NEJM: Large-scale research subverts people's perceptions of the side effects of COVID-19 vaccine

The research subverted people's understanding of the side effects of the new crown vaccine

The COVID-19 epidemic caused by the COVID-19 virus (SARS-CoV-2) has affected the world for more than a year, and the number of large-scale vaccinations being carried out globally is unprecedented

Phase 3 clinical trials have shown that several COVID-19 vaccines, including Pfizer/BioNTech’s BNT162b2 mRNA vaccine, have been proven effective, but there are many potential risks of adverse events, including appendicitis, hypersensitivity, and acute myocardial infarction And cerebrovascular accidents

However, due to the small number of participants and the average health of the sample population, a larger-scale safety assessment is required

In the past, people used passive monitoring systems to collect vaccine safety information, which relied on voluntary reports by individuals receiving the vaccine, which would result in incomplete records

The current active monitoring system can compare the target adverse event rate in the large electronic health record database with the background historical rate, which helps to highlight suspicious trends

However, the lack of a strictly constructed control group in the active surveillance system limits the ability to determine the causal relationship between vaccination and adverse events

On August 25, 2021, the Israeli Clalit Institute and the Harvard University research team published a study titled "Safety at The BNT162b2 of Covid-19 mRNA Vaccine in Nationwide Setting" in the New England Journal of Medicine (NEJM) Thesis

The study used the comprehensive database of Israel's largest medical institution to evaluate the safety of the BNT162b2 mRNA vaccine and found that the vaccine was not associated with the increased risk of most adverse events

After the new coronavirus infection, the risk of potentially serious adverse events, such as myocarditis and many other serious adverse events, is greatly increased, and the vaccine actually reduces these risks

In order to provide the necessary background for interpreting the vaccine safety results, this study investigated for the first time various adverse events between vaccinated and non-vaccinated people infected with the coronavirus

The vaccination cohort included 1,736,832 people with an average age of 43 years

Compared with the non-vaccinated group, the risk of adverse events in the vaccinated group was significantly higher than that of the non-vaccinated group: the incidence of myocarditis in the vaccinated group was 2.

In order to provide the background of the above vaccine safety results, the research team conducted a separate analysis-COVID-19 infection cohort analysis

Although the research team found vaccine-related myocarditis, 2.

Other adverse events associated with vaccination include lymphadenopathy (inflammation or swelling of the lymph nodes), which is a mild side effect that is part of the standard immune response to vaccination, every 100,000 unvaccinated coronavirus infections

Compared with relatively few vaccine-related adverse reactions, the incidence of serious adverse events of unvaccinated coronavirus infection is higher, including: arrhythmia (3.
8 times higher than vaccinated persons, 166 cases per 100,000 infections), kidney damage (14.
8 times increase; 125 infections per 100,000 people), pericarditis (5.
4 times increase; 11 infections per 100,000 people), pulmonary embolism (12.
1 times increase; deep vein thrombosis (3.
8 times increase; per 100,000 people) Infection (43 cases), myocardial infarction (4.
5 times increase; 25 cases per 100,000 people) and stroke (2.
1 times increase; 14 cases per 100,000 people currently infected))
.

In short, the largest real-world research data on the side effects of the new coronavirus vaccine shows that the BNT162b2 mRNA vaccine has nothing to do with the increased risk of most adverse events, and serious risks such as myocarditis are actually higher in unvaccinated infected people
.
This study shows that the BNT162b2 mRNA vaccine is very safe
.
This data helps individuals make decisions and eliminates public doubts about the safety of vaccines
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