Philippines halts sale of dengue vaccine as Sanofi downplays risk
Dec 05 2017 by Kathy Alvarado
Yesterday, the Philippines government ordered an investigation into the immunisation of more than 7.3 lakh children with the company's denguevaccine.
The Philippines banned a government program, which involved immunizing children with Dengvaxia after releasing Sanofi's findings. One such country, the Philippines, announced it would launch an investigation into the purchase of Sanofi's vaccine, and its Department of Health has put the vaccination program on hold.
The Philippines has suspended the sale and distribution of the Dengue Tetravalent Vaccine, the drug locally registered as Dengvaxia, the Philippine Food and Drug Administration (FDA) said Tuesday.
"Like many others in the Philippines, WHO is awaiting the expert analysis of new data and advice about its implications for use of the vaccine".
The Food and Drug Administration (FDA) called on the public to partake in the "post-marketing surveillance of Dengvaxia" by reporting any incident that shows the dengue vaccine has led to death, serious illness, or injury of a patient.
The WHO, which issued a report identifying the vaccine's safety risk in mid-2016, recommended it only be used in people who had prior dengue infection.
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"In this group, all fully recovered with proper medical treatment".
Dengvaxia, the first approved Dengue vaccine, had been forecast by Sanofi to eventually bring in almost $1 billion in annual sales.
"These included the following: first, use of the vaccine should only be considered in areas where a high proportion (preferably at least 70%) of the community had already been exposed to the virus; second, the vaccine should only be provided to people 9 years of age and above; and third, people being vaccinated should receive 3 doses", it said.
As of November 2017, about 733,713 Filipino children have been given the anti-dengue vaccine. But even recent more modest analysts' sales forecasts are now looking unattainable given the safety issue and clinical evidence revealing unequal protection against different strains of dengue. The organization has said that it hoped to conduct a full review by the end of the year on the vaccine.
It was a damaging admission from the company, which had secured approval of the shot in 19 countries - several of which had run public immunization drives.