Metro Manila (CNN Philippines, October 25) — Sen. Cynthia Villar slammed the Bureau of Animal Industry (BAI) and the Food and Drug Administration (FDA) on Wednesday for allowing a supposedly private-led clinical trial of the African Swine Fever (ASF) vaccine.
In a hearing of the Senate committee on agriculture, food, and agrarian reform, Villar flagged the KPP Powers Commodities Inc. as having a conflict of interest in conducting the clinical trials as it would be the distributor of Vietnam’s AVAC, insisting that the government should be conducting the tests.
“The private [sector] should not be involved kasi pag sila ang involved, gagawin nila yan ma-approve ‘yan kasi kikita sila [because when they are involved, they will approve it so that it can get profit],” said Villar, the panel chairperson.
“Kinorap ninyo ang BAI, nagpa-corrupt naman ang BAI [You corrupted the BAI but the BAI seems willing to be corrupted],” she added.
Reynaldo Robles, KPP Powers Commodities legal counsel and spokesperson, said the company supplied the vaccines to participating farms but did not conduct the clinical trials.
BAI Assistant Director Vytiaco said the safety trial was done by the agency, while the efficacy trial was conducted in six farms in Luzon
For Dr. Oscar Gutierrez Jr., FDA deputy director general for field regulatory operations, the agency’s role in the regulation of investigational medicines and vaccines is only to approve the clinical trial protocol, while the BAI is the monitor.
However, Sen. Francis Tolentino said current law dictates the FDA must be in charge and that it cannot delegate its function to another agency, much more to a private entity. He then asked asked the Department of Justice to provide the panel with a list of possible violations in the agencies’ proceedings.
Clinical trials ahead of Vietnam approval
Villar said the committee held the inquiry as senators learned of the unauthorized sale of ASF vaccines in the black market, saying 300,000 doses have been shipped to the Philippines.
She said BAI already recommended AVAC doses on June 2, explaining these were “proven effective” after trials done in some farms. However, Vietnam only approved the vaccine for its domestic use in July. https://www.cnnphilippines.com/news/2023/6/2/bai-seeks-fda-approval-on-asf-vaccine.html
“Marami na kasing [There is too much] clamor for a solution to the ASF,” BAI Director Paul Limson said, but Villar rebutted that the government must give a correct solution, alluding to conducting the correct process of clinical trials.
Gutierrez said the FDA issued an authorization to import 300,000 doses for field trials upon the request of the BAI, but he also told the panel that only 60 pigs were used to test AVAC in one of Vietnam’s clinical trials.
AGAP party-list Rep. Nicanor Briones, who also attended the hearing, described the process as a “large commercial trial” for a vaccine that has not yet been approved.
Edna Zenaida Villacorte, National Advisory Committee for Animal Disease Control and Emergency chairperson, also said there was evidence of shedding in the first phase of the trials, as disclosed by the BAI, which prompted the bureau to proceed with the next stage.
She explained that shedding means that the other animals were exposed because the animal that was vaccinated “shedded” or released the virus — which is a worry in a vaccination program.
“What we’re surprised is together with the phase two trial, there is already a large-scale trial ongoing using the 300,000 [doses] without the result of phase two,” she added, expressing worry about the move’s unknown effects on the industry.
As of Sept. 30, the BAI reported that active ASF cases were recorded in 97 barangays across 10 regions.
