USDA vaccine stockpile prepares US for HPAI outbreak

The U.S. Department of Agriculture (USDA) is making preparations to turn back and stop another outbreak of highly pathogenic avian influenza (HPAI). One of the most powerful tools in fighting another U.S. outbreak of HPAI may be the USDA’s stockpile of poultry vaccines.
During the WATT Global Media webinar, "Vaccination as Part of an Avian Flu Eradication Plan," Dr. David Suarez, research leader for exotic and emerging avian viral diseases research at the USDA’s Agricultural Research Service (ARS), spoke about a stockpile of vaccine the agency is building. The National Veterinary Stockpile would only be tapped in the event of a widespread outbreak of HPAI – like the one that spread across the country between December 2014 and June 2015 – but it is a key part of the USDA’s response plan.
Suarez, who’s been with the ARS since 1995, said empirical research from two decades of fighting HPAI outbreaks around the world proves that vaccines in combination with other biosecurity measures are an effective way to both stop outbreaks and reduce viral shedding, or the transmission of the virus from one infected bird to an entire flock. So, the agency has decided to stockpile as many as 500 million doses of poultry vaccines in the event of an outbreak. 
However, in accordance with U.S. regulations, the USDA can only use vaccines approved and licensed by its Center for Veterinary Biologics. This limits its access to experimental vaccines that have shown promise against extant strains of HPAI. The USDA has limited options because drug companies have very little economic incentive to independently research and produce HPAI vaccines.
“We’re certainly constrained by what the commercial companies are willing to get licensed in the U.S.,” Suarez said. “Because we don’t vaccinate for avian influenza on a routine basis, there’s very little economic incentive for these companies to license in the U.S. because obviously, they don’t want to go through the expense of licensing unless they have a product that can be sold that they can make a profit on.
“That really has constrained what is available in the U.S. In some countries, like in China and Mexico, they actually have some products available there that are not available here.”
In order to encourage drug companies to produce newer, more-effective vaccines that the USDA can stockpile in the event of a mass immunization, the agency released a request for proposals for avian influenza vaccines in 2015.
The two avian influenza vaccines purchased by USDA Animal Plant Health Inspection Service (APHIS) for the stockpile had different costs. The vaccines are being added to the stockpile at costs to USDA of $0.06 and $0.125 per dose by Ceva Animal Health and Harrisvaccines, respectively.
The agency released a second request in November. Suarez said the USDA may issue three more similar requests in the near future where APHIS may purchase additional doses of vaccine. So far, the agency has purchased 148 million doses for $12 million.
Beyond the vaccines already stockpiled, Suarez said he thinks there are new vaccines being developed that will be released soon. He believes the existence of the National Veterinary Stockpile has played a positive role in advancing the development of new vaccines in the U.S. The stockpile, at the very least, he said, gives the USDA the option to immunize with proven and reliable vaccines in the face of another HPAI outbreak.
The USDA has not yet made any decision on mass immunization. However, it has established a criteria for how it would immunize if that decision is made in the future.

Funding granted to develop poultry vaccines

A U.K. Biotechnology and Biological Sciences Research Council (BBSRC) Strategic Longer and Larger (sLoLa) grant, worth GBP5.7 (US$8.38) million, will be used to design and improve vaccines for poultry. The grant was awarded to professor Mark Stevens and collaborators at the London School of Hygiene & Tropical Medicine, Imperial College London, University of Cambridge, University of Exeter, the John Innes Centre and the Defence Science & Technology Laboratory. It is one of three recently funded grants through BBSRC's sLoLa scheme, which gives world-leading research teams five years of funding and resources to address major challenges.
Chicken is the UK’s most consumed meat and the world's most popular animal-based food. The sales of chicken meat and eggs are worth over GBP7.2 (US$11.32) billion per year in the UK alone, and demand is increasing rapidly due to population growth. However, poultry has key reservoirs of foodborne pathogens such as Salmonella and Campylobacter. The productivity and welfare of poultry products are constrained by endemic diseases caused by E. coli and Clostridia. This project aims to develop and refine vaccines to protect flocks against theseinfection.
The most successful human vaccines that give long-lasting protective immunity are often glycoconjugates (proteins coupled to sugars), but these vaccines are complex and expensive to produce. This award will enable researchers to develop glycoengineering technology to produce a new generation of inexpensive veterinary vaccines.
The principal investigator of the project Brendan Wren, professor of Microbial Pathogenesis at the London School of Hygiene & Tropical Medicine, said: "Developing effective, inexpensive vaccines for livestock has multiple advantages, not just in protecting animals from disease, but also in reducing infections in humans and antibiotics in the food chain that are often used in rearing livestock. “
Stevens, director of research at The Roslin Institute, said: “We are delighted to partner with BBSRC and leading laboratories to tackle important poultry and foodborne diseases. Taken together with BBSRC strategic investment in the National Avian Research Facility here at The Roslin Institute the project will greatly help us to address the global challenge of improving food supply and safety.”

