Health Risk: Philippines Suspends Sale Of Sanofi Dengue Vaccine


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.

While the DOJ has already commenced its probe into the controversial vaccine manufactured by the French-based company Sinofi Pasteur, Roque said the Food and Drugs Administration (FDA) suspended the sale of Dengvaxia.

With the vaccine now widely available, the Philippines health authority rushed to vaccinate almost 734,000 children, as part of a program that cost the government 3.5 billion pesos. It said its Strategic Advisory Group of Experts on Immunization would meet to review evidence next week. An analysis of long-term clinical data had revealed that, in individuals who had never contracted dengue, the vaccine could make subsequent infections more severe.

The Philippine Food and Drug Administration also directed Sanofi to conduct an information dissemination campaign and said all drug establishments should report any incidents if the vaccine was suspected to have caused any deaths or serious illnesses.

The safety fears involve possible increased risk to people who had not previously been exposed to the dengue virus prior to vaccination with Dengvaxia.

Malacañang on Tuesday assured the public that the Duterte administration will not hesitate to use the full force of the law against those who will be found to have committed irregularities in the Dengvaxia dengue vaccine issue.

They have received at least one dose of the vaccine as part of a government program that cost 3.5 billion pesos ($69 million).

The Department of Health has recommended that she be moved to a Manila hospital for closer monitoring, but Bayugo said she had shown signs of improvement with her platelet count recovering.

The company, which is under fire in various countries, including the Philippines and Brazil over the vaccine, however, said "supplementary analysis confirmed (its) significant and persistent beneficial value" in people with a prior history of dengue infection before vaccination.

According to Sanofi in Manila, 19 licences were granted for Dengvaxia, and it was launched in 11 countries, two of which - the Philippines and Brazil - had public vaccination programs.

Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.