Regulators in the Philippines on Tuesday ordered the suspension of sales of Sanofi's dengue vaccine Dengvaxia in the country. The decision, which also includes the withdrawal of the vaccine in the Philippines, comes after the nation recently halted its dengue immunisation programme in the wake of safety concerns over Dengvaxia.
The Philippines Food and Drug Administration also directed Sanofi to conduct an information dissemination campaign, while all drug establishments have been ordered to disclose cases in which the vaccine was a suspected cause of death or severe illness. Earlier this week, Sanofi reported that it has not identified any deaths related to vaccination with Dengvaxia in the Philippines.
The World Health Organization, which previously backed use of the vaccine, said Tuesday it supported the decision by the Philippines to suspend the use of Dengvaxia until more information was available. The agency, which recently said it hopes to complete a review of Dengvaxia by the end of the year, noted that its Strategic Advisory Group of Experts on Immunization would meet to review evidence next week.
The news comes after Sanofi revealed in November that it intends to ask global regulatory authorities to restrict the use of Dengvaxia to certain patients. In a long-term safety and efficacy analysis, the drugmaker discovered that among people with no prior dengue virus infection, immunisation with Dengvaxia could lead to more severe disease in the long term.
"Only one in 800 of all dengue infections…could lead to a severe infection, and the increased risk identified from the new analysis translated to two additional cases of 'severe dengue' out of 1000 previously dengue-uninfected people vaccinated over five years of follow-up," Sanofi stated, adding "in this group, all fully recovered with proper medical treatment."
Dengvaxia was initially authorised for use in Mexico in 2015, becoming the first dengue vaccine to win regulatory approval globally.
To read more Top Story articles, click here.