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The Vaccine Thread


JennyD

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10 hours ago, Corraleno said:

IMO, Moderna's penchant for issuing press releases with "great news" but zero data is really sketchy. I think they purposely word things in a way they know the press will pick up, without providing data that might contradict the favorable but somewhat inaccurate "impression" that people get from the press release.

I'm afraid that all the headlines from this are likely to be that antibodies from Moderna don't wane over time, and that efficacy is still 93% against Delta. But that 93% figure is an average of the efficacy over a six month period (most likely at the beginning of the study) — it doesn't mean efficacy was still 93% at 6 months,  or that it's anything close to 93% against Delta. Pfizer just released data last week showing a similar six month efficacy of 91%, but I suspect what most people will erroneously take from this press release is "Moderna is 93% effective against Delta even if you got vaxxed a long time ago, but antibodies from Pfizer disappear after 6 months." Which is exactly what Moderna would like people (and investors) to think.

This is what doesn't add up: In the actual press release the only reference to Delta is a statement about boosters, in which they say "Neutralizing antibody levels following the boost approached those observed after primary vaccination with two doses of 100 µg of mRNA-1273." So the levels of antibodies after a booster were not even as high as those observed after the original shots? Then either the antibodies waned so significantly that even a booster barely got them back up to the level of the original shot, or the booster was useless because it didn't change the level of antibodies at all. IIRC, Pfizer's data showed a massive increase in antibodies following a booster, to levels that were significantly higher than after the original two-shot series. (If I can find a link to that, I'll come back and add it).

ETA: I can't find actual data from Pfizer, it may not have been published yet, but Reuters reported this statement from their CSO: "Dolsten said early data from the company's own studies shows that a third booster dose generates antibody levels that are five-to-10-fold higher than after the second dose, suggesting that a third dose will offer promising protection."

 

The In the Bubble podcast had an interview with the Pfizer CEO. It's a two part interview and it was really interesting. And yes, he did say that the 3rd dose increased protection by a lot. Pfizer has been testing other formulations to try to match some of the variants, but so far the original is the most effective. They're still working on some "just in case" options if the original formulation stops being effective. 

In the Bubble has a bunch of annoying "this podcast is sponsored by..." but they're pretty easy to skip past. (4 - 30 sec jumps forward usually is good)

https://podcasts.apple.com/us/podcast/exclusive-pfizer-ceo-albert-bourla-on-delta-variant/id1504128553?i=1000530256052

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29 minutes ago, mommyoffive said:

Kudos to Novavax for a clear, concise press release full of actual data. The fact that the booster gives a 6.6-fold increase in antibodies specifically against Delta seems like especially good news. 

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1 hour ago, AmandaVT said:

The In the Bubble podcast had an interview with the Pfizer CEO. It's a two part interview and it was really interesting. And yes, he did say that the 3rd dose increased protection by a lot. Pfizer has been testing other formulations to try to match some of the variants, but so far the original is the most effective. They're still working on some "just in case" options if the original formulation stops being effective. 

In the Bubble has a bunch of annoying "this podcast is sponsored by..." but they're pretty easy to skip past. (4 - 30 sec jumps forward usually is good)

https://podcasts.apple.com/us/podcast/exclusive-pfizer-ceo-albert-bourla-on-delta-variant/id1504128553?i=1000530256052

I listened to this as well -- very worthwhile.  

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As much as I really want Pfizer to get full FDA approval, since I think that will encourage a big swathe of the population to get vaccinated, I don't want Novavax to get derailed.  Would really like for it to get EUA before Pfizer gets FDA approval.  

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7 minutes ago, mommyoffive said:

I completely disagree.

""Generally, with mandates of any kind, you want to do everything else possible before you mandate something," she said. "But when the vaccine is free, it's accessible, and you're still struggling, then mandates make sense. But you really want to give people the chance to do it on their own.""

 

There are no freedoms if saying No means that one gets forced in a different manner to make the "Approved choice"

 

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4 minutes ago, vonfirmath said:

I completely disagree.

