Independent researchers have re-analyzed the available study data that led to the approval of the two most important corona vaccines. In doing so, they found more serious vaccination side effects than had been mentioned in the official publications. This calls for an explanation – and a demand.
A man walks through the Indian city of Mumbai in early 2022 – in the background a mural depicting the vaccination campaign against Covid-19.
The complication rate for the mRNA vaccines against the new coronavirus appears to have been higher than the manufacturers Pfizer/Biontech and Moderna have stated in their publications. Scientists from America came to this conclusion after assessing the studies that led to the approval of the two vaccines.
Peter Doshi from the University of Maryland and his colleagues used the same data as the vaccine manufacturers. In their calculations, however, they sometimes proceeded differently. To give an example: Unlike the pharmaceutical companies, they did not equate the number of serious side effects with that of the test subjects affected, but rather counted all adverse events of this type. This procedure takes into account the fact that some people have had several complications after the corona vaccination.
Pfizer/Biontech and Moderna under scrutiny
As the scientists write in the journal “Vaccine”, their analyzes have shown that the vaccinated test participants had around 16 percent more serious damage to their health than the test subjects in the placebo group – i.e. those young people and adults who received a pharmacologically ineffective drug in their mouths injected muscle. Pfizer/Biontech’s mRNA vaccine saw a 36 percent increase and Moderna’s increased 6 percent. Calculated per 10,000 people, according to the scientists’ calculations, there were an average of 13 more serious incidents in the vaccinated collective than in the placebo group. At Pfizer/Biontech there were 18 and at Moderna 7.
As far as the type of complications is concerned, heart damage, such as inflammation of the myocardium, as well as thrombosis and other blood clotting disorders took a leading position. According to the American scientists, the results of their calculations suggest that significantly more serious incidents occurred after the application of the mRNA vaccine than after the use of a placebo. In contrast, the American drug agency FDA spoke of a “balanced risk”.
At first glance, it may seem surprising that a number of complications also occurred in the placebo group, i.e. in the group that was sham-vaccinated. However, this observation shows how large the health “background noise” can be and how important it is to measure it. Because not everything that is associated with the new vaccines can actually be attributed to them. And vice versa, the approval-relevant studies are not able to fully record the safety risks of the new vaccines. Their running times are too short and the number of subjects examined is not large enough.
It would be all the more important to thoroughly analyze the results that are already available. This is especially true because they affect a significant proportion of the world population. After all, the new vaccines have now been used millions of times. The increase in information is particularly large if the – albeit anonymous – data of the individual test subjects is evaluated separately and not en bloc.
Peter Doshi, University of Maryland, calls for more transparency
However, such analyzes fail due to the lack of transparency on the part of the vaccine manufacturers. Because they keep the data of their test subjects under lock and key – a common practice that Doshi and several other scientists have denounced for years, and in some cases with success. The pharmacy professor made a significant contribution to the fact that Roche had to make all study data that it had collected as part of the approval of its flu drug Tamiflu available for an independent analysis. As it turned out, this drug has a much lower therapeutic effect than specified by the manufacturer and also has some serious side effects.
Gerd Antes, former head of the Cochrane Center in Germany, also describes the lack of openness among vaccine manufacturers as extremely counterproductive. “There is absolutely no reason to withhold the anonymized data of the test subjects,” the mathematician and medical statistician clarified when asked. “The Cochrane Center – a network of independent researchers that works to ensure that health-related decisions are made on the basis of scientific evidence – has long suffered from the secrecy of pharmaceutical companies,” says Antes.
According to the mathematician, the raw study data shows, among other things, which previous illnesses a test person who had a serious incident suffered from and how long after the vaccination the complication occurred. “This makes it much easier to estimate the probability of the event being due to the immunization,” explains Antes. If pharmaceutical companies, but also academic researchers, were forced to disclose the raw data, it would also be much more difficult to manipulate data, the scientist adds. To give an example: pharmaceutical companies might be tempted to keep the bar for side effects particularly low in the placebo group so that their drug looks particularly good. Such a tendency was discovered by Doshi and his colleagues when studying Moderna. As the study author says when asked, the FDA should have recognized the increased risk of serious side effects of the vaccines and the different classification of such events in Moderna’s studies. Because these were obvious. It is difficult to understand why the authorities did not see this.
No general doubts about the safety of mRNA vaccines
Although questionable, the findings of the American researchers are no reason to fundamentally doubt the safety of the mRNA vaccines. Even Doshi and his colleagues admit that they did not allow such far-reaching conclusions. Two co-authors of the analysis give in one opinion article nevertheless, it should be borne in mind that a comparably high rate of serious side effects – one case per 800 vaccinated people – would hardly be accepted with other vaccines. The two authors, Robert Kaplan from Stanford University and Sander Greenland from the University of California, do not dispute the benefits of the mRNA vaccine. As they point out, these should primarily benefit the elderly and those with chronic illnesses. It is therefore much less clear which groups are particularly threatened by severe vaccination reactions. There may be people who have a low risk of a severe course of Covid-19 but have a high risk of serious vaccination complications. Kaplan and his colleague are therefore appealing to Pfizer, Moderna and the FDA to release all the information necessary to be able to comprehensively assess the vaccines.