KSera Posted October 19, 2021 Share Posted October 19, 2021 2 hours ago, Spy Car said: The only odd thing is that having a double dose of J&J was known to increase its efficacy for months and months. Were they just slow bringing the data forward? Or did they seek to remain being a "one shot" deal? I never understood why J&J continued to be considered a one shot vaccine. It was clear from the start that it wasn’t as effective as two mRNAs, and we had data last spring showing a single mRNA was performing better than two J&J. I think it served a purpose in providing a vaccine alternative to mRNA vaccines, but the one dose thing always seemed very shaky to me. Hopefully most people with J&J will boost with mRNA, since that looks like the best booster for them. 1 Quote Link to comment Share on other sites More sharing options...
Spy Car Posted October 19, 2021 Share Posted October 19, 2021 1 hour ago, bluemongoose said: Maybe I am cynical, but yes, I think they knew it aught to be a 2 dose shot and went with 1 to entice more people to use theirs to begin with over the mRna ones. Then later, after the others started saying boosters they said well ya, ours needs a second shot too. But the feeling behind it is the unsaid, well at least it isn't 3 shots like the mRna ones. And the behind the curtain is that while it is good and effective and everything... they knew it is not as high of an efficacy as the others. They also knew that adenovirus vector vaccines cause blood clots. I do think they knew they would have to find something that made theirs more appealing. Most people are not going to care about the storage issues in the US. They don't think about that aspect as they expect it to be handled for them. I agree with your other statements...it is a good vaccine and is appealing for those who want more traditional vaccines. My beef is with the false claims made by them and the CDC and FDA that it was a great vaccine and just as good as the others with just one shot and then given to high risk people who really needed more coverage. At least that is what happened in my state. And now I am trying to convince family members who are over 65 with high risk issues that they need to get another shot. They are stuck in the "one shot" sales pitch they were given and think they are fine. Sending you encouragement on getting your older family members to get a second shot of J&J. Keep up the positive push. It seems vital to have that additional dose or a mix and match. We got lucky to have so many vaccines that met or exceeded expectations. But the Delta mutation (and who knows what's next?) sure has complicated the picture. Best, Bill 2 Quote Link to comment Share on other sites More sharing options...
Corraleno Posted October 19, 2021 Share Posted October 19, 2021 (edited) Yeah, I've said from the very beginning that J&J would eventually admit that a second shot was needed, but they knew that the efficacy for one dose was good enough to get approval, and the idea of it being a one shot deal was their only market advantage. And it actually was an advantage — a lot of people wanted a one shot option, and it would likely have been much more popular if the blood clot issue hadn't suspended the rollout, combined with the glitches at the manufacturing facility in MD that contaminated millions of doses. That really halted their momentum, and they never really recovered after that. It seems pretty clear that they purposely withheld the data on two shots until Pfizer and Moderna announced boosters, so they could call their second shot an optional "booster" instead of what it really should have been. Edited October 19, 2021 by Corraleno 6 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 19, 2021 Share Posted October 19, 2021 New study on Pfizer vaccine effectiveness against hospitalization for 12-18 year olds over Summer (so, Delta). I first saw this graphic: and went looking for the study mostly to check if any unvaccinated adolescents in the study were admitted to the ICU, and it turns out 44.5% of the unvaccinated study patients were admitted to ICU 🙁. (29 were critically ill and on ventilator or ECMO and 2 died.) The full study results are even more compelling than this graphic, but I think the CDC actually did a pretty good job with this one: https://www.cdc.gov/mmwr/volumes/70/wr/mm7042e1.htm?s_cid=mm7042e1_w 9 Quote Link to comment Share on other sites More sharing options...
bluemongoose Posted October 19, 2021 Share Posted October 19, 2021 42 minutes ago, Corraleno said: Yeah, I've said from the very beginning that J&J would eventually admit that a second shot was needed, but they knew that the efficacy for one dose was good enough to get approval, and the idea of it being a one shot deal was their only market advantage. And it actually was an advantage — a lot of people wanted a one shot option, and it would likely have been much more popular if the blood clot issue hadn't suspended the rollout, combined with the glitches at the manufacturing facility in MD that contaminated millions of doses. That really halted their momentum, and they never really recovered after that. It seems pretty clear that they purposely withheld the data on two shots until Pfizer and Moderna announced boosters, so they could call their second shot an optional "booster" instead of what it really should have been. You said it better than I did...but yes I agree! Quote Link to comment Share on other sites More sharing options...
