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This piece is featured in Issue 26 of Works in Progress.

这篇文章刊登在《Works in Progress》第 26 期中。

Subscribe today to get Issue 27, and an issue every two months after, delivered straight to your home or workplace.

立即订阅即可获得第 27 期，以及之后每两个月出版一期，直接发送到您的家中或工作场所。

Most Americans think of mosquito-borne diseases such as malaria, yellow fever, and dengue as problems that affect people in other countries, not their own.

大多数美国人认为疟疾、黄热病和登革热等蚊媒疾病影响的是其他国家的人民，而不是本国人民。

Until recently, they would have been largely correct: malaria and yellow fever were eliminated in the United States in the twentieth century, and dengue had become extremely rare, with most cases brought back from abroad.

直到最近，他们在很大程度上还是正确的：二十世纪美国消灭了疟疾和黄热病，登革热变得极其罕见，大多数病例都是从国外带回来的。

But as temperatures have risen and mosquitoes have developed resistance to pesticides, these diseases have become a growing problem again in the United States.

但随着气温升高，蚊子对杀虫剂产生了抗药性，这些疾病在美国再次成为一个日益严重的问题。

In 2024, the country reported almost 4,000 cases of dengue, a 360 percent increase over the average of 830 per year over the previous decade; Florida, California, and Texas all saw locally acquired transmission; and Puerto Rico declared dengue a public health emergency.

2024 年，该国报告了近 4,000 例登革热病例，比过去 10 年平均每年 830 例增加了 360%；佛罗里达州、加利福尼亚州和德克萨斯州都出现了本地获得性传播；波多黎各宣布登革热为突发公共卫生事件。

Ten locally acquired malaria cases were reported nationwide in 2023, the first reported in twenty years.

2023 年，全国报告了 10 例本地获得性疟疾病例，这是 20 年来首次报告。

And though yellow fever remains gone for now, the mosquitoes capable of spreading it are still present.

尽管黄热病目前尚未消失，但能够传播黄热病的蚊子仍然存在。

But we don’t have to accept this threat.

但我们不必接受这种威胁。

We have new ways to wipe out mosquito-borne diseases with minimal environmental cost.

我们有新方法可以以最小的环境成本消灭蚊媒疾病。

The United States is sufficiently well-resourced, and its disease-carrying mosquito population sufficiently small, that it can stamp out this problem entirely within its own borders.

美国资源充足，携带疾病的蚊子数量也足够少，因此可以在本国境内完全消除这一问题。

The reason we haven’t is that the technology has spent fifteen years in regulatory limbo.

我们没有这样做的原因是该技术已经在监管中徘徊了十五年。

Ending this impasse would allow us to eliminate many mosquito-borne diseases from the United States, and eventually the rest of the world.

结束这一僵局将使我们能够从美国乃至世界其他地区消除许多蚊媒疾病。

Genetic engineering can suppress mosquitoes: researchers insert a gene into male mosquitoes that means their offspring will not survive, and then release them into the wild, where they mate with females, prevent those females having any surviving offspring, and collapse local populations.

基因工程可以抑制蚊子：研究人员将一种基因植入雄性蚊子体内，这意味着它们的后代将无法生存，然后将它们释放到野外，与雌性蚊子交配，阻止这些雌性蚊子产生任何幸存的后代，并使当地种群崩溃。

In 2000 , biologists at the University of Oxford demonstrated that this idea could work in fruit flies.

2000年，牛津大学的生物学家证明这个想法可以在果蝇中发挥作用。

They engineered the flies to carry a gene that makes a protein called tTAV, harmless in small amounts but lethal when it builds up.

他们对果蝇进行了基因改造，使其携带一种基因，该基因可以产生一种名为 tTAV 的蛋白质，这种蛋白质少量时无害，但积累量过多时就会致命。

In the lab, the insects are reared in a medium laced with the antibiotic tetracycline, which keeps the gene switched off.

在实验室中，这些昆虫被饲养在含有抗生素四环素的培养基中，这种抗生素可以使基因保持关闭状态。

But, in the wild, where there is no tetracycline, the gene switches on, and the offspring die before adulthood.

