FDA urges public to report Dengvaxia injuries

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. (Photo: MIMS)

MANILA, Philippines — 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.

“All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post-marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person,” the FDA said in a statement.

Earlier, French-based pharmaceutical company Sanofi Pasteur released an advisory indicating that their post-clinical trial study found out that Dengvaxia is effective for individuals who have had dengue before immunization, emphasizing the risk of a “severe” dengue case for people who have not.

The agency has already directed Sanofi to suspend the sale and distribution of the dengue vaccine after the latter admitted that it has potential health risks to patients who have not had the disease prior to immunization.

“In order to protect the general public, the Food and Drug Administration (FDA) 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 said in an advisory.

The FDA further instructed Sanofi to conduct an information dissemination campaign through Advisories, Dear Doctor Letters, and Patient fora.

To allay the fears of the public, Malacañang 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.

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.

Over 733,000 students from public schools in Metro Manila, Central Luzon and Calabarzon, nine years old and above, have received at least the first of three doses of the vaccine.

Health Assistant Secretary and infectious disease specialist Lyndon Lee Suy said they will continuously monitor the condition of Filipino recipients who already received doses of the 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.