According to a new research, over 298 million vaccination doses administered between December 2020 and June 2021, 92 percent (313,499/340,522) of reported adverse events were not serious, and less than 1% of v-safe participants reported seeking medical treatment following vaccination.
In December 2020, two mRNA COVID-19 vaccinations Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1723) were approved for emergency use in the United States. Both vaccines involved two primary doses and have shown excellent safety profiles in clinical trials, with mild effects such as injection site pain, fatigue, and headache being reported as the most common adverse events.
Anyone in the United States can disclose adverse events through the Vaccine Adverse Event Reporting System (VAERS), a long-standing reporting system managed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). These reports are classified as non-serious, serious, or death . With VAERS, US residents, their healthcare providers, and vaccine manufacturers can submit any event experienced following the vaccination. These surveys are usually conducted daily for the first week after the vaccination (and at longer
Vaccines are the most effective method to prevent serious COVID-19 illness outcomes, and immunisation in preventing serious illness and death are essential to vaccination, according to research authors. COVID-19 vaccination safety surveillance is the most robust in US history, and the two complementary surveillance systems used in this study should bolster confidence that mRNA COVID-19 vaccinations are safe.
Following two doses of either the Pfizer-BioNTech or the Moderna mRNA vaccines, this study examined available VAERS and v-safe self-reported data between December 2020 and June 2021. Over 298 million doses of mRNA vaccinations were administered during the study period (132 million Moderna and 167 million Pfizer).
Over 340,000 people (92%) reported adverse effects during the study, including headache (64,064/340,522 or 20%), fatigue (52,048/340,522 or 17%), fever (51,023/340,522 or 16%), chills (49,234/340,522 or 15%), and pain (47,745/340,522 or 15%). Because COVID-19 vaccinations have been approved under emergency use, healthcare providers are required to disclose all fatalities following vaccination
COVID-19 vaccinations were used in emergency situations, particularly among older people. Due to their age, this group already has a baseline mortality rate than the general population, and our findings follow similar patterns of deaths rates for individuals in this age group following other adult vaccinations, according to Dr David Shay, the CDC.
Over half of the nearly 8 million v-safe participants reported local (4.6 million) and systemic reactions post-vaccination, most often reported after dose one, including fatigue (2,158,229/5,674,420 or 56% after dose one), and injection site pain (4,890,848/5,674,420 or 69% after dose two).
After dose two, more v-safe reports of being unable to work or perform normal tasks were reported, more than after dose one (808,963/6,775,515 or 12%)
VAERS and v-safe, according to the US CDC, are important tools CDC can use in evaluating vaccine safety and to identify unexpected or unexpected events. These data are reassuring that reactions to both mRNA vaccinations are generally mild and subside after one or two days after receiving clinical trials and post-authorization monitoring.
The authors acknowledge some limitations with this research. First, the VAERS system relies on spontaneous reporting and is not representative of the whole population. This also implies that while it can monitor possible safety signals, it cannot define a causal relationship between vaccination and adverse events. Finally, although no VAERS nor v-safe can definitively measure the safety differences between the two vaccines.
According to Elizabeth Phillips, a graduate of Vanderbilt University Medical Center USA, who was not involved in the study, said that the six-month VAERS data has shown that although one in 1,000 people was vaccinated may have an adverse effect, many of them are non-serious. There were no unusual differences in the cause of death or serious adverse effects among VAERS reports. It is reassuring that there were no unexpected signals other than myopericarditis and anaphylaxis,