Poultry vaccines can stop the spread of avian flu

Dr. Leslie David Sims, a consultant for Asia Pacific Veterinary Information Service, Australia, said research collected since the first outbreaks of highly pathogenic avian influenza (HPAI) in the 1990s demonstrates successful application of vaccination can be effective in controlling and stopping the spread of HPAI.
During the Watt Global Media webinar, Vaccination as Part of an Avian Flu Eradication Plan, Sims presented information on how the use of vaccination has controlled and eliminated avian influenza viruses in nations other than the U.S. in the past.
Sims, who’s worked as a consultant for the Food and Agriculture Organization of the United Nations and the World Bank, has advised veterinary authorities in China, Thailand, Cambodia, North Korea, Mongolia, Indonesia and Vietnam. His presentation centered on lessons learned in almost two decades of fighting and studying the so-called “goose Quandong” strain of the HPAI virus in Southeast Asia.
Stamping out, culling of infected and susceptible flocks, has long been viewed as the only way to control the spread of HPAI. Sims said that’s not exactly true.
While this approach to stamping out does work if new cases are detected early and the response is rapid, it comes at a high cost. During the 2014-2015 HPAI outbreak in the U.S., he estimated 49 million birds were killed or culled. Sims said stamping out also depends on the density of poultry being low and is ineffective if the cull happens after the virus has already been transmitted to other flocks.
Vaccination, when used in combination with other biosecurity measures, can be just as effective in stopping the spread and eliminating the spread of HPAI. Sims noted that vaccination – without preemptive culling – was successful in stopping the spread of HPAI in Hong Kong in 2002. In 2003, vaccination, in combination with quarantine and depopulation of affected houses, was successful in stopping an outbreak that had already begun. More recently, Sims said, vaccination has been used successfully in Italy and with low pathogenic avian influenza in the U.S.
Vaccination works best when the vaccine’s antigen closely matches the genetic makeup of the pathogen, Sims said. An early response to an outbreak, as well as bio-secure administration by competent veterinary services is necessary to the success of an immunization program, too. Cooperation among government agencies and poultry industries and close monitoring of flocks are also needed.
“It’s great to have the vaccine and, hopefully, you won’t have to use it,” Sims said.
While empirical evidence demonstrates vaccination is successful, there is significant skepticism about the practice in the poultry industry. Sims said that likely comes from the inability to eliminate HPAI with vaccination in regions where it is endemic, concerns about the process of vaccination rather than the vaccine itself, concerns vaccines will be ineffective against new strains of HPAI, mistaken beliefs that only mass depopulation works and international trade concerns raised by wide-spread vaccination to prevent the spread of HPAI. Some countries, he said, will stop imports because of vaccination. However, China – where vaccination has been used for more than a decade – is still exporting poultry to Japan.
“They do this from areas where vaccine is not being used, but it shows it is possible for some countries to accept products from countries where vaccine is being used even though the product which is being exported is not subject to vaccination in those cases,” Sims said.

APHIS discusses criteria for potential HPAI vaccinations

The U.S. Department of Agriculture isn’t planning on widespread vaccination of poultry and layer flocks, but its considering how it might do so in the event of an outbreak of highly pathogenic avian influenza (HPAI).
During the Watt Global Media webinar, Vaccination as Part of an Avian Flu Eradication Plan, Dr. Lee Ann Thomas, director of the Avian, Swine & Aquatic Animal Health Center at the USDA’s Animal and Plant Health Inspection Service (APHIS), discussed what factors the agency would consider when making the decision of whether or not to approve use of the stockpiled avian influenza vaccines in the U.S.
Thomas said any decision to vaccinate will follow a science-based strategy focused on suppressing and eradicating the disease. With an established eradication plan and maintenance of enhanced biosecurity in mind, the agency would conduct a controlled vaccination of at-risk flocks, then monitor all vaccinated and at-risk birds before carrying out a repopulation plan.
Before making the decision to vaccinate, APHIS would consider the probability of containing the spread of the virus; the proximity of high-value genetic breeder birds to the outbreak; poultry density in the area that may be vaccinated; the possible increased risk of introduction of HPAI into uncontaminated flocks and the presence of HPAI transmitting waterfowl.
As for which birds would get vaccinated first, Thomas said APHIS would consider how effective a vaccine is in each species, which commodities would be impacted by an HPAI outbreak, how close farms are to one another, the outbreak pattern, and the type of flock.
Thomas stressed that no decision has been made to vaccinate birds in the U.S. The decision, she said, will ultimately lie with the agency’s administrator, Kevin Shea. If the decision is made, it would be supervised by incident command in the area, who would be charged with developing the plan for vaccination, reporting vaccine usage, permitting movements and monitoring all activities.
Logistically, Thomas said, immunizing millions of birds would be challenging. The efforts must be coordinated to ensure that national biosecurity is not compromised and that vaccination teams do not become unwitting transmitters of the virus. There would also need to be continuous monitoring of the immunized population to ensure there is no vaccine break.
The decision will not be made lightly, as widespread vaccination of the nation’s flocks could stymie foreign market’s appetite for U.S. poultry and eggs. Thomas said the December 2014 to June 2015 outbreak of HPAI led to the depopulation of 50 million birds and impacted the U.S.’s relationship with 17 trading partners, including China, Russia and South Korea.
While no decision has been made to immunize, USDA is already stockpiling millions of doses of vaccines that showed promise in preventing the spread the HPAI. Dr. David Suarez, the research leader for exotic and emerging avian viral disease research at the USDA’s Agricultural Research Service (ARS), said the U.S.’s options are limited because only licensed vaccines can be deployed by the USDA. In order to both incentivize the private sector to develop newer, more effective vaccines, and stock up for the event of a mass immunization, the USDA is building a stockpile of millions of doses of vaccine.
The two avian influenza vaccines purchased by USDA APHIS for the stockpile had different costs. The vaccines are being added to the stockpile at costs to USDA of $0.06 and $0.125 per dose by Ceva Animal Health and Harrisvaccines, respectively.
While there is some skepticism about the efficacy of vaccines in stopping HPAI outbreaks, Dr. Leslie David Sims, a consultant for Asia Pacific Veterinary Information Service, Australia, said empirical research gathered through decades of fighting HPAI outbreaks in Southeast Asia proves that vaccines, when properly administered, can be effective in halting the spread of the virus on specific farms and in wider geographic areas.