但是，在没有四环素的野外，基因开启，后代在成年前死亡。

The scientists then formed a company, Oxitec, which was intended to work with governments to research and deploy the technology.

随后，科学家们成立了一家名为 Oxitec 的公司，旨在与政府合作研究和部署该技术。

They engineered the same gene into male Aedes aegypti , the mosquito that spreads dengue and yellow fever.

他们将相同的基因植入雄性埃及伊蚊中，这种蚊子传播登革热和黄热病。

In this strain, the lethal effect is tuned to kill only the female offspring, while the males survive and pass the gene on for a few generations before it disappears.

在这种菌株中，致命效应被调整为仅杀死雌性后代，而雄性则存活下来并在基因消失之前将基因传递几代。

This approach means the gene continues driving down mosquito numbers for several generations without needing a fresh ‘top up’ of engineered males, but it is also self-limiting: the females that inherit it die off each generation, so the lethal gene steadily declines in the wild.

这种方法意味着该基因可以持续减少几代蚊子的数量，而不需要重新“补充”经过改造的雄性蚊子，但它也是自我限制的：继承该基因的雌性每一代都会死亡，因此致命基因在野外稳步下降。

Yet the technique is hugely effective.

然而这项技术非常有效。

Sustained releases cut a wild Aedes aegypti population in the Cayman Islands by 80 percent , and in a field trial in Juazeiro, Brazil by about 95 percent .

持续释放使开曼群岛的野生埃及伊蚊数量减少了 80%，在巴西茹阿泽罗的实地试验中减少了约 95%。

The company submitted its data to seek approval in the United States in 2010.

该公司于 2010 年提交了数据以寻求美国的批准。

But it has been slow going.

但进展缓慢。

Until that point, engineered insects had been used only for agricultural pest control.

在那之前，工程昆虫仅用于农业害虫防治。

Since the 1950s, the United States Department of Agriculture (USDA ) had been using the ‘sterile insect technique’, sterilizing male insects with radiation rather than genetic modification, which would mate with wild females and produce no offspring, steadily driving the wild population down.

自20世纪50年代以来，美国农业部（USDA）一直在使用“昆虫不育技术”，通过辐射而不是基因改造使雄性昆虫绝育，这种技术会与野生雌性交配，不会产生后代，从而使野生昆虫数量稳步下降。

The technique’s major success was in fighting screwworm: an extremely nasty insect that lays its eggs in open wounds, and whose larvae then hatch and burrow into the flesh of any animal unlucky enough to be afflicted (usually livestock), killing them within days.

该技术的主要成功在于对抗螺旋虫：一种极其讨厌的昆虫，它在开放性伤口中产卵，然后其幼虫孵化并钻入任何不幸受到感染的动物（通常是牲畜）的肉中，几天之内就会杀死它们。

The United States used the sterile insect technique to clear out this pest in the 1960s, and eventually pushed it back as far as the southern tip of Panama.

美国在20世纪60年代使用昆虫不育技术消灭了这种害虫，并最终将其赶回了巴拿马南端。

This is estimated to have saved American cattle farmers close to $800 million per year , with billions more in benefits to the wider economy.

据估计，这每年为美国养牛户节省了近 8 亿美元，并为更广泛的经济带来了数十亿美元的效益。

But containment broke, and in June 2026 , Texas detected the United States’ first case of screwworm in 60 years, likely aided by cattle smuggling from Central America, where the pest has resurged.

但遏制措施被打破，2026 年 6 月，得克萨斯州发现了美国 60 年来首例螺旋虫病例，这可能是由于从中美洲走私牛造成的，而那里的害虫已经死灰复燃。

With billions of dollars in damages, Texas officials are once again deploying sterile flies to contain its spread.

由于造成了数十亿美元的损失，德克萨斯州官员再次部署不育的苍蝇来遏制其传播。

The Mediterranean fruit fly, which attacks more than 300 kinds of fruit and vegetables and is considered the most destructive fruit pest in the world, has been beaten back the same way, with sterile flies released over California and Florida.