ieta_cassiopeia Posted October 19, 2021 Share Posted October 19, 2021 (edited) 4 hours ago, KSera said: I never understood why J&J continued to be considered a one shot vaccine. It was clear from the start that it wasn’t as effective as two mRNAs, and we had data last spring showing a single mRNA was performing better than two J&J. I think it served a purpose in providing a vaccine alternative to mRNA vaccines, but the one dose thing always seemed very shaky to me. Hopefully most people with J&J will boost with mRNA, since that looks like the best booster for them. I cannot speak for the rest of the world, but J&J was seen as 1-dose in the UK because J&J met the criteria to be a valid COVID-19 vaccine (above 50%) with one dose, but their 2-dose regimen had such a small increase in effectiveness on the test that J&J knew it had no chance of getting the two-dose through the NICE value-for-money protocol. I can't find the exact study that was UK-specific for the initial ENSEMBLE 2 study (I seem to remember it got 71% versus 1-dose's 66% there), but the J&J press release indicates that on the first Phase III trial, their vaccine globally got 75% overall efficiency for 1-dose and 2-dose alike. The 20-percentage-point difference was only found in the USA site of the trial. Since that gap didn't appear in the rest of the world, countries that don't consider USA protocols sufficient for approving medicines (e.g. the UK) could not use it as evidence. This is why 2-dose J&J still isn't approved in the UK despite having passed the clinical part of its Phase III trial back in February, but 1-dose J&J, which passed Phase III at the same time, has been approved since May. (Because of this, many UK people still think of J&J as exclusively one-dose). It was only on September 29 that the numbers came back from the second set of ENSEMBLE 2 studies to back the idea that J&J was worthwhile as a two-dose regimen anywhere other than in J&J press releases and the USA. That study seems to indicate the improvement of 2-dose over 1-dose was reflected in all countries that participated in the Phase III trial this time. Before that point, if J&J wasn't viable as one-dose, there was no point using it at all. Now, there is. Edited October 19, 2021 by ieta_cassiopeia 2 Quote Link to comment Share on other sites More sharing options...
SKL Posted October 19, 2021 Share Posted October 19, 2021 I have always thought it was really unfair that a user of mRNA had to have 2 shots even though the first shot was already more effective than the J&J shot. I suspect ulterior motives. I think someone should investigate and hold J&J etc. accountable for any treatment costs, lost work, hospitalizations, disabilities, and deaths that could have been prevented had there been more transparency about this shot. 1 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 19, 2021 Share Posted October 19, 2021 1 minute ago, SKL said: I have always thought it was really unfair that a user of mRNA had to have 2 shots That illustrates an interestingly different perspective from how I would have ever thought to look at it. I had been worried about what I was going to do if only J&J was available to me when it was my turn, because it would have felt unfair that I had to go with a lower protection shot. I never would have considered thinking it unfair that I was better protected. 5 Quote Link to comment Share on other sites More sharing options...
melmichigan Posted October 19, 2021 Share Posted October 19, 2021 21 minutes ago, ieta_cassiopeia said: I cannot speak for the rest of the world, but J&J was seen as 1-dose in the UK because J&J met the criteria to be a valid COVID-19 vaccine (above 50%) with one dose, but their 2-dose regimen had such a small increase in effectiveness on the test that J&J knew it had no chance of getting the two-dose through the NICE value-for-money protocol. I can't find the exact study that was UK-specific for the initial ENSEMBLE 2 study (I seem to remember it got 71% versus 1-dose's 66% there), but the J&J press release indicates that on the first Phase III trial, their vaccine globally got 75% overall efficiency for 1-dose and 2-dose alike. The 20-percentage-point difference was only found in the USA site of the trial. Since that gap didn't appear in the rest of the world, countries that don't consider USA protocols sufficient for approving medicines (e.g. the UK) could not use it as evidence. This is why 2-dose J&J still isn't approved in the UK despite having passed the clinical part of its Phase III trial back in February, but 1-dose J&J, which passed Phase III at the same time, has been approved since May. (Because of this, many UK people still think of J&J as exclusively one-dose). It was only on September 29 that the numbers came back from the second set of ENSEMBLE 2 studies to back the idea that J&J was worthwhile as a two-dose regimen anywhere other than in J&J press releases and the USA. That study seems to indicate the improvement of 2-dose over 1-dose was reflected in all countries that participated in the Phase III trial this time. Before that point, if J&J wasn't viable as one-dose, there was no point using it at all. Now, there is. They had the initial data on the 2-dose. They started their second study in November of last year. They didn't want it to become a 2-dose. They argued in front of the FDA that it not be labeled a second dose, but a "booster" and of course don't support a "booster" of mRNA as a second dose even though it's been shown to be more effective. 1 Quote Link to comment Share on other sites More sharing options...
