PEDv

Zoetis Receives Conditional Approval from USDA for PEDv Vaccine

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Zoetis Inc. (NYSE:ZTS) today announced that the U.S. Department of Agriculture (USDA) has granted a conditional license for a vaccine to help fight porcine epidemic diarrhea virus (PEDv) in pigs. The two-dose inactivated vaccine, licensed for use in healthy pregnant female pigs (sows and gilts), is designed to help them develop antibodies which can be transmitted to their newborn piglets. Zoetis anticipates the vaccine will be available to veterinarians and pig farmers in September.

“We at Zoetis are proud to provide our customers with a vaccine to help battle this devastating disease,” said Catherine Knupp, executive vice president and president, Zoetis Research and Development. “Rapidly emerging infectious diseases such as PEDv not only threaten animal health but also the livelihoods of farmers. Bringing this vaccine to market quickly – in a little more than a year since the disease was identified in the U.S. – exemplifies our commitment to supporting veterinarians and livestock producers with high-quality vaccines to rapidly respond to and help control the evolving and complex threat of emerging infectious diseases.”

The vaccine is given as a 2 mL intramuscular (IM) injection to sows or gilts prior to farrowing (giving birth). Two doses given three weeks apart are recommended, with the second dose given two weeks pre-farrowing. Previously vaccinated sows should receive a single dose given two weeks before farrowing. On average, female pigs farrow twice each year.

In order to receive the conditional license, the vaccine was shown to be safe in a field safety study, and a reasonable expectation of efficacy was demonstrated. Zoetis is working to complete the studies necessary to obtain full licensure in the U.S.

“This vaccine is an important part of our commitment to working with veterinarians and pig farmers to help minimize the impact of PEDv on pigs in their care,” said Gloria Basse, vice president, U.S. Pork Business Unit, Zoetis. “To achieve the best possible results, farmers should work closely with their veterinarians and Zoetis technical services team to implement the new vaccine into their biosecurity programs.”

PEDv was first diagnosed in the United States in April 2013.1 Since then, it has spread to 30 states and is responsible for more than seven million deaths in piglets.2 There are approximately 5.85 million sows and gilts in the U.S.3; however, the exact number of those infected is not known. The USDA designated PEDv a reportable disease in June 20142, and it continues to be a serious threat to U.S. pig farms with an estimated 30 percent of farms reporting a recurrence of the disease within a year after an initial outbreak.4 Although PEDv is a significant health threat to young piglets, it poses no risk to food safety or to human health.

Zoetis continues work with Iowa State University on a second vaccine approach to help control PEDv. The results from these vaccine research programs could have applicability in countries outside the U.S. where PEDv has been identified and is threatening swine herds and the livelihoods of farmers who raise and care for them.

In the meantime, ongoing efforts to slow the spread of PEDv continue to focus on improving animal husbandry and hygiene measures. From the farm to transport trucks, stepped-up efforts include additional sanitation, better control of access points and review of employee protocols. All of these steps have been demonstrated to help mitigate the risk of the virus entering a farm.

For more information about the new vaccine, veterinarians and pig farmers should contact their Zoetis representative or visit www.zoetispork.com/pedv. For more information about PEDv, visit www.aasv.org and www.pork.org.

Source: Zoetis Press Release September 3, 2014 http://news.zoetis.com/press-release/manufacturing/zoetis-granted-conditional-license-porcine-epidemic-diarrhea-vaccine

APHIS Issues Conditional License to Produce First PEDv Vaccine

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Washington, June 16, 2014 — The United States Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) today issued a conditional license to Harrisvaccines, Inc. of Ames, Iowa for a vaccine that may aid in the control of porcine epidemic diarrhea virus (PEDv) in swine. This is the first licensed vaccine for PEDv.  It will be used to vaccinate sows with the intent that they build antibody, and transmit that antibody through their milk to newborn piglets. It is intended to protect the piglets against PEDv.

APHIS licenses veterinary biologics products for use in controlling diseases of animals.  Conditional licenses are issued based on full safety, purity testing, and an expectation of efficacy.  Preliminary studies have been promising, and they’ve shown sufficient data that we think the vaccine will be effective.  The company will continue working toward completing the requirements for a full license.  In the meantime, there are no restrictions on vaccine use under the conditional license.

