The current dose of coronavirus vaccine is still finding its way into fresh arms all around the world. Drug regulators are continuing to examine the vaccinations’ 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 events may not be true safety concerns, and the screening method cannot establish that the vaccine caused these AEI,” stressed the FDA.
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Adverse events of interest (AEI) is the formal designation the FDA applies to events of concern.
The FDA has routinely been using screening methods to monitor the safety of COVID-19 vaccines and to evaluate AEI related to these vaccines.
Near real-time surveillance was one of these approaches, and it found four possible AEIs in the Medicare healthcare claims database of people 65 and older who had received the Pfizer/BioNTech COVID-19 vaccines.
The four potential AEI are pulmonary embolism (a blocked blood vessel in your lungs), acute myocardial infarction (a heart attack), immune thrombocytopenia (a blood disorder), and disseminated intravascular coagulation (a condition whereby blood clots form throughout the body).
“The screening methods have not identified these AEI after vaccination in persons 65 years and older who received the two other authorised COVID-19 vaccines,” noted the FDA.
The drug authority stressed that the development is not a cause for concern.
The FDA noted that it is “sharing the initial findings of this safety study in the spirit of transparency but does not believe there is a cause for concern”.
There are alternative explanations for the findings.
The FDA included the fact that the Pfizer vaccine was given to many high-risk individuals who were older and had significant co-morbidities.
Comorbidity simply means more than one illness or disease occurring in one person at the same time.
FDA continues to closely monitor the safety of the COVID-19 vaccines and will further investigate these findings by conducting more rigorous epidemiological studies.
FDA noted that it will share further updates and information with the public as they become available.
It added that it “strongly believes that the known and potential benefits of COVID-19 vaccination greatly outweigh the known and potential risks of COVID-19
“There is no need to delay vaccination while the FDA continues its investigation.”
It must be stressed that reports of serious side effects from the coronavirus vaccines are very rare.
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COVID-19 vaccines also have to go through several stages of clinical trials before they can be approved for use.
Clinical trials are where a vaccine or medicine is tested on volunteers to make sure it works and is safe.
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