Research project to develop new type of poultry vaccine

Cheap and effective vaccines for poultry that will reduce infections in humans and minimize antibiotic use in the food chain are to be developed by the London School of Hygiene and Tropical Medicine (LSHTM).
With project funding of GBP5.7 million (US$8.7 million) from the Biotechnology and Biological Sciences Research Council (BBSRC) of the United Kingdom, the award is one of three grants funded through a special scheme that offers world-leading research teams five years of funding and resources to address major challenges.
According to the LSHTM, poultry are the source of the world's most popular animal-based foods, and global production has tripled over the last 20 years. The world's chicken flock is now estimated to be around 21 billion, producing 1.1 trillion eggs and 90 million tons of meat every year.
Livestock health plays an essential role in any country’s economic prosperity but also for public health because infected poultry can pass on diseases to humans, particularly through foodborne infections from bacteria such as Salmonella and Campylobacter.
Vaccinating poultry is the most effective way of protecting them from disease and preventing food poisoning in humans. The most successful human vaccines that give long-lasting protective immunity are often glycoconjugates (proteins coupled to sugars). These vaccines are complex and expensive to produce but researchers at LSHTM have recently developed new glycoengineering technology that will facilitate the coupling of protein-sugar combinations for a new generation of inexpensive veterinary vaccines.
The project’s principal investigator at LSHTM is Brendan Wren, Professor of Microbial Pathogenesis.
“Developing effective, inexpensive vaccines for livestock has multiple advantages, not just in protecting animals from disease, but also in reducing infections in humans and antibiotics in the food chain that are often used in rearing livestock,” said Wren. “The BBSRC-funded proposal on veterinary vaccines will facilitate glycoengineering technology developed at the School to produce glycoconjugate vaccines that will simultaneously protect poultry against clostridia, Salmonella and Campylobacter infection and subsequently reduce the incidence of food poisoning in humans. The technology will also be used to develop glycoconjugate vaccines for cattle, sheep and goats, to protect against clostridia and coxiella infection.”

UK poultry producer to trial new Campylobacter control

U.K. poultry producer Banham Poultry has entered a partnership to help develop a feed additive that will aid in controlling Campylobacter infection in chickens.
The company is working with Akeso Biomedical and will use the latter’s Fe3C technology to reduce Campylobacter levels in its broilers. The technology, discovered by the University of Nottingham, prevents the binding of Campylobacter to the chicken’s gastrointestinal tract and subsequent infection.
Initial trials began in April, and in preliminary studies Akeso’s feed additive resulted in dramatically reduced infection levels in birds. As part of the development process, it is anticipated that Banham will evaluate the feed additives in commercial trials.
Lars Brattinga, general manager agriculture at Banham Poultry said: “This is a really exciting project for the industry. To reduce levels of Campylobacter, we need to take action throughout the supply chain. We still don’t know the source of Campylobacter, which is what makes it so difficult to control.”

Luoyang Huizhong Biotech invests in poultry vaccine lines

China’s Luoyang Huizhong Biotech Co. Ltd. has invested CNY150 million (US$24.5 million) to build six new vaccine production lines in the Luolong High Tech Industry Development Zone.
The production lines include a 100m mL capacity line for inactivated vero cell vaccines; a 200m dose capacity line for live vero cell vaccines; a 300m mL capacity line for inactivated poultry tissue vaccines; a 2bn dose capacity line for live poultry tissue vaccines; a 100m mL capacity line for inactivated bacterial vaccines; and a 100m dose capacity line for live bacterial vaccines, according a to report provided by Smart Agriculture Analytics.
Other facilities included in the company’s investment include a liquid and solid disinfectant workshop and warehouse, and a quality inspection center.
Luoyong Huizhong Biotech is involved in the research and production of new vaccines for veterinary use. It is a wholly owned subsidiary and private high-tech joint stock enterprise of Pulike Biological Engineering Inc. The company, according to its website, was founded in July 2011.

