General COVID-19 Vaccine Discussion

[Jenya]

I actually tried to reach out to QML and ask for proper test reporting as just negative/positive is not really up to scratch.

Here is what they replied:
"We do not report the quantitative value.
If the patient is unsatisfied with this, he can try another pathology company. (I called Sullivan Nicolaides Pathology in advance and they do not give a quantitative result either so good luck to this patient)
Kind Regards
Ralvin Sanchez
Duty Scientist
QML Pathology Central Laboratory"

That is all they can say - good luck....
Still on a hunt for better equipped pathology, please advice if you know one.

 

[Pushka]

I actually tried to reach out to QML and ask for proper test reporting as just negative/positive is not really up to scratch.

Here is what they replied:
"We do not report the quantitative value.
If the patient is unsatisfied with this, he can try another pathology company. (I called Sullivan Nicolaides Pathology in advance and they do not give a quantitative result either so good luck to this patient)
Kind Regards
Ralvin Sanchez
Duty Scientist
QML Pathology Central Laboratory"

That is all they can say - good luck....
Still on a hunt for better equipped pathology, please advice if you know one.

I heard the SA CHO yesterday discuss the levels of a recent positive case that tells them more about the history of the positive. It is collected, just not shared.

 

[Jenya]

It is collected, just not shared.

That's what I am trying to understand why.
Especially if its self requested test paid with my own cash, not Medicare.
I am entitled for full report one would say

 

[N860CR]

May be its something to do with most advanced, best funded healthcare system in the world, unable to deliver such simple things

Given we’ve been told out advanced and highly funded healthcare system would be overrun with a handful of covid patients, nothing is surprising

Still not sure where I go to have my Medicare levy refunded.

 

[drron]

That's what I am trying to understand why.
Especially if its self requested test paid with my own cash, not Medicare.
I am entitled for full report one would say

But why do you think it is necessary to have qualitative antibody levels to know if you need a booster at 5 or 6 months or longer?
Neither the CDC or FDA in the USA believe antibody levels should be used for that purpose.

Antibody testing is not currently recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination, to assess the need for vaccination in an unvaccinated person, or to determine the need to quarantine after a close contact with someone who has COVID-19. Some antibody tests will not detect the antibodies generated by COVID-19 vaccines. Because these vaccines induce antibodies to specific viral protein targets, post-vaccination antibody test results will be negative in persons without history of previous infection, if the test used does not detect antibodies induced by the vaccine.

Labs

COVID-19 resources and guidelines for labs and laboratory workers.

www.cdc.gov

So you need to know just what antibody your test is testing.

And from the FDA.

Test results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19. If the results of the antibody test are interpreted as an indication of a specific level of immunity or protection from SARS-CoV-2 infection, there is a potential risk that people may take fewer precautions against SARS-CoV-2 exposure. Taking fewer precautions against SARS-CoV-2 exposure can increase their risk of infection and may result in increased spread of SARS-CoV-2.

Antibody Testing Not Recommended to Assess Immunity After Vaccination

FDA reminds the public and health care providers that SARS-CoV-2 antibody test results should not be used to evaluate a person’s level of immunity from COVID-19

www.fda.gov

And an article from an MS patient who did get a qualitative antibody test done.

Do High Antibody Levels Mean I’m Protected Against COVID-19?

Columnist Ed Tobias receives the results from his SARS-CoV-2 antibody test. But do these numbers really matter? He investigates.

multiplesclerosisnewstoday.com

There is also new evidence with the delta strain that it is not only mutations of the spike protein (which is what current vaccines target) but changes in the N protein which cause an infected cell to produce way more viral copies so making it more likely to spread.

New Clues to Delta Variant’s Spread in Studies of Virus-Like Particles

About 70,000 people in the United States are diagnosed with COVID-19 each and every day. It’s clear that these new cases are being driven by the more-infectious Delta variant of SARS-CoV-2, the nov…

directorsblog.nih.gov

So with due respect if you are travelling to an area with high covid numbers get a booster at 5 months.It shouldn't be too hard to find a GP or pharmacist who will give you a third dose.It is what i intend to do if there are large community numbers in Northern Tasmania in December or early January.

 

[JohnM]

I think you mean quantitative, not qualitative, in the above @drron.

 

[Quickstatus]

So ppl will be taking more jabs

1,2,3,4,5.

