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Everything posted by Bootsie

  1. The probably are--and some may not be able to do it correctly with a calculator. I recently had a college junior using her calculator to multiply by 1 and could not figure out how to divide by 6%--she was very confused why it wasn't 0.6. Many of my college students cannot multiply by 10%--20% would really through them.
  2. These numbers were from June and there is a note that more potential cases were under review (but they give no clue of how many that might be); in the meeting some of the committee members mentioned that there were different studies that had different results. These results are after a second shot, so there is still a question about what happens after a third. These results show the incidence increasing as age decreases, with even the 40-49 year old males have a rate over 6 times greater than those over 65. My perception is the committee sees evidence that the risk is higher in younger people and that the outcomes from a covid case are better in younger people, so as you move down the age spectrum the risk of vaccine increases and the benefit decreases--they do not know how stable those results are for a third dose. I think a major issue is that it was Pfizer's job to provide evidence of benefit of a booster (and the committee found that some of the information that would generally be used to evaluate benefits was not provided) and it was Pfizer's job to provide evidence of low risk--and again the committee found that data lacking.
  3. The overall incidence was 4.8 per million (which these authors say they think is under-reporting), but the incidence in males under the age of 25 is over 50 per million--so over 10 times higher. In fact over half of the cases of myocarditis in this study are in males under the age of 25. (The incidence is only about 0.6 per million in the over 65 male population).
  4. Does anyone have any idea of how many people in the US have been vaccinated with 2 Pfizer shots long enough ago for this to apply? I haven't seen a breakdown (especially by age) of the shots in the US by manufacturer.
  5. But you would need to know how high "high" is. If even after waning antibodies the level is high enough to prevent infection, there is no benefit to a booster (and there are risks). There is also little evidence regarding how long antibodies increase after the booster, so you don't know what the benefit to infection reduction is to compare the benefits and the risk.
  6. I am totally making up numbers here--but if the incidence with vaccination is 1 in 500, you have a 1 in 500 chance of the adverse event if you receive the vaccination. If the incidence with COVID is 1 in 600, you have a 1 in 600 chance of the adverse event IF you have COVID. If your chances of getting COVID are 1 in 2, then you have a 50% chance of a 1 in 600 chance.
  7. One of the things the committee members commented on was that they didn't have any data on how much a booster reduced the risk of contracting COVID,
  8. I am not sure what the rates are, but at this point, it would not be appropriate to compare the rate between the vaccine and the rate if one has COVID. The rate of incidence for those who have COVID would have to adjusted for how much the vaccine decreases the risk of having COVID.
  9. I was surprised at the quality of the presentation by Pfizer and as well as their technical difficulties during questions and answers. I was also surprised that in their clinical trial they could not use 2% of the participants because they had been injected in error with a wrong booster; if you mess up on what you are injecting 2% of your participants with, how careful are you being?
  10. My impression is that it is primarily, but perhaps not only, myocarditis, They can base a rate off of first and second injections but do not have data on third injections--which was a big concern to them. If you have only 300 people in a study, you are unlikely to pick up incidence of events that occur in one in 500 people.
  11. They acknowledged that the safety may be different for different age groups. They had little evidence of what the safety level was in a younger population. I am not sure what the feeling of the committee was regarding the effectiveness in reducing infections--especially over a longer time period and whether this effectiveness level met the FDA definitions of effectiveness; there seemed to be some differing opinions and uncertainty in that area and I did not get a strong sense of where they stood. I think to understand the committee's think one much watch (1) what questions they raised throughout the day and (2) their discussion during the last hour. Much of what occurs earlier in the day are non-decision makers discussing their opinions. The committee heard those arguments and positions, but those arguments and positions can't be viewed as the committee member's positions. Unless the committee members specifically say what they thought about particular claims during the day and how that factored into their vote, one does not know how much they were influenced by any of those arguments.
  12. I did hear some mention of long covid--I was not specifically listening for that so I can't really qauntify how much discussion there was. I think part of the difficulty in analyzing the discussion is that the committee was not asked to decide whether they thought boosters were a good idea or not or should be up to an individual person or not. They were asked to evaluate the risks and benefits as presented in the clinical trial. I think they were very disappointed that the clinical trial was not very large and much of the data they would like to have was not provided. I was surprised by Pfizer's presentation of their data; I expected it to be much better. But, the committee can only make a decision based upon the data that is supplied.
  13. But then is it simply looking at people's profile page or stealthily looking at people's profile page.
  14. I guess I see a difference in self-deprecating humor like "I am so nosy" --which is a statement of what they are--and refering to themselves as a stalker--which is more about what someone choosing to do to someone else. Personally, I dislike when people complain about "be stalked" because someone looked at their social media they willingly decided to display more so that when someone refers to themselves in this way. I also see how much of what we consider self-deprecating humor can be hurtful to othe people who identify with the situation or condition that is being mentioned.
  15. I agree with this. Almost anything people say can be funny to some but not to others. I do not hink it is simply that it is funny in some cultures and not others. I would never say, for example, "Now I need to go beat my child" but some people say that thinking they are being lighthearted and funny. I think it depends upon our own experiences whether we find something funny, simply a colorful way to phrase something, or painful. My family and close friends know my experience and do not joke about stalking around me. I do not expect others to stop using the term or joking about it. I do have difficulty, however, understanding why people make a big deal of someone looking at what they have chosen to make public--whether they do it once, twice, or 100 times.
