| Becar28. 08. 2021 20:15:16 |
Dr. Žiga Zebec
As a microbiologist who researched interactions between viruses and microorganisms in my PhD, at the beginning of the epidemic I wanted to contribute to virus control myself. Due to the nature of my lab work, I knew a fast and cost-effective disinfection method with UV-C light. This is the light used for disinfecting operating rooms, water purification, and sterile production lines. Since UV-C light is suitable for disinfecting surfaces and aerosols where viruses are often transmitted, I thought this disinfection method would be most appropriate for destroying the virus. Nowhere did I see UV-C light being used for disinfection, so I informed the authorities. As you probably guessed, there was no response to my initiative.
Right from the start of the virus appearance, I delved into the emerging literature on the new virus and existing literature necessary to contextualize novelties. As a user of PCR and qPCR tests, I first thoroughly studied the qPCR test used for SARS-CoV-2 detection. Immediately, I noticed that the test is based on amplifying only a 100-nucleotide fragment from two different parts of the virus's genetic material, which has 30,000 nucleotides. I also noticed that one of the initial oligonucleotides mismatches the viral sequence, which was very concerning for a diagnostic test. It seemed inappropriate to me, and soon many other scientists worldwide began expressing concern.
In the following months, things became even more confusing and illogical. First, we started using masks indoors, soon outdoors too. When that didn't help, we began locking down healthy people, and when that didn't work either, we locked down everything else, even though we already knew COVID19 wasn't dangerous for children. Media rhetoric also began to change. Messages to stay calm and care for our own and loved ones' health were replaced by messages that the virus is deadly, everyone endangers everyone, and we must fear everyone, everywhere, even our own shadow if alone in the forest at night.
At this point, I started wondering why leaders in countries would cause additional panic in such a serious situation instead of calming people? An organism under stress is much more susceptible to viral infections than one not stressed. In microbiology, we use various stressors to infect bacterial cultures (chemicals, temperature, or electric current). It became clear to me that measures create a high-stress atmosphere, thus making people more susceptible to viral infections rather than preventing them.
The next step was the vaccine, praised by all experts appearing in the media. Then I clearly noticed that the information from experts summarized by media was very unbalanced. I researched this area myself and found many interesting things that helped form my opinion, which I won't share with you. I'll share only some publicly available data accessible to everyone, which our experts and media don't present.
What else hasn't been said about vaccines? A lot, especially that we simply don't know many things. But we do know certain things, and they're not reported in the media.
One thing presented very unclearly to people is vaccine efficacy. On the NIJZ website under "Most common questions and answers about COVID-19 vaccination" there's "What does 95% efficacy of Comirnaty vaccine mean?" Comirnaty is Pfizer's COVID19 prevention vaccine. NIJZ answer: "Like all vaccines, COVID-19 vaccines don't provide complete protection to all vaccinated. 95% efficacy means 95% of vaccinated are protected from infection, 5% can still get sick despite vaccination." This statistics explanation is extremely problematic, or I can say completely wrong. What does it actually mean?
In clinical testing of vaccines and drugs, we're interested in treatment effect assessment. It's essentially comparing risk of adverse outcome in control (unvaccinated for vaccines) and test (vaccinated) groups. In other words, in our case, how much vaccination reduces risk of getting COVID19. Publicly available data answers this.
Let's take data from the Public Agency of RS for Medicinal Products and Medical Devices (JAZMP) website. In their December 21, 2020 post (summarized from Polack et al. 2020) 1, they explain what Comirnaty (Pfizer) vaccine is, how it works, and its efficacy. First, it's an mRNA vaccine coding for SARS-CoV-2 protein. Then they answer questions including "What benefits did Comirnaty clinical trials show?" JAZMP: "44,000 people participated. Half got vaccine, half placebo. Participants didn't know which. Efficacy calculated for over 36,000 people over 16 (incl. over 75) without prior infection signs. Study showed 95% reduction in symptomatic COVID-19 cases in vaccinated (8/18,198 got symptoms) vs placebo (162/18,325). Thus, vaccine showed 95% efficacy in trial."
If we look at NIJZ explanation, 95% should mean 5% get sick in vaccinated group, 95% don't. This stats interpretation isn't correct, we'll see why next.
