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The Lancet and the Pfizer Vaccine: A Case Study in Academic Censorship and Deceit in the Covid Era

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Abstract

In May 2021 The Lancet published a study of the Pfizer covid vaccine on the population of Israel, claiming to show it was 95% effective. On 17 May 2021 we submitted a rapid response 250-word letter explaining why the study was flawed and how the 95% claim was exaggerated. After an initial response saying they would ask the authors for a response to our letter we heard nothing until 20 months later. On 8 January 2023 The Lancet sent an email apologising for never having got back to us about the letter, saying that they had asked the lead author Dr Sharon Alroy-Preis (SA-P) to respond to our letter but, because she did not provide any formal response, they decided not to publish our letter. We tweeted The Lancet's response and published a substack article highlighting that we were now aware of additional problems with the paper relating to SA-P’s relationship with Pfizer. These media posts got 1.5 million reads within 24 hours. On 11 January 2023 we received an email from The Lancet apologising for the ‘sub-standard experience’ and that they were now inviting us to publish the original letter or an update to it, suggesting the update ‘reflect more current experience with the vaccine’. On 12 January 2023 we submitted our updated letter (they stipulated a maximum of 350 words). On 13 January 2023 we got a response from The Lancet saying they had decided against publishing the letter, asserting that any claim questioning the efficacy and safety of the Pfizer vaccine was ‘misinformation’ and that they did not consider the position of SA-P an undeclared conflict of interest or a challenge to the integrity of the data.
1
The Lancet and the Pfizer Vaccine:
A Case Study in Academic Censorship and Deceit in the Covid Era
Norman Fenton and Martin Neil
Queen Mary University of London
17 January 2023
Abstract
In May 2021 The Lancet published a study of the Pfizer covid vaccine on the population
of Israel, claiming to show it was 95% effective. On 17 May 2021 we submitted a rapid
response 250-word letter explaining why the study was flawed and how the 95% claim
was exaggerated. After an initial response saying they would ask the authors for a
response to our letter we heard nothing until 20 months later. On 8 January 2023 The
Lancet sent an email apologising for never having got back to us about the letter, saying
that they had asked the lead author Dr Sharon Alroy-Preis (SA-P) to respond to our
letter but, because she did not provide any formal response, they decided not to publish
our letter. We tweeted The Lancet's response and published a substack article
highlighting that we were now aware of additional problems with the paper relating to
SA-P’s relationship with Pfizer. These media posts got 1.5 million reads within 24 hours.
On 11 January 2023 we received an email from The Lancet apologising for the ‘sub-
standard experience’ and that they were now inviting us to publish the original letter or
an update to it, suggesting the update reflect more current experience with the
vaccine’. On 12 January 2023 we submitted our updated letter (they stipulated a
maximum of 350 words). On 13 January 2023 we got a response from The Lancet
saying they had decided against publishing the letter, asserting that any claim
questioning the efficacy and safety of the Pfizer vaccine was ‘misinformation’ and that
they did not consider the position of SA-P an undeclared conflict of interest or a
challenge to the integrity of the data.
1 The original article
On 6 May 2021 The Lancet, supposedly the most prestigious medical journal in the world,
published the article (Haas et al., 2021) describing the largest observational study up until then
(covering most of the population of Israel) into the effectiveness of the Pfizer covid vaccine.
The paper claimed 95% effectiveness; this happened to be exactly the same figure claimed
by Pfizer in its original Phase 3 randomised controlled trial (Polack et al., 2020). Such a high
level of effectiveness in such a large population cohort was widely used as the ultimate
confirmation of how effective the vaccine was (the study did not consider safety at all, but more
on that later). Figure 1 is indicative of the many major newspaper stories and headlines about
the study.
2
Figure 1 The study was widely promoted as definitive evidence of the Pfizer vaccine
efficacy
Notwithstanding the fact that 8 of the 15 authors "hold stock and stock options in Pfizer" (see
Figure 2) the results in the paper looked impressive and seemed to provide support for the
hypothesis that the vaccine is effective in preventing infection.
Figure 2 Eight or the fifteen authors held 'stock and stock options in Pfizer'
In particular, the raw data (Table 2 of the paper**) stated the following:
Between 24 Jan 2021 and 3 April 2021 there were 109,876 'cases' of SARS-Cov-2
found among those unvaccinated
1
compared to just 6,266 'cases' found among those
vaccinated.
The table also provides the 'incident rate per 100,000 person days' which is: 91.5 for
unvaccinated compared to 3.1 for vaccinated
Based on these data the (adjusted) 'vaccine effectiveness' measure
2
is calculated as
95.3% (hence the headline figure picked up by all mainstream media).
1
Although Table 2 states that there was a total of 109,876 'cases' among the unvaccinated, there seems to be
an error in the table in that the total number of asymptomatic cases (49,138) and symptomatic cases (39,065)
do not sum to 109,876
2
The 'vaccine effectiveness' measure is defined as: 100 times (1 - the incident rate ratio). The incident rate
ratio is (approximately) the incident rate of fully vaccinated divided by the incident rate of unvaccinated.
3
Figure 3 Screenshot of Table 2 of the paper
Before discussing the flaws in the study, it is worth noting that, even if we accept as undisputed
the number for 'Covid-19 related deaths' in the Israel study (715 among the unvaccinated and
138 among the vaccinated), then the absolute percentage increase in risk of death for an
unvaccinated person is just 0.036%. That means that, even if we accept the 95% effectiveness
measure, for every 10,000 unvaccinated people who catch Covid-19, about 3 or 4 would die
as a result of not being vaccinated. Critically, however, the paper does not provide any
information about the number of adverse reactions - in particular the number of deaths - due
to the vaccine. Hence, it does not provide the necessary information to make an informed
decision about the overall risk/benefit of the vaccine.
