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This is the largest study of corona vaccines, and these are its conclusions
More than 6 million Americans have been closely monitored since being vaccinated against the corona virus in one of Pfizer & Moderna's mRNA vaccines - what side effects have the researchers identified and what is their conclusion about vaccine safety?
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Tuesday, 12 October 2021, 06:11 Updated: 07:15
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One of the frequent criticisms of the Israeli Ministry of Health and the way it conducts its epidemic treatment policy in front of the public is that it obscures reports of corona vaccine side effects.
A huge and ongoing study conducted in the USA and involving millions of vaccinators, publishes intermediate conclusions from which it emerges - the mRNA vaccines (of Pfizer and Moderna) against the corona virus have no significant side effects.
The study, which has 6 million participants, is being conducted in the United States by both federal and private insurance researchers, with the support and funding of the Centers for Disease Control and Prevention (CDC). 2020, and monitored their health status before and after receiving the vaccine.In this study, researchers will continue to monitor the same people for the next two years, but for now they have published in the Journal of the American Medical Association JAMA their interim conclusions, which indicate that these vaccines are very safe The public.
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To the full article
The study is based on the medical records analysis of 6.2 million people who received one dose of mRNA vaccine against corona, and 5.7 million who received two doses of vaccine.
The researchers who processed the data found no statistical evidence to suggest a link between the vaccine and 23 serious results tested.
These results are probably not the only negative results that can result from the vaccine, but this list has been compiled in consultation with CDC experts and in accordance with side effects that have emerged as suspected in the context of the vaccine or appear to be related to vaccine studies and early clinical trials.
Vaccinated to the corona at the Clalit Health Fund's vaccination complex in Ramat Gan, September 2021 (Photo: Reuven Castro)
Among the symptoms the researchers looked for: neurological disorders such as seizures, encephalitis and Gillian-Barre syndrome, cardiovascular problems such as pulmonary embolism, stroke or myocardial infarction and other serious symptoms such as Bell's palsy, anaphylactic shock and appendicitis.
The researchers found that in the weeks after the vaccine, there was no increase in serious medical conditions among the vaccinated, compared to people who were not vaccinated and also compared to people who passed more than 3 weeks from the date of their vaccination. Although there were a number of cases of serious side effects, they were rare and no strong enough link could be established between them and the vaccine to meet the threshold condition of statistical significance.
"The results of this study are an excellent example of how seriously the CDC addresses the issue of vaccine safety and how thoroughly and transparently we aim in our efforts to monitor vaccine side effects," said Tom Shimbokuro, deputy director of the CDC's Department of Vaccine Safety.
“Our goal is to do the scientific work and communicate quickly and clearly with healthcare providers and the public, while corona vaccines continue to be tested in the most intensive surveillance process ever in U.S. history.
"Immunization has been and still is the best way to protect yourself and your loved ones from a virus that has already claimed the lives of millions of people," he added.
Blood clots and inflammation of the heart muscle
To improve public confidence in corona vaccines, the Vaccine Safety Study has tried to address directly the concerns raised among the public, so for example one of the phenomena examined in the study is an increase in the incidence of blood clots following mRNA vaccines. But no statistical proof was found for it either (it should be noted that a connection was found between this phenomenon and the Astra-Zenka vaccine, which was developed in another technique). Another phenomenon that has arisen as a source of concern is myocarditis, an inflammation of the heart muscle that is probably more typical of young vaccinators. The study had only 34 cases of myocarditis among vaccinators aged 12-39. Most often, the phenomenon occurred within a week of administering the vaccine and almost everyone who suffered from it fully recovered by the conclusion of the study data.
The researchers calculated that for every million doses of vaccine given to the public, there will be an additional 6.3 cases of myocarditis in young men - this figure also does not meet a pre-determined criterion and defines what is a statistically significant phenomenon.
In addition, and as many scientists and physicians have noted, the statistical likelihood of developing myocarditis as a side effect or complication of coronary heart disease is higher.
The public should be aware of the risk-benefit ratio resulting from vaccination within the reality of an active global epidemic, and understand that immunization is still the safest preventative measure, even for young men, but at the same time be alert to possible symptoms, should they choose to be vaccinated.
Americans get vaccinated and follow.
US President Joe Biden receives Corona's third booster dose (Photo: Reuters)
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The researchers also identified in the database 55 cases of severe allergic reactions following the vaccine - almost all occurred within a very short time after the vaccine (about 30 after the injection) where patients were still under close medical supervision (vaccinated with known allergies receive the vaccine under doctor's supervision. As a precautionary measure).
The interim conclusions of the vaccine safety study refer to data that are only valid until June 2021, but in light of the importance of the issue of public trust in vaccines and their safety it was decided to publish the interim conclusions even though it is not yet complete, and of course continue to monitor vaccinators and gather information about possible vaccine side effects.
As mentioned, the information available to researchers so far indicates that the mRNA vaccines against corona from the companies Pfizer and Moderna are a much safer option for the general public than the possibility of being infected with the corona virus itself.
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