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还是那个V站的信息?

The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. It’s a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. The weaponization of VAERS by anti-vaccine activists serves as a reminder that having access to more information does not always lead to better decisions. Information needs to be correctly interpreted to guide us in the right direction. Nearly sued out of existence VAERS is a reporting system based in the United States and it arose, like so many other regulatory measures surrounding vaccines, as a response to a major problem. It may be hard to imagine now but there was a time in American history when vaccines and other biological products used for medical reasons were not regulated. However, when 13 children died from receiving a diphtheria antitoxin that was contaminated with tetanus, legal steps were taken to provide oversight, with the adoption by Congress in 1902 of the virus-toxin act. Subsequent tragedies over the decades led to a number of improvements, among them stricter requirements on safety and efficacy when applying for a vaccine license and the authority given to the federal government to inspect facilities where vaccines were being manufactured. But it was a different kind of problem that caused the creation of VAERS. As Seth Mnookin reported in his book, The Panic Virus, a legal quagmire revealed itself in the 1970s. As claims were filed by individuals contending they had been harmed by a vaccine, it was unclear what people’s rights and obligations were. Could drug manufacturers be sued? Were governments liable? What about the pediatrician who had vaccinated the child? Additionally, vaccine injury claims did not need to be scientifically valid to scare vaccine manufacturers. Imagine you are selling a product that does not make you much money but that enough people think is injuring them to the point where you get sued for it. If you have better sources of income, you may reach a point where you decide selling this product is no longer worth it from a financial standpoint. Indeed, the number of vaccine companies willing to distribute vaccines in the litigious United States started to tumble, and in 1986 Americans were left with a single supplier of the vaccine against diphtheria, pertussis and tetanus. Faced with the possibility of simply running out of the vaccine, Congress passed the National Childhood Vaccine Injury Act (NCVIA). In a nutshell, NCVIA would simplify the whole process and help ensure life-saving vaccines would continue to get distributed in the United States. A surtax would be collected on vaccine doses, which would go to help compensate people judged more likely than not to have been injured by a vaccine through a new vaccine court that would exist outside the traditional legal system. And to be even more thorough and transparent in monitoring vaccine safety, the new law also established VAERS, a central database that continues to be in use to this day. What is being reported in VAERS is known as a vaccine adverse event: it is any unfavourable or unintended sign, any abnormal laboratory finding (like a blood test), any symptom or disease (even death) that comes after receiving a vaccine and that could, potentially, have been caused by it. These adverse event reports are registered with this central database that is managed by a private contractor under the direction of the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). Especially when it comes to new vaccines or older vaccines that have now been approved for a new use, VAERS is a valuable early warning system for many reasons. It has the ability to detect previously unrecognized reactions to a vaccine and to spot unusual increases in a particular reaction. Vaccines are fantastic public health interventions because their benefits so often outweigh their risks by a large margin, but the outcome of this risk-benefit analysis can change over time, and VAERS and other reporting systems help with these calculations. For example, when a very rare type of blood clots was quickly found to be associated with AstraZeneca’s COVID-19 vaccine, the risk-benefit calculation changed in many countries by taking into consideration the availability of other vaccines which did not carry this very small risk. Reports submitted to VAERS are reviewed by experts, like doctors, pharmacists and statisticians, and serious events are given additional scrutiny. It was VAERS that initially detected a dangerous intestinal obstruction linked to RotaShield, a rotavirus vaccine that was subsequently withdrawn from the market by its manufacturer. VAERS can also be used to see which preexisting health conditions may be associated with certain types of reactions, and this can lead to contraindications, as in the case of allergic reactions. The reporting system can also notice vaccine lots associated with an unusually high number of reported events (which might mean a rare case of a vaccine lot being contaminated) and it can identify specific locations in the United States where events are clustering. And it provides that country with transparent, country-wide statistics on vaccine-related adverse events. From 2011 to 2014, it collected an average of 30,000 reports each year on vaccine adverse events, with roughly one in every fourteen reports classified as “serious.” This last statistic will appear quite scary. Am I saying that every year 2,100 people are seriously injured by a vaccine? No, and that is where we start to see VAERS’ important limitations, which are easily exploited by those looking to scare the vaccine-hesitant. Where is the denominator? Where is the control group? If I told you that a new vaccine triggered fifteen cases of allergic reactions, would you immediately demand the vaccine be taken off the market? I hope not. Hopefully, you would ask yourself an important question first: compared to what? Fifteen cases is the numerator of a fraction. What is the denominator? Fifteen cases out of how many that received the vaccine? Fifteen out of fifteen? That’s shocking! Fifteen out of a million? Hardly the same. This is an important limitation of VAERS. It cannot be used, on its own, to figure out if an event following vaccination is common or rare. For example, when vaccines against the SARS-CoV-2 coronavirus started to be used in the population at large, more and more reports of adverse events began to be submitted