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A study published in the journal “The Lancet Infectious Diseases” suggests that, for more than 298 million doses of vaccines administered between December 2020 and June 2021, el 92% of reported adverse side effects were not serious and less than 1% of participants recognized the need for medical care after vaccination.
In December 2020, two mRNA vaccines, Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1723), were licensed for use. Both vaccines had shown good safety profiles in clinical trials, with mild effects such as injection site pain, fatigue, and headache were reported as the most common side effects.
As with all vaccines, there are monitoring programs for adverse events that are classified as non-serious, serious or death.
“Vaccines are the most effective tool to prevent serious disease outcomes from Covid-19, and the benefits of immunization in preventing serious disease and death strongly favor vaccination,” says study author Hannah Rosenblum of the US Centers for Disease Control and Prevention (CDC) “COVID-19 vaccine safety tracking is the strongest in US history and the two complementary surveillance systems used in this study should bolster confidence that Covid-19 mRNA vaccines are safe.”
This study analyzed data from these available databases between December 2020 and June 2021 after both doses of the Pfizer-BioNTech or Moderna mRNA vaccines. During the study period, more than 298 million doses of mRNA vaccines (132 million from Moderna and 167 million from Pfizer).
Of 340,522 adverse events reported during the study period, approximately (1.3%) were deaths, with more than 80% of these deaths among people aged 60 and over. Because Covid-19 vaccines have been licensed for emergency use, health care providers are required to report all post-vaccination deaths, regardless of possible direct association. The study authors note that no unusual patterns were detected in the reporting of causes of death.
“The rapid pace at which Covid-19 vaccines were administered under emergency conditions, especially among older populations, was unprecedented. Due to their age, this group already has a higher baseline mortality rate than the general population, and our results follow similar patterns of death rates for people in this age group after other adult vaccines.” David Shay, also of the CDC.
Side effects were most frequently reported the day after vaccination and almost all were mild, with the most
fatigue 34% after dose one, 56% after dose two), headache 27% after dose one, 46% after dose two), and injection site pain 66% after dose one, 69% after dose two.
“These data are reassuring as reactions to both mRNA vaccines are generally mild and resolve after one to two days, confirming reports from clinical trials and post-licensure follow-up,” says the study’s author, Tom Shimabukuro.
In a linked comment, Elizabeth Phillips of Vanderbilt University Medical Center in the US, who was not involved in the study, says that “although approximately 1 in 1,000 people vaccinated may have an adverse effect, the majority of these They are not serious.”
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