In a large -scale study, researchers evaluated data from eight countries (excluding Germany) more than 99 million vaccines, and identified the most common side effects of inoculation of new crown vaccines.
64.9 million people in Germany have vaccinated at least once.There are also a few people reporting side effects or complications after vaccination.So what is the world?
A international research team evaluated the data from 99068901 vaccine from ten locations in a large -scale study. The investigators mainly came from Denmark, Finland, France, ScottArgentina, Australia (New South Wales and Victoria), Canada (British Columbia and Ontario) and New Zealand.Data from these countries or regions come from the multinational global vaccine data network (GVDN) funded by the Centers for Disease Control and Prevention.
Researchers focus on the three most common vaccines in the world
Biontech/Pfizers Comingaty (BNT162B2),
Spikevax (mRNA-1273) and
Oxford/ Vaxzevria (Chadox1).
secondary diseases caused by the new crown vaccine may
ResearchThe personnel mainly checked whether there were some "special attention" (AESI) within the risk time window of 0 to 42 days after vaccination of the new crown vaccine."Special Incident" is
The emergency vaccine safety platform used in 2020 to evaluate the safety of vaccine safety.Specifically, including the following 13 "special attention adverse events" (AESI):Nervous system disease
Green-Pali syndrome (muscle weak)
Specifies (spinal inflammation)
Facial paralysis
Acute disseminated cerebral fertilizer (brain inflammation)
Seizure
heat spasm
Hematology disease
E -venous sinus thrombus formation
pulmonary embolism
Throst formation of abnormal parts
platelet plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate plate?Reduction (low platelet level) and immune thrombocytopenia (forming antiplatelet antibody)
Cardiovascular disease
Cardiitis (myocarditis)
ECitis (pericardium inflammation)
ResearchThe assessment is based on the principle of "observation and expected" analysis, that is, the proportion of the expected incidence of certain diseases on the disease after vaccine is not inoculated at a certain time of the window.If the value is higher than 1.5, the researchers attribute it as "statistically signal with statistical significance."
The person involved in this study is a newly vaccinated vaccine and hospitalized in the hospital within 42 days or went to the emergency department or went to the clinic for treatmentpeople.Some countries do not clearly define patients, they use people who contact the hospital to replace them.
Safety signals for vaccination of different vaccines
Researchers recorded the following "statistical safety signal" (OE ratio):
Neurological diseases:
After inoculation of the Astracom vaccine, the OE ratio of the nervous system disease increases.The incidence of Green Bali syndrome (2.49), acute dissemination cerebral policic gelitis (2.23), and transverse corsetitis (1.91) cases increased significantly.Although both WHO and the European Pharmaceutical Administration (EMA) recognize that this side effect is very rare, it is still included in professional information.
Even after injection of only one dose of Moderna vaccine, it is found that acute disseminated encephalitis/encephalitis (3.78) and horizontal corsetitis (1.50) cases have increased significantly.
Other nervous system cases that occur after vaccination have not reached the threshold of the security signal.
Hematology:
In blood system diseases, cerebral venous sinus thrombus formation is particularly common.The most commonly occur after vaccination (3.23).It is expected to occur 21, but 69 incidents are actually observed.The corresponding observation results eventually led to Germanys age restrictions on Astraon vaccination since December 2021.
Inoculation of Biontech/PFFIZER and Moderna vaccine, the OE ratio of the formation of vein sinus thrombus reaches 1.49 and 1.48, but slightly lower than the defined 1.5 limit.
After injecting the third dose of the Astraikon vaccine, the OE ratio of platelet reduction (1.95) and pulmonary embolism (1.88) also observed an increase in increase.
The occurrence of other blood diseases after vaccination does not reach the threshold of the safety signal.
Cardiovascular disease:
There are many cases of myocarditis after using the mRNA vaccine (Biontech/Pfizer and Moderna).Whether it is the first dose, the second dose, the third dose and the fourth dose, the OE ratio is 1.5.The highest values were observed after the first and second dose of Moderna (3.48 and 6.10, respectively).
Inject Moderna and Biontech/PFIZER vaccination, the pericarditis safety signals are also lit. 1.74 and 1.54, respectively.Astracos performance on carditis was significantly better, but the third agent was exception.The OE ratio of the first dose was only 1.29, but the third dose rose to 6.91.
The safety signal of other cardiovascular disease after vaccination does not exceed the threshold.
The two important views of the study and evaluation
Scientists emphasized,
1.5 threshold is relatively high.They wrote: "This value is selected based on expert opinions inside GVDN and CDC. The focus is on the result that is most likely to be regarded as a real signal." "Although some observed events have not reached this threshold, they may still still be stillIt has clinical importance and worthy of further research. "
The vaccination safety signal determined in the study must be requiredCompared with the risk of new crown infection.When evaluating the general risk benefits of vaccination, the risk of these diseases related to the infection of the new crown virus should also be considered."A number of studies have shown that compared with the vaccine, the risk of suffering from Green-Pali syndrome, myocarditis or acute decentralized encephalitis after infection with the new crown virus.In the research in 2022, it concluded that the probability of nervous system events after acute new crown infection is 617 times higher than after vaccination.
Researchers concluded: "This study confirmed the rare security signal found before the new crown vaccine, and provided evidence of several other important results."However, further research is needed to confirm the connection and evaluate the clinical significance.
The new crown vaccine in Germany
The German Paul Erlich Institute (PEI) is responsible for evaluating and monitoring the use of vaccines. The research institute in the final report of its new crown vaccine:
2020 12 2020From March 2023, Germany vaccinated a total of 192208062 vaccination and received a report on 340282 suspected side effects or vaccination complications.This is equivalent to 1,000 timesThere were 1.77 suspected case reports in the vaccination. As of the report, nearly 42% of the peoples health had been restored or improved, and 39% had not recovered or improved.Death.
To put it more specific, Germany vaccinated more than 192 million vaccines and reported 3,315 deaths. Among them, 127 cases have a causal relationship with vaccination with vaccination./p>
Compared with the speculation of the Robert Koch Research Institute (RKI), since the beginning of the great popularity, more than 180,000 deaths are related to the infection of the new crown virus.