USDA says not yet for US avian flu vaccination

maxxyustas.Image from BigStockPhoto.com
The U.S. Department of Agriculture (USDA) said it will not approve use of avian influenza vaccines for use in the current H5N2 outbreak that the U.S. poultry industry is struggling to eradicate. 
The U.S. Department of Agriculture (USDA) announced on June 3, 2015, that it is not going to approve use of avian influenza vaccines for use in the current H5N2 outbreak that the U.S. poultry industry is struggling to eradicate. In a statement, USDA said: 
“The Department evaluated the efficacy of current vaccine options for HPAI in addition to economic impacts of vaccination and has determined that, as it currently stands, additional criteria must be met before a vaccine can be approved for emergency use. Vaccines currently available are not well matched and do not meet a suitable level of efficacy. USDA also wants to be sure that the vaccine industry is in a position to produce enough doses to create an effective control measure. Finally, additional outreach with trading partners will be required to avoid significant market disruptions.” 
The agency pledged to continue to work with researchers and vaccine companies and they develop vaccines with greater homology to the current H5N2 outbreak strain. The agency said, “USDA will continue to encourage development of vaccines for HPAI and will approve vaccines as they are developed and evaluated. Currently, there is lack of a well-matched, effective vaccine for HPAI from the public and private sectors. The vaccine currently available offers just 60 percent effectiveness in chickens, leaving 4 in 10 birds unprotected. The vaccine’s effectiveness in turkeys is still being studied. USDA’s Animal and Plant Health Inspection Service (APHIS) will re-evaluate its vaccination decision as more effective vaccines are developed and ready for use, carefully considering both the efficacy of the vaccine and the potential trade impacts. If used, vaccines will be targeted in the states and poultry sectors where they can be most effective. Areas where quarantine, depopulation, and enhanced biosecurity cannot stop the spread of HPAI would be prioritized.”
USDA has estimated that, presently, markets for around 84 percent of the value of U.S. poultry and poultry products exports are still open. The agency states that some “significant trading partners” have indicated that use of avian influenza vaccination in any portion of the U.S. would result in bans on importation of all U.S. poultry products until a risk assessment can be completed. Because the loss of these export markets could cost U.S. poultry producers billions of dollars, the USDA has determined that the cost of vaccination to the industry far outweighs its benefits, at least with the currently available vaccines.

Sanderson: More knowledge of avian flu vaccines needed

The CEO of Sanderson Farms says he is apprehensive about the potential vaccination of poultry against avian influenza (AI), citing the U.S. government's lack of knowledge about possible vaccines and their effectiveness.
Speaking recently at the Goldman Sachs Global Staples Forum, Joe Sanderson Jr. said much still needs to be learned before the U.S. can implement a vaccination program.
“They do not know much about these vaccines. It has not been tested well,” said Sanderson. “They do not know if a bird that has been vaccinated, when exposed, is going to still get the virus and have a miler case, or if it is going to shed live virus once it’s exposed. I think they need to know the answer to those two questions before they vaccinate a lot of chickens with it, or turkeys.”
Sanderson added that he would be supportive of a plan to test the vaccines on a trial basis “if they did it in one state, and they did a small sample and see what it did.” He said more widespread vaccination without the knowledge of avian influenza vaccines would be a case of “ready, fire, aim.”


Avian influenza vaccination and trade implications
Sanderson also spoke cautiously about avian influenza vaccination and its implications on international trade.
“We are concerned because once they start vaccinating, they are going to be some countries that are going to say AI is endemic to the U.S. as soon as they start vaccinating, because every one of the birds that is vaccinated is going to test positive for AI from now on,’ Sanderson said.

KSU developing vaccines for H5N1, H7N9 avian influenza

A recent study with Kansas State University researchers details vaccine development for two new strains of avian influenza found in other countries that can be transmitted from poultry to humans. Those strains, not found in the U.S., have led to the culling of millions of commercial chickens and turkeys as well as the death of hundreds of people.
The new vaccine development method is expected to help researchers make vaccines for emerging strains of avian influenza more quickly. This could reduce the number and intensity of large-scale outbreaks at poultry farms as well as curb human transmission.
It also may lead to new influenza vaccines for pigs, and novel vaccines for sheep and other livestock, said Jürgen Richt, Regents distinguished professor of veterinary medicine and director of the U.S. Department of Homeland Security's Center of Excellence for Emerging and Zoonotic Animal Diseases.
Richt and his colleagues focused on the avian influenza virus subtype H5N1, a new strain most active in Indonesia, Egypt and other Southeast Asian and North African countries. H5N1 also has been documented in wild birds in the U.S., though in fewer numbers.
"H5N1 is a zoonotic pathogen, which means that it is transmitted from chickens to humans," Richt said. "So far it has infected more than 700 people worldwide and has killed about 60 percent of them. Unfortunately, it has a pretty high mortality rate."
Researchers developed a vaccine for H5N1 by combining two viruses. A vaccine strain of the Newcastle disease virus, a virus that naturally affects poultry, was cloned and a small section of the H5N1 virus was transplanted into the Newcastle disease virus vaccine, creating a recombinant virus. Tests showed that the new recombinant virus vaccinated chickens against both Newcastle disease virus and H5N1.
Researchers also looked at the avian flu subtype H7N9, an emerging zoonotic strain that has been circulating in China since 2013. China has reported about 650 cases in humans and Canada has reported two cases in people returning from China. About 230 people have died from H7N9.
"In Southeast Asia there are a lot of markets that sell live birds that people can buy and prepare at home," Richt said. "In contrast to the H5N1 virus that kills the majority of chickens in three to five days, chickens infected with the H7N9 virus do not show clinical signs of sickness. That means you could buy a bird that looks perfectly healthy but could be infected. If an infected bird is prepared for consumption, there is a high chance you could get sick, and about 1 in 3 infected people die.
"We believe this Newcastle disease virus concept works very well for poultry because you kill two birds with one stone, metaphorically speaking," Richt said. "You use only one vector to vaccinate and protect against a selected virus strain of avian influenza."
Researchers found they were able to protect pigs against an H3 influenza strain by using the Newcastle disease virus to develop a recombinant virus vaccine. Wenjun Ma, Kansas State University assistant professor of diagnostic medicine and pathobiology, is building on this finding and using the Newcastle disease virus to make a vaccine for porcine epidemic diarrhea virus, a disease that has killed an estimated 6 million pigs.
Richt conducted the avian influenza study with Ma, Adolfo Garcia-Sastre at the Icahn School of Medicine at Mount Sinai in New York, and several other colleagues. They published their findings in the Journal of Virology study.

