MANILA (Reuters) – The Philippines has suspended clearance for Sanofi’s dengue vaccine Dengvaxia and fined the French drugmaker a symbolic $2,000 citing violations on product registration and advertising and marketing, the well being secretary mentioned on Thursday.
Concerns over the dengue immunisation of practically 734,000 youngsters aged 9 and above resulted in two Philippine congressional inquiries and a felony investigation.
The nation ordered Sanofi to cease the sale, distribution and advertising and marketing of Dengvaxia after the corporate final month warned the vaccine might worsen the illness in some instances.
“They were fined and their certificate of product registration was suspended,” Health Secretary Francisco Duque informed Reuters.
The Food and Drugs Administration of the Philippines discovered Sanofi violating post-marketing surveillance necessities, he mentioned.
“Sanofi Pasteur will continue to cooperate in full transparency with the Philippines FDA and is committed to comply with the Philippines laws and regulations,” a Sanofi spokesman mentioned in an emailed assertion.
The authorities spent three.5 billion pesos ($70 million) on a Dengvaxia public immunisation programme in 2016 to scale back the 200,000 dengue instances reported yearly.
($1 = 49.8500 Philippine pesos)
Reporting by Neil Jerome Morales; further reporting by Matthias Blamont; enhancing by Gopakumar Warrier and Jason Neely