Villafuerte to FDA, BAI: Hit gas on anti-ASF vax drive

August 18, 2023 Ryan Ponce Pacpaco 88 views

A HOUSE leader has called on the Food and Drug Administration (FDA) and Bureau of Animal Industry (BAI) to step on the gas on their respective accreditation and then purchase of vaccines already proven effective against the African Swine Fever (ASF), following President Marcos’ own pitch that an inoculation drive could revitalize the hog industry whose population has been decimated by this highly contagious viral disease.

“The FDA and BAI need to hit the gas with this vaccination drive to put an end to the wholesale deaths and selective slaughter of hogs, allow swine raisers to recover and repopulate their farms or backyards, and eventually stabilize the supply and cost of pork products in the local market,” said Camarines Sur Rep. LRay Villafuerte, whose area is one of the ASF-hit provinces in the country.

Villafuerte, National Unity Party (NUP) president, said “the FDA must speed up the registration process for the local commercial use of the Vietnamese-made vaccine, which President Marcos said has been proven 80% effective against the ASF; and the BAI, as soon as the drug is accredited by the FDA, has to accelerate its acquisition of the shots and subsequent implementation of the inoculation program nationwide.”

“The FDA and BAI should do these things double-quick, lest we end up stuck with the same logistics woes at the height of the coronavirus pandemic wherein certain delays in the documentary requirements for the procurement and indemnification processes had moved back the acquisition and roll out of the anti-Covid vaccination program for the targeted 70 million beneficiary-Filipinos to reach herd immunity,” he said.

Villafuerte stressed that, “Speed is of the essence in this mass vaccination plan that was announced by the President himself last month, given that BAI officials have said that the Vietnamese supplier has committed 600,000 doses only for the Philippines for 2023 against the backdrop of many other countries also wanting to procure their own anti-ASF shots at the soonest.”

A recent Reuters report said, though, that Vietnam will actually export two million vaccine doses to the Philippines this year, but there has been no confirmation from the BAI on this higher volume.

Villafuerte noted that the President, in his second State of the Nation Address (SONA), and at a national livestock event before that, had pointed to a vaccination program as key to revitalizing the livestock industry that continue to stagger from the ASF and Avian Influenza (AI) or bird flu outbreaks that have been around for years.

Such animal diseases have drastically reduced domestic stocks and caused upward spirals in the retail prices of pork and chicken products, Villafuerte said.

This week, for instance, the provincial government of Negros Occidental said that ASF-related losses reached P199.58 million in that province alone.

The province’s animal biosecurity incident management team was reported by the media as having listed 17,801 hog fatalities, or almost a tenth of Negros Occidental’s total pig population of 181,048.

Villafuerte reiterated his previous proposals for the government to: (1) declare a state of calamity in ASF-struck areas, so it can immediately access calamity or quick response funds for the planned immunization drive; and (2) subsidize 100%, or at least 50%, of the cost of the shots for backyard raisers, who make up the bulk of local hog growers and who are still reeling from the adverse impact on their small enterprises of this deadly animal disease that resurfaced in the country in 2019.

In the absence of funds for the proposed mass vaccination program in the current General Appropriations Act (GAA), he said that accessing Malacañang Palace’s calamity funds will enable the BAI to procure the vaccine from Vietnam and hopefully kick-off the inoculation drive before the year is over.

And to sustain the immunization project into 2024, Villafuerte said a sufficient amount of funds needs to be included in the BAI budget in the proposed 2024 GAA of P5.768-trillion—and both the House of Representatives and the Senate must support this outlay this budget deliberation season.

“The FDA and BAI must work double-time on this program as the President mentioned in his second SONA that the government is about to acquire an effective vaccine and, in the meantime, has been focused on strengthening bio-security measures to prevent the spread of animal diseases,” said Villafuerte.

In his SONA last July 24, Mr. Marcos said: “Nakabantay tayo sa anumang banta ng mga sakit at peste na maaaring dumapo sa mga pananim at alagang hayop. Malapit na tayong magkaroon ng mga epektibong gamot at bakuna laban sa mga ito. Samantala, pinapalakas natin ang bio-security levels ng mga alagang hayop bilang panlaban sa sakit.”

Before that, in his speech at the recent Livestock Philippines Expo 2023 at the World Trade Center Metro Manila, the President acknowledged the urgency of revitalizing the livestock and poultry sectors, in light of the devastating effects of unabated ASF and bird flu outbreaks on local animal raisers.

President Marcos said, “We are also happy to announce the completion of Phase One of the safety and efficacy trials for the ASF vaccines. The BAI has found to produce sufficient antibodies and to be safe for use. And as it stands, the Philippine FDA is on track to issue a certificate of product registration for these vaccines … This gives us great hope as we have been waiting for this for a very long time … The vaccine is 80% effective … Do not underestimate or downgrade the importance and the big advantage that the vaccines bring us.”

At a chance interview during that same Livestock Expo event, the President told reporters: “I think I’m confident that when it comes to livestock and the broilers, the hogs, and the cattle … if we continue to be able to fix the systems and now of course ang pinakamalaking issue ay ‘yung ASF pa rin at saka yung Avian Influenza … that’s why I think that as long as we continue to do this and develop more and take advantage of all these new vaccines that are coming, that are being rolled out, I think kakayanin natin i-sustain—hindi lamang i -sustain ito pero pagandahin pa natin, palakihin pa natin, make it more efficient, make it more streamlined.”