In every population, the majority will be doing the recommendation, then on one extreme will be the antivax, and on the other extreme will be the "more is better" crowd...

I know of a friend who has 5 jabs and waiting for SpikeVax for 6,7
Ive also heard people in US are getting multiple shots just so they can get the free burgers (Get free burger if you get covid vax)

How they actually calculate this waning protection level?

What is the clinical correlation between antibody level and actual degree of vaccine protection?
And which antibody?

Norman Swan is as scientific as the bloke in the pub:
(a) predicted that NSW ICU bed will run out by april 2020
(b) said that Australian covid19 infections would be 3 times the actual number
(c) said that public should not wear face masks then backflipped by saying face masks should have been brought in earlier
(d) Last years December outbreak in Northern sydney - said sydney should be locked down like Victoria but no lockdown was required.
(e) Said that NSW was lucky when it came out of lockdown earlier than victoria and then said victoria were unlucky.
(f) Said he looked into origins of Covid 19 and said not Wuhan lab , then backflipped this year and said wuhan lab possibly source.

 

[jrfsp]

Pfizer jab efficacy wanes 3 months after second dose

Experts who have been tracking the effectiveness of the Pfizer/BioNTech vaccine have found that the risk of Covid infection increases the longer it is since people had a second dose.

www.rte.ie

Latest study out of Israel is showing Pfizer decline from 3 month mark.

France has reduced the booster timeline to 5 Month from 2nd dose.

 

[VPS]

I actually tried to reach out to QML and ask for proper test reporting as just negative/positive is not really up to scratch.

Here is what they replied:
"We do not report the quantitative value.
If the patient is unsatisfied with this, he can try another pathology company. (I called Sullivan Nicolaides Pathology in advance and they do not give a quantitative result either so good luck to this patient)
Kind Regards
Ralvin Sanchez
Duty Scientist
QML Pathology Central Laboratory"

That is all they can say - good luck....
Still on a hunt for better equipped pathology, please advice if you know one.

I spoke to someone last night about the titre value and the problem is they just don't know what the correct titre level is eg if you want to know if you have immunity for Toxoplasmosis and your titre is 1:256 they know that is correct (actually I can't remember what it was for Toxo but that's just an example)

They still don't have enough data to know whether a titre of 1:16 shows immunity or if you need 1:1024

Hope that makes sense

 

[Lynda2475]

Latest study out of Israel is showing Pfizer decline from 3 month mark.

There is nothing really new in that study, the degree of waning is quite small over all and its observational so does not factor in any pre-existing health conditions etc nor the seriousness of illness for those who contracted the covid as a breakthrough case.

Across all age groups, 1.3% of people tested positive 21-89 days after a second dose, but this increased to 2.4% after 90-119 days; 4.6% after 120-149 days; 10.3% after 150-179 days; and 15.5% after 180 days or more.

So basically at 3 months you may have a 2.4% chance of getting a breakthrough covid case, not overly concerning and perhaps 15% chance at 6 months post jab 2. Many breakthrough cases are asymptomatic, its whether there is an increase in hospitalization, ICU or death that is of most importance.

Previous studies of the same cohort showed the decrease in protection is higher in people aged over 60, and if you look at the stats for breakthrough cases in NSW where the person ended up in hospital, ICU or Deaths most had comorbidities or were over 70 (which in Australia is mostly an AZ cohort)

 

[Jenya]

But why do you think it is necessary to have qualitative antibody levels to know if you need a booster at 5 or 6 months or longer?

1. I think it is necessary because I might not need booster jab just yet.
2. I requested test 4 weeks prior to overseas trip to determine if I need booster and to have sufficient time for it to take effect. But because test result I received was not up to scratch I didn't get jab. Now I am in remote location where jab not available and I only going to be in position to get it 1 day before departure which mean:
a) not enough time for immune response before possible exposure any way, but if I would know exact numbers I can be more o less risky selecting countries venues and activities overseas with peace of mind.
b) PCR test in airport can possibly give positive result (I know that's questionable)
3. Just because I want to have this simple information about my health. And Labs are there just to provide it on request.