4
But, ignoring the total lack of ‘safety data’, the study was flawed in many ways. For example,
(Jones, 2021) argued that the researchers had not adjusted for the declining infection rate
during the study period and that when you do so, the effectiveness drops to 74% (in the over
65's). There were also two major systemic biases in the study that have been common to
many observational studies of vaccine effectiveness:
It ignored all covid cases reported for people who had received either just a single or
a second dose less than seven days previously; such people were not considered ‘fully
vaccinated’ and this inevitably leads to a significant exaggeration of vaccine
effectiveness. The consequence of this deliberate miscategorisation is reported in our
analysis of official UK government data (Neil et al., 2021) and is explained in (Fenton
& Neil, 2022).
Those with Covid-19 symptoms were prevented from obtaining a vaccine. As
explained in (Reeder, 2021) this always leads to an overestimate of vaccine efficacy
and was also a feature of the other major observational study in Israel (Dagan et al.,
2021) and which also reported high efficacy rates for the Pfizer vaccine.
However, because rapid response letters to The Lancet are restricted to just 250 words, we
were focused on a different but very significant bias in the study which arises from the
statement found on page 8 of (Haas et al., 2021), shown in Figure 4.
Figure 4 Statement on page 8 of the paper
What this is saying is that, whereas unvaccinated people continued to be regularly and
routinely subject to PCR tests, vaccinated people no longer had to be. The number of 'cases'
stated in Table 2 is, of course, simply the number of positive PCR test outcomes (which
includes false positives). Obviously, if you stop testing vaccinated people, then you are not
going to find any 'cases' among them. The paper says that 19% of the tests were, however,
on 'exempted', i.e., vaccinated people. But this still means unvaccinated people were much
more likely to be tested than vaccinated people, so we have to take account of the absolute
number of tests performed on both vaccinated and unvaccinated.
We know that there were 4.4 million PCR tests and that 19% of these were on vaccinated
people. Hence, we can conclude that there were:
5
836,000 tests on vaccinated people (of whom there were 4,714,932, making up 72.1%
of the population; so, on average approximately one in six vaccinated people received
a PCR test);
3,564,000 tests on unvaccinated people (of whom there were 1,823,979; so, on
average, each unvaccinated person received two PCR tests)
So, the number of 'cases' per 1000 tests were:
30.8 for unvaccinated people (109,876 divided by 3,564,000 times 1000)
7.5 for vaccinated people (6,266 divided by 836,000 times 1000)
Using the simpler 'cases per 1000 tests' (rather than the biased 'incident rate per 100,000
person days'), results in an approximate 'vaccine effectiveness' measure of 75.7%. This is
before the result is adjusted for all of the other biases described above.
Of course, the failure to adjust the vaccine effectiveness calculation for different testing
protocols for vaccinated and unvaccinated people is not restricted to this observational study
in Israel. The data in (Polack et al., 2020) suggests there was a similar bias in the phase 3
trial of the Pfizer vaccine. This was a randomized, double-blinded, and placebo-controlled trial
of the vaccine in 44,000 uninfected participants. Its 95% effectiveness measure was based on
the claim that (post injection) there were 162 confirmed Covid-19 cases among the placebo
participants compared to just 8 among the vaccinated participants. However, the study also
reports that there were a much larger number of 'suspected but unconfirmed' cases and that
these were more evenly spread between placebo participants (1,816 such cases) and
vaccinated participants (1,594 such cases). This seems to suggest that a disproportionately
small number of vaccinated participants with symptoms received PCR tests compared to
placebo participants with symptoms.
Clearly the failure to properly adjust for all of the above-mentioned biases casts doubt on the
validity of the paper’s results, but here is the letter we submitted to The Lancet on 17 May
2021:
The article [1] provides impressive support for the effectiveness of the Pfizer vaccine,
but important limitations in the overall analysis mean the results over-estimate vaccine
effectiveness. One is that the study does not adjust for declining infection rate [2]. But
there is also failure to properly adjust for the different testing protocols for vaccinated
and unvaccinated people (page 8 of the paper). Whereas unvaccinated people
continued to be regularly and routinely subject to PCR tests, vaccinated people no
longer had to be. Although 836,000 (19%) of the 4.4 million PCR tests were on
vaccinated people, 3,564,000 were on unvaccinated.
So, using the Table 2 data (109,876 cases among unvaccinated, and 6,266 among
vaccinated) the number of 'cases' per 1000 tests were:
30.8 for unvaccinated
7.5 for vaccinated
Using 'cases per 1000 tests' results in an approximate 'vaccine effectiveness' measure
of 75.7%, compared to the 95% headline figure.
Failure to account for different testing protocols is also evident in the phase 3 trial of
the Pfizer vaccine [3]. It similarly reports a 95% effectiveness measure based on 162
confirmed cases among placebo participants compared to just 8 among vaccinated
6
participants. However, the study also reports a much larger number of 'suspected but
unconfirmed' cases more evenly spread between placebo participants (1,816) and
vaccinated participants (1,594). This suggests a disproportionately small number of
vaccinated participants with symptoms received PCR tests compared to placebo
participants with symptoms.
