MANILA, Philippines – Senator Cynthia Villar on Monday, September 9, criticized officials of the Department of Agriculture (DA) and the Food and Drug Administration (FDA) over delays in fighting the deadly African swine fever (ASF) that has spiked since the start of the rainy season last May.
Villar, who chairs the Senate committee on agriculture and food, said government officials should have acted faster in processing, approving, and procuring vaccines to fight ASF.
She claimed the government let one supplier “monopolize” the supply of vaccines instead of looking for other sources.
Villar was referring to the AVAC vaccines imported from Vietnam to the Philippines through private agricultural firm KPP Powers Commodities Incorporated.
Those vaccines are now being used for the controlled vaccination of hogs in Batangas.
“Kasi ang pinag-awayan natin noon, pumipili kayo ng isang supplier lang. Nagagalit ako doon. Bakit hindi tanggapin [ang] maraming supplier?” said Villar.
“So doon pa lang may duda ka na tapos kayo nag-undergo ng clinical trial, ayaw ‘nyo irelease ‘yung clinical trial ‘nyo kaya nagkakaganito tayo. Pinagtatakpan ‘nyo ‘yung supplier eh.”
(We’ve fought over that before, you chose only one supplier. I was angry at that. Why don’t you let in more suppliers? That’s already fodder for suspicions. And then you undergo clinical trials. You don’t want to release the [results of] the clinical trials. That’s why we’re experiencing this. You’re covering up for the supplier.)
The senator said that the vaccine was “not accepted internationally” and if the clinical trials were actually held last year, “we should have known by now if it’s okay or not okay” to use, Villar said in Filipino.
DA Assistant Secretary Dante Palabrica, who was appointed head of the agency’s swine and poultry unit only last March, said during the hearing they found the vaccine “effective already” from the controlled trials held in big farms in Batangas. FDA Director General Samuel Zacate agreed.
According to Maria Cecila Matienzo, director of Center for Drug Regulation and Research, the FDA initially disapproved the application for the certificate of product registration (CPR) for the AVAC vaccine.
“Noon hong una yang na-apply sa amin, na-disapprove ho kasi kailangan mag-clinical trial,” said Matienzo.
“At ginawa naman po ‘yun, ang clinical trial locally ho, under the supervision ho ng BAI kasi ito ho ‘yung may existing kaming MOA with BAI. Sa BAI ‘yung nag monitor noon.”
(When they first applied to us, the application was disapproved because the vaccine had to undergo clinical trials first. And it was done — the clinical trial locally — under the supervision of the Bureau of Animal Industry. We have an existing memorandum of agreement with BAI. BAI monitors that.)
The DA and the Bureau of Animal Industry recently started the controlled vaccination of hogs in Lobo, Batangas, in light of a rise in active ASF cases across the country.
The number of barangays with active ASF cases has gone up from 30 as of May 28 — the day before the start of the rainy season this year — to 472 as of September 6.
A total of 109 municipalities, 31 provinces, and 14 regions now have active ASF cases from 16 municipalities, 9 provinces, and 7 regions on May 28.
Among the hardest hit provinces are North Cotabato with 108 barangays with active ASF cases, followed by Batangas with 98, and Quezon with 91 cases, as of September 6.
A total of 10,000 doses of AVAC vaccine had been purchased, after KPP secured a certificate of product registration under monitored release (CPR MR) from the FDA.
A CPR MR is a precedent before a vaccine is allowed for commercial use, Zacate said on Monday during the Senate hearing.
“’Yung approved na pong CPR MR for governmental use, they have undergone po clinical trial na po. So ‘yung ginagawa po ng BAI ngayon is not clinical trial po. It’s a compliance of the marketing authorization holder for the condition imposed in the CPR MR. Mga minor na lang po siya,” he said.
(Those approved with CPR MR for governmental use have undergone clinical trials. What BAI is doing now is not a clinical trial. It’s a compliance of the marketing authorization holder for the condition imposed in the CPR MR. These are minor [conditions].)
A certificate of product registration is an authorization issued by the FDA prior to the marketing, importation, exportation, sale, offer for sale, distribution, transfer, promotion, advertisement, and sponsorship of a health product.
Controlled vaccination continues
In 2023, the World Organisation for Animal Health (WOAH) cautioned against the use of substandard vaccines that “may not confer any protection against ASF and risks spreading vaccine viruses that could result in acute or chronic disease.”
WOAH’s statement came after Vietnam approved the AVAC vaccine for domestic commercial use and announced its export of the vaccines to countries like the Philippines.
The import of the AVAC vaccines and their use in clinical trials last year were the subject of a previous Senate hearing, which Villar also presided over. During the October hearing, it was alleged that the supplier let private farms use the product even without a CPR from the FDA.
ASF has wiped out 40% of the hogs in Batangas, according to Lobo Mayor Lota Manalo. There were 31,000 hogs in Lobo, the mayor said, and 19,000 have died due to the fatal disease.
Palabrica said during the Senate hearing that his office will release the results of clinical trials and submit them to the Senate committee. “Within this week, we’ll submit it to you,” he promised.
The DA official also said that they intend to submit the findings of the controlled vaccination to the FDA by October.
“September, makikita ko na epekto noong binakunahan kong diyes mil,” said Palabrica. “So by October, mabibigay na namin ang resulta sa FDA at ang FDA ngayon ay pwede nang palitan ang monitored release. It’s up to you.”
(By September, we will see the effect of the 10,000 that we vaccinated. So by October, we can give the results to the FDA and then the FDA can replace the monitored release. It’s up to you.)
The government’s controlled vaccination comes five years after the Philippines had its first outbreak in Rizal back in 2019. – Rappler.com