November 22, 2024 | 14:44 GMT +7
November 22, 2024 | 14:44 GMT +7
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The Department of Agriculture-Bureau of Animal Industry (DA-BAI) has asked the Food and Drug Administration (FDA) to certify a Vietnam-made African swine fever (ASF) vaccine for its immediate distribution in the country.
In a press briefing at the DA main office in Quezon City on Friday, BAI assistant director Arlene Vytiaco said they are pushing for the AVAC vaccine after its trial has recorded positive results on pigs by producing antibodies. “We have endorsed it to the FDA for the issuance of Certificate of Product Registration (CPR),” she said.
“We prepared a letter of endorsement to the FDA for the issuance of a certificate of product registration as the vaccine is under its mandate. Once the FDA issues a certificate of production registration of the vaccine, the supplier will be importing from Vietnam,” said Vytiaco.
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 has no side effects on animals”.
The BAI official is hoping that the FDA will immediately issue the CPR as many counties are also waiting for supplies.
Previously, the field trial for the AVAC ASF live vaccine was conducted in six farms in Luzon. According to the official, the BAI made sure that the six piggeries selected for the field trial were ASF-free.
“After the 21-day field trial, 100 percent of the pigs vaccinated produced antibodies against ASF, which means they will be protected from the disease,” Vytiaco said.
She said that the ASF vaccine would help in the government’s campaign to control the spread of the disease. “It will be a big help in controlling ASF as we know that the outbreak of the disease persists, so many swine stakeholders are waiting for an effective vaccine against ASF,” she said, adding that the Philippines was only given 600,000 doses as quota for 2023.
She also disclosed that the BAI targets to import 600,000 doses of ASF vaccines this year once the Food and Drug Administration (FDA) issues a certificate of product registration to address the outbreak of the ASF.
“That is why we are trying to hasten the issuance of the certificate of product registration as many countries are also waiting for the vaccine. Vietnam will not supply the 600,000 doses unless the supplier is able to secure the required permit from the government,” she explained.
The BAI official noted that the issuance of the CPR, aside from one of the requirements of the manufacturer, will certify the commercial release of the vaccine in the country.
Vytiaco, however, said they have yet to determine the price of each vaccine dose from the manufacturer. Vytiaco added that the successful trial was the third testing conducted after the other two testing activities, where they partnered with the United States and Thailand. “I cannot discuss anything about the trials, they are confidential,” she said. The pigs that were given the shots are aged four to 10 weeks old.
According to Vytiaco, once the ASF vaccine is officially commercialized, it will not be mandatory as supply will still be limited compared to the nine million total hog population in the country.
The testing of the AVAC ASF LIVE vaccine started on pig farms in March 2022, with the efficacy rate reaching 95%. The vaccine was approved for circulation on July 8, 2022 and put into use under supervision at pig farms. After being approved for circulation, MARD’s Department of Animal Health continues to monitor the quality of 10 vaccine batches to evaluate the effectiveness of the 600,000 doses of AVAC ASF LIVE vaccine on pigs aged between 8-10 weeks.
Vietnam has become the first country to successfully develop and produce two vaccines against ASF, a disease that first appeared in Africa in 1921 with a mortality rate of up to 100%. The evaluation of NAVET-ASFVAC produced by Navetco National Veterinary Joint Stock Company (NAVETCO), and AVAC ASF LIVE is underway.
Translated by Dieu Linh
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