February 23, 2018

Health Risk: Philippines Suspends Sale Of Sanofi Dengue Vaccine

05 December 2017, 04:49 | Winifred Adams

A worker shows used anti-dengue vaccine Dengvaxia inside a vaccine storage room in Sta. Cruz city Metro Manila Philippines

A worker shows used anti-dengue vaccine Dengvaxia inside a vaccine storage room in Sta. Cruz city Metro Manila Philippines

Yesterday, the Philippines government ordered an investigation into the immunisation of more than 7.3 lakh children with the company's dengue vaccine. Most sales have come from the Philippines through its government immunization program involving more than 730,000 children, and Brazil, where the state of Parana has seen a three-fold increase in dengue in the past few years.

The World Health Organisation said on Tuesday it supported the decision by the Philippines to suspend vaccinations with Dengvaxia until more information was available.

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.

When asked about the status of vaccine in India, the company said it had submitted the vaccine regulatory file to the Indian authorities in October 2015.Awaiting approval for its dengue vaccine in India, French drug major Sanofi today said it has shared data with authorities here about the risk of administering its vaccine to patients who have not been infected with the virus previously. Moreover, the drug manufacturer needed to report any incidence that caused serious illness or death due to Dengvaxia.

"In this group, all fully recovered with proper medical treatment".

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The Philippines was the first country in Asia to approve the Dengvaxia vaccine for individuals aged 9 and 45 years old in 2015.

To allay the fears of the public, MalacaƱang on Monday reminded the public to not panic over the government's dengue vaccination program, saying the Department of Justice (DOJ) will start an inquiry on the purchase of the drug.

The developments have left families of children that been given the vaccine extremely concerned. 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 would review safety data on Dengvaxia by the end of December 2017.

The FDA added they are closely coordinating with DOH for any "adverse events and reactions" that may be reported by the recipients following their immunization of Dengvaxia, and vowed to immediately take appropriate measures to protect the public.

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