January 4, 2018 / 11:42 AM / 19 days ago

Philippines fines Sanofi, suspends clearance for Dengvaxia

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 marketing, the health secretary said on Thursday.

Concerns over the dengue immunisation of nearly 734,000 children aged nine and above resulted in two Philippine congressional inquiries and a criminal investigation.

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 told Reuters.

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

“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 said in an emailed statement.

The government spent 3.5 billion pesos ($70 million) on a Dengvaxia public immunisation programme in 2016 to reduce the 200,000 dengue cases reported every year.

($1 = 49.8500 Philippine pesos)

Reporting by Neil Jerome Morales; additional reporting by Matthias Blamont; editing by Gopakumar Warrier and Jason Neely

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