Cynthia Villar grills BAI over importation of anti-ASF vax meant for clinical trials

Senator Cynthia Villar on Wednesday grilled the Bureau of Animal Industry (BAI) over the huge importation of anti-African Swine Fever (ASF) vaccines from Vietnam that were meant for clinical trials.

BAI was also chided by the lawmaker for supposedly releasing press statements which apparently indicated that the clinical trial was successful even if the vaccine was not yet approved by the country of origin.

“The [local] company has already shipped 300,000 doses to the Philippines since its approval but that was on July 2… Supposed to be pupunta sa field trial. Kaya lang on June 2, 2023 BAI Assistant Director Arlene Vytiaco said they have recommended the AVAC doses which have been proven effective following the completion of the safety and efficacy trials in at least six areas in Luzon,” Villar said.

“Vytiaco noted that 100% of the hogs vaccinated during the trials produced antibodies and showed no ill or side effects. This is June 2, 2023 eh in-approve lang ng Vietnam July 2023 eh. Bakit nauna ka pa sa Vietnam?” she asked.

Vytiaco explained these findings were only endorsed to her being the spokesperson of BAI.

Also, the BAI official said the shipment was issued with a special import permit by the Food and Drug Administration (FDA).

Dr. Oscar Gutierrez, Jr., FDA Deputy Director General for Field Regulatory Operations, said it was BAI Director Paul Limson who issued the authorization to import the ASF vaccine and test kits last January 16, 2023.

Gutierrez said Limson informed the FDA chief through a letter dated December 2, 2022, stating that the certification is being issued for their application for ASF vaccine registration in the Philippines and then the registration.

But Villar asked why the Philippines would conduct a clinical trial pending the approval of the Vietnamese government.

“Bakit ka magki-clinical trial nang hindi pa approved sa Vietnam, eh kung ‘yung source di pa nila na-approve, July 2023 nila in-approve, eh ba’t tayo magki-clinical trial earlier than that? Eh kung sila na gumawa hindi pa nila na-approve, tayo mauna pa. Bakit tayo so excited?” she asked.

(Why would you conduct a clinical trial even if Vietnam has not approved it yet? They approved it only this July 2023. Why are we going to conduct a clinical trial earlier than that? Why are we so excited about this?)

Villar also wondered how many doses do a clinical trial require.

Gutierrez said in one of the clinical trials in Vietnam, they only used 60 pigs and the number of doses will depend on the clinical trial protocol.

“Eh bakit ka mag-iisyu ng 300,000 [doses]?” the senator asked.

(Why would you issue authorization for the importation of the 300,000 doses?)

Gutierrez said, “Definitely po it will not be around 300,000… That was po the request that came from BAI.”

Limson, who was present at the hearing, cited the “clamor for a solution to ASF.”

“Nu’ng time na ‘yon may available na vaccine si Vietnam pero maraming countries nag-aagawan,” Limson said.

(At that time, there was an available vaccine in Vietnam but there were many countries that were trying to avail of it.)

But Villar was not convinced and told the BAI chief, “'Di nag-aagawan. Ayaw nga tanggapin ng ibang country eh. Kayo lang may gusto. Thailand nga ni-reject.”

(They were not scrambling to get it. Some countries even reject it except you.)

The senator also questioned another press release which, she said, indicated that there will be another importation of 600,000 doses.

“Bakit sinasabi sa press release may darating pang mas malaki? Ano 'yon i-smuggle? Kasi sa press release e 600,000 eh,” Villar said.

(Why did you say in your press release that there is a bigger shipment that is coming to the country? Is that smuggled? You said in your press release there are another 600,000 doses coming to the country.)

Gutierrez explained that if the importation was not authorized by the FDA then it will be considered as smuggling.

Villar also confronted Vytiaco over information that she is related to the Filipino importer of the anti-ASF vaccine, an allegation which the BAI assistant director firmly denied.

Further, the senator argued that there was a conflict of interest when the vaccine supplier, KPP Powers Commodities Inc, was the one who  conducted the clinical trial.

Vytiaco explained that it is part of the system that a private company conducts the clinical trial and it is the BAI that will monitor it.

“Clinical trials, the government should do it. Bakit ninyo ia-allow (Why do you allow) the private to do it? May conflict of interest na sila e. Sila ang supplier (There is conflict of interest since they are the supplierz),” Villar said.

“Kinorap ninyo ang BAI, nagpa-corrupt naman ang BAI (You corrupted the BAI and BAI is willing to be corrupted),” she went on.

KPP managing director Reynaldo Robles explained that the trials were conducted in six different farms and they only supplied and administered the vaccines.

The samples were taken by the farm-owners and these were turned over to BAI for monitoring, he added.

The Senate committee on agriculture conducted a hearing into the matter due to alleged “proliferation” of the ASF vaccine in the black market.—AOL, GMA Integrated News