Villar on BAI’s haste in ASF vaccines’ clinical trials: Why are we so excited?
Senator Cynthia Villar questions officials of Bureau of Animal Industry during a Senate hearing on alleged unauthorized sale of ASF vaccines. (Photo dated October 25, 2023 from Senate PRIB)
MANILA, Philippines — The “clamor” to address the spread of the African Swine Fever (ASF) supposedly prompted Bureau of Animal Industry (BAI) to import 300,000 vaccines from Vietnam, an official told senators on Wednesday.
This justification was provided during the hearing of Senate committee on agriculture headed by Senator Cynthia Villar.
Villar confronted BAI over the alleged unauthorized sale of ASF jabs in the Philippines, even before it was approved in Vietnam for domestic use in July.
As early as June 2, 2023, BAI was already reporting the completion of the vaccine’s safety and efficacy trials in at least six areas in Luzon.
“Pwede bang mag-field trial nang hindi sinasabi ng FDA?” Villar asked.
(Can you conduct a field trial without FDA’s approval?)
“Eh, July 2023 lang inapprove ng Vietnam, gagamitin mo na ang field trial dito at tapos ka na by June 2, 2023,” she examined the timetable.
(Vietnam only approved it in July 2023, and you’d already use it for the field trial here, and you were done by June 2, 2023.)
Dr. Oscar Gutierrez Jr., deputy director general for field regulatory operations of Food and Drug Administration (FDA), said the agency only gave its approval for clinical trial of the vaccine on June 23, 2023.
But he later corrected himself, saying BAI endorsed to FDA on May 23, 2023 the issuance of a special import permit for 600,000 doses for Phase 2 of the testing.
“On January 16, 2023, BAI issued authorization to import ASF vaccine and test kits signed by Director Limson po,” Gutierrez said, referring to BAI Director Paul Limson.
“We only issued po authorization to import the 300,000 only for field trial po,” the FDA official later clarified.
Villar reiterated her question as to why field trials had been conducted when the vaccine was not yet approved for commercial use.
“Bakit tayo so excited? Why are we so excited?” she wondered with amusement.
Responding to the senator, the BAI chief said: “Marami na po kasing clamor for a solution to ASF.”
But Limson’s reason did not satisfy the lawmaker.
“Ok lang na bigyan natin ng solution ang ASF, but hindi para pagkaperahan natin ha?” the senator cautioned the director.
(It’s okay to provide a solution for ASF, but not to make money from it, ok?)
Limson further justified the need to import the ASF vaccine during that period.
“Nu’n pong time na yun, mayroong available na vaccine si Vietnam, pero marami pong countries ang nag-aagawan,” he recalled.
(At that time, Vietnam had an available vaccine, but many countries were competing for it.)
Villar dismissed the scenario portrayed by the BAI official, noting that other countries like Thailand had even rejected the vaccine.
The senator went on to question the bureau’s reported arrival of more ASF jabs from Vietnam.
“Ano yun? I-smuggle?” she asked in disbelief.
(What are those? you’ll smuggle them?)
“If it’s not authorized by the FDA, it will be considered smuggled po,” Limson answered.
Later in the hearing, KPP Powers Commodities Incorporated Legal Counsel and Spokesperson Reynaldo Robles explained the imported vaccines were already approved by Vietnamese government in early July 2022.
KPP is the supplier of ASF vaccines in the Philippines.
Robles pointed out the June 2023 approval the senator had mentioned earlier was for a different purpose.
“On July 8, 2022 approved na po ng government ng Vietnam. Yung nakalagay po na June 23, 2023, yung nationwide marketing authorization,” he clarified.
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