[1] Haas et al: “Impact and effectiveness of mRNA BNT162b2 vaccine against
SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths
following a nationwide vaccination campaign in Israel: an observational study
using national surveillance data”
https://doi.org/10.1016/S0140-6736(21)00947-8
[2] Jones: “Study Claims Pfizer Vaccine is 95% Effective in Over 65s. But
Should That Be 74%?” https://lockdownsceptics.org/2021/05/07/study-claims-
pfizer-vaccine-is-95-effective-in-over-65s-but-should-that-be-74/
[3] FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine,
https://www.fda.gov/media/144245/download
2 The long delay and remarkable ‘rejection’ of the letter
After sending the letter in May 2021, the editors (when prompted three weeks later) said they
were waiting for the authors to respond before they could publish the letter. Despite a further
prompt from us in August 2021 we heard nothing back until we received the following
remarkable response on 8 January 2023, 20 months after it was originally submitted:
From: On Behalf Of The Lancet Team
Sent: 08 January 2023 13:30
To: Norman Fenton
Subject: Your Submission THELANCET-D-21-03671
Manuscript number: THELANCET-D-21-03671
Title: Study on effectiveness of Pfizer vaccine overestimates its effectiveness
Dear Professor Fenton,
Happy new year. I hope you’ve had a good start to 2023 so far.
Here at The Lancet editorial office, we have begun the new year by sorting through
dated submissions in our online manuscript management system, Editorial Manager.
I am sorry to see that this submission of yours from 2021 is still open.
We had invited Dr Sharon Alroy-Preis and co-authors of the published article to
consider your letter, but I am sorry that we never received a formal reply from them
and therefore have not been able to pursue an exchange. But I am even more sorry
that I didn’t communicate a decision with you in a timely manner.
I will now close your submission, but I thank you for supporting post-publication debate
in The Lancet.
Yours sincerely
7
Josefine Gibson
Senior Editor
The Lancet
We were so shocked at the brazenness of this response not publishing our letter simply
because the leader author did not reply to it that we put out a tweet
3
with a copy of the
response (Figure 5).
Figure 5 Tweet about the Lancet letter on 8 Jan 2023
We were not even aware at this point that Dr Sharon Alroy-Preis was the lead author. But we
started to do some investigating. And as a result we wrote a follow-up substack article on 10
Jan 2023 (Fenton & Neil, 2023) as shown in Figure 6.
3
https://twitter.com/profnfenton/status/1612110949279752194
8
Figure 6 Our substack article of 10 Jan 2023
The key findings in this article about the lead author Dr Sharon Alroy-Preis (SA-P), who
refused to reply to our short criticism of her article, were:
Unlike 8 of the 15 authors who declared a relationship with Pfizer, SA-P was not among
them and, indeed declared no conflict of interest at all see Figure 7.
But it turns out that SA-P just happens to be the Head of Public Health Services at the
Israeli Ministry of Health (IMOH) through whom Israel essentially became ‘the
laboratory for Pfizer’
4
as reported by the Times of Israel in September 2021
5
:
Philip Dormitzer, the chief scientific officer at Pfizer, made the comments to a
Zoom gathering of academics last week. They were first reported by Channel
12 news on Friday night.
“Early in the pandemic we established a relationship with the Israeli Ministry of
Health where they used exclusively the Pfizer vaccine and then monitored it
very closely,” Dormitzer told the gathering, “so we had a sort of laboratory
where we could see the effect.”
PM Benjamin Netanyahu also made exactly this boast (and more about collection and
use of people’s DNA) in a recent video
6
4
https://brownstone.org/articles/how-the-israeli-ministry-of-health-became-an-agent-for-pfizer/
5
https://www.timesofisrael.com/pfizer-exec-calls-israel-a-sort-of-laboratory-for-covid-vaccines/
6
https://youtu.be/ItpErus4pSM
9
Figure 7 SA-P declared no conflict of interest
The collaboration between Pfizer and the IMOH (which started 6 Jan 2021, i.e., 4
months before the SA-P article in which she declared no conflict of interest was
published) is clearly laid out in the (partially redacted) collaboration agreement
between Pfizer and the IMOH
7
. Section 9.1 of this Israel-Pfizer agreement provided for
the parties to jointly approve any publication, and SAP is explicitly named as the
IMOH’s representative in resolving any differences - Figure 8.
Hence, SA-P was leading the IMOH’s collaboration with Pfizer all along.
The Lancet article provided no information at all about the number of covid-19 vaccine
adverse reactions which we now know are substantial (Guetzkow, 2023; Rancourt,
Baudin, & Mercier, 2022), and so it is also relevant and timely to point out SA-P’s role
in the emerging IMOH scandal relating to the system for monitoring serious adverse
reactions to the Pfizer vaccine
8
. In her presentation to the FDA expert committee about
the booster, SA-P claimed Israel monitors safety closely, whereas we now know they
did not in fact have a functioning system until the end of 2021 - as was exposed in a
leaked video from an internal meeting of the IMOH that they do not want anybody to
see.
9
7
https://govextra.gov.il/media/30806/11221-moh-pfizer-collaboration-agreement-redacted.pdf
8
https://www.frontline.news/post/israel-health-ministry-concealed-manipulated-vaccine-injury-data-say-
leaked-documents
9
https://youtu.be/8ibKpyKeVEc
10
Figure 8 Collaboration Agreement between Pfizer and the IMOH
3 The second apology and second rejection of the letter
The tweet
10
that we put out on 8 January 2023 gained over a million views inside 24 hours,
shown in Figure 9. The follow-up substack article on 10 January 2023 detailing SA-P’s
relationship with Pfizer (Fenton & Neil, 2023), together with the tweet promoting it also gained
over million views. Many of the commenters tagged the Lancet Letters Editor Josefine Gibson
expressing their disgust.