I want it just because I can (but can't)
My family overseas where covid rampant doing this test regularly, every few weeks, keeping track of their individual antibodies numbers declining over time. And occasionally they can see their antibody level through the roof meaning that they where exposed completely asymptomatic - maintaining natural immunity for longer, so no need for them to take boosters.
This test available there in every Lab around the corner for AUD30 within hours. Easy. But not in Australia...
Here is result that easy enough to understand:

Neither the CDC or FDA in the USA believe antibody levels should be used for that purpose.

Thanks for the links you shared. If read carefully they talking about rapid antigen self testing kits, not proper laboratory based blood test.
"Tests are also described by their Positive and Negative Predictive values (PPV and NPV). These measures are calculated using a test's sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called "prevalence" in these calculations). Every test returns some false positive and false negative results"
- this is all about rapid kits, not my case.

BUT this is probably the answer why as @Pushka said blood antibodies levels are collected by labs, just not shared to public:
"If the results of the antibody test are interpreted as an indication of a specific level of immunity or protection, there is a potential risk that people may take fewer precautions against exposure. Taking fewer precautions can increase their risk of infection and may result in increased spread."
That may be the only reason why quantitative antigen test not available in Australia.

So you need to know just what antibody your test is testing.

Sure I know, it is IgG and its confirmed in test result.

on one extreme will be the antivax, and on the other extreme will be the "more is better" crowd...

I am do not belong to either extreme.
Just trying to find firm middle ground relevant specifically for me.

 

[Quickstatus]

Still on a hunt for better equipped pathologyT

There are considerable issues with intepreting quantitative antibody levels.
Currently:

1) there is no correlation between levels of antibody and the threshold level necessary for protection. Even in the Israeli study which showed that those vaccinated people with breakthrough infections had lower antibody titres, a threshold protection level (line in the sand) was unable to be determined. "High" seems better than "low" but how "high" is unknown. And what threshold level are we targeting - protection against asymptomatic infection, mild or severe infection, protection against hospitalisation?.
Note also that thresholds and criteria for hospital admission vary from health service to health service (and indeed it may also be dependant on hospital bed availability).
Is a hospitalised Covid patient sicker than a non hospitalised covid patient?

2 )There are several quantitative antibody assays but none of them are standardised and calibrated so that results from any assay are currently not comparable.

3) Antibodies can be either "binding" and/or "neutralising". Binding antibodies without any neutralising effect do not add to immunity
4) Antibodies are not the full story of any immune response. The main story is hidden in Memory B and KillerT cells. Think of antibodies as the arresting police officer on patrol. The memory B cells are the other police officers in reserves ready to be called up. It is impossible to have large numbers of police officers constantly on patrol. Antibodies have a limited lifespan .Think of the Killer T cells as the Swat teams - they turn up to quell large riots/infections.

There are labs which can do a quantitative assay. I know who they are, but they will not do it for the average person in the street because of the difficulties in intepreting the results and the medicolegal possibilities..

Relying on antibodies alone is a flawed approach.

 

[Quickstatus]

Sure I know, it is IgG and its confirmed in test result.

IgG is just the name of a particular type of antibody. There are IgA, IgM, IgE, IgG
But which antibody is it?

Is it the antibody against the N, S1, S2, E protein of the Covid virus?. Only one of these proteins has the receptor binding domain where the antibodies are thought to be effective - has a neutralising effect.

That may be the only reason why quantitative antigen test not available in Australia.

No it is not. The reason is that no one yet knows the threshold antibody level for protection. Then there are problems defining what protection should be.
No current quantitative assay is yet standardised and therefore not comparable with other assays.
Revisit this in a year or two to find out if there has been any progress....

....


BAU
A picture above mentions BAU - this is "Binding antibody unit"
The problem with binding antibodies is that they only attach to the antigen but not change infectivity. What proportion of binding antibody is also neutralising antibody?

It appears to be the Abbott IgG antibody assay against the RBD region of the S1 protein.
Is 3444.98 high, normal or low?. Is 3444.98 enough to prevent breakthrough infection? and if breakthrough infections at what rate 5%, 10%?, and if yes to breakthrough infection how severe is the infection - home, hospital, ICU, ventilator?. Mortality rate?

Where are the studies showing the correlation between levels of antibody and potential immunity?.

As with all medical tests, they are useless unless correlated to the clinical context.

