For people who want to have a baby, false messages about fertility can be especially powerful. So I want to say upfront that the COVID-19 vaccine is safe for fertility.
对于想生孩子的人来说, 关于生育的虚假信息 可以产生很大的影响。 所以我想提前声明 新冠疫苗疫苗不会损害生育能力。
[Body Stuff with Dr. Jen Gunter]
[珍·冈特医生(Dr. Jen Gunter)的 《身体秘密》(Body Stuff)节目]
The data on this is clear. COVID-19 vaccination saves lives for everyone, especially pregnant people and their babies. But the fog of the pandemic has made it extra challenging to dispel the misinformation surrounding the COVID-19 vaccine.
相关数据很明确。 新冠疫苗挽救所有人的生命, 特别是孕妇和胎儿。 但疫情之下消除 关于新冠疫苗的虚假信息 更具挑战。
So I want to address some of these worries by talking about how a vaccine becomes a vaccine in the first place. To show that each step of creating the vaccine is closely evaluated for safety.
所以我想解决大家在这方面的一些困惑 给大家讲讲疫苗一开始是如何制成的。 我会向大家展示, 制作疫苗的每一个步骤 都经过了严格的安全评估。
One of the early stages of vaccine development involves exploratory research. In the case of the coronavirus that causes COVID-19, researchers already had years of knowledge and insight to work from. Scientists already knew a lot about other coronaviruses. And because of knowledge sharing, they were able to simply download the virus’s genetic code off a website. They were also able to take advantage of the advances made in mRNA vaccine technology, which you might have heard about.
疫苗开发的早期阶段之一 涉及探索性研究。 对于导致新冠肺炎的冠状病毒, 研究人员已经积累了 多年的知识和见解来开展工作。 科学家对于其他类型的 冠状病毒已经了解很多。 由于知识共享, 他们能够直接从网站上 下载病毒的基因序列。 他们也能够利用 信使核糖核酸(mRNA) 疫苗技术的进步。 你可能听说过 信使核糖核酸(mRNA)疫苗。
While mRNA vaccines are new to the public, researchers have been studying and working with them for decades. I want to underscore this point. One worry about the vaccine is that it felt rushed. But while the COVID-19 vaccine was developed rapidly, its creation was based on decades of research.
虽然信使核糖核酸(mRNA) 对公众来说是新事物, 几十年来研究人员一直 在从事相关的研究与研发。 这里要划重点。 民众对疫苗的一个疑虑是 它的研发看起来比较仓促。 然而,虽然新冠疫苗的研发十分迅速, 但那是基于几十年的研究成果。
Once the exploratory stage is finished, researchers move on to the preclinical stage, where testing is done in petri dishes or on animals. The goal of preclinical tests is to see if the vaccine truly works on the pathogen -- in this case, the virus that causes COVID-19 -- and also to test the safety of a vaccine. This is where researchers perform toxicity testing, using a dosage far greater than what they might use in humans to make sure it's safe. By testing on animals, they're able to see if vaccines have any impact on functions like the reproductive system. You might be surprised to learn that the chemical signaling that happens in a rat uterus is very similar to what happens in a human uterus. Here's what's important. Researchers don’t move on from the preclinical testing phase until they prove that the vaccine is unlikely to harm anyone. This is a rigorous process that goes through FDA approval.
一旦探索性阶段结束, 研究进入临床前阶段, 研发人员会在在培养皿 或动物身上进行测试。 临床前测试的目的是看疫苗是否 真能作用于病原体—— 对于此次疫情而言,即新冠病毒—— 以及测试疫苗安全与否。 在这一步研究人员会进行毒性测试, 测试使用的剂量远远大于 在人类身上使用的剂量 以确保疫苗的安全性。 通过对动物进行测试, 研究人员能够了解 疫苗是否对机体功能 例如生殖系统有任何影响。 你可能会惊讶地发现, 在小白鼠子宫内 发生的化学信号传递 与人类子宫内的十分相似。 重要的是, 在证明疫苗不太可能 对人体有伤害之前, 研究不会从临床前 测试阶段进入下一阶段。 这一过程十分严格, 需要食品与药物监督管理局的批准。
Once the FDA approves, the next step is the clinical development or clinical trials, testing in humans, which is a three-phase process. Phase one starts with a small group of people, usually less than 100 very healthy adults. By phase three, researchers are working with thousands or even tens of thousands of people. Because of the urgency of COVID-19, researchers save time by overlapping these phases, using early data from each phase to design for the next. In other words, no steps were skipped. Now, it's true that clinical trials for the COVID-19 vaccines didn't include pregnant people, and that's not unusual. Pregnant people are currently part of a protected class that typically aren't included in testing new vaccines or new drugs. I completely understand the worries around this, but remember, testing in animals is a proven way to ensure vaccine safety. The preclinical data for the COVID-19 mRNA vaccine showed no impact on fertility in animals that would lead researchers to suspect there would be issues with humans.
