Covid-19 Vaccines: What is “Effective”? By Brian Simpson
With the first eager arms being held out to lovingly receive the Covid-19 vaccine, the question needs to be asked, what does it mean to say that the vaccine is 90 or more percent effective?
“With COVID-19 vaccines on the precipice of mass distribution, news media are on fire as they talk about who will get the vaccine first and how it will be distributed. The one thing they aren’t discussing, however, is the definition of “effective” when it comes to these vaccines.
Early November 2020, Pfizer sent the stock market soaring1 when it announced its vaccine is more than 90% effective.2 One week later, Moderna — which designed its vaccine candidate in just two days3 — boasted a 94.5% effectiveness rating.4
However, if you read Pfizer’s and Moderna’s press releases and other clinical trial information, you’ll see that they have left out some really crucial information. For example:5
- They don’t say how many cycles they used for the PCR tests they gave to count COVID-19 cases, which is crucial for determining the accuracy of those tests
- They don’t say whether the “cases” had symptoms or not
- They don’t mention anything about hospitalizations or deaths, meaning there is no indication it prevents either
- There is no indication about how long the vaccine lasts if it truly is effective and protective. Some indications suggest you might need to take this vaccine every three to six months in order for it to be effective
Odds Ratios Can Be Misleading
In an article published by the Mises Institute, Dr. Gilbert Berdine, associate professor of medicine at Texas Tech University Health Sciences Center, writes:6
“The Pfizer study had 43,538 participants and was analyzed after 164 cases. So, roughly 150 out 21,750 participants (less than 0.7%) became PCR positive in the control group and about one-tenth that number in the vaccine group became PCR positive.
The Moderna trial had 30,000 participants. There were 95 ‘cases’ in the 15,000 control participants (about 0.6%) and five ‘cases’ in the 15,000 vaccine participants (about one-twentieth of 0.6%). The ‘efficacy’ figures quoted in these announcements are odds ratios …
When the risks of an event are small, odds ratios can be misleading about absolute risk. A more meaningful measure of efficacy would be the number [needed] to vaccinate to prevent one hospitalization or one death. Those numbers are not available.
An estimate of the number [needed] to treat from the Moderna trial to prevent a single ‘case’ would be 15,000 vaccinations to prevent 90 ‘cases’ or 167 vaccinations per ‘case’ prevented, which does not sound nearly as good as 94.5% effective.”
Pfizer’s Number Needed to Vaccinate = 256
In a letter to the editor, Dr. Allan Cunningham, a retired pediatrician in New York, also points out that Pfizer’s 90% effectiveness rating fails to tell the story in a way that people can understand, and goes on to estimate the number needed to vaccinate for Pfizer’s vaccine. He writes:7
“Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000.
This yields a COVID-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a ‘vaccine effectiveness’ of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039).
The Number Needed to Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just one COVID-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them.”
Major Safety Questions Still Remain
Indeed, when it comes to safety, it’s important to realize that since only a few thousand verified healthy volunteers have been exposed to the actual vaccine, the real beta testers will be the masses of people who line up first to take the vaccines when they come to market.
In his article, Berdine stresses he has yet to find a medical colleague who is willing to be among the first to take the experimental vaccine. Most say they want to review the safety data after a year or so of use before they’ll consider getting it.
“These colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination,” Berdine writes. It’s worth noting that none of the trials currently underway include immunocompromised volunteers, so the effects of these vaccines on people with suppressed immune function is wholly unknown.
This is a significant problem, seeing how an estimated 14.7 million to 23.5 million Americans suffer from some form of autoimmune disease,8 and these people are also at increased risk for COVID-19 complications and death.
If the vaccine exacerbates autoimmune problems, the outcome could be devastating for an extraordinary number of people. The volunteers currently enrolled in trials are all healthier than the average American, yet side effects appear commonplace even among this “elite” group.
What You Can Expect From the COVID-19 Vaccine
An October 20, 2020, article9 in the Observer lists the known side effects that have emerged in the various trials. Chills, fever, body aches and headache are the most commonplace, but at least two cases of transverse myelitis — inflammation of the spinal cord — have also occurred.
Even the U.S. Centers for Disease Control and Prevention warns that the vaccine’s side effects are “no walk in the park,”10 and Saad Omer, director of the Yale Institute for Global Health, has stressed the need for a broad-based outreach campaign to discuss the reality of side effects, as patients might not come back for the required second dose if the side effects take them by surprise.11
Dr. Eli Perencevich, a professor of internal medicine and epidemiology at the University of Iowa Health Care, has suggested essential workers should be granted three days of paid leave after they’re vaccinated, as many will feel too sick to work.12
A December 1, 2020, CNBC article,13 which looked at the frequency of adverse reactions, noted that 10% to 15% of participants in the Pfizer and Moderna trials reported “significantly noticeable” side effects.
Buried way down at the bottom of the article is a suggestion from a past advisory committee member, who proposes the nomenclature of “serious adverse reaction” be changed to "immune response," so they can reprogram how people think about these side effects, even if they end up having to stay home from work because of them.
The article also admits they have no idea what, if any, long-term reactions there might be, which means (as we already knew) that this is a great big public health experiment and, of course, anything that happens post-marketing will be labeled a "coincidence."
In related news, a participant in India’s AstraZeneca trial is now suing the company claiming the vaccine caused “serious neurological damage,”14 and a group of researchers warn the COVID-19 vaccines could potentially increase your risk of HIV infection.15 Then there are the concerns about the COVID-19 vaccine permanently altering your DNA, effectively turning you into a transhuman.16 As you can see, there’s a lot to consider before taking this vaccine.”
Of course, the real issue is why is a vaccine needed at all:
“COVID-19 mortality is extremely low outside of nursing homes — 99.7% of people recover from COVID-19.18 If you’re under 60 years of age, your chance of dying from seasonal influenza is greater than your chance of dying from COVID-19.19
- Data clearly show that COVID-19 has not resulted in excess mortality, meaning the same number of people who die in any given year, on average, have died in this year of the pandemic.20,21This is true even among the elderly, as evidenced in a Johns Hopkins University article published just before Thanksgiving. According to the article:22
“The deaths of older people stayed the same before and after COVID-19. Since COVID-19 mainly affects the elderly, experts expected an increase in the percentage of deaths in older age groups. However, this increase is not seen from the CDC data. In fact, the percentages of deaths among all age groups remain relatively the same.”
As soon as the article started trending on Twitter, Johns Hopkins deleted it saying it “was being used to support false and dangerous inaccuracies about the impact of the pandemic.”23
All the references are in the link.
Comments