Sanofi says no reported deaths linked to dengue vaccine Dengvaxia in the Philippines

Sanofi said Monday that there had been no reported deaths linked to its dengue vaccine Dengvaxia in the Philippines. "As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination," said Ruby Dizon, medical director at Sanofi Pasteur Philippines, adding "monitoring is continuing."

More than 730 000 children in the Philippines received Dengvaxia as part of the country's dengue immunisation programme, although the effort was put on hold last week following new data on the vaccine. Sanofi recently said that it would ask regulatory authorities, in countries where Dengvaxia is approved, to limit the use of the vaccine to people who were previously infected by the virus.

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According to Sanofi, an analysis of the long-term safety and efficacy of Dengvaxia based on as much as six years of clinical data found that the vaccine was persistently protective in patients who had been previously infected by the dengue virus. However, for individuals not previously infected by the virus, the company stated that in the longer term, more cases of severe disease were possible after immunisation upon a subsequent dengue infection. 

Also on Monday, the Philippines' Department of Justice ordered the National Bureau of Investigation to look into "the alleged danger to public health...and if evidence so warrants, to file appropriate charges thereon."

Dengvaxia was initially approved in 2015 in Mexico as the world's first dengue vaccine to gain regulatory clearance. The World Health Organization's Strategic Advisory Group of Experts on Immunization later backed use of the vaccine in countries with high dengue transmission.

 

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