Recent FDA approval of a fourth dose of the 2020 coronavirus vaccines for use against modern variants strains credulity as the FDA took this decision in a rare unilateral move without even consulting vaccine advisory committees for those approvals. In fact, those committees have not even met since Fall 2021, leaving the FDA and CDC to act without oversight.

The fact that these approvals, in part, considered on studies that questioned the need or efficacy of the fourth vaccines calls into question the neutrality and motives of this new wave of approvals, even as media discourse continuously cherrypicks data to support the unsupported narrative that last-gen vaccines are effective against the spread of Omicron.

To date, there has been no peer-reviewed double-blind study to evaluate the efficacy of the original wave of vaccines against Omicron or the latest wave of infection, only a raft of poorly designed and problematic observational studies.

One of the most frequently cited, published in the Lancet, was critically flawed in that the vaccinated and unvaccinated groups differed significantly in terms of critical health markers. While the authors claimed the groups were balanced in terms of comorbidities because the triple vaccinated group happened to have higher rates of renal failure, they neglected to consider one of the clearest markers of poor prognosis for COVID infection, BMI, whose means varied more than two full points between their vaccinated and boosted groups (29.27, on average heavily overweight), and unvaccinated (31.58, on average dangerously obese). That those two groups were considered as comparable is flagrantly sloppy, and rather than suggesting that there might be a latent cofounder, was simply ignored, an unavoidable consequence of a poor observational research design.

Another study that also received media attention, although conveniently much of it negative, criticizing the fact that it too was observational, suggested that even mild COVID could shrink brain volumes and cause damage equivalent to ten years of aging. This study, in Nature, was actually more able to control for such confounders as BMI and other health conditions, though some of its critics suggest that brain volumes between the groups prior to COVID infection also differed, suggesting more control issues.

The latest wave of studies in support of fourth vaccine have been some of the most egregious.

A largescale Israeli studies (1, 2), while focusing specifically on Omicron, also falls short because of the potential confounders in its observational design, which they clearly acknowledge (Regev-Yochay et al., 10). Their conclusions, limited as they can be because of research design limitations, as well point to marginal efficacy with such resounding statements as “low efficacy in preventing mild or asymptomatic Omicron infections and the infectious potential of breakthrough cases raise the urgency of next generation vaccine development,” begging the question as to why this study is still cited by many in support of the existing generation of vaccines.

The latest barely attempted any controls whatsoever. What it did was it took simple hospitalization statistics, and than arbitrarily generated expected likelihoods of population numbers appearing in different vaccination groups, and then compared those to the ones actually hospitalized to calculate hazard ratios. Not only were those likelihoods calculated in an opaque manner, with serious questions as to their viability, the same nature that critically flaws observational studies, that another underlying confounder shatters the almost synthetic regression models almost certainly exist, make such studies virtually worthless.

The last real double-blind placebo-controlled test, if such a study can even exist in this era because of the politicization of COVID vaccines and therefore the issue of participation bias masking a confounder, was carried out prior to Omicron, two say nothing of the two later subvariants that have emerged.

Without such a study measuring the effects of any of the now two year old vaccines against a virus that is so distinct from its original iteration, many are now catching COVID for the second or third time in as many years, the argument not only for boosters, but even the effectiveness of the base vaccines against these strains should be in serious question.

Further, the line between the validity of observational versus experimental research designs must be more clearly delineated so that cheap and easily manipulated studies can not be passed off as gold standard science. This not only applies to negligent journalistic practices by science illiterate clickbait authors, but also by epidemiological scientists, the research community, and most importantly, the current cadre of highly corrupt public health officials who time and time again put private interests ahead of human lives.

 

Sources:

https://www.sciencedirect.com/science/article/pii/S2667193X22000448#!

https://assets.researchsquare.com/files/rs-1478439/v1/24514bba-2c9d-4add-9d8f-321f610ed199.pdf?c=1648141784

https://www.cnbc.com/2022/03/29/fda-authorizes-fourth-pfizer-covid-vaccine-dose-for-people-age-50-and-older-.html

https://www.nature.com/articles/s41586-022-04569-5

https://www.nejm.org/doi/full/10.1056/NEJMoa2200674

https://www.cdc.gov/mmwr/volumes/71/wr/mm7113e2.htm

medrxiv.org/content/10.1101/2022.02.15.22270948v1.full.pdf