95% Vaccine Efficacy? Not So Fast
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Giorgio de Chirico Piazza d’Italia 1913 A -short- look at how vaccine makers like Pfizer and Moderna get to claim a 90% or even 95% effi
[See the full post at: 95% Vaccine Efficacy? Not So Fast]More from Peter Doshi, associate editor of the British Medical Journal BMJ:
Let’s put this in perspective.First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%.
Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown.
Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season).
Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations.
Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data
https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/Sources of the other quotations from the BMJ:
Can I ask a stupid question that will likely put my level of ignorance on public display … in what manner were these two groups of guinea pigs, um, I mean people, exposed to the virus? How was it determined that exposure was equal for both groups? I’ve skimmed through some of the linked publications but haven’t seen this aspect described in any detail? (not going to bring up the ethical questions surrounding the exposure of people to what can be a deadly disease – hey wait a minute, I thought none of us can be safely exposed and that’s the justification for lockdowns?)
PS … from a few days ago … thank you for pointing out my math error, Doc Robinson. Appreciated. I dropped a zero in my calculations.
What is the relative risk between each vaccinated group and each placebo control group, of feeling bad enough to stay home in bed for one or more days?
This CAN be determined from study data, or they are BAD studies.
Potential side effects from rushed vaccine.
Notice the cats, for instance. I’ve mentioned this effect before.
https://www.zerohedge.com/medical/ex-pfizer-exec-demands-eu-halt-covid-19-vaccine-studies-over-indefinite-infertility-andupstateNYer: “..in what manner were these two groups of guinea pigs, um, I mean people, exposed to the virus? How was it determined that exposure was equal for both groups?”
As far as I know, there was no intentional exposure, but in a randomized study both groups should ideally have similar demographics and similar enough exposure during their daily lives.
Intentionally infecting the subjects is planned in some upcoming “human challenge” trials.
Young, healthy people will be intentionally exposed to the virus responsible for COVID-19 in a first-of-its kind ‘human challenge trial’, the UK government and a company that runs such studies announced on 20 October. The experiment, set to begin in January in a London hospital if it receives final regulatory and ethical approval, aims to accelerate the development of vaccines that could end the pandemic.
Human challenge trials have a history of providing insight into diseases such as malaria and influenza. The UK trial will try to identify a suitable dose of the virus SARS-CoV-2 that could be used in future vaccine trials. But the prospect of deliberately infecting people — even those at low risk of severe disease — with SARS-CoV-2, a deadly pathogen that has few proven treatments, is uncharted medical and bioethical territory.
Dozens to be deliberately infected with coronavirus in UK ‘human challenge’ trials
https://www.nature.com/articles/d41586-020-02821-4Middle of the night I woke up with a strange conviction, that mandatory face masks are responsible for the runaway infection rates in Holland and other countries including the USA. Everywhere that governments have mandated the wearing of masks, infection rates have risen soon after.
Is this even a reasonable assertion to make?
I firmly believe that masks can work, but that requires that they be used properly (use once for a maximum of a few hours, put on, take off by holding the ear elastic and never touch the actual mask) and pretty much nobody does that, myself included. Instead, what happens is that each day people pull a bedraggled mask out of their pocket and put it on. They take it on and off multiple times during the day and regularly adjust it up or down always using bare hands on the mask itself. Then they rub their eyes, pick their nose or whatever and infect themselves. At the same time they stop anti-social distancing because “Hey I’m wearing a mask so I’m safe, right?”
If it’s not possible to get people to use them correctly (it isn’t) then we’d all be safer if we just strictly kept to the six-foot rule.
Prove me wrong.
Doc Robinson (thank you): “As far as I know, there was no intentional exposure, but in a randomized study both groups should ideally have similar demographics and similar enough exposure during their daily lives.”
If that is the case, researchers have failed to adequately eliminate one of the primary variables in the “study”. I’m looking forward to peer review.
