Second of two parts
In Part I of this column, we reported that the Department of Agriculture (DA) recently announced that it is preparing for the rollout of the vaccine this September from Vietnam. This, despite the absence of satisfactory responses to the questions of Sen. Cynthia Villar during the Oct. 25, 2023 Senate hearing on the introduction of the Vietnam-produced African swine fever (ASF) vaccine called AVAC ASF LIVE (AAL), and the issues raised by the Food and Drug Administration (FDA) in its letter of disapproval to issue a Certificate of Product Registration (CPR) on Dec. 19, 2023 to said vaccine.
The joint press conference of the DA and the FDA held at the end of July revealed that a CPR was already issued for the AAL vaccine. Note that the issuance of a CPR means a company can now market, import, export, distribute and sell the FDA approved product. Curiously, in that same press conference, it was also announced that AAL has been “approved for restricted use only by the DA with validity of two years.”
This indicates that there is continuing concern over the massive use and distribution of the AAL vaccine. And rightly so.
In 2022, the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service withdrew the select agent regulatory exclusions for two ASF virus strains used in the production of AAL vaccine “because it has evaluated new information and determined that they have the potential to pose a severe threat to animal health or animal products.”
A Reuters report on Dec. 6, 2023 claimed that USDA scientists have never been given access to Vietnam’s trial data. This was confirmed by the World Organization for Animal Health (WOAH), which complained that the vaccine manufacturer AVAC Vietnam JSC has not shared sufficient data with international research bodies.
WOAH further warned that if any mutation happens, it can pose real danger not only on the existing hog stocks but future ones, not to mention other animals and more importantly, human beings.
Not surprisingly, no ASF-affected countries outside of Vietnam, and soon the Philippines, has officially approved the use and distribution of AAL.
The AAL vaccine is a genetically modified organism (GMO) product. Because of alteration from established organisms, a GMO product is alien to the environment wherein its impact is unknown because there is no precedent to base judgment on whether it is safe or not to plant, animal and human beings.
It is in view of the new challenges posed by biotechnology that Executive Order 514, dated March 17, 2004, was signed by then-president Gloria Arroyo to strengthen the role and function of the National Committee on Biosafety of the Philippines (NCBP). This body is tasked, among others, to review any GMO materials, prior to distribution in the country to ensure that “administrative system and decision-making processes established in the NBF (National Biosafety Framework) shall be complied with” (Section 3 of Executive Order 514).
Since AAL is a genetically modified product, it should have been submitted for review and approval by the NCBP, besides FDA and Bureau of Animal Industry (BAI). Note also that the Court of Appeals recently ruled against the use of GMO products, such as the Golden Rice and Bt eggplant, which are plant organisms, as it viewed that insufficient research was undertaken by their proponents to ensure that they are safe for human consumption and the environment.
It therefore comes as a shock that DA announced the rollout of around 10,000 dosages of AAL to be used mostly in municipalities in Batangas hit hard by ASF. This Vietnam-produced vaccine has not been tested in other countries, and the results of the trial tests done in Vietnam have not been widely distributed for scientists to verify their findings.
In other words, the Philippines is going to be a guinea pig for this vaccine. What is worrying is that DA has not revealed to the public the protocols that will be observed in this experimentation.
The public has the right to know exactly which areas and farms will serve as trial sites. And the public has to know the duration of the trial tests, and when the results will be known and publicly shared. Furthermore, the public has the right to know that if things go wrong, what will be the indemnification mechanisms that are in place.
The public has the right to know how the DA and the private company distributor shall dispose of the carcasses of hogs should something wrong happen to the trial tests, or just even the disposition of hogs used in the experiment. And if the vaccine negatively affected not only the trial hog population but also other animals and the environment, what will be the protocol for compensating those harmed by this vaccine? Will the government and the sole distributor of the vaccine, KPP Powers Inc., shoulder the cost of damages?
The public has the right to know how much is the actual selling price of the AAL vaccine in Vietnam and how much is the DA willing to pay for it. A cursory Google search reveals that the per dosage price of the vaccine in Vietnam is 60,000 dong. This is equivalent to around $2.40 or around P136. Why is the announced procurement price of the DA around P500 to P600 per dosage?
China, one of the largest hog producers in the world, was similarly hit hard by ASF. Reports indicate that it has lost nearly 40 percent of its hog population due to the virus.
As a result, China, with all its resources and technological might, has been assiduously trying to find a vaccine for the ASF but has not attained categorical success. As a result, some of its hog raisers resorted to using illegal (not properly and fully tested) vaccines.
In a report in the publication called “Pig Progress,” E. Wayne Johnson, who is a pig veterinary consultant in Beijing, warned of the dire consequences of the use of unscientifically tested virus, as follows: “… xxx the double deleted (used in China) produces a PRRS-like viral reproductive syndrome in vaccinated sows, with stillbirths, mummifications, embryonic deaths, infertility and abortion.”
He added, “Pigs that survive into the growth-finish period appear to shed vaccine virus and pass it to other pigs. Chronic atypical ASF is the result with chronic blood vessel and immune system disease, xxx … with active zones of necrosis and hemorrhage and chronic lesions with fibrosis are seen in multiple organs microscopically and visibly, particularly in the lymph nodes and the kidneys.”
Even assuming for the sake of argument that AAL is not the same vaccine used in China, the question that remains is: Do BAI and FDA have the capability to conduct a rigorous analysis of the possible effects of AAL as China has done on illegal vaccines to determine the full extent of its impact?
Wouldn’t it be better for a third-party reputable body, like professors and scientists at the UPLB College of Veterinary Medicine, the Department of Animal Science and the National Biotechnology Center to conduct a review of the test results in Vietnam and the ones that will be conducted here?
The stake is too high for the country to leave the decision on government agencies that are politically malleable.
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