 

[drron]

1. I think it is necessary because I might not need booster jab just yet.
2. I requested test 4 weeks prior to overseas trip to determine if I need booster and to have sufficient time for it to take effect. But because test result I received was not up to scratch I didn't get jab. Now I am in remote location where jab not available and I only going to be in position to get it 1 day before departure which mean:
a) not enough time for immune response before possible exposure any way, but if I would know exact numbers I can be more o less risky selecting countries venues and activities overseas with peace of mind.
b) PCR test in airport can possibly give positive result (I know that's questionable)
3. Just because I want to have this simple information about my health. And Labs are there just to provide it on request.

I want it just because I can (but can't)
My family overseas where covid rampant doing this test regularly, every few weeks, keeping track of their individual antibodies numbers declining over time. And occasionally they can see their antibody level through the roof meaning that they where exposed completely asymptomatic - maintaining natural immunity for longer, so no need for them to take boosters.
This test available there in every Lab around the corner for AUD30 within hours. Easy. But not in Australia...
Here is result that easy enough to understand:
View attachment 265853

Thanks for the links you shared. If read carefully they talking about rapid antigen self testing kits, not proper laboratory based blood test.
"Tests are also described by their Positive and Negative Predictive values (PPV and NPV). These measures are calculated using a test's sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called "prevalence" in these calculations). Every test returns some false positive and false negative results"
- this is all about rapid kits, not my case.

BUT this is probably the answer why as @Pushka said blood antibodies levels are collected by labs, just not shared to public:
"If the results of the antibody test are interpreted as an indication of a specific level of immunity or protection, there is a potential risk that people may take fewer precautions against exposure. Taking fewer precautions can increase their risk of infection and may result in increased spread."
That may be the only reason why quantitative antigen test not available in Australia.



Sure I know, it is IgG and its confirmed in test result.

View attachment 265851

I am do not belong to either extreme.
Just trying to find firm middle ground relevant specifically for me.

With the links I posted I quoted the pieces that referred to antibody test and both the CDC and FDA recommended that they NOT be used to assess your immunity.They were general articles about coviid tests so had orther tests discussed as well.
I knew it was an IgG antibody that was tested but what IgG antibody.Which area of the spike protein or was it the nucleocapsid region?Of course vaccines are only targeting the spike region.They do not target the N protein region which turns out is an area of an important mutation that causes increase in the numbers of viral copies produced in the infected cell.

New Clues to Delta Variant’s Spread in Studies of Virus-Like Particles

About 70,000 people in the United States are diagnosed with COVID-19 each and every day. It’s clear that these new cases are being driven by the more-infectious Delta variant of SARS-CoV-2, the nov…

directorsblog.nih.gov

Again the advice from those who know most about covid infections is not to use antibody levels to assess whether you need a booster or not.

 

[Jenya]

There are labs which can do a quantitative assay. I know who they are, but they will not do it for the average person in the street because of the difficulties in intepreting the results

And this is the problem for average person. Scientists can argue endlessly that there are difficulties,
But for average person at least some meaningful indicator is available which is clearly correlates with body response, can be measured before and after jab and, can be tracked declining over time and spike again following reinfection. For me it is already something meaningful enough to make conclusions.

Relying on antibodies alone is a flawed approach

I understand this.
But just referencing to at least something traceable is better then no reference at all.

No current quantitative assay is yet standardized and therefore not comparable with other assays.
Revisit this in a year or two to find out if there has been any progress....

A WHO International Standard for neutralizing activity of anti-SARS-CoV-2 immunoglobulin has been available since December, 2020. Weather particular research institutes and labs willing to follow them due to political issues is other question.
Following the establishment of the International Standard, it is now important to ensure the correct use of the antibody standard in vaccine clinical trials to assist in the interpretation of results by providing the basis for expression of antibody titres in IU. This approach is an opportunity for exploring and possibly defining correlates of protection in IU/mL. The International Standard also permits data sets across a range of assays to be compared by reference to the IU.

It appears to be the Abbott IgG antibody assay against the RBD region of the S1 protein.
Is 3444.98 high, normal or low?. Is 3444.98 enough to prevent breakthrough infection? and if breakthrough infections at what rate 5%, 10%?, and if yes to breakthrough infection how severe is the infection - home, hospital, ICU, ventilator?. Mortality rate?

