Reflection on the pandemic: questions about the authorities' response.

astrofool

I see we've moved on from:

"I want the authorities to question CMO I don't like because I've been proven utterly wrong for 2 years"

to just a straight up:

"Anti-vax misinformation gish gallop"

How utterly unsurprising.

Beasty

dolanbaker threadbanned

walus

https://www.boards.ie/discussion/comment/119947768#Comment_119947768

When mRNA vaccines were approved in 2020 it was on the basis of their effectiveness in preventing Covid 19, and not as you falsely claim “against death and serious illness” only. At least a number of media outlets, medical professionals, CEOs of reputable companies and FDA have led us all to believe so:

https://www.cnbc.com/2020/11/09/covid-vaccine-pfizer-drug-is-more-than-90percent-effective-in-preventing-infection.html

and

https://www.fiercepharma.com/vaccines/fda-to-require-at-least-50-efficacy-for-covid-19-vaccines-wsj

and

https://www.cnbc.com/2020/11/18/coronavirus-pfizer-vaccine-is-95percent-effective-plans-to-submit-to-fda-in-days.html

That is what the accepted promise of the mRNA vaccines was at the time - to prevent Covid-19. On the promise that they were more than 90% effective in preventing the disease they were sold to the governments around the world and formed a base line that drove a number of policies including vaccine programs/passports/mandates etc..

Over time, the real world effectiveness of vaccines has been proven to be much lower than the claimed figures, especially as a function of time (quick waning) and new variants.

The real question is how effective (quantitively) the vaccines are. The recent study published by CDC just last week claims that the absolute vaccine effectiveness against symptomatic infection for a single bivalent mRNA booster received after 2 or more doses of monovalent vaccine compared with the unvaccinated for adults aged 18-49, 50-64 and 65+ was 43%, 28% and 22%, respectively.

https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e1.htm#T2_down

Back in 2020, to win the FDA approval any Covid 19 vaccine had to be at least 50% effective in preventing the disease. This time however, FDA approved it based on the 'totality of evidence' without any clinical efficacy or safety data specific to it.

Are vaccines effective? Sure they are, but considering the original promise of preventing Covid -19 the vaccines have not been anywhere close to as effective as we hoped for, not in the same ballpark when compared to efficacy of traditional vaccines that were previously developed for other diseases.

odyssey06

https://www.boards.ie/discussion/comment/119966946#Comment_119966946

The flu vaccine is a 'traditional vaccine'. I think you would be hard pressed to make that case for covid vaccines versus flu vaccines that they are not in the same ballpark of effectiveness. If anything, the comparison would be unfavourable to the 'traditional' flu vaccine.

The vaccines were formally approved on the basis of trials showing prevention of infection. The regulators also had access to data showing promising results versus severe covid. It would be contrary to known immunology expectations for it to trigger an immune response that prevented infection but somehow did not also work versus severe covid.

The decisions on vaccine mandates and vaccine purchases etc was not based solely on the trial data and to suggest that it was is false and misleading.

And finally, the current bivalent vaccine in approved to treat severe covid. Therefore to talk of the effectiveness of the bivalent vaccines without mentioning severe covid is likewise misleading.

Beasty

It seems a lot of people seem to have little recollection of how the effectiveness of vaccines evolved during the pandemic

The main intention was to reduce transmission (no-one ever claimed they prevent transmission). Their secondary benefit was to reduce symptoms

The vaccines that were developed were very good at reducing transmission of the early variant. But of course new variants emerged. It was always accepted that the vaccines were less effective (but clearly not ineffective) in reducing transmission. They still reduced symptoms though

The conspiracy theorists and anti-vaxxers then use this to make absurd claims that the vaccines did not do what was claimed. That is patently false but they still try and push that narrative

hometruths

https://www.boards.ie/discussion/comment/119967276#Comment_119967276

No doubt reducing transmission was intended, but to say it was the main intention is totally incorrect. The clinical trial data did not measure any effectiveness in the reduction in transmission, and hence they were not approved on the basis of the benefits in reducing transmission.

From the EMA Pfizer approval report:

The pivotal study was not designed to assess the effect of the vaccine against transmission of SARSCoV-2 from subjects who would be infected after vaccination. The efficacy of the vaccine in preventing SARS-CoV-2 shedding and transmission, in particular from individuals with asymptomatic infection, can only be evaluated post-authorisation in epidemiological or specific clinical studies.

In December 2020, the main intention was to prevent symptomatic infection. To claim otherwise is demonstrably false.

https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

Beasty

Yes, and then new variants emerged

Do you fail to recall that?

Are you suggesting they did not reduce transmission (symptomatic or otherwise)?

odyssey06

https://www.boards.ie/discussion/comment/119967399#Comment_119967399

If the infection doesn't transmit to you, how do you transmit it to others?

