Criticisms for new vaccine study
A new paper attempting to determine the ratio of lives saved through COVID-19 vaccination to lives lost has been published in a journal called “Vaccines”. Initially when published it claimed that 3 lives were saved for each one lost, then later an error was corrected and the headline figure was changed to 3 saved for each 2 lost.
In HART’s view, the paper was quite right to urge caution in relation to mass-vaccination of the general population. That such a proposition in relation to entirely novel agents should be controversial perhaps indicates the hysteria surrounding the matter.
However, the paper has been criticised from several quarters, criticisms which do appear to have some validity and it has attracted an expression of concern in this journal.
Proponents of mass vaccination of all adults have made the following points:
- The number needed to vaccinate (“NNTV”) calculations are performed using 6-week data so do not take into account longer protection which might be afforded by vaccination.
- The deaths data is derived from the Dutch safety data registry, from which attribution cannot be determined.
Of note, in relation to attribution, this is always difficult to determine from voluntary adverse event reporting systems, but that doesn’t mean that Regulators should not be closely scrutinising products which are — unusually — being rolled out to 100s of millions with limited controlled short-term safety data and no long-term safety data. One group has in fact performed such an analysis on a sample of USA VAERS data and the results are illuminating, with a preliminary report indicating that in 86% of the first 250 reports of deaths the vaccine may have been a factor, and in 5% it was the most likely cause.
On the other hand, there are many omissions which those urging more caution could level at the paper:
- No comments are made regarding unknown long-term side-effects.
- No consideration is given to pre-existing immunity — now known to have been present to at least prevent severe disease in more than 80%, as shown here and here.
- Immunity from infection is unacknowledged. Even asymptomatic infection is now known to create durable and robust immunity, even for variants. The duration and scope of vaccine-induced protection is unknown.
- The calculations assume a very high CFR (case fatality rate) of 2% whereas in a paper published in October 2020 on the WHO website analysing worldwide data the estimates of IFR (infection fatality rate — which would be lower than the CFR) for those below 70 without comorbidities are a tenth of that.
- No account is taken of the availability of early treatment, now shown to significantly reduce the risk of hospitalisation; see here, for example, the meta analysis published recently in a major journal re ivermectin, and here for the Oxford trial of inhaled budesonide — a commonly available asthma inhaler.
- The efficacy figures quoted for the vaccines are accepted uncritically despite many flaws in methodology becoming apparent, and real-world evidence not meeting expectations. This perhaps is not surprising given that the trials measured mostly mild symptom reduction in the relatively healthy young and middle-aged; the evidence of the ability of the vaccines to reduce Covid-related severe illness — which occurs mostly in the eldelrly or those with comorbidities, especially obesity, is weaker.
The main criticism of this paper however must surely be that the calculations assume a blanket risk-benefit landscape across the entire population; in fact it has always been known that nearly all the Covid risks are in the elderly, and it is now becoming apparent from close scrutiny that serious adverse events appear more common in the young, although this could be an artefact of these events being more distinguishable from background rate in the young.
This means that risk-benefit analyses yield completely different outcomes in different age categories, and that the article did not address this is a major omission.
On balance, therefore, it must be concluded that the main benefit of this article has been to open the debate about risks v benefits, and especially to make people think in terms of absolute risk reduction (as represented by “Number needed to vaccinate” — NNTV) as well as relative risk reductions (eg 95%), which are potentially misleading as a indicator of the benefit afforded by vaccination on an individual basis.
It is gratifying to see even JCVI members pushing back against the “one size fits all” approach to vaccination.
