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Are vaccines the light at the end of the tunnel?


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Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes…

 

Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes…
Things are looking good. Well, not just good, they are looking great. This trial was as clean as it can get. There is nothing (big) we didn't expect.
Efficacy.
• We see benefit starting 14 days after the first dose (see Figure). This makes sense because it takes about 2 weeks for the immune system to make sufficient antibody protection after vaccination.
• After the first dose, efficacy was 52%. This is a fantastic for a single dose.
• After your second dose (3 weeks later), efficacy is 95%. We are confident that efficacy ranges from 90-98%.
• Efficacy doesn’t meaningfully differ by age, race/ethnicity, or comorbidity.
Adverse events.
• Overall, the Pfizer vaccination gives more adverse events than the flu vaccination but less than the shingles vaccine.
• The most common solicited adverse reaction (i.e. what we were expecting) were mild to moderate: injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%)
• The chance of getting a serious adverse event was low (<0.5%). A severe event is more likely in the second dose than the first and were less frequent among older adults compared to younger participants.
• An unsolicited (i.e. not expected) adverse event that came up more in the vaccine group was swollen lymph nodes (lymphadenopathy). 64 people in the vaccine group compared to 6 people in the placebo group. This could be related to the vaccine.
• There were 4 people in the vaccine group that got Bell’s palsy (compared to 0 in the placebo group). These cases occurred at 3,
9, 37, and 48 days after vaccination. This isn’t much of a concern because it reflects the same rate of Bell’s palsy in the general population. Something to keep an eye on
• 6 people died during the trial (4 in placebo; 2 in vaccine group). Deaths were NOT related to the vaccine. Mostly related to heart attacks.
There are a few unknowns. From this study, we do not know…
• Duration of protection
• Effectiveness against transmission
• Effectiveness or safety among certain high-risk populations, such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals. There were just not enough people in the study to make meaningful conclusions. This likely means that the FDA will not approve emergency use for these populations. We will know more on Thursday.
• Benefits of individuals with prior COVID19 infection. But, given there is documented reinfection, the FDA stated that previously infected people could benefit from vaccination.
Translation: This vaccine will likely be approved on Thursday. Which, by the way, will be streaming live. An event that will likely go down in history, albeit a bit boring, scientific, and long.

 

These seem to be important, but that's just me

There are a few unknowns. From this study, we do not know…
• Duration of protection
• Effectiveness against transmission
• Effectiveness or safety among certain high-risk populations, such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.

 

https://www.fda.gov/media/144245/download

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I am concerned about the news stories today about UK officials warning those with serious allergies not to have the immunization except in a hospital with life support capabilities.

 

The one thing missing is an explanation of what the known allergen is for those having a reaction.

 

This reports would be similar to a warning that anyone with severe allergies should not eat peanut butter. 

 

More information is needed before  anyone refuses a vaccine based on their allergies.

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2 minutes ago, PTC DAWG said:

Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes…

 

Thanks for the analysis!

 

What about how it causes sterilization, has a microchip, puts you under control of Bill Gates, etc...?  Did they leave those parts out? 😉

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3 minutes ago, Homosassa said:

I am concerned about the news stories today about UK officials warning those with serious allergies not to have the immunization except in a hospital with life support capabilities.

 

The one thing missing is an explanation of what the known allergen is for those having a reaction.

 

This reports would be similar to a warning that anyone with severe allergies should not eat peanut butter. 

 

More information is needed before  anyone refuses a vaccine based on their allergies.

The allergen is possibly the lipid coating?  It would be hard to imagine a reaction against mRNA.  If it is the lipid then those folks with Epipen requirements might be OK with one of the other vaccines coming along.  

 

Influenza vaccines made in eggs carry the warning about allergic reactions and possible anaphylaxis.  These days people can get flu vaccines made in cell culture instead of eggs.  

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32 minutes ago, D C said:

Thanks for the analysis!

