EU Regulator Recommends 1st License for Malaria Vaccine
By THE ASSOCIATED PRESS

LONDON — The European Medicines Agency has recommended approving what would be the world’s first licensed malaria vaccine, even though it’s only about 30 percent effective and its protection fades over time.

In a statement Friday, the agency endorsed the vaccine’s use outside Europe, a regulatory process that helps speed new medicines to the market.

The recommendation to license the vaccine, known as Mosquirix and made by GlaxoSmithKline, must still be approved by the European Commission.

The World Health Organization will next consider the evidence and recommend how the shot be used. It’s unlikely donors would pay for the vaccine without WHO’s guidance, especially since it only protects about one-third of the children vaccinated.

“This is not the big game-changer that we were hoping for,” said Dr. Martin De Smet, a malaria expert at Doctors Without Borders. “The vaccine itself remains disappointing but this is an important step forward.”

Still, De Smet said the vaccine could help reduce the huge burden of malaria, which sees 200 million new cases and more than 500,000 deaths every year, mostly in African children.

“In countries where children get four to six episodes of malaria a year, this will make a big difference,” he said, adding that people should still keep using bed nets to protect against mosquitoes.

Gregory Hartl, a WHO spokesman, said the agency will issue its assessment by November and will review other factors not considered by the European regulator, including cost-effectiveness. GlaxoSmithKline had previously said they would sell the vaccine at cost value, although that doesn’t include the logistics of vaccination programs — a full course includes four doses.

De Smet suggested the vaccine would be useful in high-malaria countries even though it’s “highly imperfect.”

Several other malaria vaccines are in development but none have produced better results.

首款瘧疾疫苗 歐洲批准

歐洲藥物管理局廿四日發布聲明，建議批准全球第一款瘧疾疫苗Mosquirix。這款疫苗由葛蘭素史克公司研發，將是全球首款對抗寄生蟲疾病且獲得許可的疫苗，然而保護效力只有百分之卅，且會隨時間而遞減。

美聯社報導，歐洲藥管局在聲明中說，對於這款疫苗在歐盟以外使用「給予正面的科學評價」，這個行政程序能讓新藥加速上市。

人道救援組織「無國界醫生」瘧疾專家德斯梅說：「這並不是我們期盼的、能扭轉大局的疫苗，它的效力仍讓人失望，但已經是重要的進展。」

德斯梅說，這款疫苗能減輕瘧疾帶給世界的沉重負擔，全球每年出現兩億個瘧疾病例，死者逾五十萬，多為非洲兒童。

世界衛生組織發言人哈托說，歐洲藥管局的決定「並不是在推薦使用這款疫苗」，世衛將於十一月公布自己的評估結果。

原文參照：
http://www.nytimes.com/aponline/2015/07/24/health/ap-eu-med-malaria-vaccine.html

2015-07-25．聯合報．A17．國際．編譯李京倫