Amid an alarming rise in dengue cases across the country, the Philippine Medical Association (PMA) has urged President Marcos to expedite the approval of a next-generation vaccine to curb the outbreak, citing an 81 percent surge in nationwide cases in 2024.
However, the Department of Health (DOH) maintained that the Food and Drug Administration (FDA) must complete its evaluation process before granting approval to any new vaccine.
In a letter addressed to the Chief Executive, the PMA called for the immediate approval of the TAK003 dengue vaccine, developed by Japanese pharmaceutical company Takeda.
The group noted that the vaccine has already been licensed in over 40 countries, including Indonesia, Brazil, and the European Union, and has been recommended by the World Health Organization (WHO) for use in highly endemic countries like the Philippines.
Despite its global endorsements, the PMA pointed out that the vaccine has been pending Philippine FDA approval since April 2023.
The PMA expressed concern over the country’s reliance on traditional dengue prevention strategies, stating that additional measures, such as vaccination, should be considered.
“Despite these efforts, dengue remains a public health concern with rising cases all year round. We need to consider other innovative strategies available to address dengue,” the group stated.
The PMA also emphasized that the TAK003 vaccine has shown promise in terms of safety and effectiveness, urging the government to grant Filipinos access to immunization.
“We strongly urge the government to grant access to these new-generation dengue vaccines and allow Filipinos the right to protect themselves from this dreadful disease, as enshrined in the Philippine Constitution.”
DOH stresses need for proper evaluation
Responding to the PMA’s call, DOH spokesperson Assistant Secretary Albert Domingo defended the FDA’s role in thoroughly evaluating vaccines before granting authorization for public use.
“Ang position ng Department of Health is sumunod tayo sa ating legal framework at siyensya, ang sinasabi ko rito ay mayroon tayong Food and Drug Administration, sila ‘yung kumikilatis (The position of the Department of Health is that we must follow our legal framework and science. What I mean is, we have the Food and Drug Administration, and they are the ones responsible for evaluating),” he said in a radio interview on Wednesday, Feb. 19.
Domingo explained that manufacturers submit confidential data to regulators under non-disclosure agreements (NDA), which means even the DOH does not have full access to all information while the vaccine is being reviewed.
“Kapag ang FDA kasi ay kumilatis ng bagong gamot or vaccine, minsan may mga impormasyon na binibigay sa kanila ‘yung manufacturer na hindi natin basta-basta nakikita, kahit ba tayo ay DOH proper o ‘yung mga iba pang association (When the FDA evaluates a new drug or vaccine, sometimes manufacturers provide them with information that we, even in the DOH or other associations, do not have direct access to),” he said.
The DOH spokesperson stressed the importance of allowing the FDA to conduct an independent and thorough evaluation, without political or external pressure.
“Kunyari kung sabihin natin na may problema, hindi ko sinasabi na mayroon. Pero kung may problema, nahihiyang magsabi ang isang kumpanya kung hindi niya kausap ang isang regulator under a non-disclosure agreement. So it’s very important that we respect the process of evaluation ng FDA (For example, if there is a problem—not that I am saying there is—but if there were, a company might hesitate to disclose it unless speaking directly to a regulator under a non-disclosure agreement. So it’s very important that we respect the FDA’s evaluation process),” Domingo added.
Dengue cases continue to surge
The DOH reported that as of February, dengue cases have increased by 40 percent nationwide compared to the same period last year.
“Nationwide, as of Feb. 1, nakita natin na may pagtaas ng [kaso ng dengue] ng 40 percent (Nationwide, as of Feb. 1, we have seen a 40 percent increase in dengue cases),” Domingo stated.
He identified the top three regions driving the surge:
1. Calabarzon (Region IV-A) – 5,944 cases
2. Central Luzon (Region III) – 4,866 cases
3. Metro Manila (NCR) – 4,794 cases
Domingo also warned that dengue is spreading rapidly in densely populated areas, including Quezon City, which is among the nine local government units (LGUs) with rising cases.
“Ngayon, diyan sa mga rehiyon na ‘yan, kabilang na ‘yung Quezon City sa siyam na LGUs na nakikitaan naming na tumataas ang numero as of Feb. 1. Maaaring tumaas pa ‘yan depending on the data that’s coming in (Now, among these regions, Quezon City is one of the nine LGUs where we are seeing an increase in numbers as of February 1. This could still rise depending on the incoming data),” he added.
Earlier, the health department said that eight other LGUs are set to declare a dengue outbreak.