FDA plans to add warning about rare heart condition to Pfizer, Moderna vaccines
BIRMINGHAM, Ala. (WBRC) - The Food and Drug Administration said it’s adding a warning to COVID-19 MRNA vaccines, as health experts continue investigating reports of myocarditis and pericarditis, the inflammatory heart conditions among young adults and teens who were recently vaccinated.
In general, the cases of myocarditis and pericarditis appear to be rare and mild and usually resolve quickly.
But there have been enough reports of the conditions that the FDA felt it necessary to add the warning.
The decision was announced Wednesday after the CDC’s advisory committee found there’s likely a link between covid vaccines and myocarditis and pericarditis.
Health experts maintain the benefits of MRNA COVID-19 vaccines outweigh the risks.
So why the warning?
“Because it is involving the heart and surrounding tissues around the heart, it is worthy to have the physician look at it,” said Medical Officer of Disease Control for the Alabama Department of Public Health, Dr. Burnestine Taylor.
“So, it’s not necessarily to warn you to make you fearful, but to give you a heads up so you can be watchful and mindful and just not ignore it,” Dr. Taylor said.
She said mostly male patients under the age of 30 have been affected within a couple of weeks of getting either the Moderna or Pfizer vaccine.
Doctors said so far, no cases have been reported with the Johnson & Johnson shot.
“VAERS, which is the Vaccine Adverse Event Reporting System, received over 600 complaints about possibilities of myocarditis and pericarditis. So, what happens when they get those complaints, or reports, they have to go through and verify,” Dr. Taylor explained.
But even with the warning, doctors said the odds of developing myocarditis or pericarditis are extremely rare and still overwhelmingly support COVID vaccines.
“About 180 million United States citizens have had at least one vaccine, and we’re not minimizing these cases, but still, the rates are low enough that it’s not, at this time, any reason to say that you should not get vaccinated,” Dr. Taylor said.
She anticipates this warning will have some impact on people’s decision to get vaccinated, but stresses myocarditis can also show up with getting COVID-19, which would be much more severe without the shot.
Copyright 2021 WBRC. All rights reserved.