Canine virus vaccine against H7N9 AI in humans

A new vaccine against H7N9 avian influenza that uses a virus commonly found in dogs has been developed by researchers at the University of Georgia.
Avian influenza strain H7N9 was reported in humans in China in March 2013. Patients rapidly develop severe pneumonia that sometimes requires intensive care and mechanical ventilation. The mortality rate for the virus is over 30 percent, meaning that the need for a vaccine is urgent.
The University of Georgia’s vaccine has so far protected mice and guinea pigs against a lethal challenge of H7N9 and it is now viewed as a very strong candidate for human vaccine tests.
The researchers used parinfluenza virus 5, or PIV5, which is harmless in humans, but thought to contribute to upper respiratory infections in dogs, as a delivery vehicle for the H7N9 virus.
Small segments of H7N9 genes were placed inside PIV5, which was then used to immunize animals. While destroying the harmless PIV5 carrier, the immune system learnt to recognize and destroy H7N8 before it could cause severe illness.
“All of the vaccinated mice were protected against the N7N9 virus,” explained researcher Biao He. “But our experiments also revealed an unexpected result: The vaccinated animals did not produce a detectable level of antibodies. The antibody titer is the gold standard in vaccine development for influenza viruses, but our research brings that standard into question for H7N9 bird flu.”
The immune system has another way of fighting foreign invaders that does not involve antibodies - cell-mediated immunity. This process activates phagocytes, T-cells and other cells, all of which are able to destroy harmful viruses and bacteria.
“This suggests that our test subjects were protected through cell mediated immunity and the antibody titer may not be as reliable an indicator of immunity as we originally thought,” he said.
Investigations into the H7N9 vaccine will continue in additional animal models, and there is the hope that the discovery may lead to other researchers re-examining vaccines that did not produce a high antibody titer. 

5 concerns about avian flu vaccination

Dr. Ashley Peterson, National Chicken Council 
The U.S. poultry industry needs answers to five concerns about a vaccination strategy for highly pathogenic avian influenza (HPAI) being proposed by the U.S. Department of Agriculture's (USDA) Animal Plant Health Inspection Service (APHIS), while still preparing for the worst this fall if wild birds migrating south bring the disease to the Atlantic flyway.
That's according to the National Chicken Council's Dr. Ashley Peterson, who said at the Poultry Processor Workshop, "We need to prepare for the worst [in the U.S effort to control highly pathogenic avian influenza] – the possibility of the disease this fall in the Atlantic flyway.”
Given the geographic location of highly pathogenic avian influenza outbreak so far, mainly in turkeys and eggs in the upper Midwest, the broiler industry hasn't borne the effects of the virus in its flocks, though it has suffered some trade bans so far. But, the trade picture could deteriorate further if the proposed vaccination strategy is adopted in the U.S.; it is widely believed that some countries would restrict U.S. poultry imports once vaccination was implemented.
Peterson noted the broiler industry has a big stake in the vaccination program being formulated. It has 77 percent of U.S poultry exports, $4.5 billion in broiler meat, and $500 million in day-old broiler chicks and hatching eggs.
The broiler industry has five concerns about the vaccination strategy for highly pathogenic avian influenza currently proposed by APHIS for turkeys in five states:
1. Federal authority should be maintained over the proposed vaccination strategy, if it is implemented.
2. Trade ramifications of the proposed HPAI vaccination strategy should be fully understood before vaccination is adopted.
3. Biosecurity measures need to be improved in the U.S poultry industry, and lessons learned this year from outbreaks need to be shared in the industry.
4. There needs to be an understanding of the effectiveness of the available vaccines in turkeys and the plan for the administration of the proposed strategy.
5. The consequences, if any, on the processing of vaccinated birds for meat needs to be determined.
Trade implications of the proposed HPAI vaccination strategy are potentially huge.  OIE considers avian influenza to be endemic in countries that vaccinate for the disease, and this means countries may erect trade bans.
Peterson said, "We don't know what our trading partners would do if the proposed vaccination strategy is adopted. 
"Mexico and Canada are two of the U.S.’s biggest trading partners. Mexico relies heavily on U.S. poultry products because it has an AI issue and a population that needs a lot of meat and eggs.
"Would Mexico ban U.S. poultry because of the proposed vaccination program if it is implemented? I would say no. But that's just speculation because they need the protein," she said.
Peterson said answers are needed to questions like these before any proposed vaccination strategy is adopted and implemented.