mommyoffive Posted October 20, 2021 Share Posted October 20, 2021 Can you take Tylenol after getting the vaccine? That info is from so long ago I can't remember the details now. It is no before right? But after is ok? It doesn't mess with the shot? Quote Link to comment Share on other sites More sharing options...
Pawz4me Posted October 20, 2021 Share Posted October 20, 2021 4 minutes ago, mommyoffive said: Can you take Tylenol after getting the vaccine? That info is from so long ago I can't remember the details now. It is no before right? But after is ok? It doesn't mess with the shot? As well as I remember it’s no before and then wait at least four hours afterwards. 6 Quote Link to comment Share on other sites More sharing options...
Corraleno Posted October 20, 2021 Share Posted October 20, 2021 FDA has officially cleared boosters for J&J ad Moderna, as well as mixing-&-matching. The CDC meets tomorrow to discuss it, then Rochelle Walensky needs to sign off, and then people should be able to start getting boosters "immediately." https://www.cnbc.com/2021/10/20/fda-clears-johnson-johnson-and-moderna-booster-shots-for-millions-of-people.html?&qsearchterm=boosters 8 Quote Link to comment Share on other sites More sharing options...
Corraleno Posted October 20, 2021 Share Posted October 20, 2021 (edited) Also, the FDA advisory committee is meeting to approve Pfizer for ages 5-11 next Tuesday (26th) and, assuming it's approved and the CDC signs off, they are saying shots could start as early as Nov. 4th. They are going to focus more on doctors and pediatricians vs mass vax clinics, and apparently state health departments can start placing orders now (the kiddie vax is 10 µg and will apparently be bottled/labeled/shipped separately from the 12+ vials). Edited October 20, 2021 by Corraleno 2 Quote Link to comment Share on other sites More sharing options...
mommyoffive Posted October 20, 2021 Share Posted October 20, 2021 2 minutes ago, Corraleno said: Also, the FDA advisory committee is meeting to approve Pfizer for ages 5-11 next Tuesday (26th) and, assuming it's approved and the CDC signs off, they are saying shots could start as early as Nov. 4th. They are going to focus more on doctors and pediatricians vs mass vax clinics, and apparently state health departments can start placing orders now (the kiddie vax is 10 µg and will apparently be bottled/labeled/shipped separately from the 12+ vials). Oh yeah 2 day earlier. I hadn't heard that. Such great news. I contacted our pediatricians and they give pfizer in their offices. super excited about taht. 1 Quote Link to comment Share on other sites More sharing options...
Syllieann Posted October 20, 2021 Share Posted October 20, 2021 36 minutes ago, Corraleno said: Also, the FDA advisory committee is meeting to approve Pfizer for ages 5-11 next Tuesday (26th) and, assuming it's approved and the CDC signs off, they are saying shots could start as early as Nov. 4th. They are going to focus more on doctors and pediatricians vs mass vax clinics, and apparently state health departments can start placing orders now (the kiddie vax is 10 µg and will apparently be bottled/labeled/shipped separately from the 12+ vials). It would be extremely inconvenient if I had to make an appointment at the pediatrician’s to get these. I hope the still at least do some mass vax. 4 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 20, 2021 Share Posted October 20, 2021 3 minutes ago, Syllieann said: It would be extremely inconvenient if I had to make an appointment at the pediatrician’s to get these. I hope the still at least do some mass vax. Totally. I do not want to take my kids into the peds office for something unless absolutely necessary, as that increases their risk of getting sick (incidentally, my concern about this was validated by a study out this week showing patients are more likely to get flu in the following two weeks of a doctor's visit if they were seen immediately after a flu patient was). Hopefully they will be doing some drive up vax clinics for kids. They do that for kid flu shots around here. 1 Quote Link to comment Share on other sites More sharing options...
