The Food and Drug Administration has approved the Certificate of Product Registration for Vietnam’s AVAC ASF Live Vaccine, marking the first vaccine against the African swine fever (ASF) to be authorized in the country.

FDA director general Samuel Zacate, however, said the use of the vaccine will be restricted by the Department of Agriculture-Bureau of Animal Industry (DA-BAI).

“This is valid for two years, subject to strict monitoring and annual evaluation, and also subject to the submission of various conditions that can be seen on our verification portal,” he said on Tuesday.

Zacate said the AVAC registered under monitored release has undergone clinical trials.

“So it was started last year, so it took quite a long time, they applied for almost two years. Then the application was lodged I think only this year, but the clinical trials have been going on for almost a year or two years now. Basically, this has come through the rigorous process of the Food and Drug Administration,” he said, ensuring that the approved vaccine has been proven 100 percent safe and efficacious.

DA Secretary Francisco Tiu Laurel Jr. said the BAI is polishing the guidelines with agricultural and veterinary stakeholders for the ASF vaccine’s controlled use, with public consultations to follow.

The controlled rollout is scheduled for the third quarter of the year, with focus on eligible commercial farms, semi-commercial enterprises, and clustered backyard farms, all under the strict supervision of the BAI.

“After this rollout, the BAI will evaluate the vaccine’s efficacy before endorsing it to the FDA for final approval and registration,” Laurel said.

600K doses needed

Laurel said 600,000 doses of the ASF vaccine are needed to cover 600,000 local hog growers.

“The schedule depends on the availability of the vaccines. So, from what we understand, the existing stocks in the Philippines are only 150,000 doses,” he said. “The question is, there’s only one supplier now accredited, so it’s likely to be AVAC from Vietnam.”