地中海果蝇会攻击 300 多种水果和蔬菜，被认为是世界上最具破坏性的水果害虫，但它也以同样的方式被击退，加利福尼亚州和佛罗里达州上空释放了不育果蝇。

It’s estimated that, if the fruit fly resettles in California, the resulting crop damage could cost over a billion dollars per year in that state alone.

据估计，如果果蝇重新定居在加利福尼亚州，仅在该州每年造成的农作物损失就可能超过十亿美元。

When Oxitec first sought approval for its gene-edited Aedes , it applied to the agency that had long managed mass insect releases, the USDA .

当 Oxitec 首次为其基因编辑伊蚊寻求批准时，它向长期管理大规模昆虫释放的机构美国农业部提出申请。

But it took a year and a half for the USDA to reject the application and inform the company that it should instead apply to the Food and Drug Administration (FDA).

但美国农业部花了一年半的时间才拒绝了该申请，并通知该公司应向美国食品和药物管理局（FDA）提出申请。

The FDA had claimed jurisdiction over genetically modified animals under its authority over veterinary drugs.

FDA 声称其对兽药的管辖权对转基因动物具有管辖权。

Its guidance stated that ‘altered genomic DNA in an animal is a drug …

其指南指出，“改变动物基因组 DNA 是一种药物……

because such altered DNA is an article intended to affect the structure or function of the body of the animal’.

因为这种改变的 DNA 是一种旨在影响动物身体结构或功能的物品。”

Until then, the USDA’s insects had been sterilized through radiation, which damages an insect’s sperm so that it leaves no viable offspring.

在此之前，美国农业部的昆虫一直通过辐射进行绝育，辐射会损害昆虫的精子，使其无法留下可存活的后代。

Oxitec, by contrast, had inserted a new gene.

相比之下，Oxitec 插入了一个新基因。

Even so, the category was a poor fit for Oxitec’s mosquitoes.

即便如此，该类别并不适合 Oxitec 的蚊子。

Oxitec’s application sat with the FDA for another five years.

Oxitec 的申请又在 FDA 等待了五年。

Like the USDA, the FDA could not work out how to apply existing rules for veterinary drugs to an engineered mosquito, eventually concluding that the Environmental Protection Agency (EPA), which oversees pesticide registration, was a better fit.

与美国农业部一样，FDA 也无法弄清楚如何将现有的兽药规则应用于转基因蚊子，最终得出结论，负责监督农药登记的环境保护局 (EPA) 更适合。

The FDA issued new guidance stating that they did not regulate products ‘intended to prevent, destroy, repel, or mitigate mosquitoes for population control purposes.’ The FDA had essentially created a bespoke carve-out for genetically engineered mosquitoes, recognizing that its regulatory frameworks weren’t set up to evaluate something like this.

FDA 发布了新的指导意见，指出他们不会监管“旨在预防、消灭、驱除或减轻蚊子以达到控制人口目的”的产品。FDA 认识到其监管框架并不是为了评估此类问题而建立的，因此基本上为转基因蚊子制定了专门的规定。

In its third review, at the EPA, Oxitec’s mosquitoes were subject to the rules governing pesticides, which often require both scientific assessments and field trials before the product can be lawfully sold and distributed.

在 EPA 的第三次审查中，Oxitec 的蚊子受到农药管理规则的约束，这些规则通常需要科学评估和现场试验才能合法销售和分销产品。

In May 2020 , a full decade after Oxitec first sought approval, the EPA granted them an Experimental Use Permit, which didn’t allow them to sell their product but did finally allow them to test it to obtain the safety and efficacy data needed for commercial registration by running field trials in delimited areas.

2020 年 5 月，在 Oxitec 首次寻求批准整整十年后，美国环保局授予了他们实验使用许可证，该许可证不允许他们销售产品，但最终允许他们通过在划定区域进行现场试验来测试产品，以获得商业注册所需的安全性和有效性数据。

The location they chose for those field trials was the Florida Keys, an island chain off the southern tip of Florida, where dengue had resurged .

他们选择的实地试验地点是佛罗里达群岛，这是佛罗里达州南端附近的一个岛链，登革热在那里再次流行。

Local authorities were eager to use genetically modified mosquitoes and in 2021 , Oxitec ran the first field trials in the United States that demonstrated female mosquitoes that inherited the gene died before adulthood.