Corraleno Posted October 20, 2021 Share Posted October 20, 2021 15 minutes ago, Syllieann said: It would be extremely inconvenient if I had to make an appointment at the pediatrician’s to get these. I hope the still at least do some mass vax. They will be distributing kids vaccines to pharmacies as well. 2 Quote Link to comment Share on other sites More sharing options...
Terabith Posted October 20, 2021 Share Posted October 20, 2021 So, what is the Hive's takeaway on Moderna boosters? Since the 50 ug (I cannot get my computer to make the proper Greek symbol) was not tested, only the 100 ug, should those of us who got Pfizer or J&J go with Moderna, on the assumption that the half dose works as well or do Pfizer? Quote Link to comment Share on other sites More sharing options...
Corraleno Posted October 20, 2021 Share Posted October 20, 2021 (edited) 3 minutes ago, Terabith said: So, what is the Hive's takeaway on Moderna boosters? Since the 50 ug (I cannot get my computer to make the proper Greek symbol) was not tested, only the 100 ug, should those of us who got Pfizer or J&J go with Moderna, on the assumption that the half dose works as well or do Pfizer? Moderna's half dose is still almost double Pfizer's (50 vs 30), so for me personally, I am planning to get Moderna. Edited October 20, 2021 by Corraleno 3 Quote Link to comment Share on other sites More sharing options...
mommyoffive Posted October 20, 2021 Share Posted October 20, 2021 Philadelphia Health Department Expects To Receive Doses Of Children’s Pfizer Vaccine Prior To Approval From Federal Regulators (msn.com) Quote Link to comment Share on other sites More sharing options...
ScoutTN Posted October 21, 2021 Share Posted October 21, 2021 2 hours ago, KSera said: Totally. I do not want to take my kids into the peds office for something unless absolutely necessary, as that increases their risk of getting sick (incidentally, my concern about this was validated by a study out this week showing patients are more likely to get flu in the following two weeks of a doctor's visit if they were seen immediately after a flu patient was). Hopefully they will be doing some drive up vax clinics for kids. They do that for kid flu shots around here. The only two times my kids got the flu, it was from the peds office. 1 Quote Link to comment Share on other sites More sharing options...
ScoutTN Posted October 21, 2021 Share Posted October 21, 2021 2 hours ago, Corraleno said: They will be distributing kids vaccines to pharmacies as well. CVS has been very efficient here, for both vax and drive through testing. Quote Link to comment Share on other sites More sharing options...
Shoeless Posted October 21, 2021 Share Posted October 21, 2021 What does the give say about boostera if you have already had Moderna? Stick with Moderna or is there any benefit to getting Pfizer? Quote Link to comment Share on other sites More sharing options...
KSera Posted October 21, 2021 Share Posted October 21, 2021 (edited) 18 minutes ago, MissLemon said: What does the give say about boostera if you have already had Moderna? Stick with Moderna or is there any benefit to getting Pfizer? So far, there’s nothing to indicate there would be any advantage to switching to Pfizer. Unfortunately, the comparison data compares a higher dose booster of Moderna, but since it’s still almost twice what the Pfizer is, I expect the results that it produces the strongest response are likely still true. My teen boy is the only one that I would be likely to stick with Pfizer for. Edited October 21, 2021 by KSera Not Madonna! 1 Quote Link to comment Share on other sites More sharing options...
melmichigan Posted October 21, 2021 Share Posted October 21, 2021 (edited) 25 minutes ago, MissLemon said: What does the give say about boostera if you have already had Moderna? Stick with Moderna or is there any benefit to getting Pfizer? Here is one study results (the Moderna booster in this study was not the half dose so I think Moderna after Pfizer will be a wash). Pfizer after Moderna seems to have a little benefit. I am due for a third dose as soon as I can get a window in treatment, but I won't take any more Moderna either way. Edited October 21, 2021 by melmichigan Quote Link to comment Share on other sites More sharing options...