10
https://twitter.com/profnfenton/status/1612110949279752194
11
Figure 9 Response to tweet of 8 January 2023
Although we had not replied in any way to Josefine Gibson’s email of 8 January, she sent the
following curious, unsolicited email on 10 January 2023:
From: Gibson, Josefine (ELS-LOW)
Sent: 10 January 2023 15:50
To: Norman Fenton
Subject: The Lancet - Your letter from May 2021.
Dear Professor Fenton,
Thank you for bringing your letter from May 2021 back to our attention. We are looking
into next steps and will get back to you as soon as we can.
Kind regards,
Josefine
Josefine Gibson, Dr. rer. nat.
Senior Editor, Correspondence | THE LANCET
On 11 Jan 2023 at 10:58 we sent the following email to Richard Horton (Editor-in-Chief of The
Lancet) attaching the 8 January ‘rejection’ email:
From: Norman Fenton
Sent: 11 January 2023 10:58
To: richard.horton
Subject: Extremely concerning response by The Lancet to an obviously problematic
paper
Dear Prof Horton
12
I received the response below 20 months after first submitting a very short response
to an article that appeared in The Lancet in May 2021 (the article claimed 95%
effectiveness of the Pfizer vaccine in Israel).
I posted this response on twitter (along with a link to a blog piece we wrote in May
2021 containing more detailed concerns about the article):
https://twitter.com/profnfenton/status/1612110949279752194
That tweet gained over a million impressions within 24 hours, with many people
expressing their disgust with The Lancet in response.
But it turns out that we have since discovered further concerns regarding undeclared
conflicts of interest with the lead author of the article.
These concerns are summarised in a substack article we have just produced:
https://wherearethenumbers.substack.com/p/alroy-preis
I would be grateful to hear if, in the light of the damage to the credibility of The Lancet,
you have any plans to highlight the concerns we have raised about the article
especially given the damage it has done with respect to misinformation about vaccine
effectiveness.
Yours
Norman Fenton
Professor Emeritus
Queen Mary University of London
Twenty-three minutes later, at 11.21 on 11 January 2023 Josefine Gibson sent the following:
From: Gibson, Josefine (ELS-LOW)
Sent: 11 January 2023 11:21
To: Norman Fenton
Subject: The Lancet - invitation
Dear Professor Fenton,
I am writing to offer my sincerest apologies for the substandard experience you’ve had
with The Lancet.
We have very specific processes for submitted letters that respond to our published
content, and these are designed to ensure that an outcome is reached in a timely
manner. I regret that I was unable to uphold those processes for your letter.
Having discussed this unfortunate situation with my Editor in Chief, Richard Horton, I
would like to offer publication of your original letter. Alternatively, we could publish a
new letter that reflects more a current experience with the Pfizer vaccine. We defer to
your best judgement of what would best serve the medical community.
13
We very much hope you’ll accept this offer. Rest assured that your submission will be
handled by a colleague with upmost priority.
Kind regards,
Josefine
Josefine Gibson, Dr. rer. nat.
Senior Editor, Correspondence | THE LANCET
We replied shortly afterwards:
From: Norman Fenton
Sent: 11 January 2023 12:00
To: Gibson, Josefine (ELS-LOW
Cc: Norman Fenton ;Martin Neil
Subject: RE: The Lancet - invitation
Josefine
Thank you for this.
If we go with the new letter option what is the word limit?
Yours
Norman Fenton
Josefine agreed to a 350-word new letter with limit of 5 references:
From: Gibson, Josefine (ELS-LOW)
Sent: 11 January 2023 22:46
To: Norman Fenton
Subject: RE: The Lancet - invitation
Dear Professor Fenton,
If you choose to write in response to published content, the word limit is 250 words. If
you’d like to write a more general letter, the limit is 350 words. In both cases, please
limit the number of references to five.
Thank you.
My best wishes,
Josefine
This is the letter we sent to Josefine Gibson and Richard Horton at 16:26 on 12 January (349
words, 5 references as agreed):
14
Misleading Claims in study of Pfizer vaccine effectiveness
Norman Fenton and Martin Neil, 12 Jan 2023
An article about Israel’s experience with the Pfizer covid-19 vaccine was published in
The Lancet in May 2021, [1]. We wrote a response letter, [2], explaining why its claim
of 95% effectiveness was exaggerated, pointing out that the study failed to adjust for
a declining infection rate, and for the very different testing protocols applied to
vaccinated versus unvaccinated people. The study also ignored all covid cases
reported for people who had received either just a single or a second dose less than
seven days previously; such people were not considered ‘fully vaccinated’, inevitably
leading to an exaggeration of vaccine effectiveness [3].
These concerns expressed 20 months ago, have been borne out by data confirming
how exaggerated the effectiveness claim was.
The Lancet sent our letter to the lead author of the study, Sharon Alroy-Preis (SA-P),
for comment but she did not respond to the criticisms, so the Lancet did not publish it.
We have further concerns about the integrity of the article. SA-P was not among the 8
of 15 authors who declared holding share and stock options in Pfizer; she also declared
no conflict of interest. Yet, she is Head of Public Health Services at the Israeli Ministry
of Health (IMOH) during the period when Israel became the ‘laboratory for Pfizer’ [4].
The relationship between Pfizer and the IMOH (starting 6 Jan 2021, four months before
the Lancet article was published) is laid out in their collaboration agreement [5] which
makes clear results cannot be made public without both parties’ approval, and names
SA-P as the IMOH appointee responsible for managing this relationship with Pfizer.