""Generally, with mandates of any kind, you want to do everything else possible before you mandate something," she said. "But when the vaccine is free, it's accessible, and you're still struggling, then mandates make sense. But you really want to give people the chance to do it on their own.""

 

There are no freedoms if saying No means that one gets forced in a different manner to make the "Approved choice"

 

I am relieved that my kid is going to a school that is requiring vaccination and that my parents teach at one. I would be far more likely to go to one of the restaurants requiring vaccination than those which are not, and would feel better about working at one or having a family member doing so. I would consider going to a concert or play or musical where everyone is vsccinated, but would not without vaccination. I would be far more likely to resume travel if vaccination is required. 

 

 

 

 

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5 minutes ago, Dmmetler said:

I am relieved that my kid is going to a school that is requiring vaccination and that my parents teach at one. I would be far more likely to go to one of the restaurants requiring vaccination than those which are not, and would feel better about working at one or having a family member doing so. I would consider going to a concert or play or musical where everyone is vsccinated, but would not without vaccination. I would be far more likely to resume travel if vaccination is required. 

 

 

 

 

Yes, I agree.

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5 minutes ago, Dmmetler said:

I am relieved that my kid is going to a school that is requiring vaccination and that my parents teach at one. I would be far more likely to go to one of the restaurants requiring vaccination than those which are not, and would feel better about working at one or having a family member doing so. I would consider going to a concert or play or musical where everyone is vsccinated, but would not without vaccination. I would be far more likely to resume travel if vaccination is required. 

Same -- I am much more likely to do things if everyone is vaccinated.

That being said, I assume most people will just get fake vaccine cards. So I won't really feel safer 😕 . 

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1 hour ago, vonfirmath said:

I completely disagree.

""Generally, with mandates of any kind, you want to do everything else possible before you mandate something," she said. "But when the vaccine is free, it's accessible, and you're still struggling, then mandates make sense. But you really want to give people the chance to do it on their own.""

 

There are no freedoms if saying No means that one gets forced in a different manner to make the "Approved choice"

 

Coercion is not consent.

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5 hours ago, vonfirmath said:

There are no freedoms if saying No means that one gets forced in a different manner to make the "Approved choice"

 

You can freely choose not to be vaccinated.  And other people can freely choose not to share indoor space with you if you are unvaccinated. And business owners can freely choose whether they’d rather lose customers/employees who choose the former or the latter.

Edited by Danae
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5 minutes ago, Danae said:

You can freely choose not to be vaccinated.  And other people can freely choose not to share indoor space with you if you are unvaccinated. And business owners can freely choose whether they’d rather lose customers/employees who choose the former or the latter.

Business owners in NYC have no choice. 

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Evidently my Governor has gone viral for calling a bunch of anti-vax protestors knuckleheads and telling them they lost their minds.  

I can't tell if he's given up on reelection or thinks that might actually help him.  Could go either way around here.  Or if he was just that angry and it wasn't planned.  

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9 minutes ago, Wheres Toto said:

Evidently my Governor has gone viral for calling a bunch of anti-vax protestors knuckleheads and telling them they lost their minds.  

I can't tell if he's given up on reelection or thinks that might actually help him.  Could go either way around here.  Or if he was just that angry and it wasn't planned.  

Honestly, I'm that angry, and could see me just losing it. They ARE a bunch of knuckleheads who have lost their minds. You don't protest vaccines. 

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10 hours ago, vonfirmath said:

I completely disagree.

""Generally, with mandates of any kind, you want to do everything else possible before you mandate something," she said. "But when the vaccine is free, it's accessible, and you're still struggling, then mandates make sense. But you really want to give people the chance to do it on their own.""

 

There are no freedoms if saying No means that one gets forced in a different manner to make the "Approved choice"

 

That is true of most things. The social contract of living in this country is a delicate balancing act of the rights of the individual against the rights of the group. Most times, the group wins...the good of the many. No one here is "free". Many people coerced by threat of punishment to not murder, rape, steal, vandalize, etc. We mandate seatbelts and car seats on pain of fines, we extract taxes involuntarily, we have been known to issue the draft.

