Philippines fines Sanofi, suspends clearance for Dengvaxia

Monday, 8 January 2018 00:00 - - {{hitsCtrl.values.hits}}

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.

Concepcion Yusop, a national immunisation programme manager, shows dengue vaccine Dengvaxia in Sta. Cruz city, Metro Manila, Philippines. FILE PHOTO: REUTERS

Concerns over the dengue immunisation 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 immunisation program in 2016 to reduce the 200,000 dengue cases reported every year.

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