The Lancet article provided no information about the vaccine’s adverse reactions
which we now know are substantial. In her presentation to the FDA expert committee
about the booster, SA-P claimed Israel monitors safety closely, whereas we now know
they did not have a functioning system until the end of 2021 [4].
Hence, we feel that the paper’s findings – which led many to believe the Pfizer vaccine
was extremely safe and effective - are severely compromised and that the article
should be retracted.
References
[1] Haas et al: “Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-
CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a
nationwide vaccination campaign in Israel: an observational study using national
surveillance data” https://doi.org/10.1016/S0140-6736(21)00947-8
[2] Fenton NE and Neil M “Is the Pfizer vaccine as effective as claimed?”, 17 May 2021.
https://wherearethenumbers.substack.com/important-caveats-to-pfizer-vaccine
[3] Neil M, Fenton N, Smalley J., Craig C., Guetzkow J., McLachlan S., Rose, J. Latest
statistics on England mortality data suggest systematic mis-categorisation of vaccine
15
status and uncertain effectiveness of Covid-19 vaccination, December 2021.
http://dx.doi.org/10.13140/RG.2.2.14176.20483
[4] Fenton NE and Neil M, “The curious case of Dr Sharon Alroy-Preis and the claims
of safety and effectiveness of the Pfizer vaccine”.
https://wherearethenumbers.substack.com/p/alroy-preis
[5] Real-world epidemiological evidence collaboration agreement between the Israeli
Ministry of Health, acting on behalf of the State of Israel and Pfizer Inc, 6 Jan 2021.
https://govextra.gov.il/media/30806/11221-moh-pfizer-collaboration-agreement-
redacted.pdf
Josefine initially sent this response:
From: Gibson, Josefine (ELS-LOW)
Sent: 12 January 2023 19:39
Subject: RE: The Lancet - invitation
Thank you very much, Norman. I shall share this with Richard Horton now, and I expect
I’ll be back in touch with you re next steps tomorrow.
All best wishes,
Josefine
From: Norman Fenton
Sent: 12 January 2023 16:26
To: Gibson, Josefine (ELS-LOW)
Subject: RE: The Lancet - invitation
Josefine
I attach the letter. Excluding title and (5) references it is 349 words.
Yours
Norman Fenton
Astonishingly, this is the response we got on 13 January 2023:
From: Gibson, Josefine (ELS-LOW)
Sent: 13 January 2023 15:24
To: Norman Fenton
Subject: RE: The Lancet - invitation
Dear Professor Fenton,
Thank you for submitting your letter for consideration.
16
We have discussed the points you raise among The Lancet's Editorial Team and have
decided against publication for the following reasons:
1. Given existing evidence about the effectiveness and safety of the Pfizer
vaccine, it is factually incorrect indeed, it is misinformation - to say that
reported adverse reactions are "substantial".
2. Author Dr Sharon Alroy-Preis clearly gives her affiliation with the Israel Ministry
of Health (IMoH) in the paper "Correspondence to: Dr Sharon Alroy-Preis,
Public Health Services, Israel Ministry of Health, Jerusalem 9101002", and we
do not consider her position an undeclared conflict of interest or a challenge to
the integrity of the data.
We regret the delayed correspondence regarding the status of your letter and fully
accept your criticism of our editorial processes in this regard.
Sincerely,
Josefine
So, there you have it. Having offered to publish the original letter or an update to it, The Lancet
reneged. We are dubbed misinformation spreaders because apparently The Lancet have
unique access to the truth, while the integrity of the Israeli trial data is placed beyond question
even though the Israeli public health apparatchik, SA-P, who is supposed to be independent
of corporate interests, is legally bound to publish results approved by Pfizer.
4 Postscript
Our experience is just one of many similar that provide evidence of The Lancet becoming “the
mouthpiece of the medical establishment”. This has become ever clearer during the Covid
era, starting with its publication in Feb 2020 of a letter organized by Peter Daszak into the
origins of the Sars-CoV-2 virus (Calisher et al., 2020). As this Spectator article asserted
11
The journal’s role as the mouthpiece of the medical establishment couldn’t have been
clearer in February last year, when it published a group letter organised by the
zoologist Peter Daszak on the origins of the Sars-CoV-2 coronavirus. As well as
‘strongly condemn[ing] conspiracy theories’ that the virus did not have a natural origin,
the letter expressed ‘solidarity’ with all scientists and health workers in China, ending
with some oddly Soviet-era phrasing: ‘Stand with our colleagues on the front line! We
speak in one voice.’
The letter didn’t reveal that Daszak was himself involved with virological research at
the Wuhan Institute of Virology, the lab at the centre of the ‘lab leak’ speculation.
Medical journals are usually hyper-aware of potential conflicts of interest for
instance, if a clinical trial was funded by a pharmaceutical company but in this case
the Lancet let it slide.
11
https://www.spectator.co.uk/article/how-the-lancet-lost-our-trust/
17
Even more serious was their rapid publication of an obviously fraudulent study by Surgisphere
(Mehra, Desai, Ruschitzka, & Patel, 2020) that crucially managed to delegitimise the efficacy
and safety of hydroxychloroquine as an early treatment for covid before being retracted
12
.
A special irony is that Richard Horton, The Lancet Editor-in-Chief, who has overseen these
fiascos, previously published his own statement about corruption in the scientific literature
(Horton, 2015) that included this statement:
The case against science is straightforward: much of the scientific literature, perhaps
half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects,
invalid exploratory analyses, and flagrant conflicts of interest, together with an
obsession for pursuing fashionable trends of dubious importance, science has taken a
turn towards darkness.