Doc Robinson (again): “Young, healthy people will be intentionally exposed to the virus responsible for COVID-19 in a first-of-its kind ‘human challenge trial’, the UK government and a company that runs such studies announced on 20 October.”
Maybe it’s the lockdown, maybe the virus causes insanity. It seems we have lost our flipping minds.
Polder Dweller: “mandatory mask are responsible for runaway infections.” Too funny!! The first few weeks last spring I was good about my masks, hand sanitizer, hand washing, because I do live in NY after all.
Now days? I pick an old mask off the floor of the car, slap it on, head into the store. The other day I accidentally dropped my mask in the parking lot when I got out of the car, picked it up, put it on and went in the store. (In my own defense, it wasn’t raining so at least the pavement was dry).
Yours may be a valid observation that should be studied much more extensively so we can reach a reliable conclusion. Seems as valid as anything else we’re investing time in studying at this point.
This is the same framing used by the anti-mask sociopaths. ‘It doesn’t protect ME, so I can’t be inconvenienced.’ The more important effect is to lower the infection rate through society so we don’t infect our neighbors. When the population infection rate is so low to begin with, OF COURSE the ‘absolute risk reduction’ (for individuals, as you are framing it) will be low. But for the population, the relative rate is more appropriate since that’s what determines how many cases you’d expect in the population – and how fast or slow the virus then spreads.
Another way of putting it – using your framing, no one should ever get a measles vaccine, because your ‘absolute risk reduction’ is so close to zero you can’t measure it. Chances are, YOU are never going to get the measles, shot or no shot. This is the same selfish argument the anti-vaxers have been spouting for years.
Maybe someone here can clear things up for me. I’ve read that the virus has not yet been isolated but I’ve also read that the Chinese had sequenced the genome of the virus and published it back in February. Can both be true?
How might the human challenge be done? Will they just put volunteers in a room with infected people?cfraenkel’s arguments contain false equivalences and guilt by association fallacies.
I highlighted the concerns of Peter Doshi (an editor at the BMJ) and others published by that journal. Effectiveness is just one of the multiple concerns they raise.
Regarding the use of relative or absolute risk reduction numbers, here’s some advice published online by the National Institute of Health:
“Absolute risk reduction (ARR) – also called risk difference (RD) – is the most useful way of presenting research results to help your decision-making.”
That’s what I used to think, but I’ve yet to see a drop in infection rates following a mask mandate, quite the opposite in fact. So there has to be a reason for that. Yes, the idea is to wear a mask to protect others, everyone knows that (or at least they should), but I’m suggesting that wearing a mask actually increases the wearer’s chance of becoming infected because he or she doesn’t use it properly. If used properly, they work as expected – infected wearers infect far fewer other people and uninfected people have the same or perhaps very slightly less chance of catching the disease.
@ chettt, comparing to the effectiveness of the measles vaccine:
“…So to prevent one severe illness 1370 individuals must be vaccinated. The other 1369 individuals are not saved from a severe illness, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them. How does this compare with other vaccines? Before the measles vaccine became available 90% of children in North America had measles by age 10. Two doses of the vaccine are about 95% effective, so a vaccinated individual’s risk is reduced by 0.855 (0.90 x 0.95), and the NNTV [Number Needed To Vaccinate] = 1.17 (1/0.855); this is extraordinarily effective…Shouldn’t absolute risk reduction be reported so individuals can make fully informed decisions about vaccinations?”
chettt: “How might the human challenge be done? Will they just put volunteers in a room with infected people?”
How an earlier trial for the flu was done: “…he developed a challenge model using a wildtype strain of H1N1 that has since been sprayed up the noses of more than 400 volunteers.”
O.K. so I design a bridge to be 95% effective instead of the standard engineering practices.
Now how willing would you be to use the bridge?
No?
Neither would I!
More about masks. Ivor Cummins, the Irish statistician, has a graph which shows mortality in the UK. The increase of the illness and death appears to rise just after mask wearing became mandatory. At 56 minutes into the explanation of the graph.
