Britain warns against Pfizer vaccine for people with history of ‘significant’ allergic reactions
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cptlo
Pursuit Driver
And now this:
www.dailymail.co.uk
Four volunteers who got Pfizer's vaccine developed Bell's palsy
Bell's palsy is a form of temporary facial paralysis with no known cause, but respiratory infections are a risk factor. Four people who got Pfizer's shot developed Bell's, but none did in the placebo group.
Boss 302
Pursuit Driver
It's not unusual for some people to be allergic to vaccines or any other form of medication.
Bells Palsy is some scary stuff. Our daughter came down with a case of that while we were vacationing on the outer banks of SC where there was only 1 road in and out of the area. After being on the beach most of the day she came inside to take a nap, when she woke up she couldn't move anything on her left side. It scared the crap of our everyone so of course we rushed her to the nearest ER (an hour away). Funny, they knew exactly what it was and gave her some medicine. It took several months for it to finally go away.And now this:
Four volunteers who got Pfizer's vaccine developed Bell's palsy
Bell's palsy is a form of temporary facial paralysis with no known cause, but respiratory infections are a risk factor. Four people who got Pfizer's shot developed Bell's, but none did in the placebo group.
The Sound Guy
Pursuit Driver
Interesting comment on statistics and mass vaccinations.
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Bob Wachter of UCSF had a very good thread on Twitter about vaccine rollouts the other day, and one of the good points he made was this one. We’re talking about treating very, very large populations, which means that you’re going to see the usual run of mortality and morbidity that you see across large samples. Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.
But if you took those ten million people and gave them a new vaccine instead, there’s a real danger that those heart attacks, cancer diagnoses, and deaths will be attributed to the vaccine. I mean, if you reach a large enough population, you are literally going to have cases where someone gets the vaccine and drops dead the next day (just as they would have if they *didn’t* get the vaccine). It could prove difficult to convince that person’s friends and relatives of that lack of connection, though. Post hoc ergo propter hoc is one of the most powerful fallacies of human logic, and we’re not going to get rid of it any time soon. Especially when it comes to vaccines. The best we can do, I think, is to try to get the word out in advance. Let people know that such things are going to happen, because people get sick and die constantly in this world. The key will be whether they are getting sick or dying at a noticeably higher rate once they have been vaccinated.
No such safety signals have appeared for the first vaccines to roll out (Moderna and Pfizer/BioNTech). In fact, we should be seeing the exact opposite effects on mortality and morbidity as more and more people get vaccinated. The excess-death figures so far in the coronavirus pandemic have been appalling (well over 300,000 in the US), and I certainly think mass vaccination is the most powerful method we have to knock that back down to normal.
That’s going to be harder to do, though, if we get screaming headlines about people falling over due to heart attacks after getting their vaccine shots. Be braced.
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I think we've already seen some of this with every death in the hospital being blamed on Covid.
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Get Ready for False Side Effects
By Derek Lowe 4 December, 2020Bob Wachter of UCSF had a very good thread on Twitter about vaccine rollouts the other day, and one of the good points he made was this one. We’re talking about treating very, very large populations, which means that you’re going to see the usual run of mortality and morbidity that you see across large samples. Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.
But if you took those ten million people and gave them a new vaccine instead, there’s a real danger that those heart attacks, cancer diagnoses, and deaths will be attributed to the vaccine. I mean, if you reach a large enough population, you are literally going to have cases where someone gets the vaccine and drops dead the next day (just as they would have if they *didn’t* get the vaccine). It could prove difficult to convince that person’s friends and relatives of that lack of connection, though. Post hoc ergo propter hoc is one of the most powerful fallacies of human logic, and we’re not going to get rid of it any time soon. Especially when it comes to vaccines. The best we can do, I think, is to try to get the word out in advance. Let people know that such things are going to happen, because people get sick and die constantly in this world. The key will be whether they are getting sick or dying at a noticeably higher rate once they have been vaccinated.
