美國農業部有條件批准碩騰(Zoetis) PEDv 疫苗上市！

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Zoetis豬流行性腹瀉病毒疫苗得到美國農業部的許可條件   新的疫苗和專業知識將幫助養豬戶和獸醫打致命的疾病

發布日期：2014年9月3日

美國農業部授予條件許可Zoetis  的疫苗，以幫助對抗豬流行性腹瀉  （PED）病毒在豬體內。這兩種劑量的滅活疫苗，健康懷孕的女性豬（母豬）批准使用的，目的是為了幫助他們發展，可傳染給他們的新生仔豬的抗體。

Zoetis，該公佈發牌9月3日，預計該疫苗將提供給在一個月內獸醫和養豬戶。

“我們在Zoetis很自豪能夠為客戶提供一種疫苗，以幫助戰鬥這種破壞性疾病，”凱瑟琳Knupp，執行副總裁及總裁，Zoetis研究和開發說。“迅速崛起的傳染病，如流行性腹瀉，不僅威脅到動物的健康，而且農民的生計。把這種疫苗市場迅速 - 在多一點今年以來該疾病在美國確定的 - 體現了我們支持獸醫和畜牧生產者提供高品質的疫苗，以迅速應對，並幫助控制的不斷發展和複雜的威脅的承諾新出現的傳染病。“

該疫苗前，分娩（難產）給出的2毫升肌肉注射（IM）注射到母豬或後備母豬。兩劑之間隔3週建議，與兩星期前分娩的第二次。以前接種的母豬應接受分娩前兩週給予單劑量。平均而言，母豬產仔每年舉行兩次。

為了接收條件許可時，疫苗被證明是安全的現場安全研究和功效的合理預期被證明。Zoetis正在完成必要的研究，以獲得充分執照在美國

“這種疫苗是我們與獸醫和養豬戶的工作，以幫助減少豬流行性腹瀉病毒對豬在他們的照顧影響的承諾的重要組成部分，”凱萊巴斯，副總裁，美國豬肉業務部，Zoetis說。“為了達到最佳的效果，農民應密切與他們的獸醫和Zoetis的技術服務團隊，以實施新的疫苗納入生物安全程序。”

PED病毒最早是在美國確診的2013年4月自那時以來，它已經蔓延到30個州，並負責超過七萬人死亡的仔豬。目前大約有585萬頭母豬和後備母豬在美國; 然而，這些受感染的確切數量不得而知。美國農業部指定的PED病毒呈報疾病2014年6月，並繼續與農場的初步爆發後申報在一年內復發的疾病，估計30％的嚴重威脅到美國的豬場。雖然豬流行性腹瀉病毒是一種顯著健康威脅小豬，它不會對食品安全和人體健康的風險。

Zoetis繼續在第二個疫苗方法與愛荷華州立大學的工作，以幫助控制PED病毒。這些疫苗研究項目的結果可能適用於美國以外的國家，PED病毒已被確認，並威脅豬群和農民誰養和照顧他們的生計。

該Zoetis疫苗的許可標誌只因為首先在美國被檢測出的病毒發出用於治療PED病毒的第二條件的許可證。第一個被授予六月愛荷華公司 Harrisvaccines。

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蘇少儀

翻譯要注意細微處...................
USDA是給碩騰"有條件"的許可證照
"正式批準"和"有條件許可"是有差別的

Zoetis Granted Conditional License for Porcine Epidemic Diarrhea Vaccine*
Wednesday, September 3, 2014 8:00 am EDT

New vaccine and expertise will help pig farmers and veterinarians fight deadly disease
FLORHAM PARK, N.J.--(BUSINESS WIRE)--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.

taiwanp

蘇少儀 發表於 2014-9-7 14:58
英文不夠好，請不要硬翻
USDA是給碩騰"有條件"的許可證照
"正式批準"和"有條件許可"是有差別的

標題已更正！直接看機器翻譯，沒看內文 .. 不好意思！！