The vaccines are a chimera, right now. They may control the coronavirus pandemic. But humans are the test animals to see if the vaccines work and the risks. The bottom line is that the governments in China, Taiwan, South Korea, Thailand, Cuba, Vietnam, Australia and New Zealand are able to control the virus now with functional public health programs.
But there is a huge swath of the world from India, Russia, Europe to South and North America where nations have been so decimated by greed that they are unable to protect their citizens. Taxes on corporations and the rich are needed to fund public health programs that are proven to work. Instead, the dead and ill are paying for their failed governments. Corporate profit over human lives. The denial is huge. But, if the for-profit vaccines fail or supply and distribution collapse, wherever there is not a restoration of working government, those nations will fall into 3rd world chaos.
The USA is approaching an orange revolt. The six media owners are trying to prevent it. The swamp blob is too old, incompetent and corrupt to do anything about it. A failed vaccine program with no national public health system to continue fight against the virus would be catastrophic.
Once again, Chris Martenson sums it up better than anybody else.
The USA is approaching an orange revolt. The six media owners are trying to prevent it. The swamp blob is too old, incompetent and corrupt to do anything about it. A failed vaccine program with no national public health system to continue fight against the virus would be catastrophic.
As usual, a very astute rendering of today’s USA…
Reading the MSM (besides being pointless) is like trying to wade through waist deep molasses in winter.
The U.S. is now a full blown Facist government, parading as a democratic republic.
More polite language would call it a corporatocracy (smoke and mirrors)…
We managed to create a monster out of Franklin’s republic…heh, heh. It’s starting to get fun hanging here around waiting for the near-daily drive-by ad hominem for all those FILTHY DISBELIEVERS..
heh, heh. It’s starting to get fun hanging here around waiting for the near-daily drive-by ad hominem for all those FILTHY DISBELIEVERS..
Frankly, I’m baffled ; what the hell are you talking about??
Polder, could be the other way around. Obviously IF the powers feel concerned, they will mandate masks. And not necessarily based on anything, as we have banished science, but that doesn’t mean a head doctor’s seat-of-the-pants intuition is wrong, either. So yes, if it happens, they demand masks. If they SUSPECT it’s coming, they will demand masks, then it happens after. Correlation is not causality.
Problem: if either is true, MASKS DON’T WORK. There is an embarrassingly high rate of at least cosmetic mask wearing, and since it has no effect, cases do not thereafter drop. As NY, NJ, etc… And that’s just a sanity check on the actual studies which have said for 100 years they don’t work, and the Danish study that says they don’t work, AND the 20-nation study that says lockdowns don’t work, and ESPECIALLY the Nov 11 study that had military cadets actually follow the rules strictly or be beaten senseless and they STILL got it, showing NO measures work. …Which we knew in January, and I said. Near-Aerosol, 5 days on surfaces? “Well, everybody’s going to get it.”
And “Masks” as from the beginning in March – Goldfish! Squirrel! – was that they desperately needed N95s, citizens shouldn’t use them to preserve supplies for health workers. Why? BECAUSE ONLY N95s DO ANYTHING. And even then must follow procedure (touching), handwashing, 30m use before being soaked, gloves, sanitizing, etc. They ALREADY know, they ALREADY said it. I’m at a total loss. Did no one else read any headlines from January to April? They are no longer real? Physics changed since then?
And better, here we are a YEAR after, and no N95s for even hospital workers. They shouldn’t use them for long at all, and sometimes get one for a week. Ohhhhhh, that’s “Science” for you. That’s compassion. That shows how much even smart, scientific people believe and follow logic. As in: Not. At. All. And I’m supposed to go to a doctor and credit his judgement on heart drugs after seeing this?
I can get an N95 to paint my house, but a nurse can’t get 6 per shift (still far too low) an ICU or nursing home? Please. Explain. I’ll wait all day. Tell me again how medicine should be trusted and we “follow the science.” Yeah: right over a cliff.
