FDA stops sale, distribution, marketing Dengvaxia
Published: 2:35 p.m., Dec. 5, 2017 | Updated: 1:12 a.m., Dec. 6, 2017
The Food and Drug Administration (FDA) has ordered Sanofi Pasteur to stop the sale, distribution and marketing of its Dengvaxia vaccine in the Philippines after the French drug maker warned last week that the dengue vaccine could worsen the disease in some cases.
The FDA issued the order on Monday night after the Department of Health (DOH) halted a program to immunize schoolchildren 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,” FDA Director General Nela Charade Puno said in a statement posted on the agency’s website late on Monday.
The FDA directed Sanofi to conduct an information dissemination campaign and said all drug establishments should report any incidence that showed Dengvaxia had “caused or contributed to the death, serious illness or serious injury to a consumer, a patient or any person.”
The FDA said it was closely coordinating with the DOH for any adverse events or reactions that may be reported by the recipients following their immunization with Dengvaxia.
It said it would “immediately take appropriate measures to protect the public.”
Last week, Sanofi advised against prescribing the vaccine to those who have not had previously contracted dengue, as it may cause severe diseases in the long run.
Citing clinical data, Sanofi said it had found that the vaccine was beneficial to prevent dengue fever only to people who had been infected by the dengue virus in the past.
$1B in annual sales
The World Health Organization (WHO) said on Monday that it hoped to review safety data on Dengvaxia this month.
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 showing unequal protection against different strains of dengue.
The vaccine so far has been approved in 19 countries and launched in 11, Sanofi said.
Most sales have come from the Philippines through the DOH’s P3.5-billion immunization program involving more than 733,000 schoolchildren, and Brazil, where the state of Parana has seen a threefold increase in dengue in the past few years.
Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.
The WHO, which issued a report identifying the vaccine’s safety risk in mid-2016, recommends Dengvaxia only be used in people who had prior dengue infection.
Brazil confirmed it already had recommended restricting use of the vaccine to those previously infected with dengue but had not suspended it entirely. –With reports from the wires /kga /pdi
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