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Philippines' FDA halts sales of Sanofi's dengue vaccine

Published on 19/02/19 at 12:22pm

The marketing authorisation for Sanofi’s dengue vaccine Dengvaxia has been revoked in the Philippines after the country’s Food and Drug Administration accused the French drugmaker of failing to comply with its stipulated post-marketing requirements.

The decision means that all sales, distribution and marketing of Sanofi’s product in the country are currently on hold. The drugmaker is being reprimanded for what FDA Director General Nela Charade Puno called a “brazen defiance” of his organisation’s directives.

The FDA confirmed that Sanofi would be able to reapply for its product license to resume sales and marketing practices, but said application would be treated as “high risk”.

The revelations follow a troubled roll-out of the Dengvaxia vaccine in the Philippines in 2016 and 2017. After the nation’s government had committed 3.5 billion pesos ($67 million) to an immunisation project which aimed to reduce the 200,000 reported cases of dengue fever each month, Sanofi revealed that the vaccine could actually increase the risk of contracting a severe form of the disease in children who had never contracted the virus.

By this point, 800,000 schoolchildren had already received the vaccine, triggering a criminal investigation as Sanofi refused to provide refunds or compensation for the already-used doses.

Matt Fellows

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