HEALTH experts are urging the Food and Drug Administration (FDA) to hasten the approval of the ” Qdenga” vaccine of Japanese firm Takeda Pharmaceutical Company.
The appeal was made by the Philippine Medical Association (PMA), the Philippine College of Physicians (PCP), and the Philippine Foundation for Vaccination (PFV) during yesterday’s Dengue Summit in Manila.
“We are calling on the FDA to fast-track the approval of the application for registration for Qdenga,” said PMA president Dr. Hector Santos.
“I think we should really include vaccination in the response so that we can better control dengue in the country,” said PCP president Dr. Rontgene Solante.
“It has been applied for since last year, and we are waiting for that because, as a vaccine investigator, I’ll assure you the safety of the Qdenga,” said PFV executive director Dr. Lulu Bravo.
According to Takeda, Qdenga (TAK-003) is a dengue vaccine that is based on a live-attenuated dengue virus, and is designed to protect the public against any of the four dengue virus serotypes.
Qdenga has an overall vaccine efficacy of 80.2 percent against confirmed dengue cases, has no evidence of disease enhancement in vaccine recipients, and no important safety risks.
Solante said such a vaccine will prevent severe dengue cases.
“When we give vaccine, its benefit is not only in protecting you from dengue, but protecting you against severe form of dengue so you won’t need to be hospitalized,” he said.
Santos said the FDA will only need to look into the experience of other countries and see the benefits of approving Qdenga.
“I don’t think our criteria are more stringent than other countries that presented data that millions have already been vaccinated in other countries,” said Santos.
Bravo said, “It is recommended for high endemic countries, like the Philippines, that we consider using dengue vaccine.”
In 2016, the Philippines launched the dengue vaccination campaign using the Dengvaxia of French pharmaceutical firm, Sanofi Pasteur.
Dengvaxia use was stopped after Sanofi said the vaccine could put previously uninfected people at a higher risk of developing severe case of dengue.
