Where are all the Covid vaccine Post-Authorisation Safety Studies (PASS) which were one of the conditions of authorisation of the Pfizer, AstraZeneca and Moderna Covid vaccines?
Most people will not have heard of PASS studies, but as the name suggests they are extremely important to monitoring medicine safety. Pharmaceutical companies are almost always required to do them for any new medicine.
The Covid vaccine PASS studies are using real data from the NHS and other national healthcare systems to anonymously match recorded vaccinated and unvaccinated individuals by age, gender and Covid infection status. This allows detailed investigation of the relative incidence of side-effects between vaccinated and unvaccinated individuals.
So PASS studies are far more useful than the Yellow Card system, which just compares the frequency of (passively) reported Covid vaccine side-effects to other medicines, and far more useful that the ONS Covid vaccine safety analysis which founders (among other things) on the ‘denominator problem’: not knowing the number of unvaccinated people. The Covid vaccine PASS studies will be really informative about Covid vaccine safety.
The EMA approved the protocols for doing those PASS studies in 2021: Pfizer, AstraZeneca, Moderna and the MHRA approved the use of NHS data in those studies (see also here for Pfizer, AstraZeneca and Moderna).
Each company set out its timetable for submitting interim progress reports prior to its final report. Using the EMA links above, I counted 13 interim progress reports which should have been published by now.
I consider myself a bit of Google sleuth but I have only managed to find two: AstraZeneca’s ‘Interim Report 1’ and one Pfizer ‘Progress Report‘ which does not contain any results.
So let’s look at AstraZeneca’s ‘Interim Report 1’ dated April 21st 2022, which runs to 292 pages. You can find the U.K. results in Table 11.1, starting on page 128. My observation is that the rate of Adverse Effects of Special Interest (AESI) per 10,000 people is almost always higher in the vaccinated, sometimes significantly. But let’s just go with the report’s core conclusion (page 106):
The largest numerical differences between vaccinated and unvaccinated subjects were observed for the incidence of TTS, thrombocytopaenia with bleeding, anaphylaxis and stress cardiomyopathy.
To be scrupulously fair, that statement came with some caveats: “differences were not consistent across all data sources”, and the results “should be interpreted with caution given the short study period included in this first data extraction and the lack of standardisation or adjustment for potential confounders and potential differences in the baseline characteristics of the study cohorts, which is planned for future analyses”.
Fair enough. So what about AstraZeneca’s “future analyses”? Where is ‘Interim Report 2’, which was due January 2023? Where is its ‘Progress Report’, due April 2023, and its Feasibility Report, due June 2023? Not a sniff of any of them.
And where are any of the Pfizer and Moderna Covid vaccine PASS studies? No sign of them either. So much for transparency and informed consent.
I have an FOI outstanding with the MHRA asking them to send me the missing PASS reports and provide updated delivery dates for the ‘not due yet’ ones. While we wait for MHRA to reply, here are two obvious observations:
- It’s not just MHRA which has failed to publish them; the EMA and FDA have also not published them.
- If the missing reports confirmed that the Covid vaccines were safe, you’d bet your bottom dollar they’d have published them and be shouting them from the rooftops.
I could be wrong and they are lurking somewhere on the web, so if you find them, do let me know. But if I’m right…
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.
To join in with the discussion please make a donation to The Daily Sceptic.
Profanity and abuse will be removed and may lead to a permanent ban.
Genius. Fantastic work! Freaking brilliant!
Very many thanks.
No wonder the ammo was always top notch (except for the greek stuff, obvs!)
Same for all quackcines. Show me a PASS study for any quackcine? None exist. No control group-placebo testing before and after the launch of say MMR? None exist. There is not one single proper analysis of any quackcine ever – either pre or post rollout. No long term studies, not a single one for any of the ‘normal quackcines’ that everyone loves so much – after all without that shot of tetanus surely you would be dead? So why would the criminals be interested in mRNA poison proofs, pre or post or anything for that matter?
googled vaccine covid pass and got this:- https://www.nhs.uk/nhs-services/covid-19-services/nhs-covid-pass/
In fact it is the old vaccine passport, which is obviously still lying around for countries that still need a vaccine passport?
They’ve probably forgotten to delete it. Might be worth archiving it as a reminder of what went wrong.
I doubt they have forgotten to delete it!
A wider search has produced a BMJ article https://www.bmj.com/content/bmj/375/bmj-2021-067570.full.pdf
ICON:-
https://www.iconplc.com/insights/therapeutics/infectious-diseases/covid-19-vaccines-pass/index.xml
EMA:-
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/post-authorisation-safety-studies-pass
NIH:-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9401377/
CPRD under the HMRA:-
https://cprd.com/protocol/post-authorisation-post-marketing-observational-study-using-existing-secondary-health-data
DSRU:-
https://www.dsru.org/blog/it-is-essential-to-monitor-the-post-authorisation-safety-and-efficacy-of-new-covid-19-vaccines/
etc etc
I haven’t read any yet, but they might provide something useful? Or useful in what they don’t say?