On the same picture at the bottom there is reference:
below 7,1 Bau/ml - negative
above 7,1 Bau/ml - positive
I'd say 3444 is very high number and I know from that person, test was done 2 weeks post second Sputnik V jab in July.
And results are trending down since - as expected.
I'd say when you observe steep decline its time to revaccinate.
Easy as.
Is it too much to ask for the lab to provide this kind of reference? They are there just to provide factual info, and interpreting this info is not up to them, even if there known difficulties.

Where are the studies showing the correlation between levels of antibody and potential immunity?.

https://www.mdpi.com/2073-4409/10/8/1952/pdf
For a starter I would just follow page 7 of this document.

Again the advice from those who know most about covid infections is not to use antibody levels to assess whether you need a booster or not.

Ok advice is there. Noted.
But as per my notes above, its up to individual to to follow this advice or not even if approach can be flawed and not completely reliable.
What is needed is some firm reference which is readily available elsewhere, but not in Australia - that is the only issue.

 

[Quickstatus]

meaningful indicator

How is it meaningful?. Its a number to which you are attributing a certain effect without any scientific basis. The experts are not even attributing anything meaninful at the moment. it is under investigation though. Until then...

I'd say 3444 is very high number

Based on what? See above.
"High" meaning excellent protection against Covid19?. What does that even mean?
Is it 0.1% 1%, 5% 10% chance of hospitalisation, chance of ICU, chance of death from covid19?
Can you be specific?.
Or is it "high" because it is a bigger number compared to "7"

A WHO International Standard for neutralizing activity of anti-SARS-CoV-2 immunoglobulin

As you can see - your Abbott study does not use neutralising antibody units - rather binding antibody units. It basically does not mean much.
How does it correlate? I dont know

Is it too much to ask for the lab to provide this kind of reference

At the moment, yes, - again as I said before, because the studies are not out yet correlating level of neutralising antibody to actual level of protection.

What is needed is some firm reference which is readily available elsewhere

Excatly but It is not (yet) available anywhere. Again I am afraid to say your test is meaningless, and no medical practitioner will be able to properly advise you on your level of protection against Covid19. Its your money - spend it anyway you like, but dont assume that what you are getting is useful.

Again there is no recommendation to use antibody levels as a measure of Covid 19 protection.

More work needs to be done. Until then.....

 

[drron]

And then there is this report from Israel on antibody levels from a person deeply involved in vaccine approvals in Israel. This was writtenearly this year.However that doesn't invalidate the conclusion.

A new study conducted on Israeli health workers suggests that people infected with the coronavirus develop a large degree of immunity to the virus – even when COVID antibody levels are low or even non-existent.


According to a report Tuesday by Channel 12, a research paper signed by Dr. Tal Brosh, chief of Assuta Hospital’s Infectious Disease Unit and a member of the governmental committee on distributing the coronavirus vaccine, found that COVID reinfections are extremely rare, and that the widely-available, commercially distributed serological tests for coronavirus antibodies are ineffective at determining whether a person has developed immunity to the virus.


“According to the existing data today, serological tests for the presence of antibodies are not an effective tool for assessing whether there is a sufficient level of antibodies to offer immunity from infection, either from natural infection or from vaccination,” the research paper reads in part.

Recovered COVID patients have immunity - even without antibodies

New study in Israel confirms that reinfections are extremely rare, suggests serologic antibody tests don't reflect immunity.

www.israelnationalnews.com

 

[Lynda2475]

SO Pfzier have stated 100 days to have an Omicron tweaked vaccine in peoples arms and Hunt has confirmed our contracts with Pfizer and Moderna allow us to receive new formulas.

Of zero evidence to date that current vaccines do not work against Omicron and no evidence of serious illness. Most cases identified outside of South Africa have in fact been asymptomatic in vaxed people.

Nothing to worry about yet.

 

[wandering_fred]

The testing and manufacturing of the shot will likely "take a few weeks," the spokesperson added.

Novavax seems to develop versions more rapidly

Now if the TGA would approve the already submitted application....
Approved for Indonesia and Phillipines

The Novavax jab is a protein subunit vaccine, and so is different from the mRNA vaccines developed by Moderna and Pfizer, the viral-vectored vaccines made by AstraZeneca and Johnson & Johnson, and the inactivated-virus vaccines made by Sinovac and Sinopharm.

More choices permit better wandering
Fred
[/QUOTE]

 

[Quickstatus]

“More choices permit better wandering
Fred”

Except some politicians keep getting in the way…