This is the 'intention' - your word. From the document you linked.

By immunisation with the modified RNA (modRNA) product BNT162b2, encoding for the S protein, the intention is to trigger a strong and relatively long-lasting production of high affinity virus neutralizing antibodies, which can act through blocking the S-protein and it’s receptor-binding domain (RBD) interaction with host cell receptors but also by opsonisation mediated virus clearance. In addition, the immunisation with BNT162b2 is also intended to elicit a concomitant T cell response of the Th1 type, supporting the B cells responsible for the production of Sspecific antibodies and cytotoxic T cells that kill virus infected cells.

Your statement that "the main intention was to prevent symptomatic infection", speaks to the minds of the regulators at the time. Nothing you have provided speaks to that. Therefore your claim at present is without foundation and on the basis of the document you linked in support of it, false. You are muddying the waters between the formal basis on which the vaccines were approved, which was based on the specifics of the trial data and 'intention'. The vaccines were designed \ intended to trigger an immune response. In the trials that was detected as reduction in symptomatic infections and that was its formal basis for approval. But that is not the same thing as 'intention', or expectation.

hometruths

https://www.boards.ie/discussion/comment/119967495#Comment_119967495

No, no failure to recall variants emerging, which undoubtedly changed the effectiveness of the vaccines in prevention and hence transmission.

I was not arguing with the fact that variants had an influence.

I was correcting the revisionism that the vaccines were originally approved for something other than to prevent infection - both PeadarCos "The vaccines are effective at protecting against death and serious illness. That's the basis they were approved on" and your own: "The main intention was to reduce transmission"

I agree with your statement that "the effectiveness of vaccines evolved during the pandemic"

At time of approval "effective" meant effective at preventing infection, now it means effective at preventing severe Covid/death.

PeadarCo

https://www.boards.ie/discussion/comment/119967623#Comment_119967623

There uis no revisionism. See a link below from the HSE website. The Moderna vaccine had 94% effectiveness against symptomatic Covid (remember large numbers of people are asymptomatic) and was even more effective against severe Covid. You can get still get Covid with a vaccine. That was alwaysacknowledged . Which means what you are saying regarding Covid vaccines and the promises made are lies.

https://www.nejm.org/doi/full/10.1056/nejmoa2035389

https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/covidstudies/

hometruths

https://www.boards.ie/discussion/comment/119967616#Comment_119967616

The vaccines were designed \ intended to trigger an immune response.

It's noteworthy that you use the phrase "intended to trigger an immune response", because that is what effective means now. Effective at triggering an immune response.

For example when the recent bivalent vaccine was approved the EMA had this to say in the announcement:

Clinical studies with Comirnaty Original/Omicron BA.1 showed that the vaccine was more effective at triggering an immune response

and

Based on all these data, the CHMP concluded that Comirnaty Original/Omicron BA.4-5 is expected to be more effective than Comirnaty at triggering an immune response against the BA.4 and BA.5 subvariants.

Nowhere do they say anything about the immune response preventing COVID-19 infection.

This in stark contrast to the announcement that accompanied the original Comirnaty approval back in December 2020. Nowhere do they mention the vaccine being effective at triggering an immune response, but they do say:

EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age.

and

A very large clinical trial showed that Comirnaty was effective at preventing COVID‑19 in people from 16 years of age.

I am not muddying any waters, I am quoting the EMA's own unambiguous words - in December 2020 effective meant "effective at preventing Covid-19".

By late 2022 "effective" had evolved to mean "effective at triggering an immune response".

odyssey06

https://www.boards.ie/discussion/comment/119967802#Comment_119967802

I quoted from a document you linked. The document was dated February 2021.

What does that document say about intention and what the vaccine was intended to do?

It is not what you claim. In fact, what it states is entirely contrary to your revisionism.

I think the phrase is "hoist on your own petard."

PeadarCo

https://www.boards.ie/discussion/comment/119967616#Comment_119967616

What people forget is the purpose of trials is to do two things one ensure a medicine is safe/or at least the benefits heavily out weigh the side effects and 2 is effective when compared to a control (generally a placebo)

With anything new there is always some level of uncertainty regardless of the topic. When it comes to any scientific topic conspiracy theorists/con man exploit the natural uncertainty inherent in cutting edge science to advance their views/con.

My question to @hometruths and @Walus is what was wrong about the Irish vaccination programme? Given the topic of the thread.

hometruths

https://www.boards.ie/discussion/comment/119967864#Comment_119967864

Given the title of the thread one of things wrong with the response both in Ireland and further afield is the revisionism, in my opinion.

The misconception that the vaccines were not originally primarily approved to prevent symptomatic infections, but were primarily approved to prevent severe covid and death comes from the top down.