That is the social contract. So if the good of the many is determined to be a vaccine mandate and the political will is there to make it so, then it will be so. I am not sure when or where so very many people got it in their heads that they have freedoms they do not have, rights that do not exist. The preamble to the constitution itself pretty much guarantees that individual rights are going to get curtailed for the good of the country. I always laugh when the locals get ruffled and talk about their freedoms being taken away. For the most part, we have far fewer freedoms than members of countries like Iceland, Denmark, etc. Far fewer. Really the freedoms these days belong to corporations. They seem to get a free pass on just about anything they want to do!

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On 8/3/2021 at 2:01 PM, rebot said:
On 8/3/2021 at 1:48 PM, Not_a_Number said:

Really? Because I was having a ton of trouble finding much data about the rate of side effects in ivermectin, and I did look. Link me up some studies, please.

I'll link them tonight. I have multiple pages of links to studies that I never organized. I'll have to dig through them.

https://c19ivermectin.com

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Unfortunately Novavax have pushed back their expected EUA submission in the US from the 3rd quarter to the 4th quarter, due to manufacturing issues the FDA wants them to fix. They are continuing to manufacture vaccines in India, and have already applied for EUAs in India, Indonesia, and the Philippines, and plan to apply to the WHO this month and the EU and UK in September. But it's looking increasing unlikely that we will see Novavax vaccines in the US by the end of the year.

Science article summarizing the issue:
https://www.sciencemag.org/news/2021/08/covid-19-vaccinemaker-novavax-faces-manufacturing-setback

Novavax security filing:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001000694/000100069421000016/nvax-20210630.htm

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On 7/30/2021 at 1:07 PM, frogger said:

Because they are brainwashed to think all those people actually died from something else or at least some people. They are told that really the people died of a stroke or heart attack but just tested positive for Covid so that was put on their death certificate.

When DH's grandma died there was a lot of talk of "making sure" they didn't put Covid on the death certificate. It wasn't put on there because that isn't what she died from but they thought there would be an attempt to. 🙄

If everyone you know that has it says it feels like a cold it can be confusing and then you are fed all these other lies. I don't think people are evil and selfish; I think most are just confused and frightened by gov't actions.

I know that in my daughter's in laws family, they decided that one uncle didn't die of COVID- even though both his wife and son had it and initially it was COVID.  DD and DSIL believed that familuy pressured for non COVID death certificate.

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On 8/3/2021 at 12:38 PM, mommyoffive said:

US Covid-19 hospitalizations top 50,000 for first time since February. With the Delta variant, herd immunity will be harder to reach, NIH director says (msn.com)

"In the states with the highest case rates, daily vaccination rates have more than doubled," Zients said Monday.

"The eight states with the highest current case rates have seen an average increase of 171% in the number of people newly vaccinated, each day over the past three weeks," he said.

"Louisiana has seen a 302% increase in the average number of newly vaccinated per day, Mississippi 250%, Alabama 215%, and Arkansas 206%," Zients said.

"Americans are seeing the risk and impact of being unvaccinated and responding with action. And that's what it's going to take to get us out of this pandemic."

I don;t know about MS but I know that my gov in AL has been a very strong prpponent of vaccination from the beginning and had made a statement before this data came out that the surge in hospitalizations is due to the unvaccinated.  I also know that the Ark gov is also urging vaccination.

Which brings me to the point==media conflated talk of governors who are irresponsibel in the eyes to my governor-even though we don't have any rules banning masking anywhere, we had lockdowns, we had mask rules until this Spring, our health officials are recommending schools mask up, etc.  

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On 8/3/2021 at 1:48 PM, Not_a_Number said:

Really? Because I was having a ton of trouble finding much data about the rate of side effects in ivermectin, and I did look. Link me up some studies, please.

ivermectin has a lot of side effects-  I know my pets got side effects.

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1 hour ago, Corraleno said:

Unfortunately Novavax have pushed back their expected EUA submission in the US from the 3rd quarter to the 4th quarter, due to manufacturing issues the FDA wants them to fix. They are continuing to manufacture vaccines in India, and have already applied for EUAs in India, Indonesia, and the Philippines, and plan to apply to the WHO this month and the EU and UK in September. But it's looking increasing unlikely that we will see Novavax vaccines in the US by the end of the year.

