French pharma move follows FDA’s order to suspend sale, marketing, distribution of Dengvaxia
(Eagle News) — Pharmaceutical firm Sanofi Pasteur said on Tuesday that it was looking to have a “constructive and transparent” dialogue with the Food and Drug Administration.
The French company issued the statement after the FDA ordered the suspension of the sale, distribution and marketing of Dengvaxia following Sanofi’s admission “severe cases” could occur in individuals who have not had the virus but were administered the dengue vaccine.
The FDA, in an advisory, also ordered the withdrawal of Dengvaxia from the market.
“We will continue to seek (the dialogue with the FDA),” Sanofi said, noting that it “will work with (the FDA) to review the implementation of their direction.”
The company also reiterated its suggestion that labels on their products be updated “to include the new data findings and instructions to ensure that physicians can make appropriate vaccination decisions with their parents.”
Even then, Sanofi said Dengvaxia “does not contain any viruses that can make people ill with dengue or severe dengue.”
In a press conference on Monday, Sanofi said that instead, those administered with the drug but who have not been afflicted with the virus beforehand have an “increased risk of hospitalization for dengue and severe dengue, predominantly Grade I or II Dengue Hemorrhagic Fever (DHF)” upon administration of the vaccine.
“Severe dengue can be categorized from milder to more severe forms as DHF I, II, III, and IV according to (the World Health Organization),” the company had said.
“It is estimated that only 1 in 800 of all dengue infections (including symptom-less infections) could lead to a severe infection, and the increased risk identified from the new analysis translated to 2 additional cases of ‘severe dengue’ out of 1000 previously dengue-uninfected people vaccinated over 5 years of follow-up. In this group, all fully recovered with proper medical treatment,” Sanofi added in its recent statement.
Justice Secretary Vitaliano Aguirre has asked the National Bureau of Investigation to look into the dengue vaccine snafu.
The vaccine–which was injected in 733,000 students as part of the government’s vaccination program— was procured during the administration of former President Benigno Aquino III.
His Health Secretary, Janette Garin, noted, however, that vaccine “program plans” were started before her term.