The Philippines issued an order against Sanofi to put a stop on the sales, distribution, and marketing of its dengue vaccine Dengvaxia in the country on Monday. The order comes a week after the warning given to the French drug maker that its vaccine could have adverse effects in some cases.
“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,” said the Philippine government agency in a statement on its website.
The Philippines banned a government program, which involved immunizing children with Dengvaxia after releasing Sanofi’s findings.
As per the guidelines of the U.S. Food and Drug Administration (FDA), Sanofi needed to conduct an information dissemination campaign. Moreover, the drug manufacturer needed to report any incidence that caused serious illness or death due to Dengvaxia.
Sanofi officials reported that there were no deaths reported due to the vaccine in the Philippines. They added that Dengvaxia immunized approximately 734,000 children aged 9 years and above in the country. Children have received at least one dose through the government program.
Dengvaxia is the first approved dengue vaccine, and generates approximately $1 billion in sales every year for Sanofi.
The recent findings outline that sales forecasts may not be reached over the safety issues and clinical proofs that show unequal protection against various strains of dengue.
The World Health Organization would review safety data on Dengvaxia by the end of December 2017.