Sanofi Pasteur Officials Could Be Charged With ‘Reckless Imprudence Resulting to Homicide’
Dengue vaccine Dengvaxia is approved in 20 countries and is pending approval by the US FDA
According to media reports, the Philippine government said they would file criminal charges against 6 officials of Sanofi Pasteur, the French pharmaceutical firm which produces Dengvaxia, a Dengue virus vaccine.
The Philippine Justice Department said on February 1, 2019, its prosecutors found grounds to hold Sanofi officials criminally liable and that charges of "reckless imprudence resulting to homicide" will be filed in court, reported Agence France-Presse, with The Nation.
The department said the charges were based on an investigation into the deaths of 10 children, adding other complaints were still being probed.
Dengue infection can progress unpredictably to a life-threatening form of the disease called dengue hemorrhagic fever, says the US Centers for Disease Control and Prevention (CDC).
During December 2018, Dr. Eric Domingo, a Philippine Department of Health spokesperson said, ‘The Dengvaxia vaccine ban will not be lifted anytime soon.’
This Philippine announcement follows recent news that at least 28 un-vaccinated people have died of complications arising from the dengue fever virus in the Philippines since January 1, 2019.
Sanofi criticized Manila's decision to file charges and vowed to defend the officials.
"We strongly disagree with the conclusions reached against Sanofi and certain of its employees and we will defend them vigorously," said Sanofi in a written statement.
Sanofi has repeatedly said the Dengvaxia vaccine is safe, noting in a March 2018 statement: "No causal-related deaths were reported in 15 countries after clinical trials conducted for more than a decade with 40,000 subjects involved."
During September 2018, the World Health Organization report the Dengvaxia dengue vaccine should only be administered to individuals who have previously been confirmed to have had a specific type of dengue infection.
With more than one-third of the world’s population living in areas at risk for infection, the dengue virus is a leading cause of illness and death in the tropics and subtropics.
As many as 400 million people are infected yearly.
Dengue endemic areas include parts of the Caribbean, Central and South America, Western Pacific Islands, Australia, Southeast Asia, and Africa.
Contrary to the Philippines legal threat, other countries are embracing the Dengvaxia vaccine.
On December 19th, 2018, the European Commission granted marketing authorization for the Dengvaxia vaccine in dengue virus endemic areas in Europe.
Additionally, the United States Food and Drug Administration (FDA) has granted Dengvaxia Priority Review status, as an unmet medical need. The FDA has set a Prescription Drug User Fee Act action date of May 1, 2019.
Vaccines, like any medicine, can have side effects. You are encouraged to report negative side effects of vaccines to the FDA or CDC.