Vaccine Effectiveness in Ireland

Mr.StRiPe

The actual HSE data on vaccine breakthough cases in Ireland indicates that the effectiveness of the vaccines is significantly lower than 93%

On the 12th of August at a HSE briefing Paul Reid released the following figures on vaccine breakthrough cases (real-world indication of the effectiveness of the vaccines) in Ireland:

https://amp.rte.ie/amp/1240453/

• 49% Covid patients in hospital fully vaccinated
• 24% Of those in ICU were full vaccinated
• 18% of those in ICU were partially vaccinated

On the same day professor Philip Nolan released the following tweets to give more context to the above figures where we had 70% of the adult population protected (2 weeks after completing their regimen) and how he and his team are modeling this data.

https://mobile.twitter.com/President_MU/status/1425804652940046342

https://mobile.twitter.com/President_MU/status/1425804765326450702

https://mobile.twitter.com/President_MU/status/1425804855080259586

https://mobile.twitter.com/President_MU/status/1425804990178897927

https://mobile.twitter.com/President_MU/status/1425805175537684480

https://mobile.twitter.com/President_MU/status/1425805512818429954

This is very interesting as not only have we received official data on breakthrough cases in Ireland, for the first time, we also get insight into how professor Nolan and his team are modeling and interpreting this data.

I have attached an Excel spreadsheet of Professor Nolans model so you can change the key assumption parameters such as % vaccinated, % vaccine effectivness in preventing symptomatic infection, % vaccine effectiveness in preventing sever desiease requiring hospitalisation.

Vaccine protection HSE model.xlsx

The following is a screenshot of the spreadsheet reflecting what professor Nolan described as the current situation here on August 12th with 70% of the adult population protected (2 weeks after completing their regimen)

As you can see the figures in the spreadsheet match the figures in the visualisation in professor Nolans tweets.

Interestingly the admissions prevented was calculated on just the risk of hospitalisations % (5%) weighting and did not include the vaccine hospitalisation reduction % (65%). Including the vaccine hospitalisation reduction % increases the admissions prevented to from 137.2 to 159.5 which is an even better outcome for the message he is trying to convey so I'm not sure why he didn't include it.

The following screenshot of the spreadsheet shows the figures in professor Nolans 90% vaccinated example (tweet 5/6)

Again you can see that the figures match the visualisation presented by professor Nolan exept for the admissisions prevented which once again didn't take into account the vaccine hospitalisation reduction %

The core point professor Nolan is trying to convey is as follows:

If vaccine coverage increases to 90%, the majority of cases, and close to half the hospital admissions will be in vaccinated people, but it is a smaller number of cases (two-thirds of that with 70% coverage) and hospitalisations (less than half that with 70% vaccination)

You can see in the spreadsheet data and his own visualisation the close to half the hospital admissions will be in vaccinated people equates to 38.57% (39% rounded in visualisation)

The main issue is on the day professor Nolan posted these tweets with his model of the current situation (August 12th) the actual figure was 49% Covid patients in hospital fully vaccinated not the 14% portrayed in his model

To get professor Nolans model to reflect the real figure which was 49% Covid patients in hospital fully vaccinated both the % vaccine effectivness in preventing symptomatic infection and the % vaccine effectiveness in preventing sever desiease requiring hospitalisation have to be significantly reduced.

As an example if we assume the % vaccine effectiveness in preventing sever desiease requiring hospitalisation is 0% and leave % vaccine effectivness in preventing symptomatic infection at 80% the we get the following:

The admission % goes up to 31.82% but is still 17% off the real figure 49% so

To get to the real figure of 49% we have to reduce the % vaccine effectivness in preventing symptomatic infection to 59% which is a 21% reduction in effectiveness as shown in the following screenshot of the model

If the % vaccine effectivness in preventing symptomatic infection is set to 0% and % vaccine effectiveness in preventing sever desiease requiring hospitalisation is 93%

The hospital admissions in the fully vaccinated group would be 14.04% which is a long way off the actual value of 49%.

To get to the real value of 49% the % vaccine effectiveness in preventing sever desiease requiring hospitalisation needs to be set to 58% which is a 35% reduction in effectiveness

The vaccine breakthrough data from the HSE briefing on the 19th of August was as follows:

https://www.youtube.com/watch?v=pHPbdiClxFs&t=737s

• 45% Covid patients in hospital fully vaccinated
• 23% Of those in ICU were full vaccinated
• 15% of those in ICU were partially vaccinated

75% vacinnated

Inputting this data into the model gives us 17.36% fully vaccinated admitted to hospital which is requires a 27.64% adustment between the % vaccine effectivness in preventing symptomatic infection and/or the % vaccine effectiveness in preventing sever desiease requiring hospitalisation.

Similar data out of Israel indicated the % vaccine effectiveness in preventing symptomatic infection and transmission is an average of 39% where the effectiveness seems to decrease from the time you are vaccinated down to 16% 6 months out. However, this data showed that there was still 91% protection against serious illness but the Irish data seems to indicate the decrease in effectiveness is following though to serious illness when we are seeing that 23% of the people currently in ICU in Ireland are fully vaccinated and a further 15% were partially vaccinated.