 

What about how it causes sterilization, has a microchip, puts you under control of Bill Gates, etc...?  Did they leave those parts out? 😉

You have to admit, them not knowing the following is troubling.

 

Duration of protection
Effectiveness against transmission

 

I mean, what good is the vaccine exactly?  

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1 hour ago, TeeRick said:

The allergen is possibly the lipid coating?  It would be hard to imagine a reaction against mRNA.  If it is the lipid then those folks with Epipen requirements might be OK with one of the other vaccines coming along.  

 

Influenza vaccines made in eggs carry the warning about allergic reactions and possible anaphylaxis.  These days people can get flu vaccines made in cell culture instead of eggs.  

That is my point. 

 

Until we know if the allergic reactions are from the patients' known allergen or a cross linked reaction, a general statement as is appearing in the news stories causes undue alarm.

 

And as PTC Dawg points out about the FDA report, there may also be a response to the microchip, sterilizing agent or Bill Gates' mind control substance. 🤪

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1 hour ago, PTC DAWG said:

You have to admit, them not knowing the following is troubling.

 

Duration of protection
Effectiveness against transmission

 

I mean, what good is the vaccine exactly?  

 

Duration is going to take the long term study, unfortunately. Most of these studies were projected for close to two years. There may be a periodic vaccination requirement to maintain immunity, and that timeframe isn't known yet.

 

There may be no good way to really directly assess effectiveness against transmission. It "should", but it may come down to indirect evidence, reinforced by smaller scale studies with more respiratory testing. If the vaccines block transmission, as more people are vaccinated, you should see less infection positives in people who haven't been vaccinated. 

 

The vaccine(s) are being tested on their ability to prevent symptoms of disease, so the primary benefit is decreased morbidity, and presumably mortality.

 

Upside: Looks like a surprisingly good vaccine with few, and manageable side effects (allergic reactions will have to be explored, but it could just be bad luck that two of the first people to receive the vaccine reacted). Downside: Some almost inevitable unknowns, especially when you consider this specific effort is only a year old or less.

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2 hours ago, TeeRick said:

The allergen is possibly the lipid coating?  It would be hard to imagine a reaction against mRNA.  If it is the lipid then those folks with Epipen requirements might be OK with one of the other vaccines coming along.  

 

Influenza vaccines made in eggs carry the warning about allergic reactions and possible anaphylaxis.  These days people can get flu vaccines made in cell culture instead of eggs.  

 

its virus, not lnp.

 

maybe it's cow serum or something used for the tissue culture.

 

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53 minutes ago, UnorigionalName said:

 

ops, i'm wrong. i thought it was AZ not pfizer.

No problem!  Hard to keep track of everything.

 

Speaking of the AZ vaccine, the ongoing current US phase 3 trial will "clear up the dosing confusion" according to one of the key vaccine scientists in the US Dr. Larry Corey.  Results and an EUA for this vaccine will happen by the end of January according to the article.  So more doses coming hopefully for the USA and other countries after Pfizer and Moderna.

https://news.yahoo.com/u-astrazeneca-vaccine-trial-clear-000141926.html

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On 12/8/2020 at 4:30 PM, Fly and Sail said:

 

If Covid really causes that much long term damage as the media proclaims then society would do much better protecting young people first, not seniors who are already near the end of their lifespan.

 

Otherwise you'll have two generations with various underlying conditions such as lung damage in 5-10 years while the generation they're now seeking to protect has died of old age.

Wow. What an interesting post.  FYI, not all seniors are near the end of their lifespan!   I am 69.  One of my grandparents lived to 100, and the other three made it into their 90's.  So theoretically I could have between 20 and 30 more years left.  I'd kinda like to live those.  

 

There is admittedly a small amount of logic in your post.  But at the same time, I don't think it is necessarily the young people who are experiencing that long term damage.  Not saying none, but I think the statistics say that most of them recover completely.  The same can't be said for us disposable folks.🤔

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32 minutes ago, phoenix_dream said:

Wow. What an interesting post.  FYI, not all seniors are near the end of their lifespan!   I am 69.  One of my grandparents lived to 100, and the other three made it into their 90's.  So theoretically I could have between 20 and 30 more years left.  I'd kinda like to live those.  