You read the same things I did, about not reusing masks, not touching them.
Now we’re asking, with a 0.45% safety increase (or decrease, via side effects) that the people who GET the vaccine GET the disease. So you’re vaccinated, get a fever and are laid up two days. Literally. Hold on here – I’m not a genius – but doesn’t that mean you could give people the DISEASE in the vaccination syringe and no one could tell the difference between the disease and the cure? And when that’s statistically and physically true – that some will have a full-blown Covid reaction – I’m sorry but that’s not a vaccine. A vaccine has to be at least a wee bit better than huffing the disease up your nose like coke lines at Studio 54.
I mean, have we not totally lost our God-given minds? Prove to me this is very rare. They only had 20k, and most of them didn’t get it. So of the couple hundred who did, we ALREADY have a cure as debilitaring as doing nothing? More, because we don’t intentionally inject the disease at 100% rate.
Fraenkel, I mean seriously? The death rate for Measles highlights EXACTLY how they’re very different; it’s the perfect example. 25% are hospitalized for measles with high fever and 2 in 1,000 will die. That’s 0.2%. Covid is 0.003%, a hundredfold difference, with very few hospitalizations. And guess what we did with measles for 1,000 years? Nothing. We did not shut off the food system, liquidate the economy to give to Jeff Bezos, or end human rights. It never even occurred to anyone TO do this because they weren’t g-d insane.
Even so, about vaccines? Well, those who get it are helped. And those who don’t are at risk. And guess what? Neither side infringes the slightest on the rights or religions of the other. If you got the vaccine: congratulations, it worked! You’re safe. Your children are safe. Anyone who didn’t is of no threat to you at all. Up until 5 years ago, this was considered perfectly normal, logical choice they took measures of persuasion to encourage people to participate. But no one at all is at any risk. Been that way all my life.
Lo! Suddenly, just a bit before COVID, they went Grape-Ape on vaccines, unscientifically and illogically asserting that the unvaccinated somehow risk the vaccinated. And the doctors and reporters who said this weren’t chucked out on the ear and beaten within an inch of their life. That’s totally crazy. Impossible. …Not if your vaccine works at all. Is that what you were saying, Pfizer? ‘Cause that’s what I’m hearing. You’re also saying we must end human rights to increase your sales profile. What is wrong here?
So anyway, since the Measles IS dangerous – at least low-moderately – the comparative by real risk of the vaccine or its side effects quickly fades in comparison for the disease. When the disease is 100x LESS dangerous, i.e. not dangerous at all, as dangerous as Influenza, then the relative risk of the vaccine is at least 100x higher.
But again, totally unscientifically, totally against all law, religion, and human rights, if YOU want a vaccine, or a mask, congratulations: YOU are now perfectly safe. Don’t worry your little head about me. YOU are safe, since YOU wanted it, YOU took it. Now I’m no threat to you. …Unless, again, the vaccines and masks don’t work. Is that what you’re saying? And note, while we may mildly disagree, when I’m not convinced, I don’t go to your house and MAKE you not wear a mask, taze you, beat you and send you to prison. I don’t PREVENT you from developing and getting a vaccine. I even encourage it. We just leave you alone in diversity and tolerance. Wear all the masks you want. Stay home from all the schools you feel like. To each his own.
(Reading comments) So yes, as the Doctors report in clear numbers, you WOULD get a measles vaccine, and under 70 you WOULDN’T get the COVID vaccine…just not one that increases life by just 0.54%, and CERTAINLY not one that’s never been tested.
