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Fear of side effects is one of the most common reasons for not vaccinating against COVID-19. Experts reminded that side effects are rare and usually mild, and that vaccine safety is still being monitored. The results of a huge study of mRNA preparations have just come out. Data was collected after administration of nearly 300 million doses. The work was published in «The Lancet Infectious Diseases». As it turned out?
- The study looked at data from two vaccine safety monitoring systems: VAERS and v-safe. The information came from the patients themselves
- Data from the first six months after the introduction of COVID-19 mRNA vaccines in the United States (December 2020 – June 2021). Over the period studied, over 298 million doses of mRNA vaccines were administered
- Patient self-reported data suggested that most side effects were mild and resolved one or two days after vaccination. What exactly did the analyzes show?
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- More information can be found on the Onet homepage
Concerned about possible side effects from COVID-19 vaccination
The polls carried out since the beginning of the vaccination against COVID-19 show that Poles refusing to immunize most fear that the preparations are not safe. The European Medicines Agency reminds that vaccines meet very strict safety requirements, that possible side effects are rare and mostly mild, and that the effectiveness and safety of vaccines is constantly monitored.
However, it should also be remembered that it is not possible to completely eliminate the risk associated with taking a vaccine, not only the one against COVID-19, but also any other. As experts remind, administration of it causes a reaction of the immune system – antibodies and immune cells are produced. In some cases, the reaction of the immune system may be associated with the so-called vaccine reactions or otherwise – side effects of the vaccine. What can happen? The answer comes from a very large analysis of the effects of mRNA vaccines (Pfizer-BioNTech and Moderny) carried out in the USA (the work was supported by the government agency Centers for Disease Control and Prevention – CDC). The data covers the first six months of vaccination with these preparations (almost 300 million doses have been administered). The study was published on March 7 in The Lancet Infectious Diseases.
The rest of the article is available under the video.
Two complementary monitoring systems were used to confirm the safety profile of mRNA vaccines. The first is the Vaccine Adverse Event Reporting System (VAERS), which has been operating for many years. It is jointly run by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Thanks to VAERS, US residents and, for example, vaccine manufacturers can report any vaccine event. The second is a v-safe system managed by the CDC. This adverse reaction monitoring program was developed specifically for the COVID-19 vaccination campaign. It is based on questionnaires sent to smartphones for the first week after vaccination (daily) and in the following months (at longer intervals).
COVID-19. Side effects of mRNA vaccines. What did the analyzes from the USA show?
The researchers analyzed the information reported by vaccinated people between December 2020 and June 2021. During this period, more than 298 million doses of mRNA vaccines were administered (132 million doses of Moderna and 167 million of Pfizer). As it turned out? A review of the adverse events confirms that most of them were mild, with reactions starting to subside after one day. Here are the details.
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In the analyzed period, the VAERS system received over 340 thousand. reports of side effects. Over 313 (92%) was registered as harmless. Among them were: headache (about 20%), fatigue (17%), fever (16%), chills (16%). Out of over 22 thousand (6,6%) of adverse events registered as serious, the most common was dyspnoea (15%). Approx. 4,5 thousand (1,3%) of the reports were deaths, over 80% of these were people aged 60 or older. It is important to remember that, as COVID-19 vaccines have been approved for emergency use, healthcare professionals are required to report all deaths following vaccination, regardless of any potential direct link to vaccination.
«The rapid rate at which COVID-19 vaccines were administered in emergencies, especially among the elderly population, was unprecedented. Due to age, this group has a higher baseline mortality rate than the general population, and our results are in line with similar patterns of death rates for people in this age group after other adult vaccinations »notes the author of the study, Dr. David Shay of the CDC.
As for the v-safe system, more than half of the nearly 8 million reports concerned local (4,6 million) and systemic (3,6 million) reactions after vaccination (more frequent after the second dose). The most commonly reported side effects were the day after vaccination and almost all were mild. The most common were fatigue (34% after the first dose, 56% after the second), headache (27% after the first dose, 46% after the second) and pain at the injection site (66% after the first dose, 69% after the second dose). after dose two). Less than 1% participants reported that they had sought medical care after any dose of the vaccine.
Safety of mRNA vaccines against COVID-19. «Data calms you down»
«Monitoring the safety of COVID-19 vaccines is the most robust in US history, and two complementary surveillance systems used in this study should increase confidence that COVID-19 mRNA vaccines are safe»- emphasizes the author of the study, Dr. Hannah Rosenblum from the American Center for Disease Control and Prevention (CDC). “Vaccines are the most effective tool for preventing the serious effects of COVID-19, and the benefits of vaccination to prevent major disease and death are strongly conducive to vaccination,” says study author Dr. Hannah Rosenblum of the US Centers for Disease Control and Prevention (CDC).
- Do this immediately after vaccination. The vaccine will work better and increase your immunity
Dr. Tom Shimabukuro, who participated in the study, added: “VAERS and v-safe are important tools that the CDC can use to assess the safety of vaccines and to identify any unexpected or unusual events. These data reassure that the adverse reactions from both mRNA vaccines are generally mild and subside after one or two days. This confirms the reports of clinical trials and post-authorization monitoring«.
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