APHIS moves up deadline on AI vaccine proposal comments

The Animal and Plant Health Inspection Service (APHIS) has moved up the deadline for submitting written comments on the proposal of a vaccination program to combat avian influenza (AI) because of the urgency of the outbreak.
The deadline, originally set for May 22, is now May 15. The proposal calls for a vaccination program in commercial poultry in five states to combat the outbreak of highly pathogenic AI, according to a USA Poultry & Egg Export Council publication. Comments can be submitted to VS.SPRS.feedback@aphis.usda.gov.
The five states included in the proposal, and the hardest hit by AI, are Minnesota, Iowa, Wisconsin, North Dakota and South Dakota. Other states will be added to the list as needed.
APHIS said it has confirmed AI cases in 18 states, and more than 15 million commercial turkeys and egg layers have been culled, the USAPEEC newsletter said.


Weighing options on vaccination
APHIS said it is weighing its options on vaccination because traditional control measures have been ineffective in controlling the spread of the virus. Chicken, turkey and egg industry representatives are concerned about the implications for international trade for poultry meat, eggs and genetics.
USAPEEC President Jim Sumner said the council has not yet taken a formal stand on vaccination.
Sumner also said trade restrictions on U.S. poultry by 40 countries have cost the industry approximately $600 million this year.
“It’s impossible to know the additional trade ramifications that would result from vaccination until it’s too late,” he said. “Once vaccination has begun, it cannot be reversed.” He said many countries will use a vaccination program as a reason to restrict trade.
Also, the U.S. policy of prohibiting poultry imports from countries that vaccinate their flocks could cause problems, because the policy could be turned around on the U.S. if it begins a vaccination program.
Sumner suggested that APHIS and officials in the Top 10 international markets discuss the U.S.’s plan and other countries’ reaction and effect on trade.
While no vaccine can provide complete protection against viruses, there are several vaccines that can provide a degree of protection. Researchers are working to develop a vaccine for the H5N2 strain that is affecting commercial flocks in the Upper Midwest.

A new approach to developing vaccine solutions for avian influenza

A novel method for researching vaccines that prevent avian influenza was highlighted at the recent One Health Summit, an annual BioKansas conference that shares knowledge to strengthen public safety.
Recognizing that animal health can affect human health, the One Health Summit featured a presentation about how next-generation adjuvants — ingredients added to vaccines to improve the immune response — are a foundational tool for managing contagious diseases. Mary Ann Pfannenstiel, Ph.D., vice president, VaxLiant*, used avian influenza research as an example to show how an innovative adjuvant can improve health by preventing disease.
“Since influenza is a zoonotic disease — one that can spread among animals and humans, it represents one of the greatest threats to human health,” said Pfannenstiel. “And even when the likelihood of disease transmission from animals to humans is low, as with the H5N2 avian influenza virus (AIV) currently circulating in the United States, removing animals exposed to AIV from farms can affect the available food supply. That’s why discovering and developing new adjuvants to aid in prevention of disease in animals is so important to the concept of One Health."
Pfannenstiel showed data from laboratory research and clinical trials of a vaccine combining gene-sequenced DNA (specifically, the AIV hemagglutinin gene) with ENABL*, an adjuvant with the uncommon ability to keep a ready-to-use DNA vaccine stable for more than 18 months. The research demonstrated the vaccine gave a protective immune response against AIV as measured by HAI antibody titer. Beyond that, the protective antibody titer was achieved using a low dose of antigen — an important feature when commercializing vaccines for practical use
“This research shows that using next-generation adjuvants, like ENABL, to develop new vaccines will allow us to prevent disease more effectively than ever before,” said Pfannenstiel. “The technology enables a quicker vaccine-development timeline and the ability to distinguish vaccinated animals from non-vaccinates naturally exposed to a virus, both of which are important when managing outbreaks. Novel adjuvants bring these advantages and more to vaccines that will make a vital difference in both human and animal health.
ENABL is an innovative, ready-to-use adjuvant from VaxLiant that can be added to vaccines to help improve the resulting immune response in cattle, poultry and swine. The U.S. Department of Agriculture already has approved the safety of 10 ENABL formulations for swine and cattle vaccines with a 21-day withdrawal period, the shortest allowed for food-animal vaccines. 
VaxLiant is a joint venture between two established companies: Benchmark Biolabs, Lincoln, NB, and AgriLabs*, St. Joseph, MO.
*Registered trademarks

USDA researchers working on avian influenza vaccine

USDA researchers are working on a potential vaccine for avian influenza, agency officials say. 
The USDA is working on developing a vaccine for avian influenza, but even if such a vaccine becomes a reality, it could be a while before it becomes available to poultry producers in the United States.
USDA Southeast Poultry Research Director David Swayne said during a USDA-hosted media call on April 22 that a laboratory under his supervision is working on a potential vaccine for the virus.
“We’re making progress on that. It’s a multi-step process that involves completion of one step, evaluating the information and going back to additional steps,” said Swayne. “At this point, we have a potential seed strain but once we complete our work, which will include testing in chickens and turkeys, the decision to use that vaccine will only be made if it’s necessary in the regulatory process of the eradication. Our work is only on the front end.”
Once the laboratory does its “front end” work, the potential vaccine would then be evaluated by the Animal and Plant Health Inspection Service (APHIS), with consultation from staff members of state labs, to decide whether the vaccine created could actually be used in the industry.
The idea of finding a vaccine for avian influenza has been of particular interest to the U.S. poultry industry, as avian influenza outbreaks have been reported in commercial poultry flocks, backyard flocks, wild birds and captive wild birds in 17 states.
USDA Chief Veterinary Officer John Clifford, who joined Swayne in the call, added that the agency has also had conversations with some private companies that have expressed an interest in developing a vaccine for avian influenza.
See a related story about how Clifford and Swayne discussed their views on future avian influenza outbreaks in the United States.

