pharmafileJanuary 31, 2018
Tag: Dengvaxia , Sanofi , Dengue
In the latest development in Sanofi’s Philippines dengue vaccine scandal, the nation’s Department of Health has demanded that the French pharma firm pay out a full refund of the 3 billion Philippine pesos the government paid to immunise its citizens "because the purported or reported or claimed protection [of Dengvaxia] wasn’t felt and wasn’t there."
The demands were issued by Health Secretary Francisco Duque III, who had previously asked that Sanofi only pay back P1.5 billion ($28 million) to cover the unused Dengvaxia vials in the DOH’s warehouses – a request which the pharma firm acquiesced to, confirming that it would "shoulder the cost" of adverse events caused as a result of vaccination.
"Should there be any case related to vaccination, death or any other case, we will shoulder the cost, if there is a causality that has been demonstrated through scientific evidence," said Sanofi Pasteur Asia-Pacific head Thomas Triomphe at a Senate hearing last week.
The rollout of the Philippines $70 million vaccination effort of 837,000 children against dengue has become a catastrophe after Sanofi revealed that, after six years of clinical research, Dengvaxia can cause severe symptoms of dengue if a patient has not been infected by the virus prior to immunisation. The programme has since been shut down and Sanofi was fined $2,000, but the DOH is now surveilling affected children, and will do so for the next five years.
Sanofi maintains that Dengvaxia has not been linked to any deaths, citing the findings of an expert panel from the Philippine General Hospital. "This finding is consistent with the fact that Sanofi Pasteur has not had any reports of deaths due to vaccination in any of the clinical studies of the vaccine involving over 40,000 people nor in the public or private use of Dengvaxia where over one million doses of the vaccine have been administered in several endemic countries," a Sanofi spokesperson reported.
"Sanofi has been and will continue to work with the Philippines regulatory authorities, Department of Health and all other health and community organisations to collaborate and cooperate in finding the best solution for dengue prevention in the Philippines."
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