Evaluating the mRNA COVID-19 vaccines, Part 1: Initially ineffectual?

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There is an increasing number of experts that are questioning the necessity, efficacy, and safety of the mRNA COVID-19 vaccines, leading me to try and summarise some of the more concerning evidences. In part 1 of this 2-part article I explain that it is unclear from the 2020 clinical trial data that the mRNA COVID-19 vaccines were particularly useful, regarding the most severe outcomes. In part 2 I will explain that, as the pandemic has progressed into 2023, and more is known about adverse effects, the vaccines are now probably net harmful.

Introduction

Revisiting two recent analyses of the Pfizer and Moderna mRNA COVID-19 clinical trials I question if it was clear around the start of the COVID-19 pandemic in 2020 that these vaccines provided a significant net benefit, regarding hospitalisations and deaths, or even transmission, with the focus having been on symptomatic infection. As the COVID-19 pandemic has evolved over these past few years, several factors might have us expecting that there are fewer benefits to the vaccines, and more harms. If the net benefit for the vaccines regarding the most serious health outcomes was not obviously above 0, it could now be expected that at this stage of the pandemic, the mRNA COVID-19 vaccines offer no further net use, and could plausibly offer a net harm. I then consider safety signals which may indicate that this is indeed the case.

Net hospitalisation benefit

In a paper published late last year in Elsevier’s Vaccinejournal, Fraiman et al. sought to examine serious adverse events reported in the clinical trials of the Pfizer and Moderna mRNA COVID-19 vaccines. Their findings:

They did not find a clear net benefit with regards to hospitalisations. They might have even found a net deficit. Regarding these “serious adverse events of special interest”, they found an “excess risk”. Not a decreased overall risk. Not a net 0 risk situation, where the potential benefits of the vaccines are balanced with the potential harms. An increased risk. The authors also note several limitations:

Given that there almost certainly would be at least someadverse effects beyond 2 months, and given what we know about the rapid waning in effectiveness, it is plausible that the situation is worse than that indicated by Fraiman et al, who were hampered by the limited data.

Net death benefit

In another paper published by Elsevier, Benn et al. aimed to discover whether the COVID-19 deaths prevented by the vaccines were significantly greater or fewer than the deaths potentially caused by the vaccines, utilising data from the Pfizer and Moderna clinical trials. The authors found: “Based on the RCTs with the longest possible follow-up, mRNA vaccines had no effect on overall mortality despite protecting against fatal COVID-19.” They found no clear net benefit. In fact, echoing the above, there were more deaths in the combined jab group. Not fewer. Not equal. More. Even the presumed benefit on COVID-19 mortality alone, without factoring in deaths potentially caused by the jab, was not found to be statistically significant:

Table 1: Extract from Table 1 in Benn et al.

From Pfizer’s and Moderna’s own clinical trials, conducted in 2020, it was not at all clear that the benefits outweighed the risks, for the most severe metrics possible. Please note that this underwhelming result might even be exaggerated by potential conflicts of interest (such as that the manufacturers are trialling their own products), and the claims made since about non-ideal practices. It is also worth noting that there were more cardiovascular deaths than COVID-19 deaths in these trials, concordant with the fact that annual cardiovascular deaths (approximately 18 million/year) dwarf COVID-19 deaths, even in the earlier and more deadly phase of the pandemic, and that the vaccines appear to be contributing to cardiovascular deaths increasing, due to issues such as blood clotting and myocarditis.

Setting aside that the mRNA vaccines were approved, encouraged, and mandated without the clinical trial data showing a clear net benefit concerning the most severe COVID-19 outcomes (or even a clear gross benefit with regards to deaths), the situation now in 2023 is quite different from that of 2020, when the clinical trials were undertaken. As the pandemic has evolved, there are several reasons to expect that the benefits derived from these vaccines will now be lower, and that the risks should be considered higher, which should have us seriously reconsidering whether the benefits outweigh the risks, especially now.

To be continued…

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Author

  • Raphael Lataster

    Raphael Lataster holds a PhD from the University of Sydney, and occasionally lectures there and at other institutions. His main academic research interests include misinformation, disinformation, and fake news, in Health, Media, and Religion. He currently runs Okay Then News which presents interesting news pieces and journal articles without the biased commentary and rants that are nowadays so common.

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