The Food and Drug Administration on Tuesday announced its approval for a Certificate of Product Registration for Vietnam’s AVAC ASF Live Vaccine, the first vaccine against African Swine Fever (ASF) in the country.

FDA Director General Samuel Zacate, however, said that the vaccine will be restricted in use 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.

Zacate further said 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 undergone for almost a year or two years from now. Basically, this has come to the rigorous process of the Food and Drug Administration,” he added, ensuring that the approved vaccine  has been proven 100 percent safe and efficacious.

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

The controlled rollout is set for the third quarter of the year, prioritizing eligible commercial farms, semi-commercial enterprises, and clustered backyard farms under strict BAI supervision.

“After this rollout, BAI will evaluate the vaccine's efficacy before endorsing it to the FDA for final approval and registration,” the agri chief added.

600K doses needed

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

“The schedule depends on the availability of 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.”

Areas to be prioritized for the controlled vaccination will mostly be the red areas and the pink areas, he added.

A total of P350 million will be allocated for the controlled ASF vaccination.

ASF is a highly contagious disease affecting pigs and wild boar, with up to a 100 percent case fatality rate. 

It, however, does not infect humans, but humans can carry the virus and transmit it to pigs through vehicles, equipment, clothes, slippers, and shoes.

The Philippines recorded its first  ASF case in 2019.