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No Death Reduction, Little Benefit in Vaccine Study, but Employers Demand Jab

Update: Twitter suspended writer Alex Berenson, who accurately reported some of the disappointing results of Pfizer's COVID vaccine trial described below. The message stated, "we require the removal of content that may pose a risk to people's health, including content that goes directly against guidance from authoritative sources of global and local public health information." His account has been reinstated with the "misleading" label removed from the tweet. If you still think tech censorship is fine, I'm not sure what to say.

The vaccine evangelists have been spreading more than the good news about sanctification through injection. The incidents of breakthrough cases in vaccinated people have piled up to the point that the CDC has gone back to recommending masks even for fully vaccinated people. If you can get COVID, you can spread COVID. Of course, nobody has spread it intentionally, and I'm not faulting anybody who got a vaccination and went on about their business, but the sanctimonious nerds who've wanted to confine the unvaccinated to their quarters because they were spreading the disease ought to now take their own advice and stay home.

We shouldn't be surprised at the news of this spread, since Pfizer's vaccine trial, and presumably the vaccine, are not intended to address the spread of COVID. The trial is to 

...evaluate the safety, tolerability, and immunogenicity [provoke an immune response] of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate.

Dashboards in the US and UK show quickly rising infections, but for the most part, relatively low levels of hospitalizations. And in the past 18 months, I haven't seen anybody sick in public. So it's reasonable to assume that much of the spread is asymptomatic. The same study says, 

Data presented here do not address whether vaccination prevents asymptomatic infection, but evaluation of that question is ongoing in this study, and real-world data suggest that BNT162b2 prevents asymptomatic infection.

Yes--the clinical trial for their vaccine is still ongoing: contrary to some fact checkers, the vaccines are still in the experimental stage. Phase III trials for Pfizer's vaccine are not scheduled to end for nearly another two years. In the meantime, the British Medical Journal has a pre-print of their phase III trial at six months.

The Phase III Trial

In this study, over 40,000 people were recruited, randomized and given either two doses of the vaccine or two doses of a saline placebo. The study was blinded at the beginning, but has since been unblinded and most of the members of the control group have been vaccinated. In other words, there's no more control group for, say, studying long-term effects of the vaccine. 

This experiment looked at how well the vaccine prevented symptomatic cases of COVID, severe cases of COVID, and deaths from COVID. How well did the vaccine do? In terms of relative risk, it was 86% to 100% effective in preventing cases of COVID, 93% effective in preventing severe cases, and 50% effective in preventing deaths from COVID, although the last number might not be statistically significant: there were only three COVID deaths. 

Here were get to absolute risk. Among 21,000 healthy people in the placebo group, guess how many got COVID--with symptoms like a cold or flu--over the course of five months (seven days after the second dose through the six-month mark of the study). Also guess how many got a severe case--bad enough that if they didn't get to a hospital, they probably should have--and guess how many died of COVID. Whip out your calculator, put in the percent (as a decimal) you think died or got a severe case or got a cold-or-flu-like case and multiply by 21,000. I'll wait.

From Pexels.


Results

There were about 21,000 people each in the control group and the vaccine group. From Table 2 of the preprint and Table S4 of the supplementary material, there were:

  • 850 COVID cases in the control group; 77 in the vaccine group
  • 30 severe COVID cases in the control group; 1 in the vaccine group
  • 2 COVID deaths in the control group; 1 in the vaccine group
  • 14 deaths from all causes in the control group; 15 in the vaccine group
  • Six-month data are unavailable for 12-15 year olds since enrollment of the began in October 2020. 

Absolute risk reductions over six months

The 90% or so effectiveness you often hear about is relative risk reduction. It compares only the people in each group (vaccine and placebo) who got sick or died. Absolute risk reduction, on the other hand, looks at the entire group, including the people who didn't get COVID. It's the incidence rate of cases (for example) in the control group minus the incidence rate in the vaccine group. So, 850/21,000 - 77/21,000. 

  • 3.7% for a COVID case
  • 0.14% for a severe COVID case
  • 0% for death

How many people would have to be vaccinated to prevent one such hospitalization? It's the inverse of the absolute risk reduction, or 724 people. And since the study shows a zero percent risk reduction for deaths, the vaccine evangelists can stop going on about the life-saving vaccines--or at least provide a citation for that claim.

Two things can be true at the same time: vaccines can provide a small absolute risk reduction, AND the vast majority of COVID patients in the hospital can be unvaccinated. As an analogy, a group of homeless people might be nearly all men, but the vast majority of men in general aren't homeless and won't become homeless. A pill that would help protect you from becoming homeless (maybe by making you more conscientious) might be a good choice for people at high risk, but of little value for everyone else.

Adverse events

The study reported adverse events at six months. Adverse events were not necessarily caused by the vaccine.
  • 3,048 adverse events (mild to life-threatening) in the control group; 6,617 in the vaccine group  
  • 116 serious adverse events (resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability/incapacity) in the control group; 127 in the vaccine group
  • 150 severe adverse events (e.g., prevented daily activity) in the control group; 262 in the vaccine group
  • 26 life-threatening events in the control group; 21 in the vaccine group

The CDC gives a rundown on adverse events and provides a detailed table.   

Absolute Risk

  • 17% for adverse events 
  • 0.05% for serious adverse events
  • 5.3% for severe events
  • N/A for life-threatening events

How does this compare with numbers reported in VAERS? So far, 353,000,000 people in the US have had at least one shot. The 6,000 reports of deaths, 7,900 reports of life-threatening adverse events, and 6,800 reports of permanent disability make up tiny fractions of the shots given. However, these numbers are far higher than those of any other vaccine. And on one hand, the adverse reactions reported weren't necessarily caused by the vaccine, but on the other hand, VAERS is voluntary and figures are probably underreported.

Summary

In a nutshell, this study showed a slight decrease in absolute risk of getting a case of COVID. It didn't show any life-saving benefits. It was not designed to detect reductions of spread or asymptomatic infections. If you can't avoid a great deal of exposure to COVID or can't reduce your comorbidities or risks, getting this shot might make sense. The risks might be small, but they aren't zero, so first getting an antibody test to see if a shot would even benefit you would be a good idea.

Companies that are requiring their office workers, tech nerds, remote employees and customers(!) to get vaccinated have drunk the COVID Kool-Aid. Google hasn't even returned to the office yet. You'd think the analytical people at places like Google and Morgan Stanley would have figured out that working-age people are at low risk; you'd think they could afford bigger offices and better ventilation; you'd think they'd be concerned about liability if employees had adverse reactions; you'd think they'd be concerned about losing employees and customers. They're not so much Machiavellian as a bunch of nervous Nellies. I wouldn't work for such an employer: anyone who said get jabbed or get fired could get bent. COVID is here to stay and everybody is going to get exposed to it. At least I've figured out a way to hit back once they return to the office: put some moldy food in the microwave or a ragweed bouquet in the lobby and they'll scurry. Besides, if they're so bent on trying to stop COVID, if they hate the spread of COVID so much, shouldn't they stay home?

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