Last fall Public Health launched another COVID-19 vaccination campaign, this time focused on combating the Omicron BA.4/5 variants, a new set of emerging variants, which were apparently able to completely evade even “Up to Date” vaccine protection. Their new weapon? A new and improved bivalent booster “designed” to neutralize the BA.4/5 variants. This push was backed by Canada's National Advisory Committee on Immunization (NACI) who strongly recommended these Omicron bivalent boosters for anyone 5 years and older. Such a strong recommendation came as a bit of a surprise given that updated guidance published by the CDC in August 2022 acknowledged that the primary series was unable to halt transmission or prevent infection and that additional protection afforded by boosters was short-lived.
When practising evidence-based medicine, such a strong recommendations would necessarily be backed by level 1 evidence: positive results from a randomized trial against a current standard of care. Meeting this high threshold is even more important when working with genetic therapy, the technical classification for mRNA technology, especially as it is being given to healthy people. This article will walk through available evidence supporting use of these bivalent boosters to determine whether there is sufficient evidence to support Public Health claims of “safety and efficacy”.
Walking Through The Evidence
A quick review of the evidence supporting the NACI recommendations showed that their strong endorsement of the bivalent boosters was NOT based on level 1 evidence but rather on NO EVIDENCE AT ALL. In an unprecedented move, NACI recommended these vaccines based on clinical data from a DIFFERENT vaccine, the BA.1 booster.
It is hard to conceive how the attributes of one agent could be inferred based on the activity of an entirely different agent, especially given the unpredictable side-effets profile of gene therapy and evidence that suggests that adverse events increase with each dose of the vaccine. One would at least hope that the data on the BA.1 booster would provide the level 1 evidence that we would need to be assured of its safety. However, a walk through the article published in the NEJM showed that the study was fatally flawed - not only was it not an RCT but it asked the wrong question, assessed the wrong endpoint, misinterpreted efficacy, misrepresented safety, and was biased from the start.
The Wrong Question
At this juncture in the COVID crisis, most Canadians have strong naturally-acquired immunity through multiple exposures to the SARS-CoV-2 virus and 26% of Canadians have received boosters in the last 6 months. The BA.1 booster study compared the Omicron BA.1 booster to the original booster in adults who had received their primary series and at least one booster and had not been recently infected by SARS-CoV-2. Notably, no children were enrolled in the study. As the people enrolled in the study do not represent the majority of Canadians, the results of this trial cannot reasonably be used as the basis for recommending these shots at this time. Even more, the study did not address the most important question, which is how the BA.1 boosters compared to naturally acquired immunity. A recent retrospective study published in the Lancet showed that those with naturally acquired immunity had approximately a 50% lower risk of contracting COVID-19 and a 76% lower risk of contracting severe, critical or fatal COVID-19 than those who had been vaccinated. As the BA.1 study failed to provide information on how the Omicron booster compared to naturally acquired immunity, the clear standard of protection, these trial findings aren't really that helpful.
Assessed the Wrong End-Point
Public health officials claim that the new boosters will prevent serious illness and death from COVID-19. Surprisingly, this was not even assessed in the study. What was assessed was the increase in neutralizing antibodies produced following an injection. Authors argue that this is important as it MAY be linked to lower rates of infection even though both the FDA and the CDC have clearly stated that antibody levels cannot be used as measures of protection.
Authors considered the study a success as more neutralizing antibodies were produced 28 days following the Omicron BA.1 booster compared to the Wuhan booster. It also happened to explore the ability of each booster to prevent symptomatic infection and found a 68% INCREASE in infection rate with the Omicron BA.1 booster compared to the original booster in most participants. Although not measured in the study, it would be a great leap of logic to think that higher rates of infection could lead to lower rates of hospitalization and death.
Also, the study only assessed antibody levels for one month following the Omicron shot. A recent study published in NEJM reporting outcomes for a fourth Pfizer dose at six months showed that elevated antibody levels waned completely by 13 weeks and lead to an increased risk of contracting COVID-19 (ie. negative vaccine effectiveness) from 15 to 26 weeks. If the Omicron booster increases your chance of infection at one month, I think we'd want to assess how they would affect your immune system long-term before recommending them.
One of the main goals of the COVID-19 injections is to prevent symptomatic and severe COVID-19 infections. Although study authors report “no new safety concerns” with the Omicron booster relative to regular booster, their analysis fails to highlight that the majority of people receiving the Omicron booster (>70%) experienced COVID-like symptoms within 7 days of the injection and that these systemic adverse events were severe in 5% of recipients. The bivalent boosters are actually causing 5 out of 100 people to get really sick following the shots.
Biased from the Start
When you see recommendations that are so disconnected from supporting evidence you need to ask if there are conflicted interests at play. Financial conflicts are where we usually start. A review of the disclosures section of BA.1 study revealed that Moderna employees were the ones who designed, executed, and published the study then went on to make $4.7 billion in sales in only 3 months. I am sure they can be trusted.
What about the “independent” advisors at NACI?
When considering conflicts of interest you also need to consider the impact of research support for those involved in making the recommendations. A review of research funding for NACI chairs over the length of the COVID crisis shows a concerning level of conflict.
Dr. Caroline Quach-Thanh, the NACI chair at the time that COVID-19 shots were approved, received a real career boost from the pandemic. Immediately following the declaration of the pandemic in March 2020, Dr. Quach personally received a $2.6 million grant from the CIHR to study various aspects of COVID-19, and went on to receive more than $10 million in grants for studies for which she was a principal investigator from the CIHR.
Dr. Shelley Deeks, the vice-chair of NACI at the time that the pandemic was declared and the chair of NACI when the Omicron booster was approved, benefited greatly from the COVID-19 vaccines. In July 2020, months before there was any data available on the COVID-19 vaccines, Deeks, as a named principal investigator of CIRN, was awarded a $3.5 million “COVID-19 Vaccine Readiness” grant.
Given how Tanh and Deeks’ research careers have greatly profited from the COVID-19 crisis and the associated plan to vaccinate, it is hard to imagine how they could objectively evaluate the merits of the Omicron boosters.
Summing it All Up
This fall Public Health, under the counsel of NACI, promoted the Omicron BA.4/5 boosters to the general public as safe and effective. These recommendations were based outcomes from a study of a different genetic injection, the BA.1 booster, that was rife with flaws. This non-RCT study asked the wrong question, assessed the wrong end-point, incorrectly interpreted effectiveness and misrepresented safety. There is also a concerning degree of conflicted interest at play the COVID-19 guideline process.
One common questions that people ask when they find out that these Public Health is promoting untested vaccines is “If this were true, why are mainstream media and the medical establishment not picking up on it?” There are two reasonable answers to this question, the first is that our team is wrong, to rule out this possibility I encourage you to thoroughly investigate the links to sources and watch our Open Mike interview on the Omicron Boosters for more information. The other is that corporate interests have managed to suppress the truth through selective funding and extensive censorship of both the media and medical establishment. To further consider this possibility, I encourage you to watch our Open Mike Interview on Vaccine Conflicts of Interest.
The COVID sense team thanks you for taking the time review this material and encourages you to take responsibility for your health by making informed health choices. Yours Truly, Deanna and The COVID Sense Team