How is there not more discussion on this!?

Lumen

Your model does not account for age related hospitalisation risk and vaccine coverage.

I say "your model" because it's your spreadsheet, not Nolan's.

There may be issues with Nolan's model too, but I find your presentation a bit confusing in as far as it doesn't make a single mathematical point.

I also bothered by the omission of the important "additional" qualifier in Nolan's tweets (and your spreadsheet), which is present in JBMs infographics.

Pete_Cavan

Does your figure of 49% Covid patients in hospital fully vaccinated come from the Paul Reid quote at the beginning of your post where he says 51% in hospital have not been vaccinated? If so, it is unlikely that all of the non non-vaccinated are fully protected (2 weeks after completing their regimen, as Prof. Nolan puts it). The 49% is probably made up of fully and partially vaccinated people, with fully vaccinated making up only a portion of that.

Some of those in hospital with Covid on August 12th could have been infected more than two weeks earlier, when fully vaccinated % was less. I am note sure of the time between infection and hospitalisation for Delta, also have to account for them having been in hospital for a few days at that stage. Fully vaccinated % was probably below 70% when these people caught it.

Hospital acquired infections could also skew the figures. If the in hospital Covid figure includes people who were in hospital for other reasons and tested positive while there, it would not be a reflection on vaccine effectiveness.

I think Prof. Nolans figures are a theoretical example of the benefits of vaccinations. I doubt it was intended to fully reflect actual figures as there are variables in the real world which are incredibly difficult to account for in such figures.

Mr.StRiPe

https://www.boards.ie/discussion/comment/117795806#Comment_117795806

The spreadsheed represents professor Nolans model if you have spotted any errors please let me know and I'll correct them. This is why I attached the spreadsheet so anybody who wants to can try it out and point out if there are any errors it.

Your model does not account for age related hospitalisation risk and vaccine coverage.

It is not my model it is the HSE model populated with HSE data.

I can only go off the data and the model that was released by the HSE and can only assume they are taking everything into account when they choose release this data as a single headline figure at the briefings with no further refernce data to go off of.

The model explicitly accounts for vaccine coverage @70% as follows:

Estimated outcomes over a 7-day period where 70% of the population is fully vaccinated

Professor Nolan even clarifies this further in his 2nd tweet (which is referenced in post above) where he says:

We have 70% of the adult population protected (two weeks after completing their regimen)

There may be issues with Nolan's model too, but I find your presentation a bit confusing in as far as it doesn't make a single mathematical point.

The mathematical point I am making is when you add the real figures into the HSE model it is mathematically impossible to get to 49% people in hospital fully vaccinated with a % vaccine effectivness in preventing symptomatic infection at 80% and % vaccine effectiveness in preventing sever disease requiring hospitalisation at 93% when 70% of the Irish population is fully vaccinated

Then I showed matheatically in the extreme examples where we reduce one of these vaccine effectiveness to 0% you have to also reduce the other effectiviness % to achieve 49%

I also bothered by the omission of the important "additional" qualifier in Nolan's tweets (and your spreadsheet), which is present in JBMs infographics.

My spreadsheet includes both of the JMBs infographics I assume you are referring to the following qualifier on the infographics?

Assumptions: Background force of infection would cause 70 cases per day per 100,000 population in the unvaccinated population. Vaccine effectiviness in preventing symtomatic infection 80%, vaccine effectiveness in preventing sever disease requiring hospitalisation 93%, risk of hospitalisation in an unvaccinated case 5%

If so, I reference the exact wording of Vaccine effectiviness in preventing symtomatic infection and vaccine effectiveness in preventing sever disease requiring hospitalisation and their assumed values when making the comparrisons against their values when the real data is entered into the model.

Mr.StRiPe

https://www.boards.ie/discussion/comment/117795832#Comment_117795832

Does your figure of 49% Covid patients in hospital fully vaccinated come from the Paul Reid quote at the beginning of your post where he says 51% in hospital have not been vaccinated?

Yes, as this is all I can go on as it is the only breakthrough data available and it is how the HSE have choosen to communicate it.

If so, it is unlikely that all of the non non-vaccinated are fully protected (2 weeks after completing their regimen, as Prof. Nolan puts it). The 49% is probably made up of fully and partially vaccinated people, with fully vaccinated making up only a portion of that.

It is possible that the 49% includes partially vaccinated people however, when Paul Reid gives the ICU data for fully vaccinated people he gives this breakdown which I referenced in the post above:

• 24% Of those in ICU were full vaccinated
• 18% of those in ICU were partially vaccinated

As he broke the ICU data in to these 2 groups its not clear why he wouldn't have done the same for the hospital admission data if he had it available so I can only go off what he said.

