近20年前,联邦政府启动了一个大规模的众包项目:一个由医生和病人组成的数据库,如果数百万人中的任何一个出现问题,它都可以给出早期预警疫苗美国人每年拿。
该系统被称为VAERS疫苗不良事件报告系统,现已被认为是在强生疫苗接种后发现极少数机会出现血凝块的系统。
但是随着对VAERS的新关注,这个至关重要的公众健康系统——任何人都可以访问——被滥用、误用和明显误解的时机已经成熟。
反疫苗运动的关键人物已经锁定了公共数据库,错误地说疫苗直接导致了VAERS列出的许多伤害。与此同时,担忧的公民越来越多地被数据库绊倒,并发现自己被这些报告吓到了。
尽管VAERS有数百万份接种疫苗后受伤的报告,但绝大多数伤害都是巧合。该系统接受疫苗接种后任何不良事件的报告,即使不清楚是疫苗导致了问题。
比如在美国,每40秒就有人心脏病发作。一些人可能在心脏病发作前不久接种了新冠肺炎疫苗,该报告可能已提交给VAERS。但这并不意味着疫苗导致了问题。
“VAERS已经存在了将近20年。它被用作雷达系统来探测疫苗安全问题的信号...和传染病教授威廉·沙夫纳博士说。
波士顿儿童医院的流行病学家、美国广播公司新闻撰稿人约翰·布朗斯坦博士补充说:“这是一个前线系统,可以通过自我报告快速获取人口中发生的事情的数据。”
任何人都可以使用VAERS。你需要做的只是下载V-safe的app或者在Google中输入“疫苗报告”。它非常方便用户,任何人都可以访问关于VAERS的报告数据。
“这是真正的透明模式,”沙夫纳说。
尽管滥用和误解是可能的,但一个完全透明的系统可以建立信心,即制药行业和政府不能在大规模免疫接种活动中隐瞒不良事件。
由于这是一个众包系统,VAERS是检测极其罕见的副作用的最佳方法,否则这些副作用可能不会被发现。
“想想它有多有用。“VAERS在干草堆里找到了一根针,”沙夫纳说。“这些(低血小板)凝血事件的发生率为百万分之一。它发现了一个信号,对此进行了调查,卫生官员立即召开了紧急会议。”
北卡罗来纳大学的流行病学家纳巴伦·达斯古普塔博士解释说,当大量未接种疫苗的人群出现副作用的频率高于预期时,联邦和制药当局会得到警告。
对于公共卫生专家来说,健康问题的预期频率——如每40秒钟一次心脏病发作——被称为预期的“背景率”。VAERS系统有助于识别超出预期背景率的问题。
然而,人们必须小心进入网站的错误信息,包括虚假报告。
政府机构系统地寻找与疫苗相关的模式,当有人在接种疫苗后不久生病或死亡时,会以非常严肃的方式进行调查,以确保没有联系或不准确的报告。
“这很有趣,因为当你点击提交时,实际上有一个很大的警告标志...布朗斯坦说:“如果输入错误信息,实际上会导致法律诉讼。“有些人可能希望延续关于疫苗的错误信息,并利用恐惧作为工具来实现这一目的,这在历史上是有先例的。”
尽管有其局限性,VAERS已被证明是一个有价值的工具。强烈鼓励接受疫苗的患者使用该系统,以便能够识别未来的不良事件。
What Americans need to know about the government's VAERS database: ANALYSIS
Nearly 20 years ago, the federal government launched a massive crowdsourcing project: A database filled by doctors and patients that could give an early warning if problems arose with any of the millions ofvaccinesAmericans take every year.
The system, called VAERS, the Vaccine Adverse Event Reporting System, has now been credited with identifying an extremely rare chance of a blood clot after the Johnson & Johnson vaccine.
But with newfound attention on VAERS, this crucial publichealthsystem -- which anyone can access -- is ripe for abuse, misuse and plain misunderstanding.
Key figures in the anti-vaccine movement have latched onto the public database, incorrectly saying the vaccines directly caused numerous injuries listed in VAERS. Meanwhile, concerned citizens are increasingly stumbling upon the database and finding themselves alarmed by the reports.
Although VAERS contains millions of reports of injuries following vaccinations, the vast majority of those injuries are coincidental. The system accepts any report of an adverse event following vaccination, even if it's not clear the vaccine caused the problem.
For example, in the United States, someone has a heart attack every 40 seconds. Some may have received a COVID-19 vaccine shortly prior to their heart attack and that report may have been filed to VAERS. But it does not mean the vaccine caused the problem.
"VAERS has been in place almost 20 years. It has been used as a radar system to detect signals on vaccine safety issues ... and has been ramped up in response to the COVID vaccine," said Dr. William Schaffner, a professor of preventative medicine and infectious diseases at Vanderbilt University in Nashville.
Added Dr. John Brownstein, an epidemiologist at Boston Children's Hospital and an ABC News contributor: "This is a frontline system which can quickly capture data about what's happening in the population through self-report."
Anyone can use VAERS. All you need to do is download the app V-safe or enter "vaccine reporting" in Google. It is very user-friendly and anyone can access the data reported on VAERS.
"This is truly a model of transparency," Schaffner said.
While abuse and misunderstanding are possible, a fully transparent system builds confidence that the pharmaceutical industry and government can't hide cases of adverse events during mass immunization campaigns.
And because it's a crowdsourced system, VAERS is the best way to detect extremely rare side effects that may not otherwise have been identified.
"Think of how useful it has been. VAERS found a needle in a haystack," Schaffner said. "These clotting events with [low platelets] occurred at a rate of 1 in over 1 million doses of vaccine. It found a signal, which was investigated, and health officials immediately convened an emergency meeting."
Federal and pharmaceutical authorities are alerted when the frequency of a side effect is higher than would be expected in a large unvaccinated population, explained Dr. Nabarun Dasgupta, an epidemiologist at the University of North Carolina.
For public health experts, the expected frequency of health problems -- such as one heart attack every 40 seconds -- is called the expected "background rate." The VAERS system helps identify problems that exceed the expected background rate.
One, however, must be cautious of misinformation entered on the site, including false reports.
Government agencies look systemically for patterns related to the vaccine, and when someone gets sick or dies shortly after the vaccine, this is investigated in a very serious fashion to ensure there is no link or inaccurate reporting.
"It's funny because when you click submit, there is actually a big warning sign ... if misinformation is entered, it can actually result in legal action," said Brownstein. "There is sort of a history for those who may want to perpetuate misinformation about vaccines to use fear as a tool to do so."
Despite its limitations, VAERS has proven to be a valuable tool. Patients receiving the vaccine are strongly encouraged to use the system so future adverse events can be identified.