First Dengue Fever Vaccine Approved by Mexico
By ANDREW POLLACK

A dengue fever vaccine developed by the French pharmaceutical giant Sanofi has been approved for use by Mexico, the first approval in the world for any vaccine for the disease, which afflicts tens of millions of people around the world and is becoming an increasing threat.

Sanofi said in a news release Wednesday that the vaccine, which it is calling Dengvaxia, was approved by Mexico’s Federal Commission for the Protection against Sanitary Risk for prevention of dengue in people 9 to 45 years old living in endemic areas.

“We are making dengue the next vaccine-preventable disease,” Olivier Charmeil, executive vice president for vaccines at Sanofi, said in an interview.

But it is still uncertain how widely the vaccine will be deployed, both in Mexico and other countries, because of limits to its effectiveness and national budgets.

Also known as breakbone fever, dengue can cause high temperature and intense joint and muscle pain. In severe cases, it causes hemorrhagic fever, which is marked by bleeding and shock and can be fatal.

A viral disease that is transmitted by mosquitoes, the number of cases has been increasing sharply and the disease has been spreading out of its traditional home in developing countries in the tropics and subtropics. There is now an outbreak in Hawaii, and there was one last year in Tokyo, the first one in Japan in nearly 70 years. The Florida Keys had some cases in 2009 for the first time in decades.

In clinical trials, the vaccine reduced the risk of developing dengue by about 60 percent, which some experts have said is less effective than desired. The vaccine seems least effective in children younger than 9, particularly those younger than 6, and may even increase their risk of having more severe disease in the long run, according to a longer term follow-up from the clinical trials.

“The bumpy road to a vaccine-based solution for dengue continues,” Cameron P. Simmons of the University of Melbourne in Australia, wrote in a commentary in the New England Journal of Medicine in September.

But Sanofi itself and some other experts said that that level of effectiveness would be welcomed, given that there is now no treatment for dengue. In one trial involving children 9 to 16 in Latin America and the Caribbean, the vaccine reduced the risk of hospitalization from dengue by 80 percent.

An estimated 50 million to 100 million people a year are sickened by dengue, though that might be an underestimate. One study said about 400 million people are infected each year, with about 100 million of them feeling sick to some degree.

Mr. Charmeil said the vaccine would be available early next year in Mexico for people who want to buy it for themselves, though the price has not yet been announced. But much greater use would come if the government decides to deploy a public vaccination campaign. The government has not decided what to do yet.

Mr. Charmeil said that by the end of this month, Sanofi will have applied for approval in 20 countries in Latin America and Asia. He said the company already had 2 million doses available and by 2017 should have the capacity to make 100 million doses a year, should that much be needed.

Mr. Charmeil said the price of the vaccine would be reasonable based on its value. He said the world now spends $9 billion treating dengue and almost as much to control mosquitoes. He declined to estimate the sales of Dengvaxia but said he would not dispute estimates by others that sales could reach $1 billion a year.

Sanofi has been hurt by declining sales in its big diabetes drug business, the result of new competition and heavier discounting by manufacturers.

Dengvaxia is a live virus vaccine consisting of an attenuated yellow fever virus genetically engineered to produce proteins from the dengue virus and stimulate the body’s immune system to make antibodies to those proteins. The vaccine works against all four subtypes of the dengue virus, but better for some subtypes than others. Others are developing dengue vaccines but are thought to be at least a few years behind Sanofi.

全球首支！ 登革熱疫苗來了

墨西哥藥物管理局9日宣布核准全球首支登革熱預防疫苗「Dengvaxia」上市，此疫苗有效性雖僅六成，但可有效預防已感染登革熱病患再度感染其他病毒株。

法藥廠費時20年 投資527億研發

法國藥廠賽諾菲（Sanofi）費時逾20年，投資16億美元（約台幣527億元）研發，並在亞洲與拉美進行兩場大型臨床試驗，受試者超過4萬人。

據「世界衛生組織」去年報告，該疫苗平均有效性僅60.8%；比起小兒麻痺或麻疹疫苗超過95%的效果，可說相當低。不過對於已感染登革熱的病患，這支疫苗可有效預防感染其他登革熱病毒株，例如最危險的出血性登革熱，從而減輕病情。

墨國瞄準嚴重疫區 9至45歲民眾可施打

賽諾菲指出，Dengvaxia「每10例中可預防9例感染更嚴重的登革熱，每10例中有8例可減輕病情毋須住院」。

墨西哥當局表示，這支疫苗可針對9至45歲民眾施打，未來將用於疫情嚴重地區。登革熱每年在墨西哥感染4萬人，這支疫苗可望為墨西哥省下每年6500萬美元的衛生預算，且平均減少104人死於登革熱、8000人住院。

賽諾菲表示，今年底前將在其他20個國家申請核准，並於明後年分別在歐洲及美國提出申請。Dengvaxia將於法國製造，該公司尚未和墨西哥政府談妥定價。

登革熱經由蚊子傳播，主要流行於亞洲及中南美洲的熱帶與亞熱帶氣候區，每年在全球約造成4億人感染、奪走2.2萬人性命。目前登革熱病毒株有4類，尚無特效藥或疫苗。全球每年投入救治登革熱病患的花費約90億美元，預防措施每年花費60億至90億美元。

賽諾菲疫苗部門執行副總裁夏梅爾指出，目前已製成200萬劑疫苗，如有必要，2017年時可達到一年製造一億劑的目標。

外界估計，此疫苗銷售額可達一年10億美元（約台幣328億元），他不願評論。

原文參照：
http://www.nytimes.com/2015/12/10/business/first-dengue-fever-vaccine-approved-by-mexico.html

2015-12-10．聯合晚報．A6．國際焦點．編譯莊蕙嘉