What a surprise. By the standard definition of the term “fraud”, billions of people were victims of it, in effect. At least one organisation took the trouble of advertising how many cases (of fraud, in effect) took place on their property. The image here is on display in a public hall.
Wow. It would make me feel far better to explain these kinds of things by saying they’re part of the psyop – just more propaganda. But a lot of what we see and hear is far worse than that, and that public display makes visible the unmentioned social decay that sat as the rock-solid foundations that the whole thing was built on. Narcissism and nihilism. “Look at how fantastic I am. And I’m doing these fantastic things for no other reason than me being fantastic”. That display is Swindon Borough Council telling themselves how utterly fantastic they believe themselves to be. Controlling the masses becomes easy when the masses think as one while believing they are are unique. Basically, were f*cked.
Something else someone could do, if they’re bored, is to look up the census population levels for the areas shown on the plaque, and tot up the percentage of their “clients”. Note that Wyvern Health Partnership is an association of 5 GP surgeries that operate with Swindon Borough. No doubt they have acquired a certain amount of cash via that route. The geography of the other group and others might need a bit of digging to work it out.
Excellent work; thanks for this.
One wonders how many well stuffed brown envelopes were utilised in keeping our fearless Regulators happy with all this?
I wonder if the tax returns of Chinese blank brown envelope exporters, might tell a tale? I bet they have been working three shifts for the last four years.
Andrew Bridgen speaks in Parliament again..
Bill to prevent power grab..
https://youtu.be/QfdmYi5jH-M?si=t7L4DojA8OKc-aQM
Attempt two to post. Article “Evaluatingcovid-19vaccineefficacyandsafetyinthe post-authorisationphase” in BMJ -worth reading. You’ll have to search for it I’m afraid as I’m not posting the link again. Nothing too specific, but the first paragraph says it all:-
“Expedited approval pathways have been increasingly used over the past 30 years to bring new medicines to [the] market.The basic premise has been to give patients earlier access to medicines, often achieved by relying on less robust forms of evidence at the time of approval, such as showing efficacyagainst surrogate endpoints rather than patient outcomes.”
Surrogate endpoints are things like blood pressure, LDL Cholestol, covid antibodies. Not necesarily a bad things, but one should measure the final outcome, but surrogate endpoints are easier to measure.
Thanks for this.
I think the software they use for this site flags posts with more than a certain number of links in them for moderation, to prevent spam possibly. Though yours presumably only had one link in it.
Yes, i hadn’t realised. I wish there was a set uf rules somewhere- if there are I have missed it. Anyway one of the authors of this is Peter Doshi!
Nick – thank you for your assiduous “digging.” Do please carry on keeping us informed.
Well it is worth looking at some of this stuff:-
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section
It says:-
“Efficacy studies are large studies that evaluate the benefit of a medicine. For vaccines, these studies usually involve thousands of volunteers.
Developers first test the vaccine’s efficacy in people who have not previously come into contact with the virus that causes COVID-19 – the so-called ‘naive populations’.”
Then further down:-
“As it becomes less feasible to conduct an efficacy study, for example because more and more people have already been exposed to COVID-19 or have been vaccinated against the virus, the immunogenicity of the vaccine (e.g. levels of antibodies or other types of immune responses induced by the vaccine) can be used instead as a surrogate for efficacy.”
So they will look at the anti-body response, which does not fill me with confidence!
No links for me anymore.
I do need an explanation, assuming this site continues to want my support. It is not spam, nor offensive. MHRA site. Go and find it:-
It says:-
“Efficacy studies are large studies that evaluate the benefit of a medicine. For vaccines, these studies usually involve thousands of volunteers.
Developers first test the vaccine’s efficacy in people who have not previously come into contact with the virus that causes COVID-19 – the so-called ‘naive populations’.”
Then further down:-
“As it becomes less feasible to conduct an efficacy study, for example because more and more people have already been exposed to COVID-19 or have been vaccinated against the virus, the immunogenicity of the vaccine (e.g. levels of antibodies or other types of immune responses induced by the vaccine) can be used instead as a surrogate for efficacy.”
So they will look at the anti-body response, which does not fill me with confidence!
“No links for me anymore.
I do need an explanation, assuming this site continues to want my support. It is not spam, nor offensive. MHRA site. “
Well your post with links appears above. I am sure it’s an automated feature of the site software. It’s possible they could turn it off, but what we don’t know is how much actual spam there is that we don’t see because posts with lots of links are put into quarantine. It may take a while for the mod(s) to check posts – I doubt they have a team of people on this 24*7 – their budget is tiny.