 

There is admittedly a small amount of logic in your post.  But at the same time, I don't think it is necessarily the young people who are experiencing that long term damage.  Not saying none, but I think the statistics say that most of them recover completely.  The same can't be said for us disposable folks.🤔

 

Not going to support what I believe to be a troll post, and haven't checked the data lately, but yeah, it kind of was the 'younger' group having significant long term effects. Maybe not the youngest, but certainly those with potentially decades in the work force, or potentially with decades of health care expense. The more at risk were dying. That could be changing, and I haven't looked for information on that for some time. For the record, I don't agree with them and definitely support vaccination to save lives now!

 

Have you ever heard of the helmet paradox? Haven't seen stats in a long time, but motorcycle helmet laws saved lives, but cost a lot more money. It sounds cruel and silly, but that's what numbers and statistics do. If you were in a crash without a helmet, you were much more likely to die. Fatal head injury. One time fixed cost. If you were wearing a helmet, you were much more likely to survive, but with permanent damage, frequently neck trauma and paralyzed. Long term, years to decades, of medical care and costs. From a pure cost standpoint, not wearing a helmet saved money for everyone. But you as the cyclist were much more likely to die.

 

Healthcare statistics can be pretty cruel if you only look at the numbers...

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18 minutes ago, markeb said:

 

 

 

Have you ever heard of the helmet paradox? Haven't seen stats in a long time, but motorcycle helmet laws saved lives, but cost a lot more money. It sounds cruel and silly, but that's what numbers and statistics do. If you were in a crash without a helmet, you were much more likely to die. Fatal head injury. One time fixed cost. If you were wearing a helmet, you were much more likely to survive, but with permanent damage, frequently neck trauma and paralyzed. Long term, years to decades, of medical care and costs. From a pure cost standpoint, not wearing a helmet saved money for everyone. But you as the cyclist were much more likely to die.

 

 

A myth. Yes, some riders sometimes suffer neck injuries but you are implying helmets are the cause which they are not. You have conveniently omitted mentioning the significant cost to the health system of brain injured riders who were not wearing helmets.

https://pubmed.ncbi.nlm.nih.gov/18676782/

 

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24 minutes ago, lyndarra said:

A myth. Yes, some riders sometimes suffer neck injuries but you are implying helmets are the cause which they are not. You have conveniently omitted mentioning the significant cost to the health system of brain injured riders who were not wearing helmets.

https://pubmed.ncbi.nlm.nih.gov/18676782/

 

Thanks. It’s been a long time, and I admitted that. Didn’t mean to imply they didn’t have brain injuries. I remembered the neck injury discussion in helmet wearers more.

 

I’ll ask the mods to delete.

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39 minutes ago, lyndarra said:

A myth. Yes, some riders sometimes suffer neck injuries but you are implying helmets are the cause which they are not. You have conveniently omitted mentioning the significant cost to the health system of brain injured riders who were not wearing helmets.

https://pubmed.ncbi.nlm.nih.gov/18676782/

 

I implied no such thing from that post.

Helmet = more likely to live and have other injuries

No Helmet = more likely to die and have other injuries

TBI is a concern for survivors in either category.