The ICU data is much more alarming as its clear he is talking about fully vaccinated people here at 24%

Some of those in hospital with Covid on August 12th could have been infected more than two weeks earlier, when fully vaccinated % was less. I am note sure of the time between infection and hospitalisation for Delta, also have to account for them having been in hospital for a few days at that stage. Fully vaccinated % was probably below 70% when these people caught it.

This is true which means the HSE model assuming that 70% of the population is fully vaccinated over estimates the vaccine effecitveness, if anything, for instance if you put 65% into the spreadsheet the effectiveness drops as to drop further to get to 49%. This is the point professor Nolan is trying to convey as the % of the population fully vaccinated increases from 70% to 90% he is expecting the majority of the cases and close to half the hospital admissions will be in vaccinated people.

https://twitter.com/President_MU/status/1425805175537684480

The issue is the model shows at 70% fully vaccinated with the real data the assumed Vaccine effectiveness metrics

Vaccine effectiviness in preventing symtomatic infection 80%, vaccine effectiveness in preventing sever disease requiring hospitalisation 93%

Are mathematically impossible and the real admissions are currently 10% higher (49-39) at 70% than what they should be at the 90% fully vaccinated.

Hospital acquired infections could also skew the figures. If the in hospital Covid figure includes people who were in hospital for other reasons and tested positive while there, it would not be a reflection on vaccine effectiveness.

This is an interesting point as it doesn't skew the Vaccine effectiviness in preventing symtomatic infection % as a fully vaccinated person still got a breakthrough infection however, it could skew the vaccine effectiveness in preventing sever disease requiring hospitalisation depending on how or if they are factoring it in to the headline figure they released. We have to assume the HSE are competent enough to be factoring this in especially when they only give a headline figure but as they haven't released the raw data we can't be sure.

https://www.boards.ie/discussion/2058205487/vaccine-effectiveness-in-ireland

You have gone to an awful lot of trouble to completely misunderstand the data.

The rate of hospitalisation in under 50’s was 1/10th of that in over 50’s pre vaccine. Half of current icu patients are under 50.

The median age of unvaccinated in Ireland at the moment is probably somewhere in the teens or possibly younger.

Public health england produces some good reports on this topic. Would expect broadly similar data here

https://www.gov.uk/government/publications/covid-19-vaccine-surveillance-report

https://drrollergator.substack.com/p/damned-lies-and-vaccine-statistics

Is this what you’re getting at, OP?

That the vaccines are protective against infection but not against serious disease and death in those vaccinated who become infected?

https://www.boards.ie/discussion/comment/117799710#Comment_117799710

Seriously, you read that and thought it was worthy of sharing without immediately thinking, the DrRollerGator, I presume they are qualified to talk about what they are saying. And once you get to the actual “stats” they present. 1000 monkeys with access to a stats package would produce something with more coherent analysis.

https://www.boards.ie/discussion/comment/117799774#Comment_117799774

Thanks, raind.

I’ve followed DrRollerGator a while, actually. Their writings and analyses are fairly interesting, and since I myself make a good living by writing under a pseudonym, it’s not a thing that puts me off in and of itself.

Anyway, onto more substantial things: What are the errors you’re seeing in the stats presented?

Mr.StRiPe

https://www.boards.ie/discussion/comment/117799626#Comment_117799626

You have gone to an awful lot of trouble to completely misunderstand the data.

The only official data released by the HSE on vaccine breakthrough in Ireland is as follows:

August 12th with 70% of the adult population protected (two weeks after completing their regimen)

• 49% Covid patients in hospital fully vaccinated
• 24% Of those in ICU were full vaccinated
• 18% of those in ICU were partially vaccinated

August 19th with 75% of the adult population protected (two weeks after completing their regimen)

• 45% Covid patients in hospital fully vaccinated
• 23% Of those in ICU were full vaccinated
• 15% of those in ICU were partially vaccinated

The HSE vaccine protection model assumptions are as follows:

Background force of infection would cause 70 cases per day per 100,000 population in the unvaccinated population. Vaccine effectiviness in preventing symtomatic infection 80%, vaccine effectiveness in preventing sever disease requiring hospitalisation 93%, risk of hospitalisation in an unvaccinated case 5%

In what part of my initial post do you feel I have misundersood any of this data?

The rate of hospitalisation in under 50’s was 1/10th of that in over 50’s pre vaccine. Half of current icu patients are under 50.

The median age of unvaccinated in Ireland at the moment is probably somewhere in the teens or possibly younger.

Vaccine effectiveness is measured by the breakthrough cases which means it is only relevant to people who have been vaccinated so I don't follow why you are referring to data when the vaccines were not available and the unvaccinated when the vaccines are available? .

Public health england produces some good reports on this topic. Would expect broadly similar data here

https://www.gov.uk/government/publications/covid-19-vaccine-surveillance-report

In the latest report week 33 in the Vaccine effectiveness against the Delta variant section it lists the

Vaccine effectiviness in preventing symtomatic infection

Vaccine effectiveness in preventing sever disease requiring hospitalisation

This is inline with HSE vaccine protection model where they assume

Vaccine effectiviness in preventing symtomatic infection at 80%

and

Vaccine effectiveness in preventing sever disease requiring hospitalisation at 93%

So it appears as we would expect the HSE are doing their due dilligance and keeping up to speed with all the latest data when they created their model.

