The Philippines has conducted French drugmaker Sanofi to stop the sale, distribution and marketing of its Dengvaxia dengue vaccine in the fatherland after the company last week warned it could worsen the condition in some cases.
The move comes days after the Southeast Asian land suspended a government program to immunize hundreds of thousands of children with Dengvaxia make good Sanofi’s findings released last week.
“In order to protect the inclusive public, the Food and Drug Administration immediately directed Sanofi to interrupt the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the make available pending compliance with the directives of the FDA,” the Philippine government agency mean in a statement on its website released late on Monday.
The FDA also directed Sanofi to control an information dissemination campaign and said all drug establishments should arrive any incidence that showed Dengvaxia has caused death or serious sickness to any person.
Sanofi officials said on Monday that there had been no reported deaths joint to the vaccine which was used to immunize nearly 734,000 children grey 9 and over in the Philippines.
They have received at least one dose of the vaccine as responsibility of a government program that cost 3.5 billion pesos ($69.13 million).
Dengvaxia, the elementary approved dengue vaccine, had been forecast by Sanofi to eventually occasion in nearly $1 billion in annual sales.
But even recent assorted modest analysts’ sales forecasts are now looking unattainable given the security issue and clinical evidence revealing unequal protection against out of the ordinary strains of dengue.
The World Health Organization said on Monday it prospects to review safety data on Sanofi’s dengue vaccine this month. The reverences involve possible increased risk to people who had not previously been exposed to the dengue virus previous to vaccination with Dengvaxia.