 

 

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14 hours ago, PTC DAWG said:

Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes…

 

Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes…
Things are looking good. Well, not just good, they are looking great. This trial was as clean as it can get. There is nothing (big) we didn't expect.
Efficacy.
• We see benefit starting 14 days after the first dose (see Figure). This makes sense because it takes about 2 weeks for the immune system to make sufficient antibody protection after vaccination.
• After the first dose, efficacy was 52%. This is a fantastic for a single dose.
• After your second dose (3 weeks later), efficacy is 95%. We are confident that efficacy ranges from 90-98%.
• Efficacy doesn’t meaningfully differ by age, race/ethnicity, or comorbidity.
Adverse events.
• Overall, the Pfizer vaccination gives more adverse events than the flu vaccination but less than the shingles vaccine.
• The most common solicited adverse reaction (i.e. what we were expecting) were mild to moderate: injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%)
• The chance of getting a serious adverse event was low (<0.5%). A severe event is more likely in the second dose than the first and were less frequent among older adults compared to younger participants.
• An unsolicited (i.e. not expected) adverse event that came up more in the vaccine group was swollen lymph nodes (lymphadenopathy). 64 people in the vaccine group compared to 6 people in the placebo group. This could be related to the vaccine.
• There were 4 people in the vaccine group that got Bell’s palsy (compared to 0 in the placebo group). These cases occurred at 3,
9, 37, and 48 days after vaccination. This isn’t much of a concern because it reflects the same rate of Bell’s palsy in the general population. Something to keep an eye on
• 6 people died during the trial (4 in placebo; 2 in vaccine group). Deaths were NOT related to the vaccine. Mostly related to heart attacks.
There are a few unknowns. From this study, we do not know…
• Duration of protection
• Effectiveness against transmission
• Effectiveness or safety among certain high-risk populations, such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals. There were just not enough people in the study to make meaningful conclusions. This likely means that the FDA will not approve emergency use for these populations. We will know more on Thursday.
• Benefits of individuals with prior COVID19 infection. But, given there is documented reinfection, the FDA stated that previously infected people could benefit from vaccination.
Translation: This vaccine will likely be approved on Thursday. Which, by the way, will be streaming live. An event that will likely go down in history, albeit a bit boring, scientific, and long.

 

These seem to be important, but that's just me

There are a few unknowns. From this study, we do not know…
• Duration of protection
• Effectiveness against transmission
• Effectiveness or safety among certain high-risk populations, such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.

 

https://www.fda.gov/media/144245/download

 

Thanks for sharing this.

I found the comment about swollen lymph nodes particularly interesting. I’m am participating in the Novavax phase 3 trial and on all 3 appointments to date the doctor has examined my neck, throat and armpits. I did ask about this at the initial appointment and was told they were checking my lymph nodes. 

It would appear that this side effect may not be unexpected in the Novavax vaccine??  

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18 hours ago, PTC DAWG said:

You have to admit, them not knowing the following is troubling.

 

Duration of protection
Effectiveness against transmission

 

I mean, what good is the vaccine exactly?  

Hi,

"I mean, what good is the vaccine exactly? "

The vaccine will likely prevent you from dying or

having severe lifelong damage to your lungs.

Aren't those reasons "good"?

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8 hours ago, zanderblue said:

 

Thanks for sharing this.

I found the comment about swollen lymph nodes particularly interesting. I’m am participating in the Novavax phase 3 trial and on all 3 appointments to date the doctor has examined my neck, throat and armpits. I did ask about this at the initial appointment and was told they were checking my lymph nodes. 

It would appear that this side effect may not be unexpected in the Novavax vaccine??  

Swollen lymph nodes are a common indicator of viral or bacterial infections.  Part of our immune responses.  So it is not really unusual for them to be routinely checked in a vaccine clinical trial.

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15 hours ago, markeb said:

 

Not going to support what I believe to be a troll post, and haven't checked the data lately, but yeah, it kind of was the 'younger' group having significant long term effects. Maybe not the youngest, but certainly those with potentially decades in the work force, or potentially with decades of health care expense. The more at risk were dying. That could be changing, and I haven't looked for information on that for some time. For the record, I don't agree with them and definitely support vaccination to save lives now!

 

 

That's a good point.  At the same time, no one really knows how long term these long term effects really are, as the virus has only been identified and recorded for about a year or less (could have been around longer, but no statistics).  I think with that in mind the better description for these might be lingering effects rather than long term effects.  They may in fact be long term, but we do not know that yet.

