FDA approval sought for Vietnam-made ASF vaccine

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Metro Manila (CNN Philippines, June 2) — The Bureau of Animal Industry (BAI) has sought the go signal from the Food and Drug Administration (FDA) for the rollout of a Vietnam-made African swine fever (ASF) vaccine in the country.

BAI Assistant Director Arlyn Vytiaco said they have recommended the AVAC doses – which have been proven "effective" – following the completion of safety and efficacy trials in at least six areas in Luzon.

"Napakalaking tulong nitong bakuna nito sa pag-control ng ASF kasi alam natin na patuloy ang outbreaks natin. Marami nang swine stakeholders ang naghihintay ng effective na bakuna," she told reporters Friday.

[Translation: This vaccine will be a huge help in controlling ASF outbreaks. Many swine stakeholders have been waiting for an effective vaccine.]

Vytiaco noted that 100% of the hogs vaccinated during the trials produced antibodies, and showed "no ill or side effects."

Vietnam's AVAC is a single-shot vaccine for four to ten-week-old hogs. If approved, the BAI said the vaccines will be distributed on a "first come, first served" basis. But the administration of the doses will not be made mandatory, the agency added.

Vytiaco said they are also rushing the issuance of a certificate of product registration (CPR).

A CPR from the FDA is needed to allow the commercial distribution of the ASF vaccine in the country. Should the process take long, the BAI said it may consider seeking assistance from President Ferdinand Marcos, Jr. – who's also Agriculture Secretary.

FDA Spokesperson Job Aguzar said the application for CPR will first be subjected to pre-assessment. If deemed acceptable, he said they will "facilitate the evaluation of the submitted dossier to determine the quality, safety, and efficacy" of the ASF doses.

"We'll see to it na dapat affordable siya… dapat maproteksyunan natin 'yung ating industriya, lalo na 'yung ating backyard hog raisers," Agriculture Deputy Spokesperson Rex Estoperez said.

[Translation: We'll see to it that the vaccine will be affordable; that our swine industry will be protected, especially our backyard hog raisers.]

At least 15 provinces have active ASF cases so far, mostly in the Visayas, according to the BAI.