The current crop of coronavirus vaccines continue to find their way into new arms across the globe. Drug watchdogs continue to monitor the effects of the vaccines as they proliferate within different populations. The Pfizer vaccine came under the FDA’s microscope on Tuesday after it was linked to four concerning complications.
The FDA stressed that “these four events may not be true safety concerns, and the screening method cannot establish that the vaccine caused these AEI”.
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.
One of these methods, called near real-time surveillance, detected four potential AEIs in the Medicare healthcare claims database of persons aged 65 years and older who had received the Pfizer/BioNTech COVID-19 vaccine.
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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”.
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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.
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.
According to the NHS, most side effects are mild and should not last longer than a week.
Common side effects include:
- A sore arm from the injection
- Feeling tired
- A headache
- Feeling achy
- Feeling or being sick.