The definitive placebo-controlled study doesn’t show the Pfizer vaccine as saving lives. And what benefits the study does show are already fading rapidly in the real world.
On 28 July a Pfizer research team released a preprint of the definitive multicentre safety and efficacy study into the Pfizer Covid vaccine (BNT162b2 mRNA C). The study followed about 44,000 people over six months from July-October 2020 to March 2021. PDFs
Before this, the best study had only followed patients older than 16 for two months. Note that distributing millions of doses based on such a short study that doesn’t cover the whole patient population is…problematic.
The 6 month study split the 44,000 participants into vaccinated and placebo groups of about 22,000 each, with similar characteristics. 34% of each group was clinically obese (>30 BMI).
The preprint stresses vaccine efficiency (relative protection from infection compared with no vaccine). The vaccine did protect people from Covid infection (77 infections with vaccine, 850 without). So far so good, for the period of the sudy, but note: the current situation is different.
However, the real and surprising takeaways are:
Despite the much higher level of infections for unvaccinated people, there was no meaningful difference in deaths from Covid. One vaccinated person from 77 infected died from Covid; two unvaccinated people from 850 died from Covid. Deaths from all causes were only 14 and 15 respectively. The study does not show that the vaccine protects you from death by Covid. If it did, many more unvaccinated people would have died given the much larger rate of infection.
Vaccine efficiency drops dramatically. Most of the infections in vaccinated people occurred in the last months of the study. This means it doesn’t work as well as the familiar perfect childhood vaccines. Consistent with that, Israel is now starting a third dose for all over-60s, and Pfizer is promoting one in the US. For protection from infection people will need to take Pfizer boosters forever. We also need to watch declining protection against hospitalisation.
Covid isn’t as lethal as media and government present. It is buried away in tables, and because there are so few deaths in the two groups the stats are weak. Nonetheless, it is probable the Infection Fatality Rate is lower than has been claimed. That is, lower than the 0.26% the CDC has reported.
The vaccine did have positive effects in the study period. Protection from infection is one. Lower levels of severe Covid illness is another. Severity is measured by respiratory markers like respiratory rate, oxygen levels, different types of ventilation and markers of other organ failure. Supplementary Appendix, p7.
There were 30 severe Covid cases in the placebo group, and only 1 in the vaccine group. It is a clear effect in protecting from severity, however it doesn’t result in protection from death. Supplementary Appendix Table S6.
Strangely, the definitive study makes no explicit claim about vaccine effects on hospitalisation or ICU admission. Hospitalisation isn’t mentioned and ICU admission is only one of ten possible criteria for severe illness. This vagueness is very surprising.
Upshot? For people who panic about case numbers and severe illness, it is vindication for vaccination, though only for that time period before any possible decline in efficacy. For people who care about deaths, it suggests the vaccine is an unnecessary risk since it doesn’t make any difference. And for people who worry about antibody-dependent enhancement (ADE), the fading efficacy suggests we need to know more, and soon.
The result of this is that the politico-media-bureaucratic PR campaign outside Australia focuses on reduced hospitalisations. Sadly, in Australia our equivalent class is so ill-informed, so obstinate, or so corrupt that they are still pushing protection from infection and death. Across the board Aussies are hearing “The vaccine works”, but with no explanation of exactly how, or on what.
Efficacy is in Doubt Now
There is substantial evidence that since the study period the Pfizer vaccine has become ineffective at preventing infection (its primary endpoint), and less effective at reducing hospitalisations.
The CDC Massachusetts study of 28 July revealed the extent of breakthrough infection (vaccinated people who get infected) to normal people. Note, however, that study was clearly released in order to justify the latest push for US mask mandates.
Equally, CDC data on breakthrough infections is now compromised. On 1 May the CDC changed policy and stopped recording breakthrough infections if they did not result in hospitalisation or death. Only a subset of states are still collecting this very important information.
But consider the table below. This is a summary of only some confirmed breakthrough infection and hospitalisation issues for the Pfizer vaccine.
Israel at ~60% fully vaccinated since April. Cases spike from 20 June. 20 July Israel Dept Health released data showing 2-dose Pfizer vaccine only 39% effective at preventing infection. Israel require 3rd Pfizer dose for >60 At July 21, 58% of hospitalised patients were vaccinated.
Israeli government and Pfizer work closely together. Still claiming prevention of severe illness, but data weakening.
Grain of salt alert. Data not linked to original source, contrary PHE paper based on modelling but also grain of salt. We know about modelling.
Protection Against Severe Illness Trend May Be Down
The Pfizer study showed strong evidence of protection against a very broadly defined severe illness. The breadth of that definition is concerning because it clouds claims about ICU or hospitalisation, so no finding on them was clear.
Subsequent anecdotal data suggested the same thing – early breakthrough infections were less likely to be hospitalised than unvaccinated (see, for example, LA County above).
But consider the data from Israel (58% hospitalised fully vaccinated). Israel is the early adopter. Declines in efficacy and protection from severe illness are strongest there, especially after 6 months. Israeli Dept of Health data still shows high but falling hospitalisation protection. But more recent data identifies a drop from the 90%s to the 80%s. The CDC Massachusetts study also suggests a downward trend with 4/5 hospitalised patients vaccinated.
The data isn’t knockdown enough to claim the protection against severe illness and hospitalisation is overstated – yet. But it is suggestive.
If it does emerge that the severity protection declines, it basically means the vaccine was a serum sugar hit for both infection and hospitalisation protection.
In Australia our ruling class is still pushing the vaccine to protect against death and infection. The mantra of Vaccines Work! is chanted non-stop, and without saying what they work at. The only strong finding is that the Pfizer vaccine works at reducing severe illness or hospitalisations (though the gold class study doesn’t mention hospitalisations). But sadly, that one success is only likely to work for a limited time, as Israel indicates.
Our National Cabinet has said we won’t be free until 70% of us are vaccinated. On the basis of the information here, that may change some numbers for a few months, and then we’ll be in exactly the same spot. The same infections, cases, hospitalisations and broad repression of the people. And that doesn’t address questions of adverse events or the emergence of vaccine-generated strains or antibody-dependent enhancement (ADE).
It’s as though our leadership is living in 1956 Albania – closed off from the rest of the world, living and governing in an experiment against reality.