THE Food and Drug Administration (FDA) has received the application to certify the African swine fever (ASF) Vietnam-made AVAC vaccine and shall be subjected to pre-assessment, a high official said over the weekend.
“If acceptable, the FDA shall facilitate the evaluation of the submitted dossier to determine the quality, safety and efficacy of the ASF vaccine,” Job Aguzar, FDA spokesperson, said.
“At the same time, [there’s] a request for permit to import additional doses of the vaccine to support the on-going phase 2 clinical trial being conducted by the applicant with Bureau of Animal Industry [BAI],” Aguzar added.
The FDA is citing the request of the BAI for the issuance of Certificate of Product Registration (CPR) to the vaccine for its immediate distribution in the country.
BAI Assistant Director Arlene Vytiaco said over the weekend they are pushing for the AVAC vaccine after the 100-percent success of the field trial was recorded on pigs by producing antibodies.
“We have endorsed it to the FDA for the issuance of Certificate of Product Registration,” she said.
The BAI official noted that the issuance of the CPR, besides being one of the requirements of the manufacturer, will certify the commercial release of the vaccine in the country.
She also revealed the positive result of the testing held from March to May in six areas in Luzon.
“The safety and efficacy trials in Luzon showed that the hogs that have been injected produced 100 percent antibodies and [there is] no side effects on animals,” Vytiaco added.
The BAI official hopes the FDA will immediately issue the CPR as many counties are also waiting for supplies.
The manufacturer is ready to supply 600,000 vaccines to the Philippines.
Vytiaco, however, said they have yet to determine the price of each vaccine dose from the manufacturer.
The successful trial was the third testing conducted after the other two testing activities, where they partnered with the US and Thailand, she added.
“I cannot discuss anything about the trials, they are confidential,” Vytiaco said. The pigs given the shots are aged four to 10 weeks old.
Meanwhile, the BAI official added that acquiring the ASF vaccine is not mandatory.
“It’s a first come, first serve basis,” Vytiaco said.For her part, Janice Garcia, cluster coordinator of the National ASF Prevention and Control Program of the BAI, reported that as of June 1, at least 15 provinces have active ASF cases.
“This data is from May 15 up to June 1. In the last two weeks, the cases are only confined in the Visayas. In Luzon and Mindanao, there were only few detections,” she added.
Sinag weighs in
Even as it welcomed “all efforts in developing vaccines against ASF in commercial scale,” the country’s largest agricultural alliance Sinag cautioned, however, against promoting “a particular vaccine brand without the proper protocol, testing procedure and prescribed guidelines.”
Jayson Cainglet, Sinag Executive Director, said in a statement sent to BusinessMirror: “As with our battle with Covid-19, we let science and precautionary principles take precedence over haste and commercial profit.”
The group also urged “the BAI to release in details the field trials so a proper assessment can be done by experts and the industry itself on the efficacy of the said vaccine.”
Noting that the hog industry “remains predominantly backyard and small-scale,” Sinag stressed that “the cost of vaccines should at least be subsidized by the government so that backyard hog raisers are given the same chance of recovering lost incomes and destroyed livelihoods for the past four years.”