Patients diagnosed with dengue lie on  beds setup at General Emilio Aguinaldo Memorial Hospital’s hallway in Trece Martires, Cavite on July 26, 2019. Jonathan Cellona, ABS-CBN News/File

MANILA — Amid rising dengue infections in different parts of the country, doctors and vaccine-advocates continue to call on government to allow Filipinos access to life-saving vaccines.

Medical experts ask FDA to approve vaccine for dengue

Speaking to the media, Philippine Foundation for Vaccination executive director Dr. Lulu Bravo said many countries in Southeast Asia, where the dengue virus is also endemic, have already approved licenses for dengue vaccines.

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“Ang Indonesia ang unang nagkaroon ng lisensya para dun sa bagong dengue vaccine. Sumunod ang Thailand, sumunod ang Europa, sumunod ang Malaysia, sumunod ang Vietnam nung last year. Abay, yung Pilipinas, nasaan na? E samantalang itong bakuna has been applied for licensure since 2023. Dalawang taon na,” she said. 

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(Indonesia was the first to give a license for new dengue vaccines. This was followed by Thailand, then Europe. Malaysia and Vietnam also issued licenses last year. Where is the Philippines? An application has been applied for in 2023. That’s two years ago.)

Bravo explained their appeal stems from the demand and right of Filipinos to protect their health. 

WHAT THE FDA IS DOING

While applications for new dengue vaccines have been lodged at the Food and Drug Administration (FDA), including Japanese-made TAK-003, the Department of Health (DOH) explained the regulatory body is carefully conducting its assessment to ensure the health of Filipinos are protected.

“Ang ginagawa rin ng FDA, tinitignan yung status ng gamot o bakuna na ito sa iba pang mga FDA. May mga kahalintulad sila for example ang United States merong USFDA. Sa Singapore, sa United Kingdom meron din yan yung mga mature regulatory agencies,” said Health Spokesperson Assistant Secretary Albert Domingo.

(What the FDA is doing is to look at the status of drugs and vaccines in other FDAs. There are similar agencies in other countries like the USFDA, Singapore and United Kingdom. These are called mature regulatory agencies.)

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“Kapag nakita ng FDA na iba yung status sa isang mature regulatory agency kumpara sa iba, medyo mapapaisip yung ating local FDA personnel and experts sasabihin nila ‘bakit kaya sa isang bansa, hindi kumpleto ang registration o kaya nag withdraw yung application?”

(Once they notice that the status of these vaccines are different among mature regulatory agencies, our FDA will ask why this is so.)

In a 2023 release made on its website, Japanese Pharmaceutical Company Takeda which manufactures TAK-003, said it decided to voluntarily withdraw the US Biologics License Application of TAK-003.

This was done “following discussions with the U.S. Food and Drug Administration (FDA) on aspects of data collection, which cannot be addressed within the current BLA review cycle.”

“The future plan for TAK-003 in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico,” the statement read.

ABS-CBN News reached out to the FDA to ask for updates on the status of applications of dengue vaccines but it declined to give a statement.

What is clear for the Philippines at this point is for the public to remain cautious, maintain the cleanliness of their surroundings and act early following the onset of any symptom to avert the possibility of severe dengue.

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