Dengvaxia, developed by French pharmaceutical company Sanofi Pasteur, is the world’s first dengue vaccine.
In December 2015, Dengvaxia was licensed and approved for use in the Philippines by the Food and Drug Administration (FDA).
The approval came weeks after Sanofi secured its first regulatory approval for the vaccine in Mexico but only for people aged 9 to 45 living in endemic areas in the country.
It is given in three doses six months apart via injection in the upper arm.
Former Health Secretary Janette Garin said the Philippines participated in all three phases of the vaccine’s clinical development with subjects from Cebu province and several areas in Metro Manila.
In April 2016, the Department of Health (DOH) launched the immunization program, providing free vaccines to selected Grade 4 public school pupils in three regions with the highest number of dengue cases — Metro Manila, Central Luzon and Calabarzon.
Garin said the Philippines was the first in the world to introduce the dengue vaccine through the public health system and under a public school setting.
The government allocated P3.5 billion for the program, including the monitoring of the beneficiaries over five years for possible side effects.
In December 2017, the DOH halted the vaccination program after Sanofi announced the results of new studies that found Dengvaxia caused severe dengue in patients who had no previous exposure to the mosquito-born dengue virus.
In January 2018, Health Secretary Francisco Duque III disclosed that most of the 14 children who died after being immunized with Dengvaxia were found to have suffered from dengue shock syndrome, but he could not say whether the vaccine directly caused their deaths.
The controversy over the government’s use of Dengvaxia caused a vaccination scare. Many parents did not allow their children to receive any kind of vaccine.
Amid a deadly measles outbreak, the DOH and medical groups criticized Public Attorney’s Office chief Persida Acosta for the drop in the immunization rate, saying her claim that some children died after being vaccinated with Dengvaxia was baseless.
During a Senate hearing on the DOH budget last January, health officials told senators that no death had been confirmed to be directly attributable to Dengvaxia.
In March, government prosecutors filed charges of reckless imprudence resulting in homicide against Garin and 19 other officials in connection with the vaccination program.
After the indictment, Acosta claimed vindication, saying the suit “is proof that we did not create the vaccine scare [that led to the] measles outbreak.” —Inquirer Research
Sources: DOH, WHO, Inquirer Archives