Published: Tue, December 05, 2017
Medicine | By Brett Sutton

Trouble mounts for Sanofi dengue vaccine over safety concerns

Trouble mounts for Sanofi dengue vaccine over safety concerns

The Philippines government has ordered an investigation into a suspended dengue vaccine manufactured by the French company Sanofi Pasteur after the manufacturer recommended a limited use of the vaccine and said it could cause severe dengue cases among vaccinated people who have had no prior dengue infection.

The Philippines banned a government program, which involved immunizing children with Dengvaxia after releasing Sanofi's findings.

"In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA", FDA said in an advisory. The WHO Country Office said this position paper was "based on recommendations of the Strategic Group of Experts on Immunisation which met and published preliminary advice in mid-April 2016". An analysis of long-term clinical data had revealed that, in individuals who had never contracted dengue, the vaccine could make subsequent infections more severe.

A nurse arranges boxes of Sanofi's dengue vaccine Dengvaxia, which have been recalled from local health centers, in the district of Manila on December 5, 2017.

The safety fears involve possible increased risk to people who had not previously been exposed to the dengue virus prior to vaccination with Dengvaxia.


"In this group, all fully recovered with proper medical treatment". The scare surrounding the disease, which upon infection can progress to progress to the deadly dengue haemorrhagic fever or dengue shock syndrome, has led scientists to develop the world's first ever dengue fever vaccine called the Dengvaxia vaccine.

The Department of Health procured P3 billion worth of Dengvaxia intended for one million public school children in areas reported to have the highest incidence of dengue in the same year. The country was among the first to use Dengvaxia on children at least nine years old.

The WHO said on Monday it hoped to review safety data this month on Sanofi's dengue vaccine which the company said was approved in 19 countries and launched in 11.

Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.

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