APHIS supports and encourages the rapid development of new vaccines, particularly in emergency situations. When a company obtains a conditional license they are able to bring an important disease management tool to producers safely and quickly. Full licensing can occur subsequently while producers get the products they need to protect animal health.

Porcine epidemic diarrhea is a disease that causes significant sickness in swine, affecting their growth and health, and causes high mortality in piglets. The disease is common in parts of Asia and Europe, but is not reportable to the World Organization for Animal Health (OIE). PEDv only affects pigs and does not pose any risk to people or pets. It is not a food safety concern.

Licensing this vaccine is another step APHIS is taking to continue to help industry/producers.

Recently APHIS announced the availability of $26.2 million in funding to combat these diseases and issued a Federal Order requiring the reporting of new detections of PEDv and other new swine enteric coronavirus disease to APHIS or State animal health officials. The Federal Order also requires that operations reporting these viruses work with their veterinarian or USDA or State animal health officials to develop and implement a reasonable management plan to address the detected virus and prevent its spread. Plans will be based on industry-recommended best practices, and include disease monitoring through testing and biosecurity measures. These steps will help to reduce virus shed in affected animals, prevent further spread of the disease, and enable continued movement of animals for production and processing.

Throughout the PEDv outbreak, APHIS has worked closely with the swine industry to identify risk factors in the transmission of the virus and minimize its impact on producers and industry.

APHIS is part of a task force with the Food and Drug Administration and State and industry stakeholders, including the American Association of Swine Veterinarians (AASV), National Pork Producers Council (NPPC), National Pork Board (NPB), veterinary diagnostic laboratories (VDLs), and State Animal Health Officials (SAHOs).

This task force aims to investigate the virus, identify and trace risk factors in thetransmission of the disease, and keep producers informed.

Source: APHIS Stakeholder Registry News Release June 16, 2014

Delaware Hog Owners Required to Report Deadly Swine Viruses

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Delaware hog owners, veterinarians and laboratories are now required to report suspected cases of two rapidly spreading swine diseases to the Delaware Department of Agriculture. Delaware has had no cases of either disease reported to date.

Under a new federal order, suspected cases of porcine epidemic diarrhea virus, or PEDv, and porcine deltacoronavirus, or PDCoV, must now be officially reported. PEDv has killed seven million piglets in the last year throughout the United States, according to the U.S. Department of Agriculture. PEDv was first reported in the United States last year, and has also been reported in Canada and Mexico.

Delaware has only a handful of commercial hog farms, but also about 55 smaller hobby farms with swine, such as back-yard hogs raised for shows.

“Despite Delaware’s small hog population, this virus remains a significant concern because it can be easily spread from farm to farm on contaminated clothing, shoes, equipment, trucks, or from infected swine,” said Delaware State Veterinarian Dr. Heather Hirst. “We are keeping a close eye on this situation to protect our hog owners and make sure they are aware of what to look for. The best defense for hog owners is to employ strict biosecurity measures to help prevent the viruses from getting to their farms.”

Examples of good biosecurity measures include:

  • Purchase pigs from a reliable source.
  • Keep newly purchased pigs separate from the rest of your herd for at least 30 days before mingling them with your established herd.
  • Avoid carrying manure on clothing, boots, equipment, or vehicles from one farm to the other.
  • Prevent visitors from other hog farms from entering animal areas at your farm.
  • Avoid visiting farms where hogs are kept. If you must visit other hog farms, take special care to avoid carrying any trace of manure home with you to your herd.

Clinical signs of PEDv include severe diarrhea and vomiting, with the greatest losses occurring in pre-weaned piglets. Reports of suspected PEDv cases – any pig with severe diarrhea, vomiting, or both – should be made to the hog owner’s veterinarian as well as the Delaware Department of Agriculture’s Poultry and Animal Health Section at 302-698-4500. Hog operations with positive test results will be required to develop management plans with their veterinarian in order to prevent the spread of the disease to other farms.

More information is available at de.gov/pedv.

Source: Delaware Department of Agriculture, June 13, 2014

Contact:
Dan Shortridge
Chief of Community Relations
Delaware Department of Agriculture
302-698-4520