BAI slammed for allowing field trials of ASF vaccines

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SEN. Cynthia Villar yesterday rebuked the Bureau of Animal Industry (BAI) for allowing a supplier to conduct clinical trials of the African Swine Fever (ASF) vaccines in the country, which she said should have been done by the government.

Villar, citing reports of widespread unauthorized sale of the ASF vaccine in the “black market” while the clinical trial was ongoing, said: “The use of non-compliant and poor-quality vaccine will not confer any protection against ASF and may add to the risk of spreading other acute or chronic disease.”

Villar made the remarks during the Committee on Agriculture, Food, and Agrarian Reform hearing on proposed measures to develop, protect, and promote the livestock, poultry, and dairy industries.

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The senator said she has received information that the BAI has endorsed to the Food and Drug Administration (FDA) the importation for emergency use of the ASF vaccine from AVAC Vietnam Joint Stock Company through the KPP Powers Commodities Inc., which she said conducted the vaccine clinical trials.

“Dapat hindi supplier ang nagki-clinical trial kundi ang BAI, kasi bias na ‘yan. Gusto mo makabenta, eh di syempre aayusin mo ‘yan. Ang sinisisi ko ay BAI kung bakit sila pumapayag na ang clinical trial ay gawin ng supplier. Mali ‘yun. Dapat government ang gagawa niyan para independent (The supplier should not conduct the clinical trial, but the BAI because that will already be biased. They want to sell [vaccines] so they will fix the results. BAI is the one to be blamed because it allowed the clinical trial to be done by the supplier. That is wrong. The government should be the one doing the clinical trial so the results will be independent),” Villar said.

Reynaldo Robles, legal counsel and spokesman of KPP Commodities Inc., admitted they supplied 300,000 doses of ASF vaccines to various farms in the country for clinical trial.

“Nag supply lang kami ng vaccines para sa clinical trial, around 300,000 doses (We just supplied the vaccines for clinical trial, around 300,000 doses),” Robles said.

Villar said what KPP Commodities Inc. did was illegal since it was not authorized to hold the clinical trial.

“You are not allowed to do that. You cannot go directly to the farms and conduct clinical trials,” she stressed.

AGAP party-list Rep. Nicanor Briones, who attended the hearing as a resource person, said the vaccines are not yet “approved” by the government and yet KPP Commodities Inc. already conducted the clinical trial.

Briones said clinical trials should be conducted on a small sample only so when side effects happen, the whole hog industry will not be affected.

BAI assistant director Arlyn Vytiaco told senators that the FDA issued a special import permit for the ASF vaccines.

“The FDA granted the approval for the importation on June 23 only for clinical trial,” Vytiaco said.

To this, Sen. Francis Tolentino said the FDA can be liable for negligence since it allowed the entry of the vaccines.

But a representative of the FDA denied Vytiaco’s statement and said that it was the BAI which issued the special import permit.

The FDA said BAI sent a letter to the FDA on December 2, 2022 applying for a vaccine registration in the Philippines.

It added that it was the BAI which requested for the importation of 300,000 ASF vaccines doses, but to its knowledge, only 60 pigs will be subjected to clinical trials.

Villar said she has information that AVAC Vietnam-JSF, developer of the ASF vaccine, has already shipped around 300,000 does to the country.

 

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