by Arjun Walia, Collective Evolution:
- The Facts:The 95% efficacy of the Pfizer vaccine is widely touted by the media and the medical establishment, but there are important questions to be asked about this claim.
- Reflect On:Are we being given all information available from covid vaccine study to make informed decisions? Are the studies even being done in a way that represents what effects the vaccine may have on the whole population?
Are you going to decline the Covid-19 vaccine if it is offered to you? Why or why not? No matter how certain you are in your reasoning there will no doubt be someone else who feels exactly the opposite to you and will be just as certain of their position. We trust different sources of information, we have had different experiences with vaccines and we have different impressions of the threat of SARS-COV2 to us and our species.
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I would suggest that those in the “vaccine cautionary” community would decline the vaccine based on their ideas around its potential risks. On the other hand, supporters of the vaccine are more likely to focus on its potential benefits. The debate has largely been centered around the disagreement people have about the risks. In this essay I will consider the uncertainty I and others have about its benefits.
Is the Medical Community biased about the Vaccine?
As a contributor to Collective Evolution I am well aware of the “cautionary” perspective on vaccinations and CDC directives. As a physician, I have a reasonable understanding of how those in the medical community regard the “best of what modern science has to offer”. I am part of a Physician group on social media where doctors can seek advice from each other around all matters Covid-19, from interesting cases to rare side effects to how to address special concerns raised by patients. It has been alarming to realize how unilateral the support of vaccination is in this community.
I mean no disrespect to my medical colleagues. Many of those in this community have seen their patients die from this very real virus. They have had to struggle with the divergent directives coming from the CDC. They have had to work through many weeks where Personal Protective Equipment (PPE) was in short supply as their hospital wards rapidly reached capacity and overflowed. Now that the Pfizer and Moderna vaccines have met minimum requirements for efficacy under the Emergency Use Authorization (EUA), they are faced with yet another impediment to getting themselves and their patients through this pandemic: growing skepticism around the vaccine coming from the very same people they are endeavoring to help. Their frustration around the situation is understandable, but is it biasing them?
Before consenting to any intervention it is important to understand its relative risks and benefits. As I mentioned earlier, there has been much concern in the “vaccine cautionary” sphere about side-effects and deaths. Here I will take a closer look at what we know about the benefits of the vaccine based on Pfizer-Biontech’s briefing document to the FDA’s Vaccines and Related Biological Products Advisory Committee. How confident can we be in the efficacy of the vaccine? Has the manufacturer done its due diligence in its analysis and in being transparent? These are the central questions that need to be answered.
Understanding False Positives and Negatives
There has been a lot of discussion about the rate of “false-positives” with regard to the Polymerase Chain Reaction (PCR) test for confirming infection with SARS-COV2. The PCR test can return a positive result even if only trace fragments of the virus are present. Fragments of the virus on a nasal swab is not necessarily representative of an active infection or transmissibility. Moreover the sensitivity of this test is dependent on the number of amplification cycles, or the cycle threshold (Ct), used. The Ct is not standardized. It is not unreasonable to say that there will be a percentage of people who test positive that do not have the disease. Nevertheless, without a better test we as the public must treat all positive PCR tests as an indication of an infection. We must assume the test is right. The rate of false positives, whatever it is, is directly proportional to the overestimation of the prevalence of the disease.
Here I would like to discuss the significance of “false-negatives”. These are people who get a negative PCR result but may still be infected. The rate of false negatives is directly proportional to the underestimation of disease prevalence. This aspect of the inaccuracy of our primary diagnostic test gets relatively little attention for practical reasons. If you are suffering symptoms consistent with Covid-19 but have a negative PCR test we assume that you have Covid-19 anyway. In other words, if someone is symptomatic we assume that the test is wrong, i.e. that it is a false-negative, and necessary measures are taken. We quarantine and isolate until we feel healthy again whether we have Covid-19 or not.
Because we are in the midst of a pandemic we have no choice but to make these assumptions. We are responding appropriately given the limitations of the test. Because of the assumptions we are forced to make, we are exaggerating the prevalence of the disease and our response to it to some extent. It is the nature of the situation we are in.
