Thread by @FSBuchholzer

Our group has examined 💉s for their effects on all-cause outcomes and a clear pattern has emerged:
Live 💉have beneficial non-specific effects on all-cause mortality
The non-live 💉we have examined have had negative effects.

Many therefore asked us about COVID vaccines
🧵

Our current system for testing and approving vaccines does not take effects on all-cause outcomes, and thus non-specific effects, into account.

Vaccines are simply tested for their specific protective effects + short-term adverse events and thats it.
sciencedirect.com/science/articl…

This is a gigantic problem.

Heard about the malaria RTS,S 💉 story?
GSK💉tested in big 3-country RCT; showed modest effect against milder forms of malaria (not even the severe forms) --> approved by the EMA and cherished in the media, "historic moment": theconversation.com/who-approved-a…

The problem?

RCT data with a trend for increased all-cause mortality + meningitis & cerebral malaria safety signals. It had also been promised to analyze data by sex, but not done.

Independent researchers demanded the data & RTS,S had negative #NSEvac: journals.asm.org/doi/10.1128/mB…

According to the producer's own trial data, which they had to be forced to provide, receiving RTS,S 💉 increased the all-cause mortality risk by 91% for girls. The p-value was 0.0006 meaning that you would have to do the same trial ~1667 times to arrive at this result by chance.

Similarly, the p-value for interaction with sex was 0.001, meaning that there is only a 1 in 1000 chance that the true effect is equal in males (for whom there was no negative effect) and females.

These very worrying effects were surely investigated further by WHO, right?

Here is WHO's SAGE hand-waving the horrifying findings as post hoc / due to chance.

So you must have planned a priori to test that a vaccine causes cerebral malaria, meningitis, or a 91% increased risk of death in females in order to be taken seriously ⤵️ cdn.who.int/media/docs/def…

The 💉is currently being rolled out in an unethical stepped-wedge trial where the guardians of the children are not even informed that their child is entering a trial, nor about the worrying safety signals or modest effect against malaria. bmj.com/content/368/bm…

Anyway, back to the COVID vaccines. To date, 11.3 billion shots have been administered - 145 for every 100 people worldwide, 16.5 million per day. While this covers several COVID vaccine types, it should be compared to BCG's ~4 billion doses, administered during 100 years of use!

Surely, interventions administered in the billions must have been thoroughly examined beforehand, right?

At the very least, it was without doubt that the vaccines blocked transmission and had a neutral or beneficial effect on all-cause outcomes (admissions, deaths), right?

Think again.
Severe disease (COVID, all-cause) in the form of admissions or deaths was not even an outcome in e.g. the Pfizer trial, despite their 37 primary & 26 secondary outcomes (plz tell me more about preplanned analyses & finding stuff by chance..) clinicaltrials.gov/ct2/show/NCT04…

So NOBODY knows whether vaccinating 11.3 billion people with COVID vaccines has had any beneficial effect on people's overall health, is that it?

Yes.

This can be ascertained in observational studies, but these come with drawbacks. Confounding, healthy vaccinee bias, & so on.

My take?

Good data supports that our COVID💉s protect against severe COVID (which is important but misunderstood as most important outcome). This means that risk groups should get vaccinated.

But all-cause mortality is the least-biased and most relevant public health outcome.

The best way to assess effects on all-cause outcomes is in the least-biased study design; the RCT.

We contacted the authors of the RCTs and retrieved cause of death data from the mandatory safety surveillance in the RCTs and tested the effects of vaccination by cause of death.

@StabellBenn 's presentation of the data: linkedin.com/posts/christin…

In short, by not examining effects on all-cause outcomes & severe disease but simply relying on short-term (~3 month) effect against 🦠, most of the world likely opted for the more expensive, less beneficial 💉

Neither of the mRNA vaccines had *any* effect whatsoever on all-cause mortality risk, compared to placebo.

There was a trend towards fewer deaths from COVID, but this was counterbalanced by a roughly similarly-sized trend for increased risk of death from cardiovascular causes⤵️

It is very unlikely that mRNA 💉s actually have a beneficial effect on all-cause mortality that was just not picked up in the trials.

The data indicates a beneficial effect against COVID deaths which I believe they have, but also a similarly likely negative effect on 🫀 deaths.

Contrary to the mRNA vaccines, the live non-replicating adenovirus-vectored vaccines were associated with significantly reduced mortality risk both for overall mortality, from COVID and from cardiovascular deaths.

Below, mortality data by cause of death and vaccine platform⤵️

Effect sizes are v. large, as are the confidence intervals. Should definitely be tested in more studies and importantly, the vaccines should be tested against each other.

It is, however, not the first time that we see a 💉that reduces cardiac mortality ⤵️ ahajournals.org/doi/10.1161/CI…

Take home💬

1) Vaccines have good & bad non-specific effects

2) Effects on all-cause outcomes (mortality, morbidity) are the least-biased & most relevant for public health. Must be reported.

3) Novel 💉s should be tested against eachother before they're given to billions.

Fim

Link to the paper (preprint, not peer-reviewed):
papers.ssrn.com/sol3/papers.cf…

If this thread got you interested in non-specific effects (NSEs) of 💉, why don't you join us on April 21 for a free Webinar with world-leading scientists that has tested NSEs of live💉s against COVID-19?

More detailed description and sign up link etc⤵️

https://twitter.com/StabellBenn/status/1504431820552781831?s=20&t=sxUMiHphl_1yISM8t6JxqQ