Back to our basic clinical study question: how much does risk of adverse outcome decrease with treatment, or here, how much does vaccination reduce infection risk. Directly answers "absolute risk reduction" (ARR). Using JAZMP Pfizer data: ARR simple: subtract experimental event rate (EER) from control event rate (CER): ARR = CER – EER = 162/18.325 – 8/18.198 = 0.00884 – 0.0004396 = 0.0084, times 100 = 0.84%. ARR is 0.84%. This tells probability of infection drops 0.84% in vaccinated vs 0.88% unvaccinated. Why not report this and what does 95% mean?
Almost unbelievable stats manipulation is so simple, but sadly true. What media, experts, NIJZ report is "relative risk reduction" (RRR). Not unusual, reported for many drugs, but good to know context. Before RRR calc, see The Lancet article: "ARRs tend to be ignored because they give a much less impressive effect size than RRRs: 1·3% for the AstraZeneca–Oxford, 1·2% for the Moderna–NIH, 1·2% for the J&J, 0·93% for the Gamaleya, and 0·84% for the Pfizer–BioNTech vaccines". 2 Translation: ARR values usually ignored as less impressive than RRR. 1.3% AstraZeneca-Oxford, etc.
For RRR using JAZMP Pfizer numbers 1 for SARS-CoV2. First, relative risk (RR) = EER/CER = 0.0004396/0.00884 = 0.04937. RRR = 1 - RR = 1 – 0.04937 = 0.95 or 95%.
Now Slovenian Pharmaceutical Bulletin, 2012;63, p.211 "From controlled clinical trials to evidence-based treatment". 3 Author explains despite impressive RR/RRR indicating big effect (vaccination here), doesn't give full info without baseline risk CER (here 0.884%). Author continues only RR/RRR can't distinguish big from small effect. For 100x smaller/larger CER/EER, RR/RRR same. For drug with CER 4.1%, additional reduction has little clinical meaning at low risk. RR/RRR thus little useful clinically. Conversely, ARR includes baseline risk. His ARR 1.4%, could convince doctor differently than RR/RRR 66%/34%.
For people needing vaccine efficacy explained, neither ARR nor RRR may mean much, so "number needed to treat" (NNT = 1/ARR). For Pfizer, 119. Means vaccinate 119 to prevent one case.
With data, interested in vaccine side effects risk vs comparable severe disease or death. No studies comparing age groups, data now real-time during mass vaccination.
Official EU stats (May 21, 2021) (https://www.adrreports.eu/en/search_subst.html#) recorded 431,740 adverse effects and over 11,000 deaths from COVID19 vaccines. With ~200 million vaccinated in EU that day (https://qap.ecdc.europa.eu/.../vaccine-tracker.html...), ~1/500 have side effects, 1/20,000 die. Didn't see this in any media, though public data anyone can access.
What's else forbidden? Talking virus origin, existing treatments, etc.
Recently Dr. Antony Fauci suddenly allowed public debate on SARS-CoV-2 origin, until recently natural. Lab-made theory researched/debated scientifically early, but banned publicly/peer-reviewed. Now Fauci admits possible lab origin, permission for broader discussion? Implications if lab-made? Easy create problem (virus), offer solution (vaccine)? What know about such virus/vaccines? Scientifically/ethically/legally acceptable vaccinate first, observe short/medium/long-term effects?
All I want: discussion by all scientists/experts, impossible now. Currently forbidden express scientific/professional opinion unless supports mandated narrative. Despite public data, discussing almost everything forbidden. Banning discussion kills progress, science, free society.
1 Polack, F. P. et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. The New England journal of medicine 383, 2603-2615, doi:10.1056/NEJMoa2034577 (2020).
2 Olliaro, P., Torreele, E. & Vaillant, M. COVID-19 vaccine efficacy and effectiveness-the elephant (not) in the room. The Lancet. Microbe, doi:10.1016/S2666-5247(21)00069-0 (2021).
3 Grabnar, I. Od kontroliranih kliničnih raziskav do na dokazih temelječega zdravljenja z zdravili. Farmacevtski vestnik 63, 211-215 (2012).
| (+11) |  | |
|
|