A FORMER member of the government’s Vaccine Expert Panel during the COVID-19 pandemic is urging the Food and Drug Administration (FDA) to hasten the approval of the QDENGA vaccine amid a rise in the number of dengue cases in the coun-try.
In a radio interview, former Philippine College of Physicians (PCP) president Dr. Rontgene Solante called on the FDA to complete the evaluation and give the green light for the use in the Philippines of the dengue vaccine of Japanese firm Takeda Pharmaceutical Company.
“We have a vaccine for dengue, which is QDENGA, that is pending before the FDA for its evaluation,” said Solante.
“They should fast-track approval of the dengue vaccine so we can include vaccination as part of dengue control and preven-tion programs,” he added.
Solante said it is puzzling that it has taken the FDA a long time to evaluate the vaccine against the mosquito-borne disease.
“It is not normal because, usually, the evaluation takes only six months,” said Solante.
He also said other countries in Southeast Asia have already adopted the use of QDENGA.
“We, together with Singapore, are the only countries in the ASEAN region where the vaccine has not been approved yet,” said Solante.
According to Takeda, QDENGA (TAK-003) is a dengue vac-cine that is based on a live-attenuated dengue virus and is de-signed to protect the public against any of the four dengue virus serotypes.
It said QDENGA has an overall vaccine efficacy of 80.2 per-cent against confirmed dengue cases, has no evidence of disease enhancement in vaccine recipients, and no important safety risks.
In a separate interview, Department of Health (DOH) Assistant Secretary Albert Domingo said the FDA is only being extra careful in evaluating the QDENGA.
He said this is because they don’t want to be accused of rushing its approval for market availability.
“We should be careful in processing these applications before the FDA,” said Domingo.
In 2016, the Philippines launched the dengue vaccination cam-paign using the Dengvaxia of French pharmaceutical firm Sano-fi Pasteur.
The Dengvaxia jabbing operation was subsequently stopped after Sanofi bared that the vaccine could put pre-viously uninfected people at a higher risk of developing se-vere cases of dengue.