一旦食药局批准通过, 下一步是临床研发 又称临床试验,会在人体上进行测试, 这一步分三个阶段。 第一阶段从一小群人开始, 通常包含不到 100 名 非常健康的成年人。 到了第三阶段, 成千上万名被试者接受试验。 由于新冠疫情情况紧急, 研究人员使这些阶段相互重叠来节约时间 使用每个阶段的早期数据设计下一阶段。 也就是说,没有跳过任何步骤。 目前,新冠疫苗的临床试验的确 并未涉及孕妇,这种情况并不罕见。 孕妇目前属于受保护人群 通常不接受新疫苗或新药的测试。 我完全理解关于这方面的担忧, 但请记住,动物实验 已被证实可以确保疫苗安全。 新冠肺炎mRNA疫苗的临床数据显示 mRNA疫苗对于 动物的生殖系统没有影响 研究人员没有理由 怀疑疫苗会在人类身上出问题
Even after the vaccine has been approved by the FDA and made available to the public, there's still work to be done. These are called phase four trials, where researchers and regulatory agencies track how the public responds to the vaccine long-term. Monitoring side effects, collecting and analyzing data from a much wider population. And now we have even more data to reassure us about fertility.
即使疫苗被美国食品 和药物监督管理局批准 并向公众提供,相关工作仍在继续。 这就是第四个试验阶段, 研究人员和监管机构 会长期跟踪公众对疫苗的反应 监测副作用 并收集和分析来更广泛人群的数据。 如今我们有更多的数据 来确保疫苗不会损害生育能力。
After the COVID-19 vaccine was rolled out, there were reports online of people experiencing irregular periods or changes in their menstrual cycle. This, understandably, made people nervous about a potential effect on fertility or an unknown effect of the vaccine. We didn't have any data about irregular menstrual cycles from clinical trials to point to, and that is problematic. But given the rush to get the data, it would have been hard to collect because people would have had to track cycles before the vaccine. Differences people notice in their menstrual cycles are valid, and it's scary and uncertain to notice a change in our bodies. And because the endometrium, the lining of the uterus that sheds during a period, is part of our immune system, it is theoretically possible a vaccine could have a temporary effect in the same way a vaccine causes temporary swelling in the lymph nodes for some people or a temporary fever. Researchers responded to the concerns raised online and looked into data from almost 4,000 people who tracked their cycles using an app and compared data from the vaccinated group to those who didn't get vaccinated. On average, the menstrual cycles of people who were vaccinated varied in length by less than one day, which is interesting but not medically significant since normal menstrual cycles vary by up to seven days each cycle. The only group that was more likely to show a meaningful difference in their menstrual cycle length were those who received two doses of the vaccine in one cycle. Even then, what they observed was temporary. Their cycles went back to normal within three cycles.
新冠疫苗推出后, 网上出现了人们经期不规律 或月经周期变化的报道。 能够理解这使人们对于疫苗对生育的影响 或其他未知影响感到焦虑。 我们没有任何 关于月经不调的临床试验数据, 这确实有问题。 但是由于急需获取疫苗临床数据, 像月经不调这样的数据是比较难采集的 因为这需要人们在疫苗接种前 记录她们的月经周期。 人们注意到的她们月经周期的变化 是真实存在的, 而发现我们身体的变化 是一件可怕并且充满不确定性的事。 以及,因为来月经时, 子宫内膜的脱落, 是免疫系统的一部分, 理论上,疫苗可能造成了一种暂时的影响 类似于疫苗导致一些人的淋巴结 暂时发生肿胀 或暂时发烧。 研究人员回应了网友的疑虑 并研究了近 4000 人的数据 这 4000 人使用一个 应用程序记录她们的月经周期 研究人员将其中接种了疫苗的人的数据 与未接种疫苗的人的数据进行了对比。 平均下来, 接种疫苗后月经周期的浮动 小于一天, 这是一个有趣的现象但缺乏临床意义 因为正常情况下 每个月经周期浮动最多达七天。 唯一一组有临床意义的结果显示 月经周期的变化 发生在一个月内 接种了两剂疫苗的人群中。 即便如此,观察到的变化也是暂时的。 她们的月经在三个周期内便回归正常。
And we've continued to gather data. We now see the importance of vaccination for those who are pregnant as the risk of mortality in pregnancy with COVID-19 is 1.6 percent. That's 22 times higher than the risk of mortality in pregnancy for those without COVID. And unvaccinated mothers and pregnant people who do get COVID-19 have a much higher chance of being admitted to the intensive care unit. We also now have data showing that infants from people vaccinated during pregnancy do have antibodies to help protect them from COVID-19.
数据收集仍在继续。 我们现在了解了孕妇接种疫苗的重要性 因为感染新冠的孕妇 死亡率为 1.6% 。 这比未感染新冠的孕妇死亡率 高 22 倍。 而未接种疫苗 而感染了新冠的孕妇 有极高的几率被收入重症监护室治疗。 我们还有数据表明 母体怀孕时接种了疫苗的胎儿 拥有可以保护他们的抗体。
If your goal is a healthy pregnancy, one of the best ways to achieve that is by getting vaccinated. And we can have confidence that the COVID-19 vaccines have been rigorously tested and are being closely followed.
如果你的目标是度过一个健康的孕期, 最好的方式之一是接种疫苗。 我们确信 新冠疫苗经过了严格的试验 并且研究人员还在密切关注着。