Philippines halts sale of Sanofi dengue vaccine


Philippines halts sale of Sanofi dengue vaccine

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.

An estimate of 734,000 children aged over nine have received the first dose of the Dengvaxia through the country's dengue public immunization program, the world's first, according to officials.

Sanofi said the risk of severe dengue occurring in previously uninfected people who were inoculated with Dengvaxia was about two in 1,000 and these individuals recovered with treatment.

The World Health Organization supported a decision by the Philippines Department of Health on Tuesday to suspend vaccinations with Sanofi's dengue drug Dengvaxia, the WHO said in a statement.

The country's public immunization program was suspended on Friday.

The WHO said on Monday it hoped to review safety data this month on Sanofi's dengue vaccine which the company said was approved in 19 countries and launched in 11.

Brazil confirmed it already had recommended restricting use of the vaccine to those previously infected with dengue but had not suspended it entirely.

The outcry of dengue in Southeast Asia and the confusion and concern regarding its vaccine in the Philippines is something people in and moving to the region must be wary of, as many may be rushing to protect themselves and their family from various exotic diseases.

A spokesman for Sanofi in Paris was not immediately available for comment.

Justice Secretary Vitaliano Aguirre II said that he would tap the National Bureau of Investigation (NBI) to initiate a fact-finding investigation to determine possible accountabilities of officials behind the purchase that was approved by former health chief Janette Garin.

"In the event that there will be authorities who will point culpability to me, I am ready to face the consequences", she told ANC TV. Since previous year, 733,713 children have been vaccinated by the Department of Health in Metro Manila, Central Luzon and Calabarzon.

Both independent studies in Vaccine and Science concluded that Sanofi's own trial data on severe infections among 2-to-5 year olds offered ample warning of the health threat Sanofi finally conceded.

"When we evaluated the clinical records, it was not related to the dengue vaccination", Bayugo said.

Dengue is a mosquito-borne tropical disease.

While Sanofi's Dengvaxia is the first-ever approved vaccine for dengue, scientists already recognized it was not ideal and did not protect equally against the four different types of the virus in clinical tests.