teachermom2834 Posted October 21, 2021 Share Posted October 21, 2021 23 minutes ago, MissLemon said: What does the give say about boostera if you have already had Moderna? Stick with Moderna or is there any benefit to getting Pfizer? Dh and I got Moderna. I think we may end up with Phizer boosters because I expect them to be more readily available. Moderna boosters are a smaller dose so not just the same shot they have in stock. I wouldn’t be surprised if we had to wait longer for Moderna boosters just because they aren’t already at the pharmacy. And we are in a very low vax area. Not sure how many pharmacies will even stock the special half dose Moderna? I really don’t know anything for sure. Just a hunch that Phizer is going to be easier to get quickly. Quote Link to comment Share on other sites More sharing options...
KSera Posted October 21, 2021 Share Posted October 21, 2021 9 minutes ago, melmichigan said: Here is one study results (the Moderna booster in this study was not the half dose so I think Moderna after Pfizer will be a wash). Pfizer after Moderna seems to have a little benefit. I am due for a third dose as soon as I can get a window in treatment, but I won't take any more Moderna either way. Do you happen to have the link to the study that graphic came from? Quote Link to comment Share on other sites More sharing options...
Syllieann Posted October 21, 2021 Share Posted October 21, 2021 15 minutes ago, KSera said: So far, there’s nothing to indicate there would be any advantage to switching to Pfizer. Unfortunately, the comparison data compares a higher dose booster of Moderna, but since it’s still almost twice what the Pfizer is, I expect the results that it produces the strongest response are likely still true. My teen boy is the only one that I would be likely to stick with Pfizer for. What about the fat package? They are slightly different. Could the body block out some of the mrna because it's packaged in molecules that have been seen before? Quote Link to comment Share on other sites More sharing options...
KSera Posted October 21, 2021 Share Posted October 21, 2021 8 minutes ago, Syllieann said: What about the fat package? They are slightly different. Could the body block out some of the mrna because it's packaged in molecules that have been seen before? It doesn’t seem from the booster data so far that that’s happening. Moderna to pfizer produced the third highest antibody levels. First was Moderna to Madonna, second was Pfizer to Moderna, third was Moderna to Pfizer. https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v1.full.pdf Atlantic article: Should You Mix and Match Your Booster Shot? Quote Link to comment Share on other sites More sharing options...
Syllieann Posted October 21, 2021 Share Posted October 21, 2021 (edited) 15 minutes ago, KSera said: Do you happen to have the link to the study that graphic came from? It's from the YLE analysis of the recent mix n match. https://yourlocalepidemiologist.substack.com/p/mixing-vaccines-the-study-weve-all In the study itself the authors acknowledge several things that make it inappropriate to compare between regimens. I also noticed a stark difference in boost interval. The Pfizer mean interval is quite a bit larger than the moderna mean interval. Edited October 21, 2021 by Syllieann 1 Quote Link to comment Share on other sites More sharing options...
Syllieann Posted October 21, 2021 Share Posted October 21, 2021 1 minute ago, KSera said: It doesn’t seem from the booster data so far that that’s happening. Moderna to pfizer produced the third highest antibody levels. First was Moderna to Madonna, second was Pfizer to Moderna, third was Moderna to Pfizer. https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v1.full.pdf Atlantic article: Should You Mix and Match Your Booster Shot? Haha, you gotta stop this Madonna business. 3 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 21, 2021 Share Posted October 21, 2021 2 minutes ago, Syllieann said: Haha, you gotta stop this Madonna business. I know! I swear my phone hates me. It looooves to autocorrect words to make me look like an idiot 😂. 2 Quote Link to comment Share on other sites More sharing options...