  16. My impression was there were enough on the committee that thought the data for those of 65 was compelling to get an affirmative vote. There were definitely some who said they would be comfortable with a younger age and there was some discussion of what data did they really have to use to be able to make a break point. Overall, I got the sense that they were really frustrated that they did not have good data because of such a small sample size and were having to do the best they could do with the data they did have.
  17. So what culture thinks and teaches that stalking is funny and a joke? Anyone I know who has experienced serious stalking does not belong to a culture that thinks it is funny. I think there have been cultures that have been taught that things are funny, and people laugh at, that are underlying racist, that the person laughing thinks they are laughing because it is funny in their culture and would not consider themselves racist. When I heare someone joke about stalking, it is not that I think they are accusing anyone of a serious crime--the issue is that I think they are taking something that is extremely serious and joking about it. It isn't the accusation that some of us find troubling it is the trivilization of stalking that we have trouble with.
  18. I have heard a number of people using the term "stalking" in a joking way about someone looking at social media. I have also heard a number of young people accuse others of stalking--not as a joke but as if someone looking at their social media is wrong. I have heard young people complain, for example, that their parents are stalking them by looking at their Twitter--or whatever they are using. I have also heard college students complain that a potential employer stalked them by looking at their social media; they claim this is an invasion of their privacy or denying them free speech. They seriously think they have a complaint and have been wronged. Having experienced a serious stalker for a number of years, I think it trivializes what stalking is and what stalking is about. Some of my frustrations when I first experienced this stalker was that his stalking was not considered a crime because we had no history of a relationship, were not family, and because I was not a public figure. (The laws in my state have changed since that time). The only reason I will post this today and make as much personal information available electronically as I do is that I know that this stalker is now deceased.
  19. The committee specifically asked if they could consider the Israeli data. The question posed to them was only stated results from the cilincial trial (which was extremely small). If the committee had been told that the Israeli data could not be considered, I think they might have not voted affirmative for anything. They did discuss what age they woud be comfortable with and were looking for an age at which they could get an affirmative vote for their new question. In addition to 65 they included those who are at risk for severe COVID and later added health care workers Doesn't that leave room for a patient and doctor to discuss the individual risk assessment for someone under 65 to receive a booster?
  20. What statistics make this clear? The committee thought that there were confounding factors that were not (and some that cannot be) controlled for. In addiiton, the impact that a Pfizer booster would have in Israel in which those who were initially immunized with Pfizer would not necessarily translate to the same type of a wave control in the US in which many people received vaccines other than Pfizer initially, and on a different schedule than in Israel. Even if a third dose of Pfizer is administered to all in the US who received two doses of Pfizer originally, that is a much smaller percent of those who are vaccinated who would be getting a third booster.
  21. Having experienced an extremely dangerous and serious stalking situation, I really dislike how the word is used in such trivial ways.
  22. Below is the the question the committee was tasked with answering. My impression from listening to the meeting is that the committee was frustrated from the lack of good data to answer this question. They wanted to do something but were not comfortable answer this question in the affirmative. They asked if they could form another question that would target the population that they felt they did have information. (The youngest age in the clinical trial was 19.)
  23. I did not hear the committee discussing that when I listened to the meeting. There was a period of open comments that others outside the committee promoted that idea. I saw no indiction that those comments had a bearing on the question
  24. It is especially important for the younger population that is not vaccinated yet. That was not a decision made by the hearing committee anyway. It was something that they mentioned as regards to what they would like to see in a study to draw good conclusions. What this committee was tasked with voting on was a very narrow question. I think part of the confusion was that this committee was not tasked with making a broad policy of what is the best thing to do right now is. They were tasked with drawing a conclusion of whether the results of Pfizer's clinical trial show that the benefits outweigh the risk of a third dose. The committee discussed the results of the clinical trial, raised questions about methodolgy and discussed what kinds of things would make them comfortable or what type of data they would like to see. The committee asked a lot of questions regarding exactly what the question they were posed meant; it is not simply OKing a booster for those already vaccinated, it was deciding whether the benefits and risks warrant the protocol being a three shot series going forward.
  25. i watched the eight hours of the meeting and I did not conclude that this advisory committee accepted that the booster is safe. There were only about 300 people in the clinical trial. If an adverse event occurs in 1 in 500 people the trial size is not large enough to detect that event. There were also questions on whether the benefit to immunity is being measured correctly. Another topic the committee members raised was whether the same immunity boost could be gained from having two doses spread out longer over time; this was beyond the question that they were tasked with voting on, but many felt that we just don't know what a good schedule for vaccination is and if we can get the same results with two shots spread out more that this would reduce the possbility of adverse events in the younger population. In all, the committee seemed to feel strongly that in the older population the benefits of a third dose outweight the risks at this point in time. They also felt tha the data did not really provide them enough information to define "older". And, they felt that the data was lacking to measure safety in young people. After listening for eight hours I did not hear them discussing economic and political costs. I did hear a few speakers who had two minutes to express their opinions (not part of the committee) who had political agendas but that was not the committee members.
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