MANILA – The Food and Drug Administration (FDA) may already approve the licensing of a second-generation dengue vaccine within the year.
According to Department of Health (DOH) secretary Ted Herbosa, the possible approval of the new vaccine is timely, citing the reported rise in dengue cases due to the rainy season.
The dengue vaccine Herbosa was referring to is the QDENGA vaccine of Japan-based Takeda Pharmaceuticals, which already applied for a certificate of product registration (CPR) from the FDA last year.
“The usual process takes about a year. So kung last year nag-apply na sila, anytime this year lalabas na ‘yan,” Herbosa said in an interview on state-run PTV channel.
He added: “Wag kayong mag-alala. Dadating din sa ’tin ‘yan pero ang importante ngayon, malaman ng mga tao na tumataas ang dengue at mako-control natin ang vectors sa maraming paraan.”
Several doctors’ groups have urged the FDA last month to approve the license QDENGA as the Philippines lags behind its neighboring countries when it comes to vaccinating against dengue.
Herbosa said Takeda Pharmaceuticals is just awaiting the study of the FDA regarding the approval of the new vaccine.
“Hinihintay lang natin ang FDA. Aaralin pa ‘yung mga sina-submit nilang mga requirements at ‘pag na-approve ‘yan ay dadating,” Herbosa said.
The Philippines became the first Asian country to approve the sale of the world’s first-ever dengue vaccine Dengvaxia in 2015.
But controversy arose in 2017 after manufacturer Sanofi Pasteur announced that Dengvaxia may lead to “severe” symptoms for those who have never been infected by dengue before vaccination.
As a result, the FDA ordered the suspension of the sale, distribution, and marketing of the vaccine and the withdrawal of the product from the market./PN
