Covid-19 vaccines are safe and have not been associated with an increased risk of death, according to data from the US health system. The survey analyzed adverse events reported during the first six months of the SARS-CoV-2 coronavirus vaccination campaign. During this period, formulas with mRNA (messenger RNA) were adopted, such as those of Pfizer and Moderna.
Published in a scientific journal The Lancet, the covid-19 vaccination adverse effects study was developed by researchers at the nation’s Centers for Disease Control and Prevention (CDC). In the research, the team of scientists concluded that 92% of side effects reported after the Pfizer and Moderna vaccines were mild, such as pain at the injection site. In other words, the products are safe to use, as was already known from clinical studies.
“Safety data from more than 298 million doses of COVID-19 mRNA vaccine administered during the first 6 months of the U.S. immunization program show that the majority of reported adverse events were mild and of short duration,” the authors state. . .
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“[É] reassuring that reactions to both mRNA vaccines are generally mild and resolve after a day or two, confirming clinical trial reports and post-authorisation monitoring,” comments Tom Shimabukuro, one of the research authors and member of the CDC, at the BBC.
In the study, the researchers included reports from two US vaccine adverse event tracking systems collected between December 14, 2020 and June 14, 2021:
- Vaccine Adverse Event Reporting System (VAERS): administered by the CDC and the Food and Drug Administration (FDA), the system allows for the inclusion of reports of any possible side effects of vaccination and is open to the public and healthcare professionals;
- V-safe: a more informal reporting system, where individuals can complete an adverse reaction survey via their smartphone.
“Our goal was to review VAERS and v-safe data during the first 6 months of the US vaccination program, when more than 298 million doses of Covid-19 mRNA vaccines were administered, to better characterize the profile safety of mRNA vaccines”, detail the authors of the study.
The vaccine has no impact on the incidence of death in the population
During the period analyzed, the research team pointed out that 340,522 reports of adverse effects were recorded, regardless of their severity. Of this total, 92.1% (313,000) were not serious, 6.6% (22,500) were serious and 1.3% (4,400) resulted in death.
However, the notifications do not necessarily mean that the individual had the complication after applying the covid-19 vaccine. This is because the systems monitor complications in the post-vaccination period, which may include other types of death unrelated to the immunizing agent, such as being crushed or the effect of certain terminal illnesses, like advanced stage cancer.
In the CDC research, the scientists did not study each of the reactions and did not look for associations (or not) that linked the adverse reaction to the covid-19 vaccine, looking for a relationship causal. In this way, the number of deaths can be statistically even lower. On the other hand, it is possible that cases are under-reported, because this is passive surveillance.
Regardless of the two variables, “we found no unusual patterns of cause of death among the death reports received,” explain the study authors. “Similar to overall mortality in the adult population, death notification rates in this analysis increased with age,” they point out.
According to the authors, “The predominance of heart disease as a cause of death reported to VAERS warrants continued monitoring and evaluation, but may be driven by non-specific causes, such as cardiac arrest.”