January 4, 2018 / 6:12 AM / 7 months ago

Philippines fines Sanofi, suspends clearance for Dengvaxia

MANILA (Reuters) - The Philippines has fined Sanofi $2,000 and suspended clearance for the French drug maker’s controversial dengue vaccine Dengvaxia, citing violations on product registration and marketing, its health secretary said on Thursday.

FILE PHOTO: Concepcion Yusop, a national immunisation programme manager, shows dengue vaccine Dengvaxia in Sta. Cruz city, Metro Manila, Philippines December 4, 2017. REUTERS/Romeo Ranoco/File Photo

Concerns over the dengue immunization of nearly 734,000 children aged nine and above resulted in two Philippine congressional inquiries and a criminal investigation as to how the danger to public health came about.

The country ordered Sanofi to stop the sale, distribution and marketing of Dengvaxia after the company last month warned the vaccine could worsen the disease in some cases.

“They were fined and their certificate of product registration was suspended,” Health Secretary Francisco Duque said told Reuters.

The Food and Drugs Administration of Philippines found Sanofi violating post-marketing surveillance requirements, he added.

Sanofi was not immediately available for comment.

The government spent 3.5 billion pesos ($70.2 million) for the Dengvaxia public immunization program in 2016 to reduce the 200,000 dengue cases reported every year.

Reporting by Neil Jerome Morales; Editing by Gopakumar Warrier

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