地方当局渴望使用转基因蚊子，2021 年，Oxitec 在美国进行了首次实地试验，结果表明遗传该基因的雌性蚊子在成年前死亡。

In 2022, the EPA expanded the trials to California, clearing the release of up to 2.4 billion genetically engineered mosquitoes across the two states, but the releases were paused after public pushback.

2022 年，美国环保署将试验范围扩大到加利福尼亚州，批准在这两个州释放多达 24 亿只转基因蚊子，但在公众反对后释放被暂停。

Oxitec’s permit expired in April 2024, meaning no further mosquitoes could be released without new authorization from the EPA.

Oxitec 的许可证于 2024 年 4 月到期，这意味着如果没有 EPA 的新授权，就不能再释放蚊子。

A full commercial registration requires another review from the agency, this one focused on field trial data.

完整的商业注册需要该机构的另一次审查，这次审查的重点是现场试验数据。

Their full registration remains pending , over two years after the end of their field trial permit.

在现场试验许可结束两年多后，他们的完整注册仍在等待中。

A scientific advisory panel reviewing the case was supposed to convene in November 2025 , but the meeting was postponed with, at the time of writing, no new date set.

审查此案的科学顾问小组原定于 2025 年 11 月召开会议，但会议被推迟，截至撰写本文时，尚未确定新的日期。

As Florida Keys Mosquito Control District Executive Director Andrea Leal said, ‘our biggest challenges have been awaiting regulatory approvals.’ Luckily, this district had another mosquito control option to try out: Wolbachia -infected mosquitoes.

正如佛罗里达群岛蚊子控制区执行董事 Andrea Leal 所说，“我们最大的挑战是等待监管部门的批准。”幸运的是，该区还有另一种蚊子控制选择可供尝试：感染沃尔巴克氏体的蚊子。

Around the same time as genetically engineered mosquitoes were becoming viable, an alternative technique emerged.

大约在基因工程蚊子变得可行的同时，一种替代技术出现了。

It rests on a bacterium called Wolbachia, which naturally infects roughly 60 percent of insect species, including butterflies, fruit flies, and bees.

它依赖于一种名为沃尔巴克氏体的细菌，这种细菌自然会感染大约 60% 的昆虫物种，包括蝴蝶、果蝇和蜜蜂。

Wolbachia has two effects on insects that make it useful for preventing mosquito-borne disease.

沃尔巴克氏体对昆虫有两种作用，使其有助于预防蚊媒疾病。

First, it makes them less able to carry viruses, including those that infect humans.

首先，它降低了它们携带病毒的能力，包括那些感染人类的​​病毒。

Second, the bacterium is passed on to future generations – specifically, infected females pass it on through their eggs, and infected males can only produce offspring if they mate with infected females; if they mate with uninfected females, the offspring will not develop.

其次，这种细菌会遗传给后代——具体来说，受感染的雌性通过卵子传递细菌，而受感染的雄性只有与受感染的雌性交配才能产生后代；如果它们与未受感染的雌性交配，后代将不会发育。

By releasing infected male and female mosquitoes, wild mosquito populations can be seeded with Wolbachia until most of them carry it, becoming resistant to viruses like dengue and spreading their resistance to future generations.

通过释放受感染的雄性和雌性蚊子，野生蚊子种群可以被播种沃尔巴克氏体，直到大多数蚊子携带这种病毒，从而对登革热等病毒产生抵抗力，并将其抵抗力传播给后代。

And since this approach does not involve genetic modification, it ought to be able to bypass much of the regulation that stalled Oxitec’s gene-modified Aedes .

由于这种方法不涉及基因改造，它应该能够绕过阻止 Oxitec 基因改造伊蚊的大部分监管。

In 2009, after decades of research, scientists in Australia successfully introduced a strain of Wolbachia into Aedes aegypti .

2009年，经过数十年的研究，澳大利亚科学家成功将沃尔巴克氏体菌株引入埃及伊蚊体内。

They also confirmed that Wolbachia -infected male mosquitoes that mate with wild females produce eggs that don’t hatch, making them effectively sterile without infected females to mate with.