 

Despite responding to the troll post myself, I have to admit there is some logic to the thought behind it, even though I would never term it the way it was said.  There are two ways to look at the short term goals of the vaccines - one is to stop the spread of the virus and the other is to stop the deaths.  Clearly the current guidelines focus more on the latter.  Is that because that is truly the best way to do it, or is that because to do otherwise creates unpopular and politically incorrect optics?  There is some logic towards stopping the spread as a top short term priority rather than focusing on stopping the deaths (and I say this as a 69 year old senior myself). 

 

I think most would agree with the first priorities being healthcare workers, including IMHO paramedics.  After that, I question things.  Rather than vaccinate everyone in long term care facilities, how about we vaccinate the staff there and wait on the residents?  The staff is who is bringing in the virus, not the residents.  Then maybe a better priority would be to vaccinate those who are actually spreading the virus - even if that is the 20-40 year olds.  When all is said and done, if they are vaccinated and the virus stops spreading, ultimately we then also save more lives of the most vulnerable.  Personally, as an older person, I would 100% much rather have my adult sons and their families vaccinated before me!  That approach also helps open up things more, which makes life more enjoyable and allows people to get back to work, which helps them survive as well.  Some shrug off this approach as choosing $$ over human life, and that is not at all what I am saying (but it explains what I mean by politically correct decisions).  It is more about putting emotions and optics to the side and following the science, which is what they keep telling us to do (and rightly so).

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10 minutes ago, phoenix_dream said:

That's a good point.  At the same time, no one really knows how long term these long term effects really are, as the virus has only been identified and recorded for about a year or less (could have been around longer, but no statistics).  I think with that in mind the better description for these might be lingering effects rather than long term effects.  They may in fact be long term, but we do not know that yet.

 

Despite responding to the troll post myself, I have to admit there is some logic to the thought behind it, even though I would never term it the way it was said.  There are two ways to look at the short term goals of the vaccines - one is to stop the spread of the virus and the other is to stop the deaths.  Clearly the current guidelines focus more on the latter.  Is that because that is truly the best way to do it, or is that because to do otherwise creates unpopular and politically incorrect optics?  There is some logic towards stopping the spread as a top priority rather than focusing on stopping the deaths (and I say this as a 69 year old senior myself). 

 

I think most would agree with the first priorities being healthcare workers, including IMHO paramedics.  After that, I question things.  Rather than vaccinate everyone in long term care facilities, how about we vaccinate the staff there and wait on the residents?  The staff is who is bringing in the virus, not the residents.  Then maybe a better priority would be to vaccinate those who are actually spreading the virus - even if that is the 20-40 year olds.  When all is said and done, if they are vaccinated and the virus stops spreading, ultimately we then also save more lives of the most vulnerable.  Personally, as an older person, I would 100% much rather have my adult sons and their families vaccinated before me!  That approach also helps open up things more, which makes life more enjoyable and allows people to get back to work, which helps them survive as well.  Some shrug off this approach as choosing $$ over human life, and that is not at all what I am saying (but it explains what I mean by politically correct decisions).  It is more about putting emotions and optics to the side and following the science, which is what they keep telling us to do (and rightly so).

Good choice of words on "lingering" effects vs long-term effects.  I had a finger get 'jammed' over a year ago.  After 9 or 10 months of pain, my hand specialist said that sort of injury can take a year or two to heal.  I was thinking 6 months should have been sufficient.   

 

 

As for who to vaccinate, the problem with only vaccinating caregivers at residential facilities is that it essentially puts the residents on permanent lockdown.  No visitors, no visits to family, no trips to the store, etc...   That's certainly not beneficial for mental health. 

 

If the vaccination rate among residents was 100%, one could make the counter-argument that staff doesn't need to be vaccinated.  That assumes 100% effectiveness and the 100% participation though. 

