BRIEF—Sanofi appeals Philippines revocation of Dengvaxia's certificate

20 February 2019

French drug major Sanofi's controversial dengue fever vaccine was dealt another blow as the Philippines permanently banned the treatment that created a health scare in the country, reports The Straits Times and other media.

The Philippines' Food and Drug Administration said the French drugmaker failed to submit post-approval documents required by the country's regulator, according to a statement on Tuesday. In December 2017, the organization suspended the vaccine for a year due to similar reasons.

The vaccine has been approved for use in several countries in Latin America and Asia. It received European Commission approval in December last year and is under priority review with the US Food and Drug Administration. However, the drug has hit hurdles in getting into other countries, with local media reporting Malaysia is reviewing the vaccine.

Sanofi appealed the decision and said the regulator was not questioning “the safety and efficacy of Dengvaxia.” The vaccine brings in little revenue, and many analysts started discounting its contribution to Sanofi’s bottom line after researchers found it posed a risk to people who had never suffered from dengue -- putting them at risk of a more severe infection if they got vaccinated.

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