There is no timeline yet for approval, but the transfer of regulatory authority over veterinary vaccines from the Food and Drug Administration to the BAI is expected to streamline the approval process.
The Philippines’ Bureau of Animal Industry (BAI) said six vaccine producers with treatments for African swine fever (ASF) are currently seeking approval for commercial use of their products.
“The ASF vaccines that we are looking at… with ongoing applications for registration, are at six,” BAI Director Christian P Daquigan told reporters recently.
Mr Daquigan said there is no timeline yet for approval, but the transfer of regulatory authority over veterinary vaccines from the Food and Drug Administration to the BAI is expected to streamline the approval process.
Republic Act No. 12308, or the Animal Industry Development and Competitiveness Act, signed in September, grants jurisdiction over the registration, licensing, and regulation of veterinary drugs, biologics, and vaccines to the BAI.
Mr Daquigan said the Department of Agriculture (DA) is pushing for the commercialization of ASF vaccines following positive results in controlled vaccine trials.
“I think we need to proceed with the commercialization of vaccines because we need this. And we found out that the result is good based on our monitored release,” he said.
The DA has so far released 400,000 ASF vaccine doses out of the 500,000 allocated for controlled use, according to Mr Daquigan.
“There are still about 100,000 doses left, but our applications for monitored release are ongoing. We have a lot of applications in this office,” he said.
Currently, all ASF vaccinations remain under DA control and monitoring, with no vaccine yet approved for commercial use.
Agriculture Undersecretary for Livestock Constante J Palabrica has said that the DA hopes that at least one ASF vaccine will be cleared for commercial use within the year.
“This is a long process because we have to be very careful. Hopefully, one or two can be used this year. The Chulalongkorn DNA can be approved this year, because it is not a live vaccine,” he said, referring to a candidate vaccine developed by researchers at Thailand’s Chulalongkorn University.
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