trial run by GlaxoSmithKline.
Argentina’s food and drug administration is investigating whether the deaths are tied to the Synflorix vaccine, said an agency official who spoke on condition of anonymity.
The drug, designed to fight pneumonia, ear infections and several other pneumococcal diseases, was manufactured by the London-based GlaxoSmithKline PLC, the world’s second-largest drug maker.
Sarah Alspach, a US spokeswoman for Glaxo, said the company was not attributing the deaths to the experimental vaccine, which is being tested in three Latin American countries and in other countries around the world.
An independent board monitoring participants’ safety recommended that the Latin American trials be temporarily suspended — which they were in late June — but then gave its OK for tests to resume, she said.
More than 19,000 babies have received at least one dose of Synflorix, which Glaxo plans to test on a total of 24,000 infants, she said.
The Argentine official, who works at the National Medicine, Food and Medical Technology Administration said the agency “received complaints about irregularities in the recruitment of patients” for the drug trial and on July 31 asked that recruitment be suspended.
Glaxo stopped recruiting the following day, saying it had already gathered the necessary number of participants, the official said.
Ana Maria Marchesse, who heads one of two groups that notified the national food and drug administration, told reporters that she’d witnessed “poor ethical management” of patient recruitment.
“They didn’t explain to the parents that this was an experimental vaccine, and a lot of the parents who signed consent forms were illiterate,” said Marchesse, a pediatrician who heads the Health Professionals’ Labor Association in the northern Argentine province of Santiago del Estero, where she said seven of the 14 children died.
Glaxo’s trial includes thousands of babies in Argentina, where Alspach said 12 children died; in Panama, where another two died; and in Chile.
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