President Marcos’ endorsement of the anti-ASF vaccine came after BAI Assistant Director Arlene Vytiaco announced in June that the Bureau was pushing the Vietnam-made Avac Live vaccine after the 100%-success of the field trials conducted on pigs in six areas in Luzon over the March-May period.

Vytiaco said at a press briefing that, “The safety and efficacy trials in Luzon showed that the hogs that have been injected produced 100% antibodies and has no side effects on animals. We have endorsed it (vaccine) to the FDA for the issuance of CPR (Certificate of Product Registration),” which will authorize its commercial release in the country.

Vytiaco was hopeful back in June that the FDA would immediately issue the CPR as many countries were also waiting for their supplies, and said the Vietnamese manufacturer was ready at that time to supply 600,000 vaccines to the Philippines.

“The 600,000 doses are only for this year. For next and the next three years, we will be provided with 1 million per year,” Vytiaco said, adding that Vietnam can supply the first 300,000 doses by September, and the balance of 300,000 by the last quarter of this year.

“Once the FDA issues a CPR of the vaccine, the supplier will be importing from Vietnam,” Vytiaco said. “That is why we are trying to hasten the issuance of the CPR 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.”

The FDA confirmed later that the BAI had applied for certification of the Vietnam-made Avac vaccine, and its spokesman Job Aguzar said this application shall be subjected to pre-assessment.

At the Livestock Philippines 2023 event, DA Assistant Secretary for Operations Arnel de Mesa confirmed that the DA recommendation to certify the vaccine has been submitted to the FDA, and that, ““We’re working closely with FDA regarding the (ASF) vaccine as they are mandated to do so.”

He told reporters that the DA was also studying the proposal to subsidize private swine raisers in availing the vaccine once it is available in the country. “We are studying the proposal especially small backyard or small pig growers. We want to help them. It is a proposal to have a discount. We’re looking at that possibility.”

In a media interview, DA Assistant Secretary and its Spokesman Rex Estoperez said the DA and the BAI have started talks on potential financial assistance for hog raisers, and the options include realigning the budget from other Department-attached agencies or turning to the Congress for an additional allocation.

“Now, on the government subsidy, we have already discussed this with the BAI and we may need to seek the help of our legislators for an additional budget,” Estoperez said. “We are looking at the budget of other agencies, especially the BAI, to determine whether we need to supplement, realign or request for an additional budget.”

As proposed by certain lawmakers and swine industry groups, he said the DA has also recommended tapping the calamity fund or quick response fund for this purpose. “If we need to declare a state of calamity, we must be able to justify it to our President (Marcos) and (agriculture) secretary.”

He recalled that Senate Majority Leader Juan Miguel Zubiri had even filed Senate Resolution (SR) 858 in August 2021 seeking an inquiry into delays in the MPAs that the national government, LGUs and private entities had entered into with suppliers or manufacturers.

Zubiri had sought an inquiry by the Senate Committee of the Whole into reports that the MPAs submitted by LGUs and about 300 private groups for a combined 10 million doses were not acted upon quickly by the national government, hence affecting the country’s vaccine rollout.

National Task Force Covid-19 Chief Implementer and vaccine czar Carlito Galvez Jr and his Deputy Chief Implementer Vivencio Dizon had pointed to paper work or documentary requirements involving an indemnification fund as the culprit behind the delayed vaccine rollout schedule.

RA 10121 or the “Philippine Disaster Risk Reduction and Management Act of 2010” had replaced the Calamity Fund with the National Disaster Risk Reduction and Management Fund (NDRRM Fund)—for use for disaster risk reduction or mitigation, prevention and preparedness activities, relief, recovery, reconstruction and other work or services in connection with natural or human induced calamities.

This law set aside 30% of the NDRRM Fund for a Quick Response Fund (QRF) or “stand-by fund for relief and recovery programs in order that situation and living conditions of people in communities or areas stricken by disasters, calamities, epidemics or complex emergencies, may be normalized as quickly as possible.”

The province of Bataan and municipality of Hamtic in Antique separately declared a state of calamity in their respective areas in June because of ASF outbreaks, to enable these LGUs to better prevent the spread of the disease, give appropriate financial support to the affected hog raisers and avoid unwarranted commodity price spikes.

Citing Department of Budget and Management (DBM) data, Villafuerte said that the 2023 national budget has an NDRRM Fund totaling P23.21 billion, of which P8.44 billion has been released in the first semester—leaving P14.77 billion in calamity funds for the year’s second half.

Part of this available amount can be used for a mass vaccination program with subsidies for backyard hog raisers, he said.

Citing assessments by industry players, Villafuerte said that only an immunization drive can prevent more ASF-related animal deaths, reverse the low hog supply in the country, reduce imports and prevent a repeat of the escalation in market prices of pork products in 2021 that was one reason for the undue spike in the country’s inflation rate.

The ASF resurfaced first in China in 2018, and then in many other countries, including the Philippines where outbreaks began in 2019.

Local ASF outbreaks had spread across an alarming 460 municipalities in 54 provinces as of April this year.

According to Janice Garcia, cluster coordinator of the BAI-National African Swine Fever Prevention and Control Program, a total of 15 provinces had active ASF cases as of June 1.

This disease was responsible for a 50%-drop in our local swine population after ASF resurfaced in the Philippines in 2019 and spread across over 50 provinces by 2022, devastating commercial pig farms and backyard raisers and causing an annual revenue loss of P100 billion for allied industries.

There was a nearly 25%-decline in pork output in the period from June to October 2021 as against the same four months in 2020, driving retail prices up to P400 a kilo from the earlier per-kilo average of P250.