Pawz4me Posted October 21, 2021 Share Posted October 21, 2021 8 hours ago, Syllieann said: Haha, you gotta stop this Madonna business. 8 hours ago, KSera said: I know! I swear my phone hates me. It looooves to autocorrect words to make me look like an idiot 😂. A somewhat related funny--A couple of weeks ago I was in Walgreens browsing the supplements, which are near the pharmacy. I heard a lady tell the pharmacy clerk that she wanted "a fizzer vaccine." I could almost hear the gears grinding in the clerk's head. I'm sure she (like me) was struggling not to laugh (or what do I know--maybe she'd heard it before?). She quietly said "You mean a Pfizer?" LOL 3 Quote Link to comment Share on other sites More sharing options...
skimomma Posted October 21, 2021 Share Posted October 21, 2021 10 hours ago, KSera said: It doesn’t seem from the booster data so far that that’s happening. Moderna to pfizer produced the third highest antibody levels. First was Moderna to Madonna, second was Pfizer to Moderna, third was Moderna to Pfizer. https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v1.full.pdf Atlantic article: Should You Mix and Match Your Booster Shot? I just read this article as everyone in my family is reaching the booster eligibility date. One thing they wrote about is that people who had two doses (not J&J) AND had Covid will not see significantly increased protection from a booster. Anyone know how this might work out over time? If we know natural immunity from actually having covid wanes over time would that also mean the need for a booster increases? Dh had a "mild" but knocked-on-his-back case of Covid. Then was vaccinated three weeks after his positive test (that was the local recommendation at that time). I assume this means he should probably not get a booster now. But when, if ever, should he consider it? He is in a very high risk job situation so he is exposed on a regular basis. And.... Because dh is in a high risk situation and dd lives in a college dorm at a school with no vaccine or mask mandates, dd and I are chomping at the bit to get boosted. We both had Pfizer. It looks like Moderna is the way to go for boosters. But I do worry how we are going to have any real data with all this mixing and matching over time. I don't really like that we are all just supposed to choose our own adventure here. I would like to see some best practices before I get another jab. Is it worth waiting for a bit to see what shakes out? Quote Link to comment Share on other sites More sharing options...
Laura Corin Posted October 21, 2021 Share Posted October 21, 2021 Latest survey of protection from death by Delta https://www.bbc.co.uk/news/uk-scotland-58987835 2 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 21, 2021 Share Posted October 21, 2021 23 minutes ago, Laura Corin said: Latest survey of protection from death by Delta https://www.bbc.co.uk/news/uk-scotland-58987835 I didn’t know AZ was performing as well as Pfizer vs death. That is very good. 3 Quote Link to comment Share on other sites More sharing options...
melmichigan Posted October 21, 2021 Share Posted October 21, 2021 I found this interesting this morning. Basically T cells stepped up in response to mRNA vaccines, regardless of attenuated antibody levels. Quote Link to comment Share on other sites More sharing options...
Laura Corin Posted October 21, 2021 Share Posted October 21, 2021 4 hours ago, KSera said: I didn’t know AZ was performing as well as Pfizer vs death. That is very good. I think it has to be doing well, given how widely it was used in older people in the UK and the extent to which the death rate has decoupled from the case rate in this wave. 4 Quote Link to comment Share on other sites More sharing options...
Corraleno Posted October 21, 2021 Share Posted October 21, 2021 (edited) Pfizer released some really excellent data on the booster this morning. They divided 10,000 people, all of whom had previously had the 2-shot Pfizer series, into booster and placebo groups, and in 2.5 months of follow-up there were 5 cases in the boosted group and 109 in the unboosted group, for an efficacy rate of 95.6% against symptomatic illness. And that is compared to people who had 2 doses of Pfizer, not unvaxxed people. Presumably the rate would be even higher compared to those who have not had any vaccine. Pfizer announcement: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-phase-3-trial-data-showing Edited October 21, 2021 by Corraleno clarification 7 5 Quote Link to comment Share on other sites More sharing options...