No such safety signals have appeared for the first vaccines to roll out (Moderna and Pfizer/BioNTech). In fact, we should be seeing the exact opposite effects on mortality and morbidity as more and more people get vaccinated. The excess-death figures so far in the coronavirus pandemic have been appalling (well over 300,000 in the US), and I certainly think mass vaccination is the most powerful method we have to knock that back down to normal.
That’s going to be harder to do, though, if we get screaming headlines about people falling over due to heart attacks after getting their vaccine shots. Be braced.
***********************************
I think we've already seen some of this with every death in the hospital being blamed on Covid.
Looking like the Moderna vaccine might be the best
www.newsmax.com
FDA Review: Moderna's Coronavirus Vaccine Highly Effective
Moderna Inc.'s COVID-19 vaccine appears set for regulatory authorization this week after U.S. Food and Drug Administration staff members did not raise any major new concerns about it in documents released Tuesday.
www.newsmax.com
The Sound Guy
Pursuit Driver
Modena Vaccine Efficancy Readout
As expected, we have more vaccine news this morning. And the news is good. Moderna reports that their own mRNA candidate is >94% effective (point estimate), with 95 total cases in the trial to date, split 90/5 between the control group and the vaccinated group. 11 of those were severe infections: all 11 in the controls and zero in the vaccine patients. Of the 95 total cases, 15 were in participants 65 years and older, but there’s no word on the split between controls and the vaccine arm there. All of these points are at 14 days past the second dose of the vaccine, which is going to be a standard time point for all the trials (except the J&J one-dose candidate, of course).
The safety readout looks like what we were expecting as well: the Grade 3 events were fatigue in 9.7% of patients, myalgia (muscle pain) in 8.9%, arthralgia (joint pain) in 5.2%, headache in 4.5%, and just “pain” in 4.1%. I would assume that there is overlap in these categories. The company says that these were “generally short lived”. The FDA’s guidance on event reporting would class these as “significant, prevents daily activity”, but not requiring hospitalization. So my read now with the data we have is that up to 10% of people taking the shot will spend the next day or so in bed, feeling like they’ve been hit with a really bad flu. That’s not enjoyable, but I will definitely make that trade in exchange for coronavirus immunity (see below). More data are being collected, of course, so we’ll get better reads on both safety and efficacy as the trial goes on, as will be the case with the Pfizer candidate and the others as well. We have to make sure (as much as we can) that there aren’t worse effects poking up out of those Grade 3 events, but so far, so good. Update: the most reaction I’ve personally had to a vaccine is to GSK’s Shingrix, and I see that it also has about 10% Grade 3 events. So if we’re in that range as the trial goes on, that should work out.
The second press release from the company today is also significant: Moderna says that new stability testing shows that their vaccine remains stable for up to six months under standard freezer conditions, up to 30 days under standard refrigeration conditions, and up to 12 hours at room temperature. There’s no dilution or further handling at the point of administration. This is much more like what you want to see, as compared to the more demanding storage conditions that seem to be needed for the Pfizer candidate. This is how a lot of medicine (and food, for that matter) is already distributed and stored – our infrastructure is a lot more prepared for this.
So we’re already starting to see some differentiation between the candidates, with likely more to come. We’ll see if there’s any statistical daylight in efficacy between the Pfizer and Moderna candidates as more cases accrue (I have no idea if that’ll be the case or not). Likewise with safety. But we already have a difference in shipping and storage, and it’s in Moderna’s favor. As mentioned before here, there are several other categories that could differentiate all the vaccine candidates: point efficacy (as we have now, 14 days after the second), effect on severity of disease when it does occur, duration of efficacy (which we’ll need time for, and there’s no other way), overall safety (which also needs big numbers and will sharpen with longer time points), and whatever differences in all these categories may show up in different patient populations. Those will take time to emerge, too, most likely,
But make no mistake: right now the vaccine news is very good indeed. Effective ones are coming, and what I said when the Pfizer results came about applies even more now, because this good news is coming against a stark background. The coronavirus statistics here in the US now are very, very bad, with cases, hospitalizations, and deaths all rising. Many areas of the country are facing ICU capacity shortages as we head into these rising numbers, and in the coming weeks a lot of people are going to die. It’s never been more important for people to take action against the pandemic: isolation as much as possible, mask wearing, avoiding indoor groups, and all that stuff that we already know about but that apparently too few people are following through on. The curves from Europe have been accelerating at a similar alarming rate, but take a look: their case numbers starting to turn back down again, and there’s no reason we can’t do that here. And we’re not going to be doing all this forever; I really think that the vaccine results we’re seeing mean that the end of all this is finally in sight. We have to make it through to getting our population
As expected, we have more vaccine news this morning. And the news is good. Moderna reports that their own mRNA candidate is >94% effective (point estimate), with 95 total cases in the trial to date, split 90/5 between the control group and the vaccinated group. 11 of those were severe infections: all 11 in the controls and zero in the vaccine patients. Of the 95 total cases, 15 were in participants 65 years and older, but there’s no word on the split between controls and the vaccine arm there. All of these points are at 14 days past the second dose of the vaccine, which is going to be a standard time point for all the trials (except the J&J one-dose candidate, of course).
