MANILA, Philippines – The Philippine licensee and distributor of an African Swine Fever (ASF) vaccine, which is still undergoing wide-scale testing, insisted on Friday, August 25, it is safe and effective.

KPP Powers Commodities Incorporated (KPP), the local distributor of the Vietnamese-developed anti-ASF product, said AVAC Vietnam’s (AVAC) “vaccine was proven to be safe and there is no shedding after injecting ten times the normal dosage in the safety trial conducted at the [Philippine] Bureau of Animal Industry’s (BAI) facilities.” 

“At the end of the trial, the pig animals remained healthy and were even kept at BAI for more than 90 days without any problems, which is beyond the 21-day trial requirements,” said the Quezon City-based firm. 

Its partner-producer in Vietnam, and the vaccine producer’s business associate in the US sent separate feedback to the story published by Rappler on August 20, Sunday, saying it was “blatantly untrue.”

Law firm Chan Robles and Associates, counsel for KPP, cited VietnamPlus, an official publication of the Vietnamese government, which announced the approval of the nationwide use of the AVAC vaccine starting July this year. It cited an “independent assessment” made by a US Department of Agriculture delegation conducted in April-May this year that the vaccines (AVAC ASF LIVE and NAVET-ASFVAC) “meet international standards, including those that have been developed by scientists and submitted to the World Organisation for Animal Health.”

Healthy pigs after trial

KPP said the company was required to conduct many trials at BAI and in “large farms sponsored by well-known and reputable farms managed by leading companies in the Philippines.”

KPP also defended its chemist CEO, Pinky Tobiano, saying she “has been in the animal health business for more than 30 years, formulating, manufacturing, dealing with animal medicines, raw materials and ingredients, and many animal (swine and poultry-related) biological products.” 

It described the ASF vaccine producer as a “reputable company in Vietnam [that] has been in operations since 2012 with a portfolio of more than 30 vaccine products for animals.” 

It said AVAC tested the vaccines in over 500 farms in Vietnam “with a result of 95% rate of successfully providing immunity from ASF.” 

“The Ministry of Agriculture and Rural Development of Vietnam oversaw and closely monitored the use of the vaccine, and has recommended mass vaccination in Vietnam,” KPP said. 

‘Sabotaging AVAC vaccine approval’

KPP’s counsel said the story “cast aspersion on the government-regulated, science-based process of review and registration the AVAC ASF vaccine underwent and is still undergoing.”

The firm’s managing partner Reynaldo Robles, also the brother of KPP top official Juancho Robles and brother-in-law of Tobiano who serves as CEO, alleged that the story was intended to pre-empt and sabotage the approval of the AVAC ASF vaccine in the Philippines. (Editor’s Note: There was no such intention.)

KPP also alleged that the detractors of the ASF vaccine range from “competing products, those not allowed to conduct trials by the government because of deficiencies, those who want to stop the vaccine because of conflicted interests…and those that are simply ignorant of the science behind live vaccines.” 

Citing a report by the Pork Producers Federation of the Philippines, KPP also said the Philippines’ swine industry has lost more than P200 billion from ASF since 2019, with at least 50% of the total hog population affected by the disease. 

“Many local farmers have lost their livelihood and life savings. The ASF vaccines along with other bio-security measures and products, used together in partnership, will allow our country to move forward,” KPP said.

Not for breeder farms

Responding to a Thai company officer’s quote in the story that they will not use the AVAC vaccine, KPP said the vaccine is really “not for breeder farms” which the Thai company operates. The vaccine is appropriate “only for growers or growing pigs from 6 to 8 weeks of age,” it said.

“Breeder pigs are not recommended to be injected with the vaccine because the breeders are sensitive especially when pregnant and may easily get sick and/or reduce the number of piglets born,” KPP said.

AVAC Vietnam, KPP’s foreign partner, denied there had been incidents of shedding and other post-injection side effects that took place in pig farms in Pulau Bulan, Sumatra, Java and Sulawesi as a result the vaccine. 

AVAC president and CEO Nguyen Van Diep said that “as of August 20, 2023, AVAC has not shipped even a single dose of its vaccine to Indonesia.”

Rappler’s story, however, did not say that the AVAC vaccines introduced in the Indonesian farms were officially shipped. The insider who was the unnamed source in the story about the ASF vaccine personally witnessed the deaths in the Indonesian farms. 

Aptimmune says no deal yet, US interested

Meanwhile, Aptimmune Biologicals (Aptimmune), identified in the story as AVAC’s American business partner, has yet to enter into a formal partnership, which they are both still contemplating. Aptimmune supplied the Vietnamese company with the US Department of Agriculture (USDA)-withdrawn ASF virus strain. 

“The relationship was preliminarily formalized in a term sheet, although the actual agreement was not formalized,” Aptimmune CEO Heather Bessoff in an e-mail sent to this writer.

Bessolf disclosed that Aptimmune provided AVAC with materials under a Material Transfer Agreement to perform a certain study, specifically “a proof-of-concept challenge study to confirm that the material is efficacious against the Vietnamese strain of African Swine Fever.” 

“Aptimmune made one and only one shipment to AVAC. ∆MGF vaccine virus was put back on the Select Agent list in the US by USDA in January 2022. Until that time, Aptimmune had no knowledge of any USDA concerns, and Aptimmune did not supply the ASF strain at any point after USDA Animal and Plant Health Inspection Service (APHIS) had withdrawn the select agent regulatory exclusions for African swine fever virus strain ASFV–G–∆MGF,” Bessoff said.

She also said that after the USDA issued the withdrawal notice in January 2022, Aptimmune wrote AVAC asking the Vietnamese firm to stop working on the virus strain, which was determined  by US authorities to be unsafe and could have the potential to pose a severe threat to animal health or animal products. 

“A Cease-and-Desist Letter was sent to AVAC from Aptimmune upon learning that they had continued to work with the virus strain after informing us that they had terminated their interest in the virus,” Bessoff said. 

When asked for copies of letters and documents pertaining to AVAC and the ASF virus strain, Bessoff declined, citing confidentiality.

A Reuters report last June, however, quoted US Agriculture Secretary Thomas Vilsack as saying there was “likely to be interest in precautionary purchases in the United States, despite the country having so far been spared from the virus.” – Rappler.com