The Philippines has ordered French drugmaker Sanofi to stop the sale, distribution and marketing of its Dengvaxia dengue vaccine in the country after the company last week warned it could worsen the disease in some cases.
The move comes days after the Southeast Asian nation suspended a government program to immunize hundreds of thousands of children with Dengvaxia following Sanofi’s findings released last week.
"In order to protect the general public, the Food and Drug Administration 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," the Philippine government agency said in a statement on its website released late on Monday. bit.ly/2je0L8Y
The FDA also directed Sanofi to conduct an information dissemination campaign and said all drug establishments should report any incidence that showed Dengvaxia has caused death or serious illness to any person.
Sanofi officials said on Monday that there had been no reported deaths related to the vaccine which was used to immunize nearly 734,000 children aged 9 and over in the Philippines.
They have received at least one dose of the vaccine as part of a government program that cost 3.5 billion pesos ($69.13 million).
Dengvaxia, the first approved dengue vaccine, had been forecast by Sanofi to eventually bring in nearly $1 billion in annual sales.
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 World Health Organization said on Monday it hopes to review safety data on Sanofi’s dengue vaccine this month. The fears involve possible increased risk to people who had not previously been exposed to the dengue virus prior to vaccination with Dengvaxia.
($1 = 50.6300 Philippine pesos)
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