What it doesn't change however, is when you put the real vaccine breakthrough figures, as reported by the HSE for Ireland, into their vaccine protection model it is mathematically impossible to have vaccine effectiveness @ 80% for preventing symtomatic infection and 93% for preventing sever disease requiring hospitalisation.

As demonstrated in my first post the effectiveness % in both cases require a signifficant reductuion to reflect the real data Ireland has reported over the last 2 weeks.

Mr.StRiPe

https://www.boards.ie/discussion/comment/117799710#Comment_117799710

No, what I'm getting at is if you enter the real vaccine breakthrough data reported by the HSE into the HSE vaccine protection model it is mathematically impossible to have vaccine effectiviness the model assumes which is Vaccine effectiviness in preventing symtomatic infection at 80% and vaccine effectiveness in preventing sever disease requiring hospitalisation at 93%

That the vaccines are protective against infection but not against serious disease and death in those vaccinated who become infected?

When the official HSE data for breakthrough cases in Ireland on August 12th are inputted into the HSE model (also released on August 12th) even if you reduce the Vaccine effectiviness in preventing symtomatic infection from 80% to 0% you also have to reduce the vaccine effectiveness in preventing sever disease requiring hospitalisation from 93% to 58% otherwise the model does not reflect the real breakthough numbers that were reported.

Cuddlesworth

Seems like your getting your figure not from the number of people admitted to hospital and then the ICU, but off of figures of people currently in Hospital/ICU.

timmyntc

One thing to keep in mind is that numbers hospitalised for covid would be overstated in HSE reports - as virus becomes more prevalent population wide, there will inevitably be more people admitted to hospital for non-covid reasons, who happen to test positive for covid.

The other is that age & comorbidities are the 2 biggest factors for risk of covid - and these people would have been prioritised for vaccination. So the vaccine group have a higher risk from covid to begin with.

The crux of the problem is that no proper long term studies of vaccine vs no vaccine have been done. Those initially done by Pfizer et al actually ended up informing the control groups (placebo injection) that they were unvaccinated - 90% of them promptly got vaccinated for real.

We desperately could do with a control group of different ages, comorbidities, etc to get a true measure of vaccine effectiveness - but we wont. We have long since decided to vaccinate everyone regardless of how effective it really is - the lack of control groups means we dont really know how well its working.

Cuddlesworth

That makes no sense, you don't need a control group past the initial trials, of which there were multiple done for numerous vaccines.

Also you have a "control group" in the population anyway, it's the unvaccinated people. And everything I can see says they are worse off then unvaccinated.

timmyntc

https://www.boards.ie/discussion/comment/117800927#Comment_117800927

The unvaccinated people are overwhelmingly younger - so you cant get an accurate measure of effectiveness because vaccinated people are majority older - and therefore, higher risk.

The purpose of a control group is that they should mirror the test group in composition, with the only significant difference being the vaccine they get. That is not true with the current vax/unvax split.

And yes you do need control groups past the initial trials - you cannot count the prevalence of side effects or vaccine effectiveness without a control group to benchmark against. IF you vaccinate your entire control group - how can you calculate efficacy if you dont know risk of unvaccinated control group?

schmoo2k

https://www.boards.ie/discussion/comment/117800947#Comment_117800947

What you say is true if you want accurate numbers - but for now the real world tends are clearly showing that the higher the vaccinated % is, the safer it is to lift restrictions.

Cuddlesworth

So in your mind when do you no longer have a trial and control group. Whats the point where you yourself declare that the data is good and go forward with a vaccine rollout in the middle of a global pandemic? Whats the number of trials, the locations, the group size, the timeframe in which its run? Do you start again with each new variant, do you segregate by region and restrict access to the vaccines so that you can retain a good sample size for future never ending trials? Do you pick out the populations with higher median ages over populations with lower median ages?

Why do you believe your viewpoint of more trials, control groups, higher death rates and long term covid effects on the populace which are known and documented, is at odds with multiple independent groups of public heath experts spread across the world?

astrofool

I'd love to be the politician announcing that the vaccines continue to remain effective because we're seeing more people in the population control group dying.

For a variety of reasons, this isn't what happens in the real world (where there is also unvaccinated countries to compare against).

timmyntc

https://www.boards.ie/discussion/comment/117801069#Comment_117801069

In emergency conditions you can use emergency protocols. They got emergency use approval (or equivalent thereof) in many jurisdictions, and went vaccinating before phase 3 trials had finished, nevermind phase 4. And rightly so - however you cannot stand by the efficacy numbers and say they are "true" when the process of measuring them is inherently flawed. Ideally, the trials that Pfizer initially had would have been kept going and not been ruined by vaccinating the control groups. But then you get into ethics issues I suppose - either way there are ethical issues really - to keep a small group of people unvaccinated to get a true measure of efficacy and baseline rate of possible side effects would be more valuable to society as a whole.