Bummer….I won’t take any of the other vaccines.

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1 hour ago, Sdel said:

Bummer….I won’t take any of the other vaccines.

It is a bummer. I know of a few people waiting for Novavax. But, I think it is good that there is some amount of checking on manufacturing situations (in the US) to make sure the vaccine doses are made correctly. 

I noted that someone quoted in the article mentioned that Novavax might be important as a booster, "Mamtani expects the Novavax shot will play an important role in the United States as a booster for currently authorized vaccines."

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31 minutes ago, RootAnn said:

I noted that someone quoted in the article mentioned that Novavax might be important as a booster, "Mamtani expects the Novavax shot will play an important role in the United States as a booster for currently authorized vaccines."

Mamtani is a stock analyst, though, he may have said that simply based on the positive news about Novavax's booster trial. If they won't even be ready to submit an EUA application until the end of the year, when not only Pfizer but likely Moderna and possibly even J&J, have full approval, I don't know what their odds are for getting an EUA at that point.

Maybe if they could prove that a Novavax booster had better results than the Pfizer or Moderna ones? But the data Pfizer released recently on their booster trials showed numbers as good or better than Novavax, so I don't know if that's likely either. My guess is that Novavax will have to wait until they have enough data to apply for full approval, and then depending on where things stand in the US at that point w/regard to cases, variants, % vaxed, etc., they may or may not even get an "expedited" approval process like Pfizer did. Maybe they can get their flu/covid shot approved for fall 2022?

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6 minutes ago, Corraleno said:

Mamtani is a stock analyst, though, he may have said that simply based on the positive news about Novavax's booster trial. If they won't even be ready to submit an EUA application until the end of the year, when not only Pfizer but likely Moderna and possibly even J&J, have full approval, I don't know what their odds are for getting an EUA at that point.

Maybe if they could prove that a Novavax booster had better results than the Pfizer or Moderna ones? But the data Pfizer released recently on their booster trials showed numbers as good or better than Novavax, so I don't know if that's likely either. My guess is that Novavax will have to wait until they have enough data to apply for full approval, and then depending on where things stand in the US at that point w/regard to cases, variants, % vaxed, etc., they may or may not even get an "expedited" approval process like Pfizer did. Maybe they can get their flu/covid shot approved for fall 2022?

Doesn't the novavax have less demanding storage requirements than the mrna?  It seems like it might be a better option for mobile clinics or rual, homebound folks.  The J&J seems to be most in need of boosting and was used in those same population s early on.

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52 minutes ago, Syllieann said:

Doesn't the novavax have less demanding storage requirements than the mrna?  It seems like it might be a better option for mobile clinics or rual, homebound folks.  The J&J seems to be most in need of boosting and was used in those same population s early on.

The question is whether that would be enough to warrant "emergency" authorization in 2022, when most Americans who want to be vaccinated will have already done so, and many will have even had boosters by then. Maybe they can get a special authorization for the military use? I think the US Military recently ordered 100 million doses, presumably because of the storage benefits. But Novavax is also getting orders from many many other countries that are struggling to get vaccines, so even if the US eventually grants an EUA, there might be a wait for delivery of doses here while they fill the more urgent orders first. 

The current issues they are having with the FDA involve ensuring consistent potency in every dose, so that's what's holding up the EUA application. The trials are continuing while they deal with the manufacturing issues, so by the time those issues are sorted out they may already have enough data that it makes more sense just to apply for full approval in 2022. 

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I'm wondering what the "immunocompromised" guidelines will be, and how strict. My mom had Moderna, and she is 70 yrs old, frail, had lung cancer years ago with surgery to remove 1 lobe of a lung, has COPD, etc. So not as much immune suppressed but frail and very high risk. She does take inhaled steroids daily for her lungs, not sure if that matters. 

I know she would really like a booster. 

