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Covid-19 vaccines: Saving three lives while putting two at risk

The mRNA vaccinations against Covid-19 are seen worldwide as the ultimate saviour to overcome the health crisis. So far, the surprisingly quick approvals by the European Medicines Agency (EMA) have been provisional and are only so-called “conditional approvals”, as there is still too little data on the safety of this vaccine.

Published: June 28, 2021, 10:00 am

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    A peer-reviewed study published online in the journal Vaccines on June 24, 2021 sheds light on this.

    Harald Walach, visiting professor at the University of Witten /Herdecke and professor at the children’s clinic at the Medical University of Poznan, Rainer Klement, medical physicist from the Leopoldina Hospital in Schweinfurt, and Wouter Aukema, an independent data analyst from Holland, took the data from the EMA and the Dutch Pharmacovigilance Centre Lareb under the microscope.

    They offset this against the results of a large Israeli field study that examined the effectiveness of the Pfizer/BioNTech vaccine in more than one million people, as well as the results of the approval studies. According to this, the potential for side effects of the vaccinations is alarmingly high: The Dutch health authorities registered 4,11 deaths with every 100 000 vaccinations, around 700 people suffered side effects for every 100 000 vaccinations, 16 of which were severe.

    “That might be high, but acceptable costs, if the vaccinations could save a lot more lives, but the problem is that the high effectiveness of the vaccination, which has undoubtedly been proven, is only a relative effectiveness,” says Wallach. Nobody looks at the absolute effectiveness, i.e. the clinical effectiveness, according to the doctor. What is meant is the so-called “absolute difference in effectiveness”.

    This is very low with this vaccination for two reasons: The prevalence of the infection is very low, namely around three percent in the control group of the Israeli field study. In Germany, for example, the prevalence of the infection was never higher than eight percent, even at the peak of the wave of infections. The technical term prevalence stands for the rate of people suffering from a certain disease at a certain point in time or in a certain period of time (in relation to the number of those examined).

    The “infection fatality rate”, i.e. the number of people who are infected and die of the disease, is also low at around 0,5 percent. “These two facts taken together mean that the absolute effectiveness of the vaccination is very low, so that you have to vaccinate many people in order to be able to see a real benefit,” emphasized Rainer Klement, who carried out the comparative calculations.

    Since the vaccinations are associated with side effects, a relatively large number of people who have been vaccinated will also suffer such side effects, and the ratio increases compared to the advantages. From the Israeli field study, in which more than half a million people in the control group remained unvaccinated for six weeks, Klement deduced: “You have to vaccinate between 9000 and 50 000 people to prevent death. A good estimate is around 16 000 people. If you extrapolate that to 100 000 vaccinations, we will prevent around six deaths.”

    To compare this with the side effects of the Dutch data, analyst Wouter Aukema examined the side effect database of EMA. “The European countries report very differently,” says Aukema. “The European average is 127 side effects per 100 000 vaccinations. Holland leads the way with 701 cases per 100 000 vaccinations, Poland is last with 15 side effects per 100 000 vaccinations. Germany reports only 38 cases, or 30 percent of the EU average.”

    Based on the Dutch data as an approximation for this, according to the trio of authors, the ratio of deaths that can be expected in connection with the vaccination and that can be prevented by the vaccination is around 2:3. In other words: in order to prevent three deaths, one will have to accept two deaths as a result of the side effects. There are also 700 side effects, 16 of them severe.

    If the data from the approval studies is added, which show slightly better clinical effectiveness, then the ratio is at best 1:8, i.e. one death related to the vaccination and eight prevented deaths due to the vaccination.

    “These numbers can of course change,” says Wallach. “They depend on the sensitivity of the vaccinated groups. Because first the old and sick were vaccinated. One can hope that the relationship will improve if one observes for a longer period of time.”

    It is also unclear whether the data from a field study of the BioNTech vaccine is applicable to the other vaccines. This is because the AstraZeneca vaccine was not included in this analysis because there was no corresponding data on it.

    “At the national level, groups of independent scientists should investigate these side effect reports carefully,” according to Walach. “Because the data from the registers is unsystematic. They can represent an overestimation, but they are more likely an underestimation. Because we know from other studies that up to 95 percent of the side effects are not recorded in these registers.”

    According to Walach, it is difficult to say whether the results of this study are reliable. “We used the best data available at the moment. But they are actually not good enough. However, the fact that a similar study in the US comes to an estimate of 3,4 deaths for every 100 000 vaccinations – a number that is very close to the number we found of 4,11 – shows that our estimate is probably closer in reality.”

    “In any case, we shouldn’t start vaccination campaigns on children,” warned both Wallach and Klement. “Because the risk that a child becomes seriously ill with Covid-19 is very low – less than that of being killed in a traffic accident. Given these risks, vaccinating children is irresponsible.”

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