Philippine officials took a tough stance when Sanofi disclosed its Dengvaxia shot could cause more serious dengue cases if given to patients without a previous infection—just as the country was in the midst of a broad vaccination campaign. Now, they’ve taken the issue a step further by finding probable cause to indict Sanofi and government officials.
The Philippine Department of Justice released a 127-page resolution Friday outlining allegations of “reckless imprudence resulting to homicide” in connection with the vaccine’s rollout, which officials say led to the deaths of 10 children.
Prosecutors have so far focused on six Sanofi officials, plus a range of government administrators, including former Department of Health secretary Janette Garin and managers in the Department of Health, the Food and Drug Administration, and the Research Institute for Tropical Medicine.
The reckless imprudence charge carries a potential sentence of up to six years in prison for each count.
After reviewing the case, prosecutors concluded the defendants implemented a mass vaccination program with “inexcusable lack of precaution and foresight” and circumvented regulations in the process. The vaccine wasn’t yet approved when the government purchased it, prosecutors said, and the shot didn’t meet qualifications for an exception. Clinical trials weren’t complete when officials moved forward with the campaign, they said.
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Officials in charge made even more mistakes during the rollout, prosecutors say. Dengvaxia was intended to be administered by physicians and nurses who could inform patients about efficacy and risks, but volunteer health workers administered the shots instead. Parents said their children weren’t asked for a basic health history, and some children appeared sick when they received the shot, the DOJ said.
The department said Sanofi failed to monitor vaccine recipients and didn’t offer medical assistance after reports arose about serious adverse events.
Sanofi says it “strongly” disagrees with the findings and will “vigorously” defend its employees.
“As this is an ongoing proceeding, it would not be appropriate for us to comment further at this time,” a spokesman added.
RELATED: Sanofi’s Dengvaxia needs a dengue diagnostic, stat, thanks to WHO
Sanofi rolled out its vaccine in 2016 and disclosed in late 2017 that the shot can cause more serious dengue cases if given to those who haven’t had a prior infection. The announcement sparked outrage in the Philippines. Officials quickly called off a mass vaccination campaign and started up investigations.
Now, the World Health Organization says further use of the shot should be supported by an on-site dengue diagnostic to show whether patients have been infected before—a diagnostic which doesn’t yet exist. Sanofi has said it’s working to develop one.
The company isn’t giving up on its vaccine despite the controversy; it recently won European approval and is pushing for a U.S. nod.
Meanwhile, Takeda could be close behind with a competitor. The company recently reported positive results for a phase 3 study of its TAK-003.
