According to the Pfizer PR machine, their mRNA vaccine in its Clinical Trial proved to be 95% effective after 7 days. But what does this figure really mean?
Recently, Clinical Trial Data has been released for the Pfizer mRNA vaccine. Originally, the FDA wanted to keep this data from you for 75 years. But a Court Order forced them to reveal the data, in parts, every 2 weeks.
Now a team of Canadian Doctors (1) have looked at the Clinical data and feel that the way it was presented (using Relative risk percentages) may have been confusing at best and even potentially misleading. You will see that this is even something the FDA say generally about drug and vaccine data presentation. Read on, and/or watch the video which is less than 2 minutes.
In Phase II of the COVID mRNA vaccine clinical trial, 18,325 people were monitored. Roughly half were given the vaccine and half were given a placebo. Remember, this was a vaccine that was going to be used Worldwide.
In the Placebo group 162 people developed Covid; in the vaccinated group 8 people developed Covid. This equates to 0.88% of the unvaccinated group developing Covid, and 0.04% of the vaccinated. 0.88% minus 0.04% is 0.84; and 0.84 as a proportion of 0.88 gives you 95%, the figure Pfizer quoted. This is termed Relative Reduction Risk. 0.88 – 0.04 = 0.84 which, when divided by the people at risk if unvaccinated, is 95%. WOW!
95% risk reduction sounds like 95% of the population are protected if vaccinated; or does it mean that you are 95% protected with just a 5% chance of developing Covid; or does it mean you are protected 95% of the time?
The answer is that many scientists, Doctors and even the FDA believe this Relative figure is too confusing and quite possibly misleading.
Take the 2003 Lancet-reported study on Lipitor (2). 1.9% of people taking Lipitor had a heart attack; while 3% not taking it had one. Work the figures the same way as Pfizer did in their Clinical Trial and 1.1% of people would be saved by taking Lipitor. Divide that by 3.0 and you get 36%. 36% is the Relative Reduction Risk explained above and which, obviously, drug companies prefer to use in their promotional material, when in reality, 1.1% of people are saved with Lipitor, which is termed the Absolute Reduction Risk.
What happens next is that people work out the Number Needed to Treat figure. It is the inverse of the figure produced. With statins, using the Relative Reduction figure it looks like you need to give statins to 3 people to save a life (100 divided by 36), when, in reality, taking a Statin saves 1.1 lives so you need to give the statin to approximately 100 people save a life. Get the difference? The first is drug company promotion, the second figure is reality. But it has huge implications – 99 people would possibly face side-effects like myopathy and even dementia to save one other person from a heart attack. And think of the cumulative cost to the Health Service.
Returning to Covid vaccines – the Absolute Reduction risk found in the Clinical Trial was 0.84%. So 8.4 people in every 1000 would have been prevented from developing Covid if all 1000 were vaccinated.
Be clear: the FDA in their advisory booklet (3) ‘Communicating Risks and Benefits – An Evidence-based Users Guide’ say that “Patients are unduly influenced when risk information is presented using a relative risk approach; this can result in Suboptimal decisions. Thus an Absolute Risk format should be used.”
Watch the video, make up your own mind – click here: CanadianCovidCareAlliance
- Canadian Covid Care Alliance – https://www.canadiancovidcar
ealliance.org/media-resources/ relative-vs-absolute-risk- reduction/
- Number Needed to Treat – Health NewsReview.Org – https://www.
healthnewsreview.org/toolkit/ tips-for-understanding- studies/number-needed-to- treat/
- FDA Booklet ‘Communicating Risks and Benefits; Evidence-based Guide’ – https://www.fda.gov/about-
fda/reports/communicating- risks-and-benefits-evidence- based-users-guide