Every viewpoint is at odds with multiple groups of experts and scientists. There is very rarely (if ever) widespread consensus on any of this stuff. For every "expert" you find who supports your position, I can find same who supports the opposite. Consensus does not create truth - facts and data do. And my point here, is that the numbers on efficacy are not calculated with best practice and are inherently flawed. They may be more efficient than we are led to believe, or less, or vary largely with age and other factors. The truth is that we do not know.

timmyntc

https://www.boards.ie/discussion/comment/117801102#Comment_117801102

Its a bit grim but this is the normal approach. When you enroll in a clinical trial you accept all these risks - thats just how it is.

All other vaccines before this were approved/denied based on a difference in outcomes between test and control groups. Even the emergency use for pfizer/moderna etc were all based on a reduction in death compared to a control group. Its not anything new.

And sure with the way society is partitioning into us vs them on vaccines vs unvaccinated, people would cheer politicians announcing such things.

Darc19

Did people waste time and actually read the OP's post?

All I saw was some random person online that seems to have no expertise whatsoever and less grasp of how figures work trying to show that he/she is an" expert" (YET ANOTHER EFFIN ONLINE EXPERT)

OP - i reckon you spent a couple of hour constructing that - what a waste of a couple of hours

For me, a quick glace showed that you really have not got a clue

astrofool

https://www.boards.ie/discussion/comment/117801123#Comment_117801123

Once the phase 3 trials are finished, then a control group isn't necessary, there are other ways of gathering the needed data, it's not quite as accurate, but it doesn't need to be at that stage (and yes, they continue to monitor the vaccinated group even after the phase 3 trial is finished, but the control group is free to do whatever they want at that stage).

Medicine effectiveness is calculated with a confidence interval that is published with the date, the confidence interval grow larger when a control group isn't involved but there are other techniques used to keep it statistically significant.

timmyntc

https://www.boards.ie/discussion/comment/117801433#Comment_117801433

Yes I agree - but the phase 3 trials have not finished. And they wont finish - since the control groups used in those trials have since been vaccinated.

It's a total breach in protocol for conducting such studies - and casts doubt over the long term efficacy of these vaccines. They may be over or under estimated.

ohnohedidnt

The Israeli government are saying protection against infection is as low as 16% for people who received a 2nd dose in January, the methodology for collecting that data isn't clear, but I'm not sure why they would lie.

The oxford study which nobody has really managed to find a fault with, says about 50% effective after 4 months, starting from 92% and extrapolating out from Jan to August, makes the Israeli estimates seem reasonable to me

www.ft.com/content/23cdbf8c-b5ef-4596-bb46-f510606ab556

brickster69

The thing is with Israel is that now they have given 3 rd shots to those who got jabbed first so no more data will be coming from them now. UK wont have much more data for a while either because they gave second doses 3 months later, so that is no use to most countries to see what is going on in real time.

godzilla1989

https://www.boards.ie/discussion/comment/117801689#Comment_117801689

Israel data is as legit as it comes.

Pfizer and Israel are in partnership, 10 million people injected, electronic medical records.

The CEO of Pfizer had an interview yesterday talking about Israel and the relationshop with them, 6mins in on this video.

CEO says they are developing a Delta specific vaccine which they hope won't be needed, but boosters of the same vaccine will be needed.

He seems confused, as in the interview video below he thinks there will be no need for a delta vaccine, but then says in another interview a vaccine resistant strain is very likely

https://www.insider.com/pfizer-ceo-vaccine-resistant-coronavius-variant-likely-2021-8

A pre print paper released few days ago suggests we are 4 mutations away from a vaccine resistant strain eg Delta 4+

https://www.biorxiv.org/content/10.1101/2021.08.22.457114v1

"Surprisingly, most BNT162b2-immune sera enhanced infectivity of the Delta 4+ pseudovirus in a dose-dependent manner at relatively low concentrations of BNT162b2-immune sera, but showed weak neutralization only at the highest concentration of the sera."

9 of the 12 antibodies they tested didn't really seem to bind at all and two of the other 3 were at like 40% of Delta binding (figure 6a). In the neutralization assay, only one antibody had any neutralization at dilutions less than 1:10, compared to all 20 tested against Delta (figure 6d and 2a).

Another recent paper where the authors serially passaged the virus through diluted convalescent plasma shows that only three mutations were enough to abrogate neutralization by about 70% (E484K + a NTD deletion + a NTD insertion)

So it seems to me anyway that vaccine resitant strains, boosters, new variant vaccine's will be big news this winter

https://www.youtube.com/watch?v=GdZ7RsrsLzI

brickster69

The main concern will be that Israel are wrong with waning in severe illness among those who got jabbed early. All over the UK media today, amazing how slow they are when all of this was made public 6 weeks ago.