Of course they’re not to be found anywhere, we all know that the results are too dreadful for them to publish.
Another study that hasn’t appeared is in some ways more interesting, as it was ordered after the rollout and in direct relation to a flagged AE.
After spending several months of ignoring notifications of myocarditis in young men (in particular) by such bodies as the Israeli and US army, the CDC decided to hold an ’emergency’ meeting on the ‘rare’ cases of myocarditis being reported. They promptly postponed what they themselves called an emergency meeting for the at that time non-existent holiday of juneteenth. When they did finally hold the meeting, if my memory serves me correctly, they ordered pfisser to conduct a study on reports of myocarditis, to be finalised around January 2022. A report on this study was to be published around August 2022. To the best of my knowledge, as of November 2023 such report still has not been published. This goes beyond just giving a head-nod to post-authorisation studies – this study was specifically ordered in relation to a clear risk.
I haven’t looked at the FDA site in some time, but the last time I looked (spring 2023) the data on which it based its ongoing claim of safe and effective was data gathered to 13 March 2021. Why has no one ever questioned why they have not updated the claims regarding the vaxx to data to March 2022, or March 2023? It was one thing to claim they had to make haste due to the most deadly, deadliest lurgy ever, and so sufficed with barely 2 months’ worth of data – but why was it never updated? It was, supposedly, being rigorously monitored at all times.
Slightly off topic, about the Covid Inquiry. Good letter in the DT today from a KC. Lady Hallett should be sacked:
Covid inquiry concernSIR – It is becoming harder to disagree with the growing chorus of well-reasoned concern about the Covid inquiry, and to avoid the impression that its chair and counsel are proceeding, as Lord Frost suggests (Comment, October 27), on the preconceived basis that lockdowns were the correct solution, and the only real issue is the timing of them.
The treatment of Professor Carl Heneghan may be indicative. Professor John Edmunds, a lockdown proponent, had earlier that day gone effectively unchallenged. Professor Heneghan was subjected to sustained – if softly spoken – denigration. Lady Hallett’s only intervention was to ask about the emergence of evidence of long Covid. When Professor Heneghan began to answer, “Well, yes, so everything exists as evidence, even my opinion exists as evidence within –”, she interrupted to contradict him: “Not in my world it doesn’t, I’m afraid. Well, not in a court of law it doesn’t.”
What could she possibly mean? Evidence of expert opinion is routinely received by civil and criminal courts and the inquiry has already heard a great deal of it. Why should Professor Heneghan’s opinion fall into some different, inadmissible category? Most worryingly, where does this leave the authority of the inquiry’s final conclusions?
His Honour Charles Wide KC
Peterborough
Encouraging that a senior judge is happy to sign his name to this view, publicly.
I submitted a letter to the DT 2 days previously saying the same thing, but without the initials KC after my name. It wasn’t published!! Glad to see that one of my learned friends has the courage to put their head above the parapet. The DT must have taken the decision to publish on the strength of feeling in their BTL online comments.
What we need is a crowd-funded private prosecution of Witty for genocide, murder, whatever. There is loads of proof, so it shouldn’t be difficult. His Honour Charles Wide KC would be the lead, in fact if this were his personal opinion he might be prepared to do it pro bono.
https://www.conservativewoman.co.uk/where-are-sages-scientists-now-priming-us-for-un-agenda-2030-part-4/
Part 4 from Karen Harradine over at TCW looking at two more Nuremberg code violators – Edmunds and McLean. Another couple of Oxygen thieves.
“not disabled enough”…. The disgusting attritional so called vaccine damage payment scheme…
https://youtu.be/gdeYzaTZsOA?si=BPXoRJQcuGRCDpNl
A friend of mine from Denmark suffered a massive urticaria following his 2nd vaccine. It was confirmed by biosy that he had the spike protein in his skin. At the same time he suffered from tinnitus which is still ongoing.
He remains in full time work, however because his urticria/tinnitus was attributable to the jabs he can apply for a vaccine damage payment.
But that is Denmark not the UK where I doubt he would get anything.
Applying and receiving the payment are two different things.
I hope his claim in successful.
Here in the UK it’s historic that successful vaccine damage payouts are extremely hard to achieve, anyway what’s 120k (max payout) if you need care for the rest of one’s life..
Giving these big pharma companies exemption from litigation in the event of vaccine injuries and death was the most abhorrent aspect of this whole affair, and I’d like to know exactly how this came about and exactly who agreed and authorised it.
P
Presumably because the PASS will show the experimental gene therapy treatments to be ineffective and darn right dangerous they will hope the whole operation will be forgotten about and left to rot in the weeds.Just a guess.