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Covid surges are basically a semi-annual event.. one in the summer and one in the winter, with the winter surge being historically, the bigger surge of infections. This year MIGHT be different with the summer surge being larger than the coming Winter surge. Due to aging natural or immunization immunity - protection.

They are all Omicron sub-variants, so vaccines for JN.x should provide solid immunity boosting ability…just not the maximum. I knew the “95% effective” reports back in 2020/2021 were mostly wrong, not mis-represented just not good environmental and test data compared to regular vaccines for Flu and other viruses. The data was valid, it just wasn’t a very good scientific test for the intended objective.
What is different about the way the studies are being conducted today?
There were many studies that confirmed the "95% effective" numbers.
 
What is different about the way the studies are being conducted today?
The virus is different, and the control group is highly protected, with multiple infections and/or vaccinations. This isn’t like the old days, where you breathe in a few droplets of virus and get sick!

Super low rates of spread/attack rate in spite of it “being like measles.” 😂
 
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What is different about the way the studies are being conducted today?
There were many studies that confirmed the "95% effective" numbers.
Again, the numbers were accurate, but the study was flawed from a truly scientific one where what is truly being tested in immunity to exposure to a virus that is circulting. Because, actual EXPOSURE was being purposefully but artificially dramatically reduced.

At the time the studies were conducted, we had still partial national lock downs. People were still masking indoors, and we had social distancing policies across the board. Airlines were transporting 5% of their typical daily travelers. We had MASK mandates on public transportation and in large indoor settings. Hotels had entire floors shut-down. Universities were closed and remote learning. Schools were still practicing at home learning, not in person for much of the country. People were washing their hands frequently and often with alcohol based sanitizer. Restaurants had for the most part outdoor seating, separated by 8-10 feet of space. People were dying left and right, and the population was rightly concerned with getting infected in the absence of a good vaccine, good therapeutics or other clinical based remediations.

That is not a typical environment for vaccine testing. Typically, for flu, RSV, other virus / vaccine testing, people get a vaccination, some get a placebo and everyone goes about their lives as they normally would. Some get exposed and get sick.. some get exposed and don’t get sick. We have traditionally no real understanding of who was exposed. Clinically, there are SOME vaccine and medication trials where they vaccinated everyone AND EXPOSE them. Then we get much better actual results of efficacy. Rightly so, this was not done with covid testing.

So, it’s very hard to take the data-which again ARE VALID in their data points, and truly extrapolate that IF exposed to covid virus AND vaccinated that only 5% of people would show infection.

If we did the same sort of environmental alterations, protections, social distancing, keeping people at home and not going into an office, wearing masks on planes, only having 15 people per plane, for a regular flu season viral testing, we’d end up with similar 95% efficacy results, if not higher.
 
Again, the numbers were accurate, but the study was flawed from a truly scientific one where what is truly being tested in immunity to exposure to a virus that is circulting. Because, actual EXPOSURE was being purposefully but artificially dramatically reduced.

At the time the studies were conducted, we had still partial national lock downs. People were still masking indoors, and we had social distancing policies across the board. Airlines were transporting 5% of their typical daily travelers. We had MASK mandates on public transportation and in large indoor settings. Hotels had entire floors shut-down. Universities were closed and remote learning. Schools were still practicing at home learning, not in person for much of the country. People were washing their hands frequently and often with alcohol based sanitizer. Restaurants had for the most part outdoor seating, separated by 8-10 feet of space. People were dying left and right, and the population was rightly concerned with getting infected in the absence of a good vaccine, good therapeutics or other clinical based remediations.

That is not a typical environment for vaccine testing. Typically, for flu, RSV, other virus / vaccine testing, people get a vaccination, some get a placebo and everyone goes about their lives as they normally would. Some get exposed and get sick.. some get exposed and don’t get sick. We have traditionally no real understanding of who was exposed. Clinically, there are SOME vaccine and medication trials where they vaccinated everyone AND EXPOSE them. Then we get much better actual results of efficacy. Rightly so, this was not done with covid testing.

So, it’s very hard to take the data-which again ARE VALID in their data points, and truly extrapolate that IF exposed to covid virus AND vaccinated that only 5% of people would show infection.

If we did the same sort of environmental alterations, protections, social distancing, keeping people at home and not going into an office, wearing masks on planes, only having 15 people per plane, for a regular flu season viral testing, we’d end up with similar 95% efficacy results, if not higher.
What VE did studies conducted in the fall of 2021 show? When air travel was only down 25%. I guess I’ll have to check.
 
