FDA Warns Pfizer And Moderna Vaccines May Cause Heart Inflammation.
The FDA, (Federal Drug Association), issued the update warning on Friday, June 25, following an extensive review of information and discussions with the CDC’s (Centre For Disease Control) advisory committee.
The warning noted that reports of adverse events following vaccination – particularly after the second dose – suggest increased risks of myocarditis, which is inflammation of the heart muscle, and pericarditis, or inflammation of the tissue surrounding the heart. Both vaccines are based on mRNA technology which allows for one vaccine to provide protection for multiple diseases, thus decreasing the number of shots necessary for full protection against coronavirus.
At end of the second week of June, over 1,200 cases of myocarditis or pericarditis had been reported to the US Vaccine Adverse Event Reporting System. The cases reportedly appear to be notably higher in males and occurred in the week after the recipients received their second vaccine dose.
The fact sheets for healthcare providers for each vaccine have now been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with the onset of symptoms within a few days after vaccination, the FDA said.
Pfizer announced on June 9 that it will test its vaccine in children under 12 years of age in a larger group of children after having chosen which doses to give them during the early stages of the trial.
The giant pharmaceutical company confirmed that 4,500 children between the ages of six months and 11 years will participate in it’s study spread across 90 clinical centres in Spain, Finland, Poland and the United States.
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