Doctors are urging the PHL FDA to issue a decision on a new dengue vaccine
Doctors on Tuesday urged the Philippine Food and Drug Administration (FDA) to release the results of the approval of the new generation dengue vaccine, noting that, if approved, it could help curb the country’s high number of cases and deaths from the disease.
“Is it yes or no from the FDA on the vaccine? We hope that the results will be released soon,” said Dr. Enrique A. Tayag, former undersecretary of the Department of Health (DoH), Filipino during a dengue forum led by the Philippine Medical Association (PMA) and the Empowering Networks to Defeat Dengue) coalition Dengue (END.
“Let’s not wait as if we are still looking to see if this will benefit many mothers or if it will lead to backlash,” said Mr. Tayag.
He also said he is not pressuring the agency to release its tests, but encourages it not to wait for the “right time” and instead release the results—whether positive or negative—when they are available.
The vaccine in question is Qdenga, developed by Japan-based pharmaceutical company Takeda, and its application for approval by the Philippine FDA is due in 2023.
According to the World Health Organization (WHO), Qdenga is an active vaccine that contains weakened strains of dengue virus serotypes 1, 2, 3, and 4.
The vaccine has been shown to be effective in preventing dengue fever in children and adolescents within 12 months after the second dose, reducing confirmed cases by almost 80% compared to those given a placebo in a large study in eight countries in Latin America and the Asia-Pacific region, said the European Medicines Agency (EMA).
It also reduced hospitalizations for dengue by nearly 90 percent within 18 months after the second injection.
However, its common side effects include pain and redness at the injection site, headache, muscle pain, depression, weakness, and fever in up to 1 in 10 people, which are usually mild and resolve within a few days, the EMA said.
The vaccine is not recommended for people with a history of allergy to Qdenga, immunocompromised people, and women who are pregnant or breastfeeding.
This new vaccine is being used in more than 40 countries and is currently in the qualification stage of the World Health Organization (WHO), which shows that it has been evaluated for quality, effectiveness, and safety, said Dr. Erica Tania Davillo, who is the chairperson of the PMA interim committee on dengue advocacy, said Dr.
“If a product is qualified, it means that it has been tested for quality, efficiency, and most importantly, safety,” said Ms. Davillo during the Philippines forum.
BusinessWorld sought comment from an FDA spokesperson on the medical doctors’ complaint, but no response had been received as of press time.
Mr. Tayag clarified that if the new generation dengue vaccine is approved, its rollout will not be implemented nationwide immediately, but instead may begin in regions with high dengue infections such as Metro Manila, Region III, and Region IV-A to test its effectiveness and possible side effects.
He added that the vaccine will serve as a complement to DoH’s existing efforts to prevent dengue, such as the 4S strategy.
Dengue cases were reported at 7,471 from January 4 to 24, a significant decrease from 25,652 cases during the same period in 2025. Edg Adrian A. Eva