How do we know that the Vaccine is 95% effective?
With this in mind I would like to discuss a post in the opinion blog of the British Medical Journal (BMJ) that appeared earlier this month. The author, Peter Doshi (PhD and Associate Editor at the BMJ), takes a rigorous look at the results reported by Pfizer regarding the efficacy of their mRNA vaccine. The success of their vaccine has been widely publicized to be 95%. Where exactly does this figure come from?
During the four weeks of observation (three weeks between 1st and 2nd dose followed by 7 days), 162 participants who received the placebo expressed symptoms of Covid-19 and tested positive by PCR. Compare that with only 8 in the group that received their experimental vaccine. The chance of getting Covid 19 after receiving the vaccine was about 20 times lower than if you got the placebo. This is the basis of the claim that their vaccine was 95% effective, well over the 50% threshold required for Emergency Use Authorization that allows their product to be deployed despite the fact that the two-year Phase III trial is still 20 months from completion.
How did Pfizer handle study participants in the “Suspected Covid-19” group?
It is less commonly known that of the nearly 38,000 participants in the Pfizer study, 3,410 fell into a group labeled “suspected Covid-19”. These are people who developed symptoms consistent with disease but tested negative by PCR. 1,594 of those in this group received the vaccine and 1,816 received the placebo. It should be quite clear that how we regard this much bigger group of symptomatic participants will have an enormous impact on the true efficacy of the vaccine. In other words, if we assume that the PCR test was accurate in all of these people and that they didn’t have Covid-19 and developed symptoms from another virus, the flu for example, then the vaccine would in fact be 95% effective as reported. On the other hand, if the PCR test was wrong every time and they all in fact had Covid-19, the efficacy of the vaccine would be much different: 1602 (1594 + 8) in the vaccine wing vs. 1978 (1816 + 162) in the placebo wing results in a vaccine efficacy of only 19%.
The PCR test (like any test) can be wrong some of the time and right some of the time. The true efficacy of the Pfizer vaccine can only be calculated if we know how many symptomatic people in each wing had Covid-19 despite testing negative. It is likely that the percentage of false negatives are different in each arm. As the FDA briefing document on the Pfizer study and the BMJ piece correctly note, there should be fewer false negatives in the vaccine group. Why? It is because there is a greater chance of developing Covid-19 symptoms after receiving the vaccine compared to getting a placebo. Reactogenicity, or the acute response of the body to the vaccine, is common. Most of the acute inflammatory reaction to the vaccine occurs in the first seven days after receiving the vaccine. Looking more closely at the data, 409 patients in the vaccine group developed symptoms in the first seven days after inoculation. Compare this to 287 in the placebo group. If we assume that any participant who expressed symptoms in the first seven days must be suffering from the side effects of the vaccine or the placebo and not a new Covid-19 infection, the efficacy of the vaccine is still only 29%.
How important is this matter of the 3,412 “suspected Covid-19” participants? Let us say hypothetically that we as a nation decide to vaccinate our entire population with the Pfizer vaccine assuming that it has a 95% efficacy in preventing the disease. We can predict that within a month about 6.3% people will develop Covid-like symptoms from something other than vaccine reactogenicity or the disease itself. This is based on the number of participants who became symptomatic (from something other than reactogenicity) despite getting the vaccine and tested negative (1,185) divided by the total number who got the vaccine (18,801) = 0.063. With a population of 300 million we would expect roughly 19 million people to develop symptoms of Covid from something other than SARS-COV2 within a month. We can agree that we must be extremely confident in our assumptions about whether these 19 million people have the disease or not. Why would we assume they all don’t have Covid-19 when the vaccine trial itself considered them to be “suspected” of having it?
There is another extreme possibility. If all of the vaccinated participants who were suspected of Covid-19 truly did not have the disease and all of the unvaccinated (placebo) participants who were suspect did have the disease we would have a true miracle vaccine. Why? It would mean that only 8 people got the disease in the vaccinated group compared to 1978 in the placebo group. This would mean that the vaccine was approximately 99.6% effective.