WHO：H1N1疫苗與季節性流感疫苗一樣安全
作者：Emma Hitt, PhD
出處：WebMD醫學新聞
November 19, 2009 — 根據世界衛生組織（WHO）指出，H1N1 2009年大流行流感疫苗顯然與季節性流感疫苗一樣安全。
WHO疫苗研究計畫主任Marie-Paule Kieny在網路記者會上表示，根據目前的報告，大約10,000次預防注射才會有1件不良事件；這些不良事件報告中，100件中約有5件被認為是嚴重的。
Kieny博士指出，目前這些嚴重不良事件包括30件死亡，以及大約12件格林巴利症候群（Guillain-Barre syndrome）；但她強調，目前並沒有任何1件死亡事件被證實是疫苗造成的。除此之外，所有格林巴利症候群都是暫時的，僅有少數被證實與疫苗有關。
Kieny博士附帶表示，季節性與大流行流感疫苗的安全性資料顯然並沒有差異，這兩個疫苗的不良反應事件數目也是相當的。除此之外，不同的大流行流感疫苗安全性也差不多。
Kieny博士表示，與大流行流感疫苗有關的不良反應包括不同程度的局部疼痛，注射部位的疼痛、腫脹、發紅、以及發燒、頭痛、肌肉疼痛或是疲倦；這些一般在一、兩天內緩解。
她指出，目前接獲的報告並未發現新的安全性問題。
Kieny博士表示，迄今至少已經釋出8,000萬劑流感疫苗，其中已接種劑量達6,500萬劑；這些資訊來自16個國家，但我們認為這些是保守估計，因為這些疫苗注射行動目前還在40個國家進行中。
WHO預計從這個月底開始將這些疫苗運送到開發中國家。根據Kieny博士表示，這仍有一些延遲，但他們期待在接下來的三個月，疫苗會分配到達95個符合標準的國家。
H1N1 Vaccine as Safe as Seasonal Vaccine, WHO Says
By Emma Hitt, PhD
Medscape Medical News
November 19, 2009 — The H1N1 2009 pandemic influenza vaccine appears to be as safe as the seasonal flu vaccine, according to the World Health Organization (WHO).</p> <p>About 1 adverse event is being reported for every 10,000 doses, said Dr. Marie-Paule Kieny, director of the WHO's Initiative for Vaccine Research, at a virtual press briefing today. Of those adverse event reports, about 5 of 100 are considered serious.</p> <p>According to Dr. Kieny, serious adverse events so far include 30 deaths and about 12 cases of Guillain-Barre syndrome; however, she emphasized that none of the deaths reported to date has been confirmed as being caused by the vaccine. In addition, all cases of Guillain-Barre syndrome have been transient, and only a few have been linked to the vaccine.</p> <p>Dr. Kieny added that there appears to be no difference between the safety profile of the seasonal and pandemic influenza vaccines, and the number of adverse events is comparable between the 2 vaccines. In addition, the safety profiles of the different forms of pandemic vaccine are also similar.</p> <p>Adverse reactions associated with the pandemic vaccine include a variety of local reactions including "pain at injection site, swelling, redness, and reactions such as fever, headache, muscle pain, or fatigue," Dr. Kieny said. "These generally resolve within 1 or 2 days."</p> <p>"No new safety issues have been identified from reports received to date," she said.</p> <p>At least 80 million doses of vaccines have been distributed and 65 million doses have been administered. "These are figures that we have received from 16 countries, but we think they are conservative estimates because immunization campaigns are under way now in 40 countries," Dr. Kieny added.</p> <p>The WHO expects to start shipment of the vaccine to developing countries at the end of this month. According to Dr. Kieny, this represents a slight delay, but they expect that all vaccine doses will reach 95 eligible countries during the next 3 months.