Of course, The Lancet is just one of many prominent medical journals which have been
protecting the interests of Pfizer and other pharma companies and censoring submissions that
question the ‘official’ covid narrative. We have provided many other examples
13
where we
have been directly affected by this. While re-investigating the flaws in (Haas et al., 2021) we
discovered that other major observational studies making similar claims of efficacy for the
Pfizer and other vaccines such as (Dagan et al., 2021; Pilishvili et al., 2021) also had blatant
statistical flaws which were revealed in reports that never managed to get published, such as
(Reeder, 2021). None of this should come as a surprise to those who have examined in detail
the full Pfizer phase 3 trial data which, contrary to showing 95% efficacy, may reveal zero or
negative efficacy
14
. This is something we shall review in a subsequent article.
References
Calisher, C., Carroll, D., Colwell, R., Corley, R. B., Daszak, P., Drosten, C., Turner, M.
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Chapter
There is a vast literature on COVID-19, and this update cannot hope to cover all of what is known about infection in children. Instead, the approach taken is to consider evidence in the light of what I will call ‘myths’ that predominated the pandemic narrative. Now that SARS-CoV-2 is an endemic virus, and much of the panic has subsided, it is important to revisit these myths in order to learn from our mistakes so that we do not repeat the same in the future. I will give evidence to show that SARS-CoV-2 was never a great threat to children, sequelae of infection in children were exaggerated, and vaccine safety and efficacy in children were exaggerated. Nevertheless, the response to the pandemic caused immense predictable and preventable harm to children. Better responses would have considered focused protection of those at high risk from the virus (i.e., older people with severe comorbidities), reducing fear in the population, augmenting surge capacity in healthcare, and cost-benefit analyses of possible responses (i.e., considering the predictable collateral damage acknowledged in previous literature). The Emergency Management process was not followed. This process should now be followed in devising a plan for recovery from the pandemic responses.
Preprint
Full-text available
Given that population COVID-19 vaccination does not appreciably reduce SARS-CoV-2 transmission, instead, the potential to reduce hospitalization has been used to justify coercive vaccine passports. We aim to use a recently published research study as an example in order to demonstrate how data can be misinterpreted and result in deriving misleading ethical and policy implications. Bagshaw et al wrote that unvaccinated patients with COVID-19 in Alberta, Canada “had substantially greater rates of ICU admissions, ICU bed days, and ICU related costs than vaccinated patients did. This increased resource use would have been potentially avoidable had these unvaccinated patients been vaccinated.” The authors in Bagshaw et al then concluded that their findings “have important implications for discourse on the relative balance of increasingly stringent public health protection (restrictions), including mandatory vaccination policies, and the sustainability and function of health system infrastructure and capacity during the ongoing COVID-19 pandemic.” Here we show the following. First, the effect of vaccination on intensive care admissions were grossly over-estimated due to several limitations of this and almost all other vaccine studies. Second, an effect of vaccination on access to acute care and on all-cause excess deaths was grossly over-stated due to several more likely causes being omitted from discussion and from the common narrative. Third, policy implications were overstated and at best unclear due to missing consideration of more relevant aspects required to inform policy. Overall, the data cannot support what Bagshaw et al called “increasingly stringent public health protection (restrictions), including mandatory vaccination policies”.
Preprint
Full-text available
All-cause mortality by time is the most reliable data for detecting and epidemiologically characterizing events causing death, and for gauging the population-level impact of any surge or collapse in deaths from any cause. Such data is not susceptible to reporting bias or to any bias in attributing causes of death. We compare USA all-cause mortality by time (month, week), by age group and by state to number of vaccinated individuals by time (week), by injection sequence, by age group and by state, using consolidated data up to week-5 of 2022 (week ending on February 5, 2022), in order to detect temporal associations, which would imply beneficial or deleterious effects from the vaccination campaign. We also quantify total excess all-cause mortality (relative to historic trends) for the entire covid period (WHO 11 March 2020 announcement of a pandemic through week-5 of 2022, corresponding to a total of 100 weeks), for the covid period prior to the bulk of vaccine delivery (first 50 weeks of the defined 100-week covid period), and for the covid period when the bulk of vaccine delivery is accomplished (last 50 weeks of the defined 100-week covid period); by age group and by state. We find that the COVID-19 vaccination campaign did not reduce all-cause mortality during the covid period. No deaths, within the resolution of all-cause mortality, can be said to have been averted due to vaccination in the USA. The mass vaccination campaign was not justified in terms of reducing excess all-cause mortality. The large excess mortality of the covid period, far above the historic trend, was maintained throughout the entire covid period irrespective of the unprecedented vaccination campaign, and is very strongly correlated (r = +0.86) to poverty, by state; in fact, proportional to poverty. It is also correlated to several other socioeconomic and health factors, by state, but not correlated to population fractions (65+, 75+, 85+ years) of elderly state residents.
