Pfizer vaccine side effects: The FDA has linked four “adverse events” to the vaccine, according to a recent report.
On Tuesday, the United States Food and Drug Administration (FDA) linked the Pfizer coronavirus vaccine to four serious occurrences. However, the US Drug Enforcement Administration stated that there is currently no proof of a causative link.
The current generation of coronavirus vaccinations is still finding its way into new arms all across the world. Drug regulators are continuing to evaluate the vaccines’ effects as they spread across diverse communities. On Tuesday, the FDA looked into the Pfizer vaccination after it was connected to four serious side effects.
“These four episodes may not be actual safety concerns,” according to the FDA, and “the screening approach cannot demonstrate that the immunization caused these AEI.”
The FDA uses the term “adverse events of interest” (AEI) to describe incidents of concern.
The FDA has been employing screening procedures to monitor the safety of COVID-19 vaccinations and assess AEI associated with these vaccines on a regular basis.
Near real-time surveillance was one of these ways, and it found four probable AEIs in the Medicare healthcare claims database of people 65 and older who had received the Pfizer/BioNTech COVID-19 vaccination.
Pulmonary embolism (a blood artery in your lungs that is clogged), acute myocardial infarction (a heart attack), immune thrombocytopenia (a blood problem), and disseminated intravascular coagulation are the four possible AEI (a condition whereby blood clots form throughout the body).
“After immunization, the screening procedures have not discovered these AEI in persons 65 years and older who got the two other authorised COVID-19 vaccines,” the FDA stated.
The medication regulator emphasized that the finding is not alarming.
The FDA stated that it is “providing the preliminary findings of this safety research in the spirit of transparency,” but that it “does not believe there is cause for alarm.”
The findings could be explained in a variety of ways.
The FDA mentioned that the Pfizer vaccination was given to a lot of high-risk people who were older and had a lot of co-morbidities.
Comorbidity refers to when a person has more than one ailment or disease at the same time.
The FDA is continuing to closely monitor the safety of the COVID-19 vaccinations and will conduct more thorough epidemiological studies to further evaluate these findings.
The FDA stated that it will provide the public with additional updates and information as they become available.
It went on to say that it “strongly thinks that the known and potential advantages of COVID-19 vaccination vastly outweigh the known and possible risks.”