I think this is potentially very damaging to long term public confidence in the health service.

Stormyteacup

https://www.boards.ie/discussion/comment/119967914#Comment_119967914

Tbh I find the statement that covid vaccines were never intended to prevent infection completely baffling. We know now they temporarily reduced transmission and reduced serious illness and death in vulnerable groups, but - and I’ve argued this before - why was there months of talk of herd immunity throughout vaccine rollout?

This can’t be denied as there are any number of prominent people in HSE, NPHET, media and government citing figures of needing 70% or 80% vaccination, then revising to 90% or more total population vaccinated to achieve herd immunity…

A popular response to this question is something along the lines of not enough people could be vaccinated within a short enough timeframe to achieve herd immunity. This makes no sense, as the pace of the vaccine rollout was known all the while herd immunity was still being postulated.

So why the huge push for herd immunity through vaccination if vaccines weren’t thought to prevent transmission?

Dohnjoe

https://www.boards.ie/discussion/comment/119967980#Comment_119967980

The expectations for the vaccines evolved, along with the virus.

Initial expectations were high, especially for a one-shot vaccine that would "stop" Covid, herd immunity and safety were naturally on everyone's lips. Early trials with good results bolstered this. Experts even chimed in (with others giving warnings). Out in the wild though, the virus had other ideas and mutated a lot.

PTH2009

It was an embarrassing mess thinking back

Shutting down non essential services for so long and firstly giving away €350 per week then realising 'oh **** we can't keep this up and must cut it'. Closing down Gyms and sports clubs for so long was also disgraceful

Making up rules as they went along, fingers pointing and instilling fear at every opportunity. RTE huge culprits off this

The whole hospitality fiasco felt the industry was 'targeted" by some individuals. Ffs in October 2020 they allowed places to open outdoors with a max of 15 allowed (many places closed instead). The whole €9 meal was ridiculous and they doubled on it for the 'thanks for saving Xmas time' but it had no 'scientific reasoning'. Takeaway pints/cans and having too piss in an alley way etc was not right and a bit insulting

The 8pm close for non essential around this time last year a mess also. Sure tbh non senseical timings were enforced during the whole thing. Covid must only of came out after 8pm/11pm etc

The whole thing killed people's mental health (including myself) and was OTT for most part. Then the admittance about 'been the strictest in Europe' is quickly forgotten about by the media/leaders. Earlier opening in summer 2020 and earlier reopen on 2021 should of been done. Christmas 2020 could of been done better if we had reopened earlier that year

It's all in the past now and we got through it. Never shall it return

odyssey06

https://www.boards.ie/discussion/comment/119968114#Comment_119968114

I think we were slow to reopen for summers, especially in summer 2020 for outdoor.

But what is this admittance about 'been the strictest in Europe'? At one point, we were in lockdown when other countries weren't but over the course of the pandemic, our strictest measures were far less than what was in place in Spain, France, Italy at certain times.

People behave and interact differently when out drinking than going out for a meal. We weren't the only jurisdiction that distinguished between those scenarios, or had outdoor dining \ drinking only, or had curfew \ earlier closing times. The €9 meal was chosen as it was an existing reference in legislation. In France the curfew was 9pm for example.

Dohnjoe

https://www.boards.ie/discussion/comment/119968114#Comment_119968114

Your personal opinions and gripes. It's easy to retroactively nitpick everything with hindsight. Every single aspect of every measure of course wasn't perfect, but we were dealing with a new disease rapidly spreading across the world, taking lives and threatening national health systems, what we did was generally in line with most other countries, we didn't do anything dramatically different.

The 8pm close for non essential around this time last year a mess also. Sure tbh non senseical timings were enforced during the whole thing. Covid must only of came out after 8pm/11pm etc

Odd view. People go out and socialise in the evening, which increases the spread of the virus, so having a curfew like that at that stage (and that stage in our knowledge of the virus) made sense.

If there's another similar global pandemic, we'll use similar methods to tackle it.

PTH2009

https://www.boards.ie/discussion/comment/119968190#Comment_119968190

https://today.rtl.lu/news/world/a/1598331.html

'PM Michael Martin said the Republic's present restrictions were "probably Europe's strictest regime" but that "further action is now required".'

Stormyteacup

https://www.boards.ie/discussion/comment/119968095#Comment_119968095

Well, yes exactly. What’s puzzling is the claim multiple times on this thread and others, is that the vaccines were never intended to prevent transmission from the outset, and that it’s a deluded memory that initially vaccines “stopping” Covid absolutely was implied and was thought possible.

Flinty997

No doubt some of the rules were a bit crazy. But they mostly made some sense. if enforced, which they often weren't.

