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ASF vax maker applies for product certification – FDA

Metro Manila (CNN Philippines, July 21) — The Food and Drug Administration (FDA) on Friday said it is working on the approval of an African Swine Fever (ASF) vaccine.

It said a manufacturer applied for a certificate of product registration (CPR) even as the vaccine is still undergoing its second phase of clinical trial.
\”Hinihintay lang po namin ‘yong result ng kanilang clinical trial and we already gave them a positive nod for their phase 2 clinical trial. Pero ang gumagawa po ng clinical trial ay di naman po si FDA, ‘yong Bureau of Animal Industry (BAI),\” FDA Director-General Samuel Zacate said.
[Translation: We’re waiting for their clinical trial results and already gave them a positive nod for the phase 2 clinical trial. But the BAI is the one conducting these trials.]
\”We’re looking forward na ma-submit nila ‘yong mga necessary findings nila para po ma-evaluate natin kasi kami po ang nag-i-issue ng CPR,\” he added.
[Translation: We’re looking forward to them submitting the necessary findings so we can evaluate (the vaccine) because we are the agency issuing the CPR.]
The FDA noted a product should be at the third phase of clinical trial to be approved for a CPR.

In June, the BAI sought approval from the FDA for the rollout of AVAC, a Vietnam-made ASF single-shot vaccine for four- to ten-week-old hogs.

READ: FDA approval sought for Vietnam-made ASF vaccine

In July, President Ferdinand Marcos Jr., who is also agriculture secretary, said the first phase of the ASF vaccine safety and efficacy trials have resulted in 80% efficiency rate. He said ASF and the bird flu are still the biggest threats to livestock that the government should address.

READ: Marcos: Taking advantage of ASF, bird flu vaccines will sustain livestock stability

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