他们还证实，感染沃尔巴克氏体的雄性蚊子与野生雌性交配后产生的卵无法孵化，这使得它们在没有受感染的雌性交配的情况下实际上是不育的。

This is the basis for an alternative strategy: releasing only males has the same effect as the sterile insect technique, collapsing local populations.

这是另一种策略的基础：仅释放雄性与昆虫不育技术具有相同的效果，使当地种群崩溃。

The approach has succeeded at the scale of cities.

这种方法在城市规模上取得了成功。

In a randomized trial in Singapore, releases of Wolbachia -infected males cut mosquito populations by 85 percent compared to control areas and dengue infections by roughly 70 percent.

在新加坡的一项随机试验中，与对照地区相比，释放感染沃尔巴克氏体的雄性蚊子数量减少了 85%，登革热感染减少了大约 70%。

In April 2024 , after fifteen years working its way through the system, MosquitoMate became the first company to receive full nationwide commercial registration for a live mosquito biopesticide.

2024 年 4 月，经过十五年的努力，MosquitoMate 成为第一家在全国范围内获得活蚊生物农药全面商业注册的公司。

MosquitoMate’s insects can now be deployed across the United States, subject to local approval.

MosquitoMate 的昆虫现在可以在美国各地部署，但需获得当地批准。

Mosquito control districts have moved quickly to make use of the technology, including the Florida Keys in 2025 and the San Gabriel Valley in 2026 .

蚊虫控制区已迅速采取行动，利用该技术，包括 2025 年佛罗里达群岛和 2026 年圣盖博谷。

The technology is also attracting interest from larger players.

该技术也吸引了大型企业的兴趣。

In June 2026, Google’s Debug project requested the EPA’s approval to release 64 million Wolbachia mosquitoes in California and Florida (in this case, targeting a different species: Culex quinquefasciatus , which carries West Nile virus).

2026 年 6 月，Google 的 Debug 项目请求 EPA 批准在加利福尼亚州和佛罗里达州释放 6400 万只沃尔巴克氏体蚊子（在本例中，目标是不同的物种：库蚊，携带西尼罗河病毒）。

But it must complete the Experimental Use Permit process from the beginning, even though the basic underlying technology is the same.

但它必须从一开始就完成实验使用许可流程，即使基本的底层技术是相同的。

In the last few decades, biotech has developed enormously.

在过去的几十年里，生物技术取得了巨大的发展。

We can edit DNA , treat diseases by silencing harmful genes, and engineer bacteria to eat plastic waste and oil spills: all things that would have sounded like science fiction not even fifty years ago.

我们可以编辑DNA，通过沉默有害基因来治疗疾病，并改造细菌来吃掉塑料垃圾和石油泄漏：所有这些在五十年前听起来都像是科幻小说。

But the regulation that governs the use of these new technologies hasn’t kept pace.

但管理这些新技术使用的法规并没有跟上步伐。

No major new biotech regulation has been passed since the 1980s, and the agencies responsible for review are not resourced or designed for speed.

自 20 世纪 80 年代以来，还没有通过任何重大的新生物技术法规，负责审查的机构也没有足够的资源或设计来加快速度。

The 1986 Coordinated Framework remains the governing structure, and it divides jurisdiction according to categories designed for the previous century.

1986 年的协调框架仍然是治理结构，它根据上个世纪设计的类别划分管辖权。

Sometimes, it’s not even clear which regulatory body should have oversight of a new technology, a question which can create years-long delays before testing even begins.

有时，甚至不清楚哪个监管机构应该对一项新技术进行监督，这个问题可能会在测试开始之前造成长达数年的延误。

Cell-cultured meat faced this problem: was it a food, and thus under the jurisdiction of the FDA, or an agricultural technique, under the jurisdiction of the USDA?

细胞培养肉面临这样的问题：它是一种食品，因此受 FDA 管辖，还是一种农业技术，受美国农业部管辖？

The deadlock broke only when Congress forced them to split the review.

