Sanofi to Refund Philippines for Dengvaxia
French vaccines producer Sanofi Pasteur, under pressure from the government of the Philippines, has agreed to refund the country $28 million for unused doses of its Dengvaxia dengue fever vaccine, despite what it said is “no casual link” between the vaccine and the deaths of Philippine children who had taken it.
The government had initially demanded a full refund.
Sanofi noted that “there have been no deaths established to have been causally linked to the dengue vaccine, not even among the closely monitored 40,000 people involved in the clinical trials of the vaccine conducted across 15 countries.”
In November 2017, after the drugmaker released an analysis based on six years of clinical data showing that Dengvaxia could lead to more severe dengue infections for vaccine recipients who had not been previously infected, Philippine health officials immediately suspended the mass immunization program, while at the same time freezing the vaccine’s approval for a year.
The Philippines fined Sanofi a symbolic $2,000 for allegedly failing to meet post-marketing surveillance requirements. Sanofi said the allegation was false. The government also has launched an investigation into the procurement processes for the $70 million vaccination program, which some commentators said had been hastily cobbled together. The Senate of the Philippines is holding hearings into the matter.
In late December, reports said, more than 70 families of vaccinated children had filed for criminal prosecution of former government officials, including ex-President Benigno Aquino III, former Department of Health (DOH) chief Janette Garin and two other government officials, as well as five Sanofi executives including CEO Olivier Brandicourt and Asia-Pacific head Thomas Triomphe.
The Phliippines Public Attorney’s Office performed autopsies on children who died after receiving Dengvaxia, with initial results finding that the common causes of death included bleeding in vital organs consistent with severe dengue, or dengue shock syndrome.
Current DOH chief, Francisco Duque III, has been quoted widely as saying Dengvaxia cannot be directly linked with those deaths unless experts reach that conclusion. A wider-reaching investigation may be conducted.