Not_a_Number Posted October 22, 2021 Share Posted October 22, 2021 5 hours ago, Corraleno said: Pfizer released some really excellent data on the booster this morning. They divided 10,000 people, all of whom had previously had the 2-shot Pfizer series, into booster and placebo groups, and in 2.5 months of follow-up there were 5 cases in the boosted group and 109 in the unboosted group, for an efficacy rate of 95.6% against symptomatic illness. And that is compared to people who had 2 doses of Pfizer, not unvaxxed people. Presumably the rate would be even higher compared to those who have not had any vaccine. Pfizer announcement: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-phase-3-trial-data-showing I assume the rate compared to unvaxxed people would be excellent, since the 2 doses of Pfizer are already something like 60% protective. (I'm kind of pulling out this number out of thin air, since it depends so heavily on how long ago the doses were... so just an estimate.) Quote Link to comment Share on other sites More sharing options...
ieta_cassiopeia Posted October 22, 2021 Share Posted October 22, 2021 On 10/20/2021 at 12:51 AM, melmichigan said: They had the initial data on the 2-dose. They started their second study in November of last year. They didn't want it to become a 2-dose. They argued in front of the FDA that it not be labeled a second dose, but a "booster" and of course don't support a "booster" of mRNA as a second dose even though it's been shown to be more effective. As the item I quoted said, outside the USA, the initial data did not support 2-dose J&J over the 1-dose version. Had it done so, J&J would have offered it as an option to Britain (since they did one of the initial Phase IIIs in Britain), because why say no to free additional money? The first study protocol for ENSEMBLE 2's second attempt at Phase III (without which it could not have begun Phase III attempt 2) didn't exist until December 18 2020, so it couldn't possibly have started in November (I went with February as that was when the second Phase III for ENSEMBLE 2 started in the UK). Note that ENSEMBLE (for the single-dose version) also had two attempts at Phase III in those places where approval was not granted on the basis of the first one (the UK accepted it pending paperwork that then took several more months to complete, but not everywhere else did). It is hardly surprised J&J would object to not being allowed to market a vaccination option it had previously been permitted to use, when the threshold it was required to meet was still met by that dose regimen. Especially when the threshold has not been officially raised. There might be arguments about whether J&J makes more money from 1-dose than 2-dose, but J&J is bound to make more money if both choices are available to it, rather than only one. 1 Quote Link to comment Share on other sites More sharing options...
wathe Posted October 23, 2021 Share Posted October 23, 2021 Does anyone know if Pfizer's paediatric covid vaccine data has been published yet? And could point me to it? I's really like to look through it. Quote Link to comment Share on other sites More sharing options...
wathe Posted October 23, 2021 Share Posted October 23, 2021 Found it: the data is embedded in the FDA briefing document 4 Quote Link to comment Share on other sites More sharing options...
mommyoffive Posted October 25, 2021 Share Posted October 25, 2021 Moderna Says Vaccine Produces Powerful Immune Response in Those 6 Through 11 (msn.com) 2 Quote Link to comment Share on other sites More sharing options...
mommyoffive Posted October 26, 2021 Share Posted October 26, 2021 Moderna says its vaccine is safe, effective for kids 6-11; US reentry will be harder for unvaccinated Americans: Today's COVID-19 updates (msn.com) The FDA has not yet announced a decision on Moderna's vaccine for youths ages 12 through 17. Moderna submitted results from that study in June. Does anyone know why this is? Why would the FDA not make a decision since June? 1 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 26, 2021 Share Posted October 26, 2021 5 minutes ago, mommyoffive said: Does anyone know why this is? Why would the FDA not make a decision since June? I've been wondering that as well. Would they have been waiting to see if Pfizer had a better profile for kids? I don't know if approval works that way, where they would hold off on one approval while waiting for data from a similar product. 2 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 26, 2021 Share Posted October 26, 2021 (edited) Has anyone already shared the study published the end of last week showing the risk of non-Covid mortality is much higher in unvaccinated than vaccinated individuals? I didn't see it get a whole lot of press, but I think it's a big one for people who are worried about side effects from the vaccine. Clearly, it's not expected that the vaccine is somehow preventing deaths from other causes, but it's a strong indication that there is not an issue of vaccinated people dying at a higher rate than unvaccinated, but it not being noticed because they didn't die of covid. In fact, quite the reverse. It's most likely that people who are vaccinated are also healthier in other ways and make better health choices in general than people who are not vaccinated, and that most likely accounts for the difference in mortality. The study included 11 million people, by the way, so this was a huge sample. The reduction rates in non-Covid mortality were: Pfizer 1st dose: 59% lower risk Pfizer 2nd dose: 66% lower risk Moderna 1st dose: 66% lower risk Moderna 2nd dose: 69: lower risk Jansen: 46% lower risk Should be great news for anyone still on the fence worrying that there is greater risk from taking the vaccine than from not! Edited October 27, 2021 by KSera fixed link 11 Quote Link to comment Share on other sites More sharing options...