 

There are also far fewer old-folks than there are 'kids', so when rationing doses, there is more coverage on the upper end of the age scale for a given number of doses.   (Why does my definition of 'kids' seem to have a continually increasing upper age cutoff as time goes on??)

 

 

Edited by D C
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1 hour ago, TeeRick said:

Here is quite an interesting short article published today in the highly respected journal Nature.  On why most kids are not susceptible to SARS-CoV-2 virus infection.  

 

https://www.nature.com/articles/d41586-020-03496-7

On the BBC tonight’s news the Health Secretary has stated they are going to test kids all 11 to 18 year olds as Kent Essex and parts of London as they have the fastest infection rates that have been traced to this age group.

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1 hour ago, TeeRick said:

Here is quite an interesting short article published today in the highly respected journal Nature.  On why most kids are not susceptible to SARS-CoV-2 virus infection.  

 

https://www.nature.com/articles/d41586-020-03496-7

Fascinating stuff. There was a discussion at lunch today about the variability of Covid disease, and some of us, myself included, think that initial dose, initial viral load, mat play a part in severity - maybe if you don’t get as big a dose of virus up front, your body has more time to mount an effective immune response and you are spared downstream complications. Against that theory is data that shows young children, less than 5, have some of the highest nasal/nasopharyngeal viral loads measured. Yet they don’t get sick, and there’s some evidence that they don’t pass the disease around as easily as adults.

 

We were discussing all that we don’t know, and the fact that some of the questions we were asking have never been debated about other viruses even other coronaviruses. The other issue with ongoing research is that the testing, the measuring “tools”, have accuracy problems that throw doubt onto any one study.

 

The other general consensus was that science may be on the edge of learning a lot about the immune system that we haven’t understood and the research coming out of this tragedy may save/extend millions of lives on into the future. It’s terrible, but hopeful at the same time.

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42 minutes ago, cangelmd said:

Fascinating stuff. There was a discussion at lunch today about the variability of Covid disease, and some of us, myself included, think that initial dose, initial viral load, mat play a part in severity - maybe if you don’t get as big a dose of virus up front, your body has more time to mount an effective immune response and you are spared downstream complications. Against that theory is data that shows young children, less than 5, have some of the highest nasal/nasopharyngeal viral loads measured. Yet they don’t get sick, and there’s some evidence that they don’t pass the disease around as easily as adults.

 

We were discussing all that we don’t know, and the fact that some of the questions we were asking have never been debated about other viruses even other coronaviruses. The other issue with ongoing research is that the testing, the measuring “tools”, have accuracy problems that throw doubt onto any one study.

 

The other general consensus was that science may be on the edge of learning a lot about the immune system that we haven’t understood and the research coming out of this tragedy may save/extend millions of lives on into the future. It’s terrible, but hopeful at the same time.

So we're not wrong in saying that little kids are snot-nosed germ-farms, except it turns out that their bodies essentially say "ANOTHER? virus? fine. bring it on" 🙂 

 

You would think that viral load would play a factor, and maybe it's more important in adults than kids.  "Ct count" or "cycles" in the PCR test seems to be trending a little lately.  It's essentially how many times they have to run a replication in the PCR test in order to get it to test positive.  Lower numbers mean less multiplication is required and the amount of virus in the sample (and likely the person) was higher.  This article seems to suggest that those with higher loads are more likely to become gravely ill.  

 

https://www.sciencemag.org/news/2020/09/one-number-could-help-reveal-how-infectious-covid-19-patient-should-test-results

 A report in June from researchers at Weill Cornell Medicine found that among 678 hospitalized patients, 35% of those with a CT value of 25 or less died, compared with 17.6% with a CT value of 25 to 30 and 6.2% with a CT value above 30.

 

Some reports are saying that some tests are being run to far higher cycles than they should be, looking for any bit of evidence of the virus.  I wonder if the tests on those kids had a lower cycle cutoff and thus they didn't test positive.  

 

Interesting stuff either way as we learn what we didn't know and possibly didn't expect.

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