Quote

 

 

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1 hour ago, ktgrok said:

I'm wondering what the "immunocompromised" guidelines will be, and how strict. My mom had Moderna, and she is 70 yrs old, frail, had lung cancer years ago with surgery to remove 1 lobe of a lung, has COPD, etc. So not as much immune suppressed but frail and very high risk. She does take inhaled steroids daily for her lungs, not sure if that matters. 

I know she would really like a booster. 

 

Steroids was on a list of drugs and conditions I read that might qualify people for a booster if they don’t make them generally available. I’ll see if I can find the article again.

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3 hours ago, ktgrok said:

I'm wondering what the "immunocompromised" guidelines will be, and how strict. My mom had Moderna, and she is 70 yrs old, frail, had lung cancer years ago with surgery to remove 1 lobe of a lung, has COPD, etc. So not as much immune suppressed but frail and very high risk. She does take inhaled steroids daily for her lungs, not sure if that matters. 

I know she would really like a booster. 

 

With the availability of vaccines I’m hoping they won’t be that strict and will also include family of immune compromised.  My DH being frontline was immunized very early. I need him boosted as much as myself with my current treatment.

Edited by melmichigan
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2 minutes ago, melmichigan said:

With the availability of vaccines I’m hoping they won’t be that strict and will also include family of immune compromised.  My DH being frontline was immunized very early. I need him boosted as much as myself with my current treatment.

Very good point. My 67 yr old father really needs a booster so he isn't exposing her (he does the shopping) and so he can continue to care for her if she gets sick. 

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Has anyone posted this? This is the senior Pfizer scientist on vaccines for kids: 

https://www.medscape.com/viewarticle/956187

I am not finding this interview comforting. For example, they are saying they may not hit their target for being able to determine efficacy, due to low cases. Now, I don't know when this interview was filmed, exactly, and maybe this is now longer true due to Delta, but the fact that they are saying this in August is concerning. 

He was also outlining a timeline where they submit numbers in October, it goes to advisory committee, and it gets approved "hopefully before the end of the year," if I'm remembering correctly. That's sounding a LOT like a December approval in the best of all possible worlds to me 😕 . 

ETA: it looks like they were going to use antibody response as proxy for efficacy, but I find that a LOT less reassuring than actual numbers.

Edited by Not_a_Number
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3 hours ago, melmichigan said:

With the availability of vaccines I’m hoping they won’t be that strict and will also include family of immune compromised.  My DH being frontline was immunized very early. I need him boosted as much as myself with my current treatment.

Yes, I want my dh getting a booster in Sept if I get one this week because he is my caretaker.

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13 hours ago, Not_a_Number said:

ETA: it looks like they were going to use antibody response as proxy for efficacy, but I find that a LOT less reassuring than actual numbers.

I think that measuring antibody response as a proxy has always been the plan for the pediatric vaccines.  Of course, that was before kids were getting infected in huge numbers, so maybe now they will (unfortunately) have real-world efficacy data as well.

 

 

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5 minutes ago, JennyD said:

I think that measuring antibody response as a proxy has always been the plan for the pediatric vaccines.  Of course, that was before kids were getting infected in huge numbers, so maybe now they will (unfortunately) have real-world efficacy data as well.

Ah, I didn't realize this, although I have to say that I feel worse about it when they are mid-trial (when they know that this is really happening) than in the planning stages. 

Either way, I don't like that much.  

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COVID-19 Breakthrough Case Investigations and Reporting | CDC

 

As of August 2, 2021, more than 164 million people in the United States had been fully vaccinated against COVID-19.

During the same time, CDC received reports from 49 U.S. states and territories of 7,525 patients with COVID-19 vaccine breakthrough infection who were hospitalized or died.

 

*1,816 (26%) of 7,101 hospitalizations reported as asymptomatic or not related to COVID-19.
†316 (21%) of 1,507 fatal cases reported as asymptomatic or not related to COVID-19.

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I wonder if Novavax's problems with standardization have to do with their adjuvant, which uses a substance that is only derived from the bark of a South American tree that is in very short supply. I read a few months ago that they were working with another firm to experiment with different extraction methods that might allow them to get more of the active ingredient from each unit of bark, which makes me wonder if maybe they're having a hard time standardizing the potency of the adjuvant.

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