Preprint
Full-text available
This paper has been updated and the new version can be found here: Official mortality data for England suggest systematic miscategorisation of vaccine status and uncertain effectiveness of Covid-19 vaccination UPDATED WITH ONS DECEMBER DATA RELEASE & HEALTHY VACCINEE/MORIBUND ANALYSIS http://dx.doi.org/10.13140/RG.2.2.28055.09124 https://www.researchgate.net/publication/357778435_Official_mortality_data_for_England_suggest_systematic_miscategorisation_of_vaccine_status_and_uncertain_effectiveness_of_Covid-19_vaccination ------- The risk/benefit of Covid vaccines is arguably most accurately measured by an all-cause mortality rate comparison of vaccinated against unvaccinated, since it not only avoids most confounders relating to case definition but also fulfils the WHO/CDC definition of "vaccine effectiveness" for mortality. We examine the latest UK ONS vaccine mortality surveillance report which provides the necessary information to monitor this crucial comparison over time. At first glance the ONS data suggest that, in each of the older age groups, all-cause mortality is lower in the vaccinated than the unvaccinated. Despite this apparent evidence to support vaccine effectiveness-at least for the older age groups-on closer inspection of this data, this conclusion is cast into doubt because of a range of fundamental inconsistencies and anomalies in the data. Whatever the explanations for the observed data, it is clear that it is both unreliable and misleading. While socio-demographical and behavioural differences between vaccinated and unvaccinated have been proposed as possible explanations, there is no evidence to support any of these. By Occam's razor we believe the most likely explanations are systemic miscategorisation of deaths between the different categories of unvaccinated and vaccinated; delayed or non-reporting of vaccinations; systemic underestimation of the proportion of unvaccinated; and/or incorrect population selection for Covid deaths.
Article
Background The prioritization of U.S. health care personnel for early receipt of messenger RNA (mRNA) vaccines against severe acute respiratory disease coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (Covid-19), allowed for the evaluation of the effectiveness of these new vaccines in a real-world setting. Methods We conducted a test-negative case–control study involving health care personnel across 25 U.S. states. Cases were defined on the basis of a positive polymerase-chain-reaction (PCR) or antigen-based test for SARS-CoV-2 and at least one Covid-19–like symptom. Controls were defined on the basis of a negative PCR test for SARS-CoV-2, regardless of symptoms, and were matched to cases according to the week of the test date and site. Using conditional logistic regression with adjustment for age, race and ethnic group, underlying conditions, and exposures to persons with Covid-19, we estimated vaccine effectiveness for partial vaccination (assessed 14 days after receipt of the first dose through 6 days after receipt of the second dose) and complete vaccination (assessed ≥7 days after receipt of the second dose). Results The study included 1482 case participants and 3449 control participants. Vaccine effectiveness for partial vaccination was 77.6% (95% confidence interval [CI], 70.9 to 82.7) with the BNT162b2 vaccine (Pfizer–BioNTech) and 88.9% (95% CI, 78.7 to 94.2) with the mRNA-1273 vaccine (Moderna); for complete vaccination, vaccine effectiveness was 88.8% (95% CI, 84.6 to 91.8) and 96.3% (95% CI, 91.3 to 98.4), respectively. Vaccine effectiveness was similar in subgroups defined according to age (<50 years or ≥50 years), race and ethnic group, presence of underlying conditions, and level of patient contact. Estimates of vaccine effectiveness were lower during weeks 9 through 14 than during weeks 3 through 8 after receipt of the second dose, but confidence intervals overlapped widely. Conclusions The BNT162b2 and mRNA-1273 vaccines were highly effective under real-world conditions in preventing symptomatic Covid-19 in health care personnel, including those at risk for severe Covid-19 and those in racial and ethnic groups that have been disproportionately affected by the pandemic. (Funded by the Centers for Disease Control and Prevention.)
Article
Background: Following the emergency use authorisation of the Pfizer-BioNTech mRNA COVID-19 vaccine BNT162b2 (international non-proprietary name tozinameran) in Israel, the Ministry of Health (MoH) launched a campaign to immunise the 6·5 million residents of Israel aged 16 years and older. We estimated the real-world effectiveness of two doses of BNT162b2 against a range of SARS-CoV-2 outcomes and to evaluate the nationwide public-health impact following the widespread introduction of the vaccine. Methods: We used national surveillance data from the first 4 months of the nationwide vaccination campaign to ascertain incident cases of laboratory-confirmed SARS-CoV-2 infections and outcomes, as well as vaccine uptake in residents of Israel aged 16 years and older. Vaccine effectiveness against SARS-CoV-2 outcomes (asymptomatic infection, symptomatic infection, and COVID-19-related hospitalisation, severe or critical hospitalisation, and death) was calculated on the basis of incidence rates in fully vaccinated individuals (defined as those for whom 7 days had passed since receiving the second dose of vaccine) compared with rates in unvaccinated individuals (who had not received any doses of the vaccine), with use of a negative binomial regression model adjusted for age group (16-24, 25-34, 35-44, 45-54, 55-64, 65-74, 75-84, and ≥85 years), sex, and calendar week. The proportion of spike gene target failures on PCR test among a nationwide convenience-sample of SARS-CoV-2-positive specimens was used to estimate the prevelance of the B.1.1.7 variant. Findings: During the analysis period (Jan 24 to April 3, 2021), there were 232 268 SARS-CoV-2 infections, 7694 COVID-19 hospitalisations, 4481 severe or critical COVID-19 hospitalisations, and 1113 COVID-19 deaths in people aged 16 years or older. By April 3, 2021, 4 714 932 (72·1%) of 6 538 911 people aged 16 years and older were fully vaccinated with two doses of BNT162b2. Adjusted estimates of vaccine effectiveness at 7 days or longer after the second dose were 95·3% (95% CI 94·9-95·7; incidence rate 91·5 per 100 000 person-days in unvaccinated vs 3·1 per 100 000 person-days in fully vaccinated individuals) against SARS-CoV-2 infection, 91·5% (90·7-92·2; 40·9 vs 1·8 per 100 000 person-days) against asymptomatic SARS-CoV-2 infection, 97·0% (96·7-97·2; 32·5 vs 0·8 per 100 000 person-days) against symptomatic COVID-19, 97·2% (96·8-97·5; 4·6 vs 0·3 per 100 000 person-days) against COVID-19-related hospitalisation, 97·5% (97·1-97·8; 2·7 vs 0·2 per 100 000 person-days) against severe or critical COVID-19-related hospitalisation, and 96·7% (96·0-97·3; 0·6 vs 0·1 per 100 000 person-days) against COVID-19-related death. In all age groups, as vaccine coverage increased, the incidence of SARS-CoV-2 outcomes declined. 8006 of 8472 samples tested showed a spike gene target failure, giving an estimated prevalence of the B.1.1.7 variant of 94·5% among SARS-CoV-2 infections. Interpretation: Two doses of BNT162b2 are highly effective across all age groups (≥16 years, including older adults aged ≥85 years) in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalisations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant. There were marked and sustained declines in SARS-CoV-2 incidence corresponding to increasing vaccine coverage. These findings suggest that COVID-19 vaccination can help to control the pandemic. Funding: None.