whitestavern Posted October 26, 2021 Share Posted October 26, 2021 (edited) 26 minutes ago, mommyoffive said: Moderna says its vaccine is safe, effective for kids 6-11; US reentry will be harder for unvaccinated Americans: Today's COVID-19 updates (msn.com) The FDA has not yet announced a decision on Moderna's vaccine for youths ages 12 through 17. Moderna submitted results from that study in June. Does anyone know why this is? Why would the FDA not make a decision since June? Finland's health authorities announced that men under 30 will not get the Moderna shot. Sweden banned Moderna for everyone under the age of 30; Denmark did the same for people under 18. Norway is urging people under 30 to choose Pfizer rather than Moderna. Iceland halted all distribution of Moderna. England, Norway, and Hong Kong limiting teens to only one dose of any vaccine I believe. A Canadian boardie posted not too long ago about her province limiting or not recommending one or more vaccines for teens/young adults. Lots of countries not recommending Moderna. Maybe that is why? ETA: My intent was not to come off as flip or obnoxious. I genuinely wonder if maybe that is the reason. Why are so many countries not recommending Moderna specifically? Edited October 26, 2021 by whitestavern 3 Quote Link to comment Share on other sites More sharing options...
KSera Posted October 26, 2021 Share Posted October 26, 2021 6 minutes ago, whitestavern said: Finland's health authorities announced that men under 30 will not get the Moderna shot. Sweden banned Moderna for everyone under the age of 30; Denmark did the same for people under 18. Norway is urging people under 30 to choose Pfizer rather than Moderna. Iceland halted all distribution of Moderna. England, Norway, and Hong Kong limiting teens to only one dose of any vaccine I believe. A Canadian boardie posted not too long ago about her province limiting or not recommending one or more vaccines for teens/young adults. Lots of countries not recommending Moderna. Maybe that is why? It makes sense to recommend the lowest risk vaccine for each group when there are multiple choices available; I would likely choose Pfizer for a teen boy, unless they were at particularly high risk from Covid, in which case I would take the small increase in myocarditis in order to get higher protection from Covid via Moderna. Many of the countries only recommending one dose for teens have much lower vaccine supply than the US does, in which case it makes sense to prioritize. 5 Quote Link to comment Share on other sites More sharing options...
TCB Posted October 26, 2021 Share Posted October 26, 2021 (edited) 11 minutes ago, KSera said: Has anyone already shared the study published the end of last week showing the risk of non-Covid mortality is much higher in unvaccinated than vaccinated individuals? I didn't see it get a whole lot of press, but I think it's a big one for people who are worried about side effects from the vaccine. Clearly, it's not expected that the vaccine is somehow preventing deaths from other causes, but it's a strong indication that there is not an issue of vaccinated people dying at a higher rate than unvaccinated, but it not being noticed because they didn't die of covid. In fact, quite the reverse. It's most likely that people who are vaccinated are also healthier in other ways and make better health choices in general than people who are not vaccinated, and that most likely accounts for the difference in mortality. The study included 11 million people, by the way, so this was a huge sample. The reduction rates in non-Covid mortality were: Pfizer 1st dose: 59% lower risk Pfizer 2nd dose: 66% lower risk Moderna 1st dose: 66% lower risk Moderna 2nd dose: 69: lower risk Jansen: 46% lower risk Should be great news for anyone still on the fence worrying that there is greater risk from taking the vaccine than from not! This is great but I have a feeling the narrative might then shift towards what they think might happen in the longer term. Maybe there are people prepared to look at things rationally and logically though. I think the irrational and illogical voices in my life are very loud, so maybe I overestimate how many people there are in the not open to logic side. ETA - I have suggested to some vaccine hesitant people I know that looking at what happens in New Zealand and now Portugal may be something that they feel are more unbiased sources of information. Edited October 26, 2021 by TCB 3 Quote Link to comment Share on other sites More sharing options...
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