COVID Vaccines – A Deeper Dive into the Data
Operation Warp Speed was well named. The typically tortoise-paced government and pharmaceutical bureaucracies moved with hare-like speed bringing several vaccines to market and available to millions. Hopefully this will soon return America to normal, although don’t hold your breath on that.
The all-knowing Dr Fauci tells us that masks and social distancing will be with us for at least another year, despite his earlier assertions that distancing and masks were unnecessary in the early days of the pandemic. So why the hoopla over a vaccine?
Vaccines are not the destination, but merely a pathway to the final goal of herd immunity. As per the Mayo Clinic,
Herd immunity occurs when a large portion of a community (the herd) becomes immune to a disease, making the spread of disease from person to person unlikely. As a result, the whole community becomes protected — not just those who are immune.
There are two paths to herd immunity for COVID-19 — vaccines and infection.
For COVID, we could have taken the Sweden approach. After the initial “15 days to slow the spread” back in March, allowing the healthcare system a breather to assess what lay ahead, we could have resumed normal life, protecting the elderly and vulnerable, quarantining only the sick, allowing the inevitable viral spread through the rest of the population, a few getting sick, some dying, just as we do every year with seasonal influenza.
With that approach we might have achieved herd immunity already, without the socio-economic destruction due to recurring lockdowns and business closures. Now we have several vaccines, the other side of the two-pronged approach to herd immunity.
Let’s look at the vaccine data, specifically the FDA report on the Pfizer vaccine. The studies were solid, meeting the Fauci standards of a “randomized, double-blinded and placebo-controlled trial”. This also happens to be the FDA’s requirement for approving a new medication or treatment.
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44,000 individuals participated in the trial, with the primary endpoint being the “incidence of COVID-19” as defined as a positive COVID PCR test and at least one of the typical symptoms such as cough, fever, sore throat, and so on. These represent true cases, not simply positive tests. This distinction is lost on the media braying endlessly about “surging cases” which represent simply positive tests, a notoriously unreliable metric as even the New York Times noted.
Severe cases in the study were quantified by respiratory parameters of oxygen saturation or respiratory failure, as “severe” could be in the eye of the beholder. Specifically defining “severe” eliminated any wiggle room. The study was well balanced in terms of demographics including race and comorbidities, not to be woke but because this is how good science is performed. Unfortunately, only 4 percent of participants were age 75 or older, despite this group being most in need of a vaccine.
162 individuals receiving placebo developed a case of COVID as defined above while only 8 in the vaccine group did so, meeting a successful primary endpoint and providing the 95 percent efficacy number reported in the media.
The FDA looked specifically at the “evaluable efficacy” population who were treated as per the study protocol. They received both prescribed vaccinations at the proper time, representing the true study population of 35,000 individuals. The total population (all available efficacy) may have only received only one vaccination. This distinction is important scientifically but not to the media who cherry pick what to report.
While the case reduction is impressive, remember this represents patients who basically had a cold or flu which they recovered from. More important are the severe cases. In the true study population, the “evaluable efficacy” group, 1 in the vaccine group and 3 in the placebo group became severely ill.
The 1 in the vaccine group had an oxygen level of 93%, meeting the “severe” criteria but was not hospitalized. Of the 3 in the placebo group, one also had a low oxygen level of 92% and was not hospitalized, one had pneumonia, was hospitalized but was not intubated, and one had an oxygen level of 92% but was admitted to the ICU for heart block, not for COVID.
Leaving aside all this medical mumbo-jumbo, which may send readers to a more interesting article speculating on which John Roberts visited Epstein Island, what do these vaccine numbers mean?
Yes, the vaccine works, significantly reducing the percentage of “COVID cases” among those vaccinated. But the more important goal, in my mind, of a vaccine is to keep people from getting really sick, as opposed to just a cold or flu, which while inconvenient is part of normal life.
Looking at the data from this perspective, the placebo group of 17,511 had only three cases of severe COVID, two of whom were hospitalized, one of the two for a cardiac issue, not COVID per se.
Meaning the odds of the average person (unvaccinated) in this study cohort being hospitalized is 1/17,511 or 0.006 percent. The odds of such a person developing mild COVID, simply cold or flu symptoms, is 162/17,511 or 0.9 percent.
These are the odds of the average person coming down with COVID and are quite low. Is this worth shutting down large swaths of the economy for? Have we ever done that for season flu?
If you look at the entire study population of about 35,000, this many individuals would need to be vaccinated to keep one person out of the hospital. And that one would likely recover. That’s what the vaccine provides.
The cost of vaccinating these 35,000, at a cost of $39 per dose course, is $1.4 million. Vaccinating the entire US population of 330 million would cost almost $13 billion.
Is that money well spent? Is it necessary? What are the costs of lost businesses? Or of social destruction from addictions and suicide due to deferred medical care? No easy answers but worthy of thoughtful discussion rather than censorship and ostracization if you ask these questions.
What about vaccine side effects? In the vaccine group, about two thirds developed a systemic adverse reaction compared to less than half in the placebo group. Fortunately, serious adverse events were less than 1 percent, but far higher than the 0.006 percent chance of an unvaccinated person being hospitalized.
The severe reactions were generally random events expected in such a population such as heart attacks and appendicitis. Now that vaccinations are in full swing we will soon know if these safety events are insignificant or not, as with the swine flu vaccine in the mid 1970s.
This study had a “median follow-up of 2 months” meaning late appearing side effects are unknown. There were internet rumors of infertility due to the vaccine, which the media pounced on to refute. But such a side effect would not be detected in a two-month study due to the timing unpredictability of conception.
The FDA warns in their vaccine fact sheet, “Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.” Will early data stand the test of time? Or does an “emergency use authorization” reflect the adage “haste makes waste”? We shall see.
What does this all tell us?
For the average unvaccinated person, the odds of becoming mildly ill with COVID is less than 1 percent, and the odds of being hospitalized is less than one in ten thousand. Yet this vaccine is likely to become mandatory if one wants to work, travel, or shop. And a new means of virtue signaling as physicians are posting photos of themselves on social media getting their vaccines. Do any post photos while undergoing a colonoscopy or mammogram, also procedures of benefit in preventative care?
Failed presidential candidate Andrew Yang wants downloadable bar codes proving vaccinations. Why not a V tattooed on everyone’s forehead?
Despite these low numbers, we have destroyed our economy due to lockdowns and quarantines. Were these necessary? Was the socio-economic devastation worth it? When if ever will it end? The experts say we are not even halfway through the misery, promising at least another year of this.
I’m not an anti-vaxxer but simply want a reasoned discussion based on “follow the science.” I will likely get the vaccine as it will be needed for work and travel. I’ll leave the virtue signaling to my colleagues and won’t post a photo of myself to Facebook with a needle in my deltoid.
Also unknown is how long the vaccine lasts. Will we need it again in a year? What if the virus mutates? Will we be getting multiple vaccines each year for influenza and whatever other respiratory viruses are making the rounds? What does that do to our immune systems? Does the vaccine prevent transmission of the virus? If Dick is vaccinated is it safe for him to visit Grandmother Jane in the nursing home?
What happens when a new mutated strain of COVID develop, as recently noted in the UK? Will our lives forever be filled with new vaccines and ongoing masks and distancing, fighting what has been part of the human experience long before there were vaccines? Will “your travel papers please” become necessary for life, liberty, and the pursuit of happiness?
Is this about the science and the virus or are there other forces and agendas a play?
Brian C Joondeph, MD, is a Denver based physician and freelance writer for American Thinker, Rasmussen Reports, and other publications. Follow him on Facebook, LinkedIn, Twitter, Parler, and QuodVerum