Chinese, Finnish groups partner on AI vaccine project

Ganyuanhao Co., a subsidiary of China Agricultural Development Group, is collaborating with Finnish company FIT Biotech to develop a gene transfer unit (GTU) vaccine technology aimed at vaccinating against avian influenza,  Newcastle disease and other diseases that affect poultry.
On March 19, the two companies announced their results at an event attended by Finland’s Ambassador to China, as well as Ministry of Agriculture officials and representatives from the China Veterinary Medicine Association, according to a report provided by Smart Agriculture Analytics. 
The creation of a vaccine to curb the spread of avian influenza has been of wide interest to the global poultry industry, as the virus has impacted flocks on multiple continents and has caused widespread losses in Asia, Europe and North America. Avian influenza has also harmed many countries’ poultry industries, as numerous poultry trade bans have been put in place over fears that the virus could spread.
Currently, domestic Chinese development efforts for DNA vaccine products have struggled to achieve the technical standards necessary to deliver immunity to the inoculated livestock and poultry. FIT’s GTU platform, protected by international patents, is a third generation animal vaccine technology that offers improved safety, low production costs, and a low immunization dose. At present, the technology has been applied in HIV vaccine research, and has passed U.S. Phase III clinical trials.

Viral genotyping can improve infectious bronchitis control

Infectious bronchitis virus continues to cause losses for broiler and layer operations around the globe in spite of extensive vaccination and diagnostic efforts. Dr. Richard Currie, veterinarian, molecular biologist, and co-founder of x-OvO, said that there are three types of diagnostic test for determining the infectious bronchitis status of a flock of chickens. He told the audiences of the WATTAgnet.com webinar, Infectious Bronchitis – Using PCR analysis to identify the predominant strain, sponsored by MSD Animal Health, that three diagnostic methods, ELISA, Hemagglutination inhibition, and molecular diagnostics (PCR), all have distinct advantages and disadvantages.
Currie explained that ELISA testing can be low cost, automated and convenient, but it doesn’t differentiate between different subtypes of the virus. Hemagglutination is low cost, serotype differentiation is possible and he said it can be more useful than ELISA for the construction of an appropriate vaccination program. Unfortunately, he said that the results of Hemagglutination inhibition are sometimes not clear, because there is no differentiation between vaccine response of the same serotype.
Genotyping the virus lets you differentiate vaccine strains from true field viruses so you know where your disease challenge is coming from, said Currie. He explained that vaccines from the same serotype of bronchitis virus can still be different genetically. So vaccines from different companies will be different genetically even though they are the same serotype. Currie said that using DNA sequencing is what lets you differentiate between different vaccine strains and field viruses
Currie’s three practical applications of infectious bronchitis molecular diagnostics:


1. Ensure your flocks are vaccinated
In a test of 300 flocks of commercial broilers in the EU, Currie reported that 18 percent were negative for Infectious bronchitis virus (which means they weren’t effectively vaccinated), 8 percent were sample untypeable (Usually meaning they were exposed to a field type Bronchitis virus that you can’t identify because there is so little genetic material).


2. Vaccinate against true field viruses
This method allows for clear differentiation of vaccine strains from field viruses.
When applied to field outbreaks, it can clarify the apparent large number of field viruses and allow their reclassification.


3. Optimize protection: determine what vaccination programs are associated with the fewest field viruses
Currie explained that current technology does not provide conclusive proof via sequencing analysis that a particular vaccine will protect against a certain field virus. However, molecular characteristics can be identified that are supportive of a protectotype response of a particular vaccine strain for an identified field strain.
To learn more about the field data Currie has gathered on the genotypes of infectious bronchitis virus found in broilers in layers in Europe and the Middle East view the archived webinar.