Cuddlesworth

https://www.boards.ie/discussion/comment/117801150#Comment_117801150

Yeah I read it. Its convoluted enough some people would be convinced his assumptions are correct. And I've already pointed out where his assumption and the example given differ. Now he can go off to find something else to prove his own confirmation bias correct.

astrofool

https://www.boards.ie/discussion/comment/117801613#Comment_117801613

The phase 3 trials are finished, the ongoing monitoring of the vaccinated group does not need a control group, sorry to bang on, but it's an anti-vax "talking point" to say that the "phase 3 trials aren't even finished yet" and is completely not true, once the results are in and once approval has been granted, phase 3 essentially becomes ongoing monitoring without control and is common with all medicines.

Monitoring future efficacy does not require a control group.

timmyntc

https://www.boards.ie/discussion/comment/117802330#Comment_117802330

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue to collect efficacy and safety data in participants for an additional two years.

Within 6 months of the phase 3 trials beginning, the majority of participants ended up double doses - including people in the control group.

Phase 3 trials typically last between 1 and 4 years - Pfizer indicate in the above press release (Nov 2020) that they intend to continue the trial for a further 2 years. But yet theyve already vaccinated the majority of their control group!

astrofool

https://www.boards.ie/discussion/comment/117802383#Comment_117802383

I've explained why that is multiple times, but sure, continue to ignore.

"The trial will continue to collect efficacy and safety data in participants for an additional two years"

I hate to break it to you, but in 2 years time, they'll commission a further extension and further study (if COVID is still a thing to be worried about).

I started in a trial 11 years ago that still sends updates, the conclusion was reached and published long ago, yet I still receive follow ups asking for information, no control group was kept after the initial trial period.

godzilla1989

https://www.boards.ie/discussion/comment/117802422#Comment_117802422

What's point continuing the trial if the control group is gone?

timmyntc

https://www.boards.ie/discussion/comment/117802422#Comment_117802422

"To collect efficacy and safety data"

You cannot measure efficacy or safety data without an adequate control group to compare against. If in 1 years time, theres 100 heart attacks observed - we cannot know if that is above the baseline or not if all the participants have been vaccinated.

The reality is there is no long term safety data available, and there will not be any because of the way this trial has been conducted. The push to get 100% vaccination coverage in a population wide scale also, means we cannot get accurate safety data either.

Unicorn Milk Latte

Percentage calculations are completely meaningless.

If you have 0% of the population vaccinated, like a year ago, and 500 people in hospitals, 100% are unvaccinated.

If you have 100% of the population vaccinated, and 5 people are in hospitals, 100% of people in hospitals are vaccinated.

Here are two studies/papers out of Israel (I already posted those in the Delta Variant thread..) that look at the actual numbers.

https://www.covid-datascience.com/post/israeli-data-how-can-efficacy-vs-severe-disease-be-strong-when-60-of-hospitalized-are-vaccinated

if you have breakthrough infections, any factors that indicate a weakened immune system - being immunosuppressed, pre-existing conditions, and age - need to be considered for a realistic assessment.

https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X%2821%2900367-0/fulltext

The results indicate that vaccines do exactly what they are supposed to do - reduce possibility of death and hospitalisation significantly - and that when you look at hospitalisation and death from break through infection, only 4% have no pre-existing conditions, and 40% are immunocompromised.

astrofool

https://www.boards.ie/discussion/comment/117802440#Comment_117802440

Because you don't need a control group to continue measuring efficacy (against various measures, e.g. antibody count, #Infected by age etc.).

https://www.boards.ie/discussion/comment/117802455#Comment_117802455

That's just not how medical trials are run, you can continue disagreeing, but it won't change what happens in the real world with medical trials.

The smaller the number of participants, the longer the trial takes to run to get to an agreed confidence interval, having a large amount of participants ensures a large amount of events can occur in a shorter space of time to reach the expected confidence interval that the medicine works or not. It's why the vaccines had such large numbers in the trials and why people need to think in terms of number of events and not linear time.

Pfizer are continuing to collect efficacy and safety data despite the control group now being vaccinated, are they just doing this for laughs?

lee_baby_simms

Is the concept of waning immunity from vaccination limited to pzifer or do we have similar observations with AZ or Janssen for example?

astrofool

https://www.boards.ie/discussion/comment/117802652#Comment_117802652

The antibody count drop is similar for AZ, Janssen is probably too new to have the full set of data yet. The antibody count drop is expected and the numbers seem to hold up quite well, but is an issue for those with underlying conditions or with a poorer immunity. We'll see if it becomes an issue for gen. pop. (but do expect to see lots of scary headlines extrapolating on the data).

timmyntc

https://www.boards.ie/discussion/comment/117802630#Comment_117802630

efficacy and safety figures are based on comparison with a control group. That is how they are defined.

Typical Phase 3 trials are several years long, to monitor efficacy over prolonged periods of time (antibody waning would be caught in these studies), as well as to monitor for any long-term safety concerns.

It is not standard practice to vaccinate your control group while a study is ongoing. This does not happen for any other vaccine trials in the past.