当国会迫使他们分开审查时，僵局才被打破。

In Oxitec’s case, a single early meeting to resolve the tensions would have saved years.

就 Oxitec 而言，如果尽早召开一次会议来解决紧张局势，就可以节省数年时间。

A few years ago, Washington seemed to agree.

几年前，华盛顿似乎也同意这一观点。

President Biden’s 2022 executive order directed the agencies to resolve regulatory uncertainties, and they committed to formally update how the 1986 Coordinated Framework is implemented.

拜登总统的 2022 年行政命令指示各机构解决监管不确定性，并承诺正式更新 1986 年协调框架的实施方式。

But almost none of it happened; President Trump rescinded the order in March 2025, and the updates never materialized.

但几乎这一切都没有发生。特朗普总统于 2025 年 3 月撤销了该命令，但更新从未实现。

Even aside from harmonization and safety testing, it can still take years for products to be reviewed.

即使除了协调和安全测试之外，产品的审查仍然可能需要数年时间。

Other programs might expedite the process.

其他计划可能会加快这一过程。

The EPA introduced a Vector Expedited Review Voucher program in 2022, which rewards companies that successfully register a novel mosquito control product with a voucher entitling them to expedited review on their next application.

美国环保局 (EPA) 于 2022 年推出了矢量快速审查优惠券计划，该计划向成功注册新型灭蚊产品的公司奖励一张优惠券，使他们有权在下一次申请中获得快速审查。

This ought to ensure that many of the best applications would be fast-tracked.

这应该确保许多最好的应用程序能够得到快速跟踪。

But it doesn’t do anything about the long regulatory backlog itself.

但它对长期监管积压本身没有任何作用。

Much better would be to grow regulatory agencies’ capacity to review and approve applications, to speed up the pipeline as a whole.

更好的办法是提高监管机构审查和批准申请的能力，从而加快整个管道的速度。

Currently, the EPA unit responsible for reviewing new mosquito control products is a small office that reviews a wide range of products from biochemical compounds to genetically engineered mosquitoes, and mosquito products are generally reviewed with the same protocols as other conventional pesticides, even though they raise different questions than pesticides on dispersal, inheritance, and their impact on populations.

目前，美国环保局负责审查新的蚊虫控制产品的部门是一个小办公室，审查从生化化合物到基因工程蚊子的各种产品，蚊子产品通常采用与其他传统杀虫剂相同的方案进行审查，尽管它们在传播、遗传及其对人口的影响方面提出了与杀虫剂不同的问题。

Reforming these departments and clearing their backlogs is possible.

改革这些部门并清理积压的工作是可能的。

Because of the Prescription Drug User Fee Act, passed in 1992, two thirds of the FDA’s budget for human drug review now comes from industry fees.

由于 1992 年通过的《处方药使用者收费法案》，FDA 人类药物审评预算的三分之二现在来自行业费用。

In the late 1980s, the median time to review a new drug was 29 months ; under the fee system, the targets are ten months for a standard review and six months for a priority one, and the agency now meets them in the large majority of cases.

20 世纪 80 年代末，审查新药的中位时间为 29 个月；根据收费制度，标准审查的目标是十个月，优先审查的目标是六个月，该机构现在在大多数情况下都达到了这些目标。

Increased staffing helped drive the speed up: it’s estimated that review times fell by roughly 3.3 months for every 100 reviewers the FDA added.

人员配备的增加有助于加快速度：据估计，FDA 每增加 100 名审稿人，审稿时间就会缩短约 3.3 个月。

The EPA, by contrast, is much more reliant on congressional appropriation, with two thirds of its budget coming from Congress and only one third from fees.

相比之下，美国环保署更加依赖国会拨款，其预算的三分之二来自国会，只有三分之一来自费用。

It shouldn’t have to take fifteen years to deploy effective products that can save lives.

部署可以拯救生命的有效产品不应该需要十五年的时间。

New technologies mean that mosquito-borne disease is now a choice in the United States.

新技术意味着蚊媒疾病现在已成为美国的一种选择。

We have the power to eliminate it; all we have to do is choose to.

我们有能力消灭它；我们所要做的就是选择。