Published: Вт, Декабря 05, 2017
Health | By Jay Jacobs

Philippines government investigates Dengvaxia dengue vaccine

Philippines government investigates Dengvaxia dengue vaccine

(WHO will now review Sanofi's safety data in more detail.) This followed an earlier warning that the vaccine should only be administered in countries where dengue is more than 50% prevalent.

On Monday, there were reports that the Philippine Justice Department had ordered an investigation into the government-mandated vaccination of more than 730,000 children over new evidence received from the French multinational pharmaceutical company Sanofi.

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

Last week, the Philippines' health department suspended the vaccination after Sanofi announced evidence showing that people who receive the vaccine, known as Dengvaxia, without previous dengue infection could face the risk of their disease worsening.

The Food and Drug Administration (FDA) called on the public to partake in the "post-marketing surveillance of Dengvaxia" by reporting any incident that shows the dengue vaccine has led to death, serious illness, or injury of a patient.

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

Almost 734,000 children aged 9 and over in the Philippines have received one dose of the vaccine as part of a program that cost 3.5 billion pesos ($69.54 million).

One 12-year old girl in Tarlac province, north of the capital Manila, who completed the three-dose vaccine treatment, showed symptoms of severe dengue, Health Undersecretary Gerardo Bayugo told Reuters by phone.

Sanofi is also working with the Philippine Food and Drugs Administration to update product labels to reflect the new information, she added.

Dengvaxia is the first approved dengue vaccine, and generates approximately $1 billion in sales every year for Sanofi.

Brazil's healthcare regulator Anvisa said in a statement that it now recommends that people who have never been infected with dengue not take the vaccine, which was approved for use in Brazil at the end of 2015.

Dengue is a mosquito-borne viral infection found in tropical and subtropical climates worldwide.

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