Confidence intervals are all well and good - but you cant estimate confidence interval for something that has not yet been observed - i.e. long term efficacy or side effects. And you cannot observe them if you do not have some control group to compare against. This is how scientific trials are conducted.

https://www.boards.ie/discussion/comment/117801150#Comment_117801150

All you have to do is point out where you think their analysis is wrong, as others have done, instead of posting a snotty reply. That just says you don't understand anything and are just trying to pretend to be smart.

astrofool

https://www.boards.ie/discussion/comment/117802776#Comment_117802776

That is not how medical trials are conducted, as you have already said, ethically, once you know you are saving or improving lives, then the control group also gets access to the treatment.

Is "ongoing phase 3 trials" a talking point you use?

Mr.StRiPe

https://www.boards.ie/discussion/comment/117800856#Comment_117800856

This is a very good point i.e. we know the vaccine breakthrough cases were admitted to hospital but not when they were admitted as the HSE haven't given this breakdown and dont consistentantly give us the data on how many are discharged from hospital each week as far as I can see. However, the average hospital stay seems to be holding at 6.5 days.

All we know from the data the HSE have released so far is on the 12th of August 49% of peope in hospital were breakthrough cases and on the 19th of August 45% of people in hospital were breakthough cases so the admissions each week on average will reflect this with an average turnover of 6.5 days but I agree we don't know the exact number.

Are you happy if I go with the rolling average % of people with breakthough cases in Ireland until the HSE gives us this data? i.e. 47% (49+45)/2

If not, what would you suggest is the most accurate way to reflect the admission % based on the data the HSE are giving us.

If we can agree on the most accurate way to reflect the admission % are you happy the spreadsheet accurately reflects the HSE vaccine protection model presented by professor Nolan?

Mr.StRiPe

https://www.boards.ie/discussion/comment/117801150#Comment_117801150

All I saw was some random person online that seems to have no expertise whatsoever and less grasp of how figures work trying to show that he/she is an" expert" (YET ANOTHER EFFIN ONLINE EXPERT)

All I did was input HSE data into a HSE model on vaccine protection so all of the figures are from the HSE

It is the HSE's expertise that created the model which was presented by professor Nolan on the 12th of August do you trust their expertise and figures?

For me, a quick glace showed that you really have not got a clue

I'd appreciate if you could highlight what part of my post you had an issue with.

As I've said previously I have attached the spreadsheet that represents the model professor Nolan presented for anyone to pull apart as I want to make sure it is accurate.

Mr.StRiPe

https://www.boards.ie/discussion/comment/117802493#Comment_117802493

Percentage calculations are completely meaningless.

If you have 0% of the population vaccinated, like a year ago, and 500 people in hospitals, 100% are unvaccinated.

If you have 100% of the population vaccinated, and 5 people are in hospitals, 100% of people in hospitals are vaccinated.

When you have 0% of the population vaccinated the % of hospital admissions for covid is the baseline you measure the effectiveness of the vaccine against.

If you look at the HSE vaccine protection model their assumption on risk of hospitalisation in an unvaccinated case is 5% this means if the vaccine is 0% effective you would still have 5% risk of hospitalisation if the vaccine is 100% you would have 0% risk of hospitalisation i.e. the closer the rate gets to 0% afther vaccination the greater the effectiveness of the vaccine.

This is my understanding anyway.

Unicorn Milk Latte

https://www.boards.ie/discussion/comment/117802652#Comment_117802652

I think it's probably a misconception to see the reason of possible waning immunity in the vaccine, rather than the virus itself.

When you look at research of coronaviruses pre-Covid, like coronaviruses that cause common cold, you will find that when a person got naturally infected and therefore produced antibodies, these antibodies gradually disappear over a time span of around 5 years. Unlike some other viruses, where antibodies produced after an infection remain in the human body indefinitely.

In other words, if there is waning immunity with SARS-COV-2, it is most likely identical between vaccinated people, and people who got infected with SARS-COV-2 and produced antibodies that way.

Unicorn Milk Latte

https://www.boards.ie/discussion/comment/117803237#Comment_117803237

But I'm not talking about the 'risk of hospitalisation' percentage of a vaccine - in that case, having percentage numbers makes sense, of course.

I'm talking about drawing conclusions about the efficacy of vaccines from 'x% of hospitalised are vaccinated', because that is misleading when the number of hospitalised overall is small, while the number of overall vaccinated in the population is high.

Pete_Cavan

OP, the figures you keep quoting are not what you claim them to be. The figure of 49% which you say is Covid patients in hospital fully vaccinated clearly includes partially vaccinated people. Some of those who are fully vaccinated could also be within two weeks of their second dose so outside the parameters set by Prof. Nolan.

The figure of 45% Covid patients in hospital fully vaccinated also includes those who caught Covid within two weeks of when they received their second dose.

Neither of those figures are what Prof. Nolan's spreadsheet was intended to measure so it should be no surprise that he didn't come up with either. I understand that we don't have the exact % of Covid patients in hospital having received their second dose more than two weeks previously, but that doesn't mean you can just pick a different number and throw it in instead.

