(First of two parts)
IN his State of the Nation Address (SONA) last July 22, the President announced that a vaccine for the African swine fever (ASF) would soon be rolled out. ASF is a deadly swine virus that has wiped out around a quarter of our hog population since its outbreak in 2019.
A week after the SONA, Agriculture Secretary Francis Tiu Laurel and the head of the Food and Drug Administration (FDA), Samuel Zacate, in a joint press conference, declared that a certificate of product registration (CPR) had been issued by the latter to the Vietnam-produced ASF vaccine called AVAC ASF Live (AAL). The issuance of a CPR by FDA is a green light that a company can now market, import, export, distribute and sell the approved product.
But there is something amiss about the CPR issued. For in that same press conference, it was also announced that AAL has been “approved for restricted use only by the Department of Agriculture (DA) with the validity of two years.”
Why restrict the use of the ASF vaccine to DA when an issued CPR allows a company to sell the product to the open market?
The answer to this conundrum lies in the short history of the previous attempt to introduce this Vietnam-produced ASF vaccine to the country.
Last year, key stakeholders in the animal industry were able to bring to the attention of the Senate concerns about the possible adverse effects of the allegedly unproven ASF vaccine from Vietnam. On Oct. 25, 2023, the head of the Senate Committee on Agriculture, Sen. Cynthia Villar, conducted a hearing on the AAL. In her opening statement, Villar noted a number of infirmities regarding the premature use and distribution of the said vaccine.
First was that the FDA had not issued a CPR (during that time) and hence, she was puzzled why Bureau of Animal Industry (BAI) Assistant Director Arlene Asteria Vitiaco recommended the use and distribution of the vaccine then.
Second, she was puzzled on who gave the authority to import the said vaccine that allegedly contains a genetically modified virus of questionable features. She asked which agency has the authority to approve the animal vaccine. Is it BAI or FDA?
Third, she stressed that at the time of the Senate hearing, the World Organization for Animal Health (WOAH) has not come out yet with a new standard manufacturing and trial protocol on ASF vaccines for regulatory approval. Hence, utmost care must be exercised by the government prior to engaging in clinical or field trial tests of the AVAC vaccine.
She noted that there were trials and tests undertaken for the vaccine between February and May 2023, and May and October 2023, but their results have not been shared with the scientific community for independent peer review to determine their veracity. It is not clear what protocols were used in the selection of farms, the disposition of the animals used for the trials, and whether the process is scientifically rigorous, among many questions.
Lastly, she expressed concern over the unclear mode of indemnification if the trials conducted by the company promoting the product, allegedly under close supervision of BAI, went wrong.
To this date, satisfactory answers have not been provided to the issues raised by Villar. As a result, on Dec. 19, 2023, Zacate issued a letter of disapproval for the issuance of a CPR to the ASF vaccine applied for by KPP Powers Commodities Inc. In the letter of disapproval, Zacate cited the following reasons, to wit:
“1. Failure to provide information on the exact source of the ASF isolate. … xxx;
“2. Failure to provide specification of all starting materials used in the production of the vaccine product … xxx;
“3. Failure to provide the Technical Specification and Certificate of the Analysis of the Finished Product … xxx;
“4. Inconsistencies noted on the manufacturing process and the quality control testing based on the initial submission and compliance documents;
“5. Failure to provide the validation of the tests conducted to the antigen used in the production of the master and working seed of the virus … xxx;
“6. And, failure to substantiate the safety and efficacy of the vaccine … xxx.”
However, Zacate noted that the product application may be resubmitted after six months from the date of disapproval.
The litany of concerns raised by Zacate must have been addressed to the satisfaction of FDA as it was announced in the joint press conference by the DA and the FDA that the latter agency already issued a CPR for the AAL vaccine. The only problem is that more than six months after its disapproval, the FDA has not released to the public how the agency's concerns were satisfactorily complied with by the applicant.
The concern over the safety of the use of this vaccine was initially flagged down by the US Department of Agriculture (USDA). In its Federal Register bulletin of October 27, 2022, it issued that its “Animal and Plant Health Inspection Service (APHIS) has withdrawn the select agent regulatory exclusions for two African swine fever virus strains, namely, ASFV-G-ΔMGF and ASFV-G-Δ9GL/ΔMGF.”
It added, “APHIS withdrew the select agent regulatory exclusions for these strains because it has evaluated new information and determined that they have the potential to pose a severe threat to animal health or animal products.”
The problem is that ASFV-G-ΔMGF, one of the banned virus strains identified by USDA as potentially highly dangerous, is the same strain being used in the production of the Vietnamese vaccine.
It is claimed though by the Vietnam Center for Veterinary Drug and Vaccine Quality Control that the AAL vaccine underwent rigorous scientific trials in various parts of Vietnam.
But a Reuters report on Dec. 6, 2023, noted that USDA scientists have never been given access to Vietnam's trial data. This was confirmed by WOAH which complained that the AVAC Vietnam JSC has not shared sufficient data to international research bodies.
Undeniably, this makes it impossible for a third impartial body, like WOAH, to validate whether the claim that Vietnam's ASF vaccine really works, and more importantly, whether it is safe and will not pose a severe threat to the existing swine population here and abroad.
It is feared that if any mutation happens, which may likely be the case even in a monitored trial, can pose a real danger not only on the existing hog stocks but future ones.
It is for this reason why the gene-altered virus strains were banned in the US and its further distribution stopped.
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