BMJ: Data collection of over 100 million people in 8 countries to discuss adverse events after COVID-19 vaccination

The COVID-19 vaccine has been developed at an unprecedented speed.
Less than a year after the World Health Organization announced a pandemic, some vaccines’ Phase III clinical efficacy trials reported relevant results
.
Since December 2020, the European Medicines Management Agency, the US Food and Drug Administration and the British Medicines and Healthcare Products Regulatory Agency and other regulatory agencies have approved several vaccines

.

COVID-19 since December 2020, the European Medicines Management Agency, the US Food and Drug Administration and the British Medicines and Healthcare Products Regulatory Agency and other regulatory agencies have approved several vaccines

Although the speed of vaccine development should be recognized, based on limited test data, most vaccines have only been approved for emergency use

.

As with all medicines, vaccine safety must continue to be monitored after obtaining regulatory authorization to supplement the knowledge learned during clinical development

The incidence of adverse events plays an important role in monitoring the safety of vaccines.

Based on this, a research team quantified the background incidence of 15 pre-designated adverse events of special concern (aes) related to the covid-19 vaccine

This transnational network cohort study analyzed electronic health records and health data from eight countries: Australia, France, Germany, Japan, the Netherlands, Spain, the United Kingdom, and the United States.

More than 126 million people were 365 days of observation and mapped to a public data model

This transnational network cohort study analyzed electronic health records and health data from eight countries: Australia, France, Germany, Japan, the Netherlands, Spain, the United Kingdom, and the United States.

Events of interest are 15 pre-designated AESIs (non-hemorrhagic and hemorrhagic stroke, acute myocardial infarction , deep vein thrombosis , pulmonary embolism, allergic reaction, Bell's palsy, myocarditis or pericarditis, narcolepsy, appendicitis, immune platelet reduction, diffuse blood vessels within coagulation, myocardial infarction, thrombotic vascular encephalomyelitis (including acute disseminated encephalomyelitis), Guillain-Barré syndrome, myelitis and cross section)

The results of the study found that the background rate of different databases varies greatly

Some AESIs increase with age

Incidence of 15 adverse events stratified by age and gender

Incidence of 15 adverse events stratified by age and gender

In summary, this study assessed the descriptive epidemiology of the potential AESIs of the covid-19 vaccine

.

In summary, this study assessed the descriptive epidemiology of the potential AESIs of the covid-19 vaccine
.
The observation rates of AESIs in different age groups and genders are very different, which indicates that stratification or standardization is needed before using background rates for safety monitoring
.
Considerable population-level heterogeneity was also found in the AESI rates between databases, which means that individual study estimates should be interpreted with caution, and systematic errors related to database selection should be included in any analysis
.
In summary, this study assessed the descriptive epidemiology of the potential AESIs of the covid-19 vaccine
.
The observation rates of AESIs in different age groups and genders are very different, which indicates that stratification or standardization is needed before using background rates for safety monitoring
.
The observation rates of AESIs in different age groups and genders are very different, which indicates that stratification or standardization is needed before using background rates for safety monitoring
.
The observation rates of AESIs in different age groups and genders are quite different, which indicates that stratification or standardization is needed before using background rates for safety monitoring
.
Considerable population-level heterogeneity was also found in the AESI rates between databases, which means that individual study estimates should be interpreted with caution, and systematic errors related to database selection should be included in any analysis
.

Reference: Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study BMJ 2021; 373 doi: https://doi.
org/10.
1136/bmj.
n1435 (Published 14 June 2021) Cite this as: BMJ 2021;373:n1435

Reference: Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study BMJ 2021; 373 doi: https://doi.
org/10.
1136/bmj.
n1435 (Published 14 June 2021)Cite this as: BMJ 2021;373:n1435 References: Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study BMJ 2021; 373 doi: https://doi .
org / 10.
1136 / bmj.
n1435 (Published 14 June 2021) the Cite the this AS: BMJ 2021; 373: n1435 https://doi.
org/10.
1136/bmj.
n1435 in this message