Mr.StRiPe

https://www.boards.ie/discussion/comment/117803403#Comment_117803403

Some of those who are fully vaccinated could also be within two weeks of their second dose so outside the parameters set by Prof. Nolan.

The HSE define fully vaccinated as follows:

I believe it is clear when the HSE refer to fully vaccinated in their data they are referring to same definition as professor Nolan which does not include people who haven't reached the recommented time period after getting their second shot.

The figure of 49% which you say is Covid patients in hospital fully vaccinated clearly includes partially vaccinated people.

You appear to agree with the 45% figure as Paul Reid explicity says it on August 19th? he also goes on to say 52% not vaccinated and 3% no status he does not mention any figure for partially vaccinated but as the other figures add up to 100% we know there were none.

On both the 12th and the 19th he breaks the ICU data into fully and partially vaccinated and we know there were no partially vaccinated reported in the hospitilisation breakthroughs on the 19th which was the following week. Do you not think he would have reported the partially vaccinated figure on the 12th if he had it? Not reporting the partially vaccinated figure, if it was available, would be very misleading to the public so it is hard to believe he would choose to do this. Surely you can't believe Paul Reid choose to omit it? and if he omitted it in error I'm sure they would have corrected the record once they realised.

Even if you belive he did deliberately omit it hopefully the clarification on the HSE's definition of fully vaccinated addresses your concerns that the figures I quoted do not include those who caught Covid within two weeks of when they received their second dose? If so, then you shouldn't have any issue with the examples when the spreadsheet is set to achieve the 45% breakthough.

yoke

I think it’s important to note that mr.stripe is not actually saying that the vaccines are useless, I think he’s more making the point that the manufacturers claims (like most manufacturers claims) are overly optimistic, based on the data available.

The problem with relying purely on overly-optimistic manufacturer’s claims is that it can lead to policy errors down the line, ie. if the vaccine is 93% effective at preventing something, then you might implement different policies than if it was only 80% effective.

My initial reaction was also “his figures are probably fudged”, but actually on closer inspection it looks like international consensus may be moving towards reviewing exactly how efficient the vaccines are, as it seems the manufacturer claims may have been overly optimistic (which is usually the case with all manufacturers claims, to be fair).

eg: https://www.yalemedicine.org/news/covid-19-vaccine-comparison

Lumen

@yoke no, Mr.StRiPe is claiming that Irish data fed into his spreadsheet model shows that the vaccines are significantly worse at preventing serious disease than has been demonstrated in Israel.

The article you linked to says

Another study, not yet peer-reviewed, provided more new data that brought the efficacy number down to 84% after 6 months, although efficacy against severe disease was 97%.

Pete_Cavan

https://www.boards.ie/discussion/comment/117804395#Comment_117804395

I don't think "overly-optimistic manufacturer’s claims" is an accurate or fair way of putting it. They gave the data they got from their trials and that was reviewed by the regulators. It is expected that real world experience can differ from trial results.

Also the earlier efficacy results which we keep going back to were a snapshot at that moment in time. Efficacy can change over time, that seems to be an established fact now with these Covid vaccines. I don't think anybody is "relying purely" on manufacturer’s claims, there are lots of studies ongoing at the minute.

Going back to the OPs calculations, there are lots of flaws in it. It assumes one set rate for vaccine effectiveness, but in reality there are likely several rates. These range from the high manufacturer figure for those recently fully vaccinated to lower rates for people vaccinated earlier in the year. Then you have to factor in the demographic and general health differences between those vaccinated recently and those vaccinated 6+ months ago (i.e. that the most likely people to be hospitalisated currently have the lowest protection of the people fully vaccinated).

Obviously these issues are built into the spreadsheet which the OP didn't create. However, I don't think Prof. Nolan ever intended the spreadsheet be used for the purposes the OP is using it for (i.e. calculating actual vaccine effectiveness from a few broad figures). I think Prof. Nolan was just giving a high level example of how vaccines can prevent hospitalisations based on some assumptions. I'msure he would be the first to acknowledge that the assumptions don't account for several factors.

Cuddlesworth

https://www.boards.ie/discussion/comment/117804395#Comment_117804395

He is doing two things.

He is trying to extrapolate a result from the data that has been provided which validates his viewpoint.

In which is a attempt to insinuate that the given figures are wrong and therefore, create a sense of distrust in the the parties involved, government, health officials, companies that manufactured the vaccines etc etc.

The other poster is doing the same thing, the trials are still ongoing, there is no control group, it/they can't be trusted. Please start distrusting things so that my own viewpoint can be validated, while ignoring the clear and obvious fact that the vaccines clearly are working globally.

https://www.boards.ie/discussion/comment/117803142#Comment_117803142

And this word vomit is a good example of this. He is just repeating the same things over and over again to try get back to his biased conclusion that the vaccines can't be working as well as they say it is.

The figures are in, vaccines are working. Multiple organisations across the world have provided this independently of each other. And if the figures show booster shots help with that(and it appears that they do), then boosters will become available.