The safety readout looks like what we were expecting as well: the Grade 3 events were fatigue in 9.7% of patients, myalgia (muscle pain) in 8.9%, arthralgia (joint pain) in 5.2%, headache in 4.5%, and just “pain” in 4.1%. I would assume that there is overlap in these categories. The company says that these were “generally short lived”. The FDA’s guidance on event reporting would class these as “significant, prevents daily activity”, but not requiring hospitalization. So my read now with the data we have is that up to 10% of people taking the shot will spend the next day or so in bed, feeling like they’ve been hit with a really bad flu. That’s not enjoyable, but I will definitely make that trade in exchange for coronavirus immunity (see below). More data are being collected, of course, so we’ll get better reads on both safety and efficacy as the trial goes on, as will be the case with the Pfizer candidate and the others as well. We have to make sure (as much as we can) that there aren’t worse effects poking up out of those Grade 3 events, but so far, so good. Update: the most reaction I’ve personally had to a vaccine is to GSK’s Shingrix, and I see that it also has about 10% Grade 3 events. So if we’re in that range as the trial goes on, that should work out.
The second press release from the company today is also significant: Moderna says that new stability testing shows that their vaccine remains stable for up to six months under standard freezer conditions, up to 30 days under standard refrigeration conditions, and up to 12 hours at room temperature. There’s no dilution or further handling at the point of administration. This is much more like what you want to see, as compared to the more demanding storage conditions that seem to be needed for the Pfizer candidate. This is how a lot of medicine (and food, for that matter) is already distributed and stored – our infrastructure is a lot more prepared for this.
So we’re already starting to see some differentiation between the candidates, with likely more to come. We’ll see if there’s any statistical daylight in efficacy between the Pfizer and Moderna candidates as more cases accrue (I have no idea if that’ll be the case or not). Likewise with safety. But we already have a difference in shipping and storage, and it’s in Moderna’s favor. As mentioned before here, there are several other categories that could differentiate all the vaccine candidates: point efficacy (as we have now, 14 days after the second), effect on severity of disease when it does occur, duration of efficacy (which we’ll need time for, and there’s no other way), overall safety (which also needs big numbers and will sharpen with longer time points), and whatever differences in all these categories may show up in different patient populations. Those will take time to emerge, too, most likely,
But make no mistake: right now the vaccine news is very good indeed. Effective ones are coming, and what I said when the Pfizer results came about applies even more now, because this good news is coming against a stark background. The coronavirus statistics here in the US now are very, very bad, with cases, hospitalizations, and deaths all rising. Many areas of the country are facing ICU capacity shortages as we head into these rising numbers, and in the coming weeks a lot of people are going to die. It’s never been more important for people to take action against the pandemic: isolation as much as possible, mask wearing, avoiding indoor groups, and all that stuff that we already know about but that apparently too few people are following through on. The curves from Europe have been accelerating at a similar alarming rate, but take a look: their case numbers starting to turn back down again, and there’s no reason we can’t do that here. And we’re not going to be doing all this forever; I really think that the vaccine results we’re seeing mean that the end of all this is finally in sight. We have to make it through to getting our population