Almost two years after the Food and Drug Administration (FDA) gave emergency authorization for Pfizer and Moderna’s COVID-19 vaccines, the pharmaceutical giants are launching clinical trials to determine heart risks from their administration.
The FDA ordered the vaccine makers to undertake a series of studies to assess the risks of myocarditis. This is an inflammation of the heart muscle which may result in chest pain and shortness of breath.
Studies show that it has mostly affected older boys and young men who received the COVID-19 vaccines.
Wow. Researchers find Moderna has more myocarditis than Pfizer 👇
Imagine if we had a competent FDA who cared about safety and banned Moderna in men under 40, as I and others suggested repeatedlyhttps://t.co/7XGy96kzkS
— Vinay Prasad MD MPH (@VPrasadMDMPH) November 8, 2022
Pfizer is partnering with the Pediatric Heart Network and focusing on those who were vaccinated and had heart issues afterward.
The FDA-ordered clinical trials will monitor the subjects for five years.
Dr. Dongngan Truong, a pediatrician at the University of Utah Health and co-lead for the study, reported the team has identified to this point over 250 patients with myocarditis.
Initial findings are expected to be released in 2023.
Earlier this month, Florida Surgeon General Joseph Ladapo withstood a firestorm of criticism over the issue. Basing his statement on a state study that linked COVID-19 vaccines to cardiac-related deaths in young men, he advised males 18-39 to avoid getting jabbed.
As it came from the administration of Republican Gov. Ron DeSantis, it quickly drew disfavor and even fury.
However, there are scientists and doctors — and now the FDA — that express concern over the cardiac side effect of COVID-19 vaccines. And even as most continue to promote the first two vaccine doses for young people, boosters have emerged as a troublesome issue.
Pediatric cardiologist Michael Portman of Seattle Children’s Hospital expressed his hesitation to recommend COVID boosters to healthy teenagers.
Portman said he has no desire to “cause panic,” but there needs to be more information on the risk-benefit ratio.
A German study published in “The New England Journal of Medicine” pointed towards an inflammatory response to the vaccine’s spike protein. A cardiac pathologist who helped lead the research said he thinks the body’s reaction to the booster is “really another mechanism” for myocarditis.
And as early as the summer of 2021, the Centers for Disease Control and Prevention released a statement asserting that “an elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed.” The victims were mainly males aged 12-29 years old.