"Usually, concerning medical drugs, the focus of attention is on the frequency of severe adverse, i.e., potentially harmful, events (SAE), whose occurrences range from 'very rare' (< 0.01% of treatments) to 'very common' (≥ 10%)...
[I]n this communication, we are concerned with quantifying the basic balancing relation of harms and benefits of a vaccine introduced...
Applying the same standard for hbr [harm-to-benefit ratio] as for the frequency of SAE when administering medical drugs, it appears reasonable to aim at hbr < 0.1, i.e., at maximum one additional (short-term) SAE in ten prevented ... cases.
Our attention was attracted by the accumulating evidence of adverse events due to the world-wide SARS-CoV-2 vaccination campaign being far more frequent than advertised initially, together with notes of the practically vanishing efficacy of the vaccines against infections with new variants of SARS-CoV-2... [B]eing inherently inquisitive, we had a closer look at the safety and efficacy data published with the available (phase-3) papers on pivotal clinical trials of mRNA/vector vaccines...
[W]e found that only two studies documented a [hbr] ratio lower than one... Figure 1 illustrates at a glance the studies' hbr values and their classification. It is evident that the overall short-term performance of the vaccines 'BNT162b2' and 'mRNA-1273', based on the Supplementary Material published with these studies, can not be rated other than 'harmful', entirely unbalanced. 'Ad26.COV2.S' performs nearly 'harmful', definitely unbalanced. A 'gambling' classification is suitable, because its administration is a bet on unknown long-term harms being less likely then short-term harms already known. Astonishingly enough, the vaccine 'Sputnik V' seems to perform as a 'universal remedy'...
The numbers presented in our Table 1 and Figure 1 have been widely visible since their publication. We wonder why neither a reviewer nor an approving authority seems to have noticed these jaw-dropping values of harm-to-benefit ratios. Us having missed some other vaccine-beneficial rationale would be an explanation of good nature. A crucial question has thus emerged: What scientific data and criteria other than the severe-event harm-to-benefit ratio, or rationales, have the above vaccines' approvals by authorities been exactly based on?"
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