Article
Background Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit. Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19. Methods We did a multinational registry analysis of the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19. The registry comprised data from 671 hospitals in six continents. We included patients hospitalised between Dec 20, 2019, and April 14, 2020, with a positive laboratory finding for SARS-CoV-2. Patients who received one of the treatments of interest within 48 h of diagnosis were included in one of four treatment groups (chloroquine alone, chloroquine with a macrolide, hydroxychloroquine alone, or hydroxychloroquine with a macrolide), and patients who received none of these treatments formed the control group. Patients for whom one of the treatments of interest was initiated more than 48 h after diagnosis or while they were on mechanical ventilation, as well as patients who received remdesivir, were excluded. The main outcomes of interest were in-hospital mortality and the occurrence of de-novo ventricular arrhythmias (non-sustained or sustained ventricular tachycardia or ventricular fibrillation). Findings 96 032 patients (mean age 53·8 years, 46·3% women) with COVID-19 were hospitalised during the study period and met the inclusion criteria. Of these, 14 888 patients were in the treatment groups (1868 received chloroquine, 3783 received chloroquine with a macrolide, 3016 received hydroxychloroquine, and 6221 received hydroxychloroquine with a macrolide) and 81 144 patients were in the control group. 10 698 (11·1%) patients died in hospital. After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223–1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368–1·531), chloroquine (16·4%; 1·365, 1·218–1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273–1·469) were each independently associated with an increased risk of in-hospital mortality. Compared with the control group (0·3%), hydroxychloroquine (6·1%; 2·369, 1·935–2·900), hydroxychloroquine with a macrolide (8·1%; 5·106, 4·106–5·983), chloroquine (4·3%; 3·561, 2·760–4·596), and chloroquine with a macrolide (6·5%; 4·011, 3·344–4·812) were independently associated with an increased risk of de-novo ventricular arrhythmia during hospitalisation. Interpretation We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19. Funding William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women's Hospital.
Article
Background: As mass vaccination campaigns against coronavirus disease 2019 (Covid-19) commence worldwide, vaccine effectiveness needs to be assessed for a range of outcomes across diverse populations in a noncontrolled setting. In this study, data from Israel's largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine. Methods: All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19-related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan-Meier estimator. Results: Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes at days 14 through 20 after the first dose and at 7 or more days after the second dose was as follows: for documented infection, 46% (95% confidence interval [CI], 40 to 51) and 92% (95% CI, 88 to 95); for symptomatic Covid-19, 57% (95% CI, 50 to 63) and 94% (95% CI, 87 to 98); for hospitalization, 74% (95% CI, 56 to 86) and 87% (95% CI, 55 to 100); and for severe disease, 62% (95% CI, 39 to 80) and 92% (95% CI, 75 to 100), respectively. Estimated effectiveness in preventing death from Covid-19 was 72% (95% CI, 19 to 100) for days 14 through 20 after the first dose. Estimated effectiveness in specific subpopulations assessed for documented infection and symptomatic Covid-19 was consistent across age groups, with potentially slightly lower effectiveness in persons with multiple coexisting conditions. Conclusions: This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19-related outcomes, a finding consistent with that of the randomized trial.
Is the Pfizer vaccine as effective as claimed?
  • N E Fenton
  • M Neil
Fenton NE and Neil M "Is the Pfizer vaccine as effective as claimed?", 17 May 2021. https://wherearethenumbers.substack.com/important-caveats-to-pfizer-vaccine
More on the illusions of vaccine efficacy
  • N E Fenton
  • M Neil
Fenton, N. E., & Neil, M. (2022). More on the illusions of vaccine efficacy. Retrieved January 14, 2023, from https://wherearethenumbers.substack.com/p/more-on-the-illusions-ofvaccine-efficacy
The curious case of Dr Sharon Alroy-Preis and the claims of safety and effectiveness of the Pfizer vaccine
  • N E Fenton
  • M Neil
Fenton, N. E., & Neil, M. (2023). The curious case of Dr Sharon Alroy-Preis and the claims of safety and effectiveness of the Pfizer vaccine. Retrieved from https://wherearethenumbers.substack.com/p/alroy-preis
CDC Finally Released Its VAERS Safety Monitoring Analyses for COVID 12
  • J Guetzkow
Guetzkow, J. (2023). CDC Finally Released Its VAERS Safety Monitoring Analyses for COVID 12 https://roundingtheearth.substack.com/p/the-chloroquine-wars-part-xiv