to VAERS. This should not come as a shock. Obviously, the more a vaccine is used, the more adverse events are likely to be reported. If a vaccine requires two doses instead of one, that’s twice as many opportunities for an undesired event to take place after a shot. Moreover, if the background rate of the event being reported, meaning how common this event is in the population, goes up, it’s likely that its frequency in VAERS will also go up. If the diagnostic criteria for a condition are expanded, more people will receive the diagnosis, which will make it look like its incidence has suddenly increased. This is what happened with autism over the years, and since the diagnosis for autism is usually made around the time a child receives a number of vaccines, it’s easy to witness more reports of autism being filed following vaccination and to wrongly claim causation. VAERS can also be biased in an interesting way: mild events following a vaccine are less likely to get reported compared to more severe ones. Finally, there is also the fact that as an adverse event gets widely reported in the media, more people will pay attention to it, leading to an increase in reports to VAERS. This is known as stimulated reporting. It is, of course, possible that a particular adverse event is actually an adverse reaction, meaning that it was indeed caused by the vaccine, but being able to correctly point your finger at the jab is more complicated than it looks. A team working at the CDC reported back in 1994, a few years after VAERS had been instated, that the reports submitted to its system usually contained less than a quarter of the information necessary to make an expert assessment of what caused this adverse event. The information submitted can also be inaccurate: indeed, anyone, including non-healthcare professionals, can submit a report to VAERS. This can be seen as both a strength, for casting a wider net, and a weakness, for allowing unverified information to be filed. It has by now been said a thousand times, but it bears repeating a thousand more: correlation does not necessarily imply causation. Just because an undesirable event happens after receiving a vaccine does not automatically imply that the vaccine is responsible. The experts who keep track of the adverse events reported to VAERS have to contextualize the numbers they see and look for clues. Are they seeing reports of a highly specific set of signs and symptoms—a syndrome—linked to a particular vaccine? The peculiar type of blood clot associated with low platelets that was tied to AstraZeneca’s COVID-19 vaccine is an example of a very specific event, and it makes the attribution of causation easier. (For a good summary of what this risk means to Canadians, see this article.) Another indicator of causality is to compare how common the adverse event is in the vaccinated population to its frequency in an unvaccinated population. This is not a comparison that is directly available when consulting VAERS. Without this comparison, fear can easily take hold. For example, during the 2015 measles outbreak in the United States, a blogger looking at data from VAERS claimed that the vaccine against measles had directly killed over 100 people in the previous decade. When the evidence was looked at by experts, it turned out this was not true. Many of the filed reports of children who had died after receiving the measles vaccine were for children who had had a serious medical condition to begin with or who had died of sudden infant death syndrome. The most common causes of death in VAERS were consistent with the leading causes of death in the American population. Scrolling through a VAERS data set does not allow us to conclude anything; VAERS can be used to generate hypotheses but not to test them directly. It’s not how big your tool is, it’s how you use it To show that VAERS listings should not be taken at face value to mean that the vaccine caused the reported event, I trawled through the database’s reports on the COVID-19 vaccines. There were many, many reports of fever and injection site reactions (to be expected), but there were also, shall we say, head-scratching reports. A woman reported a large bald spot on top of her head following vaccination. Someone simply wrote in, “Nosebleed.” I saw a report of “anal leakage.” More than one person complained of suddenly becoming impotent. Meanwhile, at the other end of the spectrum, the funniest report I saw stated, “My penis swelled to ten times its size.” It is easy for an anti-vaccine activist—someone who is categorically opposed to vaccines and who sees themselves as a hero saving humanity from a costly mistake—to simply cherry-pick scary VAERS reports and present them as proof that a vaccine is known to cause serious harm and death, a tactic we could call “VAERS scare.” VAERS, when utilized in the right way by the right people, can be a fantastic early warning system to detect vaccine adverse reactions, especially those that were too rare to be detected in the clinical trials that preceded approval of the vaccine. It is a tool and like any tool it can unfortunately be misused. Note: in Canada, the way to report an adverse event following vaccination is to ask your doctor, nurse, or pharmacist to complete the Adverse Events Following Immunization form. Details can be found here. Take-home message: -VAERS is an American reporting system to keep track of unfavourable or unintended events that take place after vaccination, like a fever or a rash, and that may (or may not) have been caused by the vaccine -Anti-vaxxers routinely publicize reports from VAERS as if they are proof that a vaccine is causing clear harm -On its own, VAERS cannot be used to conclude anything, but it can tip off experts that a particular safety signal might be real and deserves to be further studied @CrackedScience Leave a comment!
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  • 枫下家园 / 医药保健 / 安省衛生廳表示已收到首批針對Omicron變種的二價疫苗
    安省衛生廳長瓊斯表示,已收到第一批由莫德納生產的二價疫苗,指省府已準備好為民眾接種,長期護理院住客和醫護人士可獲優先接種。二價疫苗是新一代的疫苗加強劑,能有效針對新冠病毒的原始病毒及多個變種,包括最新的BA.4和BA.5。聯邦衛生部指,會有足夠的二價疫苗在今年秋季和冬季,為所有18歲以上的國民接種一劑。//另外, 安省今個星期新增8131宗新冠感染個案,絕大部分新增個案為20歲以上,其中60歲以上人士感染比例仍高於其他年齡群組。而住院個案新增265宗,死亡42宗。省內同期進行了60302次核酸測試,確診率為12.7%。
    • 莫得拿疫苗,没得选,不反疫苗人士是不会打滴,身体不会说谎。加拿大政府关注你的健康?笑笑就好,呵呵。 +6
      • 我对公共医疗卫生的拙见:就是尽量维护大众不都出问题,不是个体不出问题
    • 我打了国药疫苗,临回来时去问第四针怎么打回答是没有计划。我担心的是加拿大如果认为第四针是完全接种我需要打MRNA就麻烦了。现在看来是不需要。
    • 新的調查發現本國有超過600萬國民沒有家庭醫生

      全國-新的調查發現本國有超過600萬國民沒有家庭醫生

      0

      民調機構Agues Reid於上月8 日至 10 日期間網上訪問了2,279 名國民,有關本國醫療保健系統的問題。結果顯示,本國仍有超過 600 萬人無家庭醫生。當中35%表示他們已花超過一年時間尋找家庭醫生,約 29%表示已放棄尋找。年齡越小沒有家庭醫生的可能性就越大, 例如 18 至 34 歲的男性和女性國民中,分別有 28% 和21%表示無法找不到一個家庭醫生。卑詩省的受訪者中 59%表示找不到家庭醫生, 海洋省份則有 60%。另有41%受訪者表示,即使夠預約醫生, 通常需要等待幾天,或至少需要一周或更長時間。 報告指出,若病人無法及時與家庭醫生取得聯繫可能會令他們難以獲得檢測、轉診或預約專科的機會。

    • 辉瑞疫苗获准可供5岁以下儿童接种

      根据Global News消息,可供加拿大5岁以下儿童接种的第二款COVID-19疫苗已获得批准。

      周五(9月9日),加拿大卫生部授权辉瑞为6个月至4岁的儿童注射COVID-19儿童疫苗。

      根据早前报道,该机构已于今年7月批准莫德纳成为第一款可供该年龄组接种的疫苗。

      • U.S Gov. Reports reveal many Children have been Permanently Disabled or Killed by COVID Vaccination & just 4 to 6% of the Vaccine Batches produced are responsible but Medicine Regulators have refused to act (#14800054@0)
        • 还是那个V站的信息? +1
          The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. It’s a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. The weaponization of VAERS by anti-vaccine activists serves as a reminder that having access to more information does not always lead to better decisions. Information needs to be correctly interpreted to guide us in the right direction. Nearly sued out of existence VAERS is a reporting system based in the United States and it arose, like so many other regulatory measures surrounding vaccines, as a response to a major problem. It may be hard to imagine now but there was a time in American history when vaccines and other biological products used for medical reasons were not regulated. However, when 13 children died from receiving a diphtheria antitoxin that was contaminated with tetanus, legal steps were taken to provide oversight, with the adoption by Congress in 1902 of the virus-toxin act. Subsequent tragedies over the decades led to a number of improvements, among them stricter requirements on safety and efficacy when applying for a vaccine license and the authority given to the federal government to inspect facilities where vaccines were being manufactured. But it was a different kind of problem that caused the creation of VAERS. As Seth Mnookin reported in his book, The Panic Virus, a legal quagmire revealed itself in the 1970s. As claims were filed by individuals contending they had been harmed by a vaccine, it was unclear what people’s rights and obligations were. Could drug manufacturers be sued? Were governments liable? What about the pediatrician who had vaccinated the child? Additionally, vaccine injury claims did not need to be scientifically valid to scare vaccine manufacturers. Imagine you are selling a product that does not make you much money but that enough people think is injuring them to the point where you get sued for it. If you have better sources of income, you may reach a point where you decide selling this product is no longer worth it from a financial standpoint. Indeed, the number of vaccine companies willing to distribute vaccines in the litigious United States started to tumble, and in 1986 Americans were left with a single supplier of the vaccine against diphtheria, pertussis and tetanus. Faced with the possibility of simply running out of the vaccine, Congress passed the National Childhood Vaccine Injury Act (NCVIA). In a nutshell, NCVIA would simplify the whole process and help ensure life-saving vaccines would continue to get distributed in the United States. A surtax would be collected on vaccine doses, which would go to help compensate people judged more likely than not to have been injured by a vaccine through a new vaccine court that would exist outside the traditional legal system. And to be even more thorough and transparent in monitoring vaccine safety, the new law also established VAERS, a central database that continues to be in use to this day. What is being reported in VAERS is known as a vaccine adverse event: it is any unfavourable or unintended sign, any abnormal laboratory finding (like a blood test), any symptom or disease (even death) that comes after receiving a vaccine and that could, potentially, have been caused by it. These adverse event reports are registered with this central database that is managed by a private contractor under the direction of the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). Especially when it comes to new vaccines or older vaccines that have now been approved for a new use, VAERS is a valuable early warning system for many reasons. It has the ability to detect previously unrecognized reactions to a vaccine and to spot unusual increases in a particular reaction. Vaccines are fantastic public health interventions because their benefits so often outweigh their risks by a large margin, but the outcome of this risk-benefit analysis can change over time, and VAERS and other reporting systems help with these calculations. For example, when a very rare type of blood clots was quickly found to be associated with AstraZeneca’s COVID-19 vaccine, the risk-benefit calculation changed in many countries by taking into consideration the availability of other vaccines which did not carry this very small risk. Reports submitted to VAERS are reviewed by experts, like doctors, pharmacists and statisticians, and serious events are given additional scrutiny. It was VAERS that initially detected a dangerous intestinal obstruction linked to RotaShield, a rotavirus vaccine that was subsequently withdrawn from the market by its manufacturer. VAERS can also be used to see which preexisting health conditions may be associated with certain types of reactions, and this can lead to contraindications, as in the case of allergic reactions. The reporting system can also notice vaccine lots associated with an unusually high number of reported events (which might mean a rare case of a vaccine lot being contaminated) and it can identify specific locations in the United States where events are clustering. And it provides that country with transparent, country-wide statistics on vaccine-related adverse events. From 2011 to 2014, it collected an average of 30,000 reports each year on vaccine adverse events, with roughly one in every fourteen reports classified as “serious.” This last statistic will appear quite scary. Am I saying that every year 2,100 people are seriously injured by a vaccine? No, and that is where we start to see VAERS’ important limitations, which are easily exploited by those looking to scare the vaccine-hesitant. Where is the denominator? Where is the control group? If I told you that a new vaccine triggered fifteen cases of allergic reactions, would you immediately demand the vaccine be taken off the market? I hope not. Hopefully, you would ask yourself an important question first: compared to what? Fifteen cases is the numerator of a fraction. What is the denominator? Fifteen cases out of how many that received the vaccine? Fifteen out of fifteen? That’s shocking! Fifteen out of a million? Hardly the same. This is an important limitation of VAERS. It cannot be used, on its own, to figure out if an event following vaccination is common or rare. For example, when vaccines against the SARS-CoV-2 coronavirus started to be used in the population at large, more and more reports of adverse events began to be submitted to VAERS. This should not come as a shock. Obviously, the more a vaccine is used, the more adverse events are likely to be reported. If a vaccine requires two doses instead of one, that’s twice as many opportunities for an undesired event to take place after a shot. Moreover, if the background rate of the event being reported, meaning how common this event is in the population, goes up, it’s likely that its frequency in VAERS will also go up. If the diagnostic criteria for a condition are expanded, more people will receive the diagnosis, which will make it look like its incidence has suddenly increased. This is what happened with autism over the years, and since the diagnosis for autism is usually made around the time a child receives a number of vaccines, it’s easy to witness more reports of autism being filed following vaccination and to wrongly claim causation. VAERS can also be biased in an interesting way: mild events following a vaccine are less likely to get reported compared to more severe ones. Finally, there is also the fact that as an adverse event gets widely reported in the media, more people will pay attention to it, leading to an increase in reports to VAERS. This is known as stimulated reporting. It is, of course, possible that a particular adverse event is actually an adverse reaction, meaning that it was indeed caused by the vaccine, but being able to correctly point your finger at the jab is more complicated than it looks. A team working at the CDC reported back in 1994, a few years after VAERS had been instated, that the reports submitted to its system usually contained less than a quarter of the information necessary to make an expert assessment of what caused this adverse event. The information submitted can also be inaccurate: indeed, anyone, including non-healthcare professionals, can submit a report to VAERS. This can be seen as both a strength, for casting a wider net, and a weakness, for allowing unverified information to be filed. It has by now been said a thousand times, but it bears repeating a thousand more: correlation does not necessarily imply causation. Just because an undesirable event happens after receiving a vaccine does not automatically imply that the vaccine is responsible. The experts who keep track of the adverse events reported to VAERS have to contextualize the numbers they see and look for clues. Are they seeing reports of a highly specific set of signs and symptoms—a syndrome—linked to a particular vaccine? The peculiar type of blood clot associated with low platelets that was tied to AstraZeneca’s COVID-19 vaccine is an example of a very specific event, and it makes the attribution of causation easier. (For a good summary of what this risk means to Canadians, see this article.) Another indicator of causality is to compare how common the adverse event is in the vaccinated population to its frequency in an unvaccinated population. This is not a comparison that is directly available when consulting VAERS. Without this comparison, fear can easily take hold. For example, during the 2015 measles outbreak in the United States, a blogger looking at data from VAERS claimed that the vaccine against measles had directly killed over 100 people in the previous decade. When the evidence was looked at by experts, it turned out this was not true. Many of the filed reports of children who had died after receiving the measles vaccine were for children who had had a serious medical condition to begin with or who had died of sudden infant death syndrome. The most common causes of death in VAERS were consistent with the leading causes of death in the American population. Scrolling through a VAERS data set does not allow us to conclude anything; VAERS can be used to generate hypotheses but not to test them directly. It’s not how big your tool is, it’s how you use it To show that VAERS listings should not be taken at face value to mean that the vaccine caused the reported event, I trawled through the database’s reports on the COVID-19 vaccines. There were many, many reports of fever and injection site reactions (to be expected), but there were also, shall we say, head-scratching reports. A woman reported a large bald spot on top of her head following vaccination. Someone simply wrote in, “Nosebleed.” I saw a report of “anal leakage.” More than one person complained of suddenly becoming impotent. Meanwhile, at the other end of the spectrum, the funniest report I saw stated, “My penis swelled to ten times its size.” It is easy for an anti-vaccine activist—someone who is categorically opposed to vaccines and who sees themselves as a hero saving humanity from a costly mistake—to simply cherry-pick scary VAERS reports and present them as proof that a vaccine is known to cause serious harm and death, a tactic we could call “VAERS scare.” VAERS, when utilized in the right way by the right people, can be a fantastic early warning system to detect vaccine adverse reactions, especially those that were too rare to be detected in the clinical trials that preceded approval of the vaccine. It is a tool and like any tool it can unfortunately be misused. Note: in Canada, the way to report an adverse event following vaccination is to ask your doctor, nurse, or pharmacist to complete the Adverse Events Following Immunization form. Details can be found here. Take-home message: -VAERS is an American reporting system to keep track of unfavourable or unintended events that take place after vaccination, like a fever or a rash, and that may (or may not) have been caused by the vaccine -Anti-vaxxers routinely publicize reports from VAERS as if they are proof that a vaccine is causing clear harm -On its own, VAERS cannot be used to conclude anything, but it can tip off experts that a particular safety signal might be real and deserves to be further studied @CrackedScience Leave a comment!
          • 很多“辟谣”实际上是造谣 +2
            • 两个凡是:凡是为疫苗辩护的就是真理,凡是说疫苗问题的就是造谣。 +1
              • 那篇文章里通篇没有"谣"这个字眼,反疫苗人士还是心虚呀! +1
    • 专家们指出,新出现的研究表明,在美国流行的最新变种BA.4.6,是上周美国新感染病例的约8%,似乎比占主导地位的BA.5更善于躲避免疫系统。
      • "更善于躲避免疫系统"?这句话一看就是外行说的,人家原文说的是“更强的免疫逃逸能力”,大白话说就是:刚出来的这个二价疫苗又无效了,你们不要说疫苗无效哈,是这个病毒免疫逃逸能力变强了。哈哈哈,骗子骗傻子。这是第三次。 +10
        • 骗术屡试屡行,老厉害了😄 +10
        • 买只猫拿耗子,结果猫太懒太笨太慢拿不到耗子,猫说耗子太精了。说了多次,主人信了,因为猫说的很认真,猫自己也信了。连邻居后来也信了。还连连夸猫 “good try”! 狗看不下去了,正要动手拿掉耗子,猫和主人挡住狗说狗你啃你的骨头多管啥闲事啊!😄 +5