Here we go on this:
“Ex-Pfizer Exec Demands EU Halt COVID-19 Vaccine Studies Over ‘Indefinite Infertility’ And Other Health Concerns
On the one hand, the petitioners demand that, due to the known lack of accuracy of the PCR test in a serious study, a so-called Sanger sequencing must be used. This is the only way to make reliable statements on the effectiveness of a vaccine against Covid-19. On the basis of the many different PCR tests of highly varying quality, neither the risk of disease nor a possible vaccine benefit can be determined with the necessary certainty, which is why testing the vaccine on humans is unethical per se. -2020 News
The pair also point to concerns raised in previous studies involving other coronaviruses – in-cluding (via 2020 News):
• The formation of so-called “non-neutralizing antibodies” can lead to an exaggerated immune reaction, especially when the test person is confronted with the real, “wild” vi-rus after vaccination. This so-called antibody-dependent amplification, ADE, has long been known from experiments with corona vaccines in cats, for example. In the course of these studies all cats that initially tolerated the vaccination well died after catching the wild virus.• The vaccinations are expected to produce antibodies against spike proteins of SARS-CoV-2. However, spike proteins also contain syncytin-homologous proteins, which are essential for the formation of the placenta in mammals such as humans. It must be abso-lutely ruled out that a vaccine against SARS-CoV-2 could trigger an immune reaction against syncytin-1, as otherwise infertility of indefinite duration could result in vaccinated women. [Exactly as in the vaccine show “Utopia” A billionaire trying to make a better, greener world releases a pandemic where the rushed vaccine causes infertility as is in “Children of Men”.]
• The mRNA vaccines from BioNTech/Pfizer contain polyethylene glycol (PEG). 70% of people develop antibodies against this substance – this means that many people can develop allergic, potentially fatal reactions to the vaccination. [As happens with many vaccines and drugs. But we kill the 99% to save the 0.003%]
• The much too short duration of the study does not allow a realistic estimation of the late effects. As in the narcolepsy cases after the swine flu vaccination, millions of healthy people would be exposed to an unacceptable risk if an emergency approval were to be granted and the possibility of observing the late effects of the vaccination were to follow. Nevertheless, BioNTech/Pfizer apparently submitted an application for emergency approval on December 1, 2020.
“Rich People & Journalists Made Exempt From Having To Enter COVID Quarantine In UK
“High value business travelers” won’t have to self-isolate…”…Very scientific. The ‘Rona is our god! The ‘Rona knows! “Some animals are more equal than others.” Like every DNC governor, mayor, and doctor in the news lately for ignoring all procedures. Sayeth they: “I’m Sorry.” Sorry I got caught, because clearly I don’t believe the disease is dangerous or care.
…He’s saying “Burn the witches!” “Burn the heretics”, burn the Covid non-believers. De-platform, beat, and arrest them. That is, people who believe it is 99.97% safe for most people and lockdowns shouldn’t be used. You know, people like the CDC and WHO are the source of said official information. Weird how the people who quote the CDC and WHO are considered dangerous, radical anti-science, a threat to others. If you think so, maybe you should go arrest the CDC and WHO instead?
@ Dr. D:
The interesting thing is that human math is as rooted in greed/violence as in pattern recognition: “This is mine; that is yours. 1,2,3…”
@Mister Roboto – Martenson’s latest video – about COVID treatment – got pulled by YouTube. Can still see it on his site. Frankly I’m surprised the Tubes of You let him stay up this long. His explanations are detailed, thorough, reasonable and acknowledge that his interpretation and the science could be imperfect. Oh well, down the memory hole with you, Chris. Totally expected. Googles became an entrenched establishment mouthpiece slowly at first, but it’s race to the bottom now.
@Polder Dweller – I have worried about that as well, that masks could indeed make a virus spread faster. Wearing a mask wrong (even a gold-standard N95) can be more dangerous than not wearing one, an N95 must be fitted leak-free and handled properly and thrown out after a few hours’ use so it can be replaced with a fresh one (as if you could get one that often.) For us laypersons, a cloth mask with pores that barely stop a visible droplet, that gets worn wrong and tugged and touched and tucked into a pocket because they’re inconvenient and uncomfortable – well that’s an infection route for the cooties and the common cold, let alone a raging ‘ronavirus. (edit: scroll up a bit, Dr D says it better than I did :D)
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