Zoetis reintroduces Zoamix to help battle coccidiosis

Zoetis Inc. has reintroduced Zoamix (zoalene), a versatile synthetic anticoccidial for the prevention and control of coccidiosis in broilers and turkeys.
“The U.S. poultry industry loses an estimated $600 million a year to coccidiosis, so the return of Zoamix could not be coming at a better time,” said Don Waldrip, DVM, DACPV, a senior technical services veterinarian with Zoetis.
He noted that U.S. poultry producers have not seen a new in-feed anticoccidial in 15 years, and concerns remain about existing products becoming less effective over time. “Having one more anticoccidial to use in a rotation program — especially one like Zoamix, which has a unique chemical structure — could help preserve the efficacy of other coccidiosis medications,” Waldrip said.
Versatile product
Zoamix is a Type A medicated article that can be used safely year-round with no withdrawal. Because it is a synthetic compound, Zoamix is compatible with antibiotic-free or conventional production systems. As with all in-feed anticoccidials, Zoetis recommends resting the medication periodically to maintain good efficacy.
According to Waldrip, Zoamix is unique in that it’s a synthetic compound but works similarly to an ionophore by allowing some cycling of Eimeria, the parasite that causes coccidiosis. “That cycling, commonly called leakage by poultry producers and veterinarians, allows the development of natural immunity against the disease,” the veterinarian explained.
Waldrip said the arrival of Zoamix would further strengthen Rotecc Coccidiosis Management, a science-based initiative Zoetis launched earlier this year to help poultry producers develop more strategic, cost-effective and sustainable programs for battling the costly parasitic disease.
More uses
In addition to preventing and controlling coccidiosis in broilers and turkeys, Zoamix can be used for the development of active immunity against coccidiosis in replacement chickens.  Zoamix is also approved for use in combination with BMD (bacitracin methylene disalicylate), a feed medication used to manage necrotic enteritis in chickens and transmissible enteritis in turkeys.
Formerly produced by Alpharma, Zoamix was used by the U.S. broiler and turkey industries for more than four decades before leaving the market in 2005 due to shortage of a key ingredient.  Zoetis later acquired the product, saw the poultry industry’s need for Zoamix, and worked with suppliers to resolve supply issues and relaunch the product. 

MSD viral infectious bronchitis vaccine gets EU approval

Following a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission has granted the marketing authorization for the veterinary medicinal product Nobilis IB Primo QX from MSD Animal Health to protect chickens against viral infectious bronchitis caused by QX-like variants of infectious bronchitis virus.
MSD Animal Health is known as Merck Animal Health in the United States and Canada.
Nobilis IB Primo QX will be the first vaccine developed using Sphereon technology in the EU, which freeze-dries live vaccines to small, highly soluble particles (spheres) that allow for packaging in light-weight aluminum cups in convenient dose sizes. The spheres produced by Spheron technology dissolve easily and quickly for improved preparation and administration of the vaccine.
“We are pleased that the European Commission has approved Nobilis IB Primo QX,” said Ian Tarpey, executive director, global poultry R&D, MSD Animal Health. “The QX strain of infectious bronchitis virus has become increasingly common, and Nobilis IB Primo QX will be an important tool for producers due to its proven efficacy and its easy administration method.”
Nobilis IB Primo QX is given to chickens from one day of age or older by spraying onto the chickens or by applying by eye-drop, and provides protection for eight weeks. The vaccine can be mixed with Nobilis IB Ma5 to provide additional protection against Massachusetts strains of the infectious bronchitis virus.

Zoetis gets USDA approval for Georgia 2008 IBV vaccine

Based on research which included isolation and characterization of the GA 08 virus, Zoetis developed a new vaccine that has performed well in areas hard hit by this costly virus. 
Zoetis has obtained a full license from the USDA to sell Poulvac Bron GA 08, the first commercially available vaccine to reduce disease caused by Georgia 2008 (GA 08) type infectious bronchitis virus (IBV) in poultry.
Poulvac Bron GA 08, a live vaccine, is licensed for vaccination of healthy chickens at one day of age or older as an aid in the reduction of disease caused by GA 08. The vaccine was licensed based on clinical data showing that the vaccine meets USDA’s standards for safety, efficacy, purity and potency. The full license follows USDA’s provision of a conditional license in the fall of 2013, which authorized the vaccine’s sale in states affected by GA 08.
According to Kalen Cookson, DVM, MAM, a technical services veterinarian for Zoetis, close collaboration with the USDA, the University of Georgia and poultry producers from affected states helped bring the vaccine to market on an ambitious timeline.
“In April 2013, representatives of major U.S. poultry companies invited Zoetis to join a task force at the University of Georgia to discuss ideas for tackling GA 08, particularly the development of a vaccine,” said Cookson. “Thanks to the continued support of industry, the USDA and the university, which provided the viral isolates on which the vaccine is based, we are pleased to offer our customers a fully licensed vaccine for GA 08 before winter, when disease challenge is highest.”
Making poultry vaccine available was a ‘top priority’ for Zoetis
First identified in Georgia in December 2007, GA 08 has since been isolated on farms in Alabama, Mississippi, North Carolina, South Carolina, Tennessee and Kentucky.  Over the past three winters, its incidence and severity have increased dramatically, along with associated costs.
Unlike other IBV strains, which typically affect the upper respiratory tract, GA 08 primarily affects the lower tract, particularly the air sacs.
According to Holly Sellers, PhD, professor at the University of Georgia’s Poultry Diagnostic and Research Center, GA 08 rarely makes its presence known on the farm, but becomes a real issue at the processing plant due to higher incidence of airsacculitis. This results in increased condemnations, reduced plant efficiency and ultimately economic loss for producers.
“Each winter for the past three years, the number of states and companies affected by GA 08 has increased dramatically,” commented Sellers. “Outbreaks have taken a major economic toll on producers and processors in the Southeast, so making a vaccine available has been a top priority. Based on UGA’s initial research, which included isolation and characterization of the virus, Zoetis has developed a new vaccine that has performed well in areas hard hit by this costly virus, against which other IBV vaccines offer little protection. We are grateful for the support that Zoetis and the poultry industry have provided in this productive collaboration, and are confident that it will have a positive impact on producers in Georgia and in other affected states.”