What VE did studies conducted in the fall of 2021 show? When air travel was only down 25%. I guess I’ll have to check.
It does appear that the VE with a booster was about 95% in the fall of 2021 despite lockdowns being over.
 
What VE did studies conducted in the fall of 2021 show? When air travel was only down 25%. I guess I’ll have to check.
I believe the following studies done in 2021 were in the high 70’s low 80’s…some were sub 50% (non MRNA based vaccines). Someone will post, or I’ll find it over the weekend. What would be interesting would have been post LATE 2021, after omicron and see a study in the real world. But with ~ 4K ppl dying a day, many vaccinated, many with “natural” immunity of some sort, I’m sure efficacy would have been lower.

But I don’t really think they have done anywhere near as large, or long studies since ~ 2022 if at all. It’s more done in the lab.
 
but the study was flawed from a truly scientific one where what is truly being tested in immunity to exposure to a virus that is circulting. Because, actual EXPOSURE was being purposefully but artificially dramatically reduced.
It's not clear to me how much this would change the efficacy results. This is the purpose of the control group.

and truly extrapolate that IF exposed to covid virus AND vaccinated that only 5% of people would show infection.
That's not what vaccine efficacy measures. It's just not what it means. That was never the claim.


If we did the same sort of environmental alterations, protections, social distancing, keeping people at home and not going into an office, wearing masks on planes, only having 15 people per plane, for a regular flu season viral testing, we’d end up with similar 95% efficacy results, if not higher.
I don't think that is true at all. Efficacy would be much lower because everyone is fairly well protected. The rate of infection would be far lower though; you’d be much less likely to get COVID. But that is not what efficacy measures.
 
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Good news after some initial reports they were going to stick with an older version of the JN.1 lineage; might be worth holding out on getting COVID this summer after all:

IMG_1195.jpeg



It’s unclear what Novavax will end up doing, but at least mRNA will have something more related to whatever is circulating next winter. Novavax has previously said they are unable to produce KP.2 “in time.”

Though based on prior results KP.2 may still be poorly matched to winter circulation. Hopefully the evolution slows down.

The press release is funny. It’s basically a complete about face from the FDA but it is not described that way. Changed their minds to the obvious best answer in a week.

“Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible. This change is intended to ensure that the COVID-19 vaccines (2024-2025 Formula) more closely match circulating SARS-CoV-2 strains. FDA has communicated this change to the manufacturers of the licensed and authorized COVID-19 vaccines. The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines for the United States.”
 
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Good news after some initial reports they were going to stick with an older version of the JN.1 lineage; might be worth holding out on getting COVID this summer after all:

View attachment 1056616


It’s unclear what Novavax will end up doing, but at least mRNA will have something more related to whatever is circulating next winter. Novavax has previously said they are unable to produce KP.2 “in time.”

Though based on prior results KP.2 may still be poorly matched to winter circulation. Hopefully the evolution slows down.

The press release is funny. It’s basically a complete about face from the FDA but it is not described that way. Changed their minds to the obvious best answer in a week.

“Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible. This change is intended to ensure that the COVID-19 vaccines (2024-2025 Formula) more closely match circulating SARS-CoV-2 strains. FDA has communicated this change to the manufacturers of the licensed and authorized COVID-19 vaccines. The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines for the United States.”
Harder for Novavax than an mRNA platform.. maybe they just get it out later?
 
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Meanwhile, Novavax says they will have JN.1 doses ready in the US in mid-July. This seems fine, though of course there is no efficacy data. And they would need to get approval.

 
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Meanwhile, Novavax says they will have JN.1 doses ready in the US in mid-July. This seems fine, though of course there is no efficacy data. And they would need to get approval.

My understanding at this point from the biotech contacts I have is that novavax is actually going to engineer for the KN variants and slip the release date.
 
All extremely silly. They should just get approval for July release.
could be… but frankly if they are thinking COLLECTIVELY, for purposes of creating the best options for interested parties (I’ll put that level of domestic USA interest at ~ 17-23%)… they should let the mRNA produce what they can by early fall, and produce what they (novavax) can produce by late fall early winter.. For those interested parties, probably <15%, who don’t think the vaccine creates more problems than the disease, they will possibly get an mRNA sometime late summer, or sooner if available and then possibly get a Novavax late fall early winter. I’m fine with that. I won’t do BOTH, but will probably see what my late summer early fall looks like for travel and work, and try to get to a Novavax vaccination when it arrives.
 
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