FDA Delays Moderna for Young Teens Pending Investigation into Heart Inflