One way I tried to explain "severe" and "serious" adverse events to the general reader was this way:
<snip>
"Severe adverse event” [is] anything that interferes with normal function. That includes things like, you got a headache and so you didn’t cook dinner as you normally would, or you called off work for a day or two because you had a fever (as many people were told to expect).
Which sounds scarier?
“I got the Pfizer vaccine, and I had a severe adverse event.”
Or
“I got the Pfizer vaccine, and I had a fever and stayed home for a day.”
These are equivalent. In other words, a severe adverse event is not the scary thing that it sounds like.
Same for the “serious” adverse events, which ...resulted in a hospital trip. There were 127 people in the Pfizer group and 116 people in the placebo group who ended up taking a trip to the hospital. We know that in clinical trials, there’s very much a bias toward “When in doubt, go to the hospital” because the patients’ safety is paramount.
But we know, don’t we, that the 116 people in the placebo group who went to the hospital had a tiny amount of salt water in their arms and there was absolutely nothing seriously wrong with them [related to the shot], right? Common sense. So 116 people went to the hospital because they had some kind of random symptom unrelated to the salt water, were scared, and everyone erred on the side of caution.
It's reasonable to suppose, human nature being what it is, and random symptoms being what they are, that a similar number of people who received the Pfizer vaccine also had some kind of random symptom unrelated to their injection, were scared, and everyone erred on the side of caution with them too. Probably in the neighborhood of …116, like the other group.
So then the question becomes: if 127 in the Pfizer group went to the hospital, versus 116 in the placebo group, is that 11-person difference between groups, in the context of 46,331 people total in the Pfizer trial, a statistically significant difference? Without doing the statistics, I’m going to guess “probably not.”
What is clear, at the very least, is that people were not experiencing effects from the vaccine bad enough to send them to the hospital, any more than they were experiencing bad effects from the salt-water placebo that sent them to the hospital.
<end snip>
It's really a problem with language and communication isn't it? People who are fearful of the vaccine are going to hear the words "serious adverse event" and not even know what those words mean, and certainly they won't know what the numbers mean in context, or what they represent. Our big-name science communicators have done a terrible job conveying information to the public.
Regarding the scariness of the word "severe": "Severe COVID-19" also sounds scary, but does not require hospitalization. With so much focus on the illness, fear was likely a bigger factor in diagnosing "severe COVID-19" than "severe adverse events".
In fact HR > 125 and a positive PCR test count as severe COVID-19 according to the FDA. Severe adverse events require HR > 130. Which is worse?
Your discussion of placebo recipients who suffered severe adverse events is facile. It is wrong to dismiss the 0.6 % who had such an event in the placebo group. Bad medical things always happen at some background rate and the placebo group measured that. Many more severe outcomes happened in the vaccine group. That is what we know.
"Severe" (Grade 3) is only one step away from "potentially life-threatening" (Grade 4), but the study was too weak to determine a ratio of excess Grade 4 adverse events vs. critical COVID-19 cases. Reasonable extrapolation would say that if the placebo is better than the vaccine for grade 3 and lower severity outcomes (due to adverse events or COVID-19), the placebo is also likely better for critical and fatal severity.
Where is the evidence that the vaccine reduces net harm? There is statistically significant evidence that the vaccine causes net harm, and the only arguments against this conclusion consist of hand-waving about one type of "severe" being worse than another type of "severe" when both definitions come from the same government agency that takes communication seriously.
We can take preventative measures to improve chances of less severe Covid. Improve our health and take vitamins.
But the injections, why Russian Roulette oneself with them, and live in sick fear of unknown tinkering long term. Being healthy won't save one from the clot shot.
One way I tried to explain "severe" and "serious" adverse events to the general reader was this way:
<snip>
"Severe adverse event” [is] anything that interferes with normal function. That includes things like, you got a headache and so you didn’t cook dinner as you normally would, or you called off work for a day or two because you had a fever (as many people were told to expect).
Which sounds scarier?
“I got the Pfizer vaccine, and I had a severe adverse event.”
Or
“I got the Pfizer vaccine, and I had a fever and stayed home for a day.”
These are equivalent. In other words, a severe adverse event is not the scary thing that it sounds like.
Same for the “serious” adverse events, which ...resulted in a hospital trip. There were 127 people in the Pfizer group and 116 people in the placebo group who ended up taking a trip to the hospital. We know that in clinical trials, there’s very much a bias toward “When in doubt, go to the hospital” because the patients’ safety is paramount.
But we know, don’t we, that the 116 people in the placebo group who went to the hospital had a tiny amount of salt water in their arms and there was absolutely nothing seriously wrong with them [related to the shot], right? Common sense. So 116 people went to the hospital because they had some kind of random symptom unrelated to the salt water, were scared, and everyone erred on the side of caution.
It's reasonable to suppose, human nature being what it is, and random symptoms being what they are, that a similar number of people who received the Pfizer vaccine also had some kind of random symptom unrelated to their injection, were scared, and everyone erred on the side of caution with them too. Probably in the neighborhood of …116, like the other group.
So then the question becomes: if 127 in the Pfizer group went to the hospital, versus 116 in the placebo group, is that 11-person difference between groups, in the context of 46,331 people total in the Pfizer trial, a statistically significant difference? Without doing the statistics, I’m going to guess “probably not.”
What is clear, at the very least, is that people were not experiencing effects from the vaccine bad enough to send them to the hospital, any more than they were experiencing bad effects from the salt-water placebo that sent them to the hospital.
<end snip>
It's really a problem with language and communication isn't it? People who are fearful of the vaccine are going to hear the words "serious adverse event" and not even know what those words mean, and certainly they won't know what the numbers mean in context, or what they represent. Our big-name science communicators have done a terrible job conveying information to the public.
Regarding the scariness of the word "severe": "Severe COVID-19" also sounds scary, but does not require hospitalization. With so much focus on the illness, fear was likely a bigger factor in diagnosing "severe COVID-19" than "severe adverse events".
In fact HR > 125 and a positive PCR test count as severe COVID-19 according to the FDA. Severe adverse events require HR > 130. Which is worse?
Or someone could have SpO2 < 93 % with a positive lab test to count as severe COVID-19. But many healthy community-dwelling older people have SpO2 < 93 %, independently of COVID-19. https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.12580
Your discussion of placebo recipients who suffered severe adverse events is facile. It is wrong to dismiss the 0.6 % who had such an event in the placebo group. Bad medical things always happen at some background rate and the placebo group measured that. Many more severe outcomes happened in the vaccine group. That is what we know.
"Severe" (Grade 3) is only one step away from "potentially life-threatening" (Grade 4), but the study was too weak to determine a ratio of excess Grade 4 adverse events vs. critical COVID-19 cases. Reasonable extrapolation would say that if the placebo is better than the vaccine for grade 3 and lower severity outcomes (due to adverse events or COVID-19), the placebo is also likely better for critical and fatal severity.
Where is the evidence that the vaccine reduces net harm? There is statistically significant evidence that the vaccine causes net harm, and the only arguments against this conclusion consist of hand-waving about one type of "severe" being worse than another type of "severe" when both definitions come from the same government agency that takes communication seriously.
Well said.
We can take preventative measures to improve chances of less severe Covid. Improve our health and take vitamins.
But the injections, why Russian Roulette oneself with them, and live in sick fear of unknown tinkering long term. Being healthy won't save one from the clot shot.