But if it spreads in a crowd situation and your industry is driven by crowds and social mixing, its not rocket science why that was restricted.

I don't get why you'd want to reopen sooner in the midst of the worst variants. Considering the explosion the limited reopening's caused at the time.

Flinty997

https://www.boards.ie/discussion/comment/119968234#Comment_119968234

Anyone with common sense knows there are no 100% guarantees in medicine or science.

hometruths

https://www.boards.ie/discussion/comment/119967843#Comment_119967843

What does that document say about intention and what the vaccine was intended to do?

The applicant requested consideration of its application for a Conditional marketing authorisation in accordance with Article 14-a of the above-mentioned Regulation, as it is intended for the prophylaxis of a life-threatening disease.

and

Intended indication: ‘Active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus, in individuals 16 years of age and older’.

and

Pfizer and BioNTech have developed a vaccine that targets SARS-CoV-2, intended to prevent COVID19

and

Comirnaty is intended for active immunisation against SARS-CoV-2, thereby preventing COVID-19.

and

Effects Table for Comirnaty intended for active immunisation to prevent COVID19

odyssey06

https://www.boards.ie/discussion/comment/119968209#Comment_119968209

That's miles away from what you were claiming previously. That relates to a very specific point in time and the measures we adopted were followed later by other countries. So unless you are talking very specifically about October 2020, this falls far short of backing up your previous claim.

hynesie08

https://www.boards.ie/discussion/comment/119968209#Comment_119968209

Reading comprehension is your friend.....

shesty

https://www.boards.ie/discussion/comment/119968234#Comment_119968234

The pharma companies may have realised early on alright that the vaccines wouldn't stop transmission.Quite possibly they highlighted thst possibility to Governments But politicians, whether intending or not, certainly implied that vaccines would stop transmission and prevent serious illness.They may not have actually realised they did that, but they did.In fact I have a memory of several politicians, and NPHET saying after a number of months that the vaccines had not been as successful at stopping transmission as was hoped.Which implied to me that they weren't certain, but they was certainly a hope there that they would prevent disease transmitting as part of what they did.

It is what it is.Unwittingly or not, the implication was there at the very start that vaccines would prevent transmission.How long individual people thought that, probably depended on what their news sources were.

hometruths

https://www.boards.ie/discussion/comment/119967980#Comment_119967980

Tbh I find the statement that covid vaccines were never intended to prevent infection completely baffling.

It's extraordinary. It is literally spelt out specifically and unambiguously and repeatedly in both the trials and the regulators approval documents that the vaccines were intended to prevent COVID19 and yet people still stay they were never intended to prevent COVID 19.

I think most people have just got confused by the mixed messaging along the way and their recollections are shaped by the most recent messaging.

But what I find really extraordinary is that even when you quote verbatim the regulators findings and decision, there are still those who say the words "intended to prevent Covid-19" do not mean intended to prevent Covid-19. See above for an example!

odyssey06

https://www.boards.ie/discussion/comment/119968264#Comment_119968264

It could be argued that prevention of the (life-threatening) disease is different to prevention of infection by the virus, and would encompass protection against severe covid. The vaccines were authorised, had to be authorised, on the basis of the trial data which was based on prevention of symptomatic infection. That in no way means that was the only intention \ expectation regulators, politicians, people had of them.

And that's not all the document says though.

You deliberately left out the parts from the document that is awkward for your claims that immune response only started being mentioned in 2022.

This excerpt below is from the document you linked to. To leave it out is deliberately deceptive and intended to mislead.

By immunisation with the modified RNA (modRNA) product BNT162b2, encoding for the S protein, the intention is to trigger a strong and relatively long-lasting production of high affinity virus neutralizing antibodies, which can act through blocking the S-protein and it’s receptor-binding domain (RBD) interaction with host cell receptors but also by opsonisation mediated virus clearance. In addition, the immunisation with BNT162b2 is also intended to elicit a concomitant T cell response of the Th1 type, supporting the B cells responsible for the production of Sspecific antibodies and cytotoxic T cells that kill virus infected cells

https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

hometruths

https://www.boards.ie/discussion/comment/119968426#Comment_119968426

It can be easily argued that prevention of the (life-threatening) disease is different to prevention of infection by the virus, and would encompass protection against severe covid.

It really can't. But by all means give it your best shot if you want to find out how hard it will be to argue that.

You deliberately left out the parts from the document that is awkward for your claims that immune response only started being mentioned in 2022.

My claim re the immune response was in the context in the evolution of what effective means, not that it had never been mentioned before. Of course in the discussion of vaccines there would be mention of immune response.

in December 2020 effective meant "effective at preventing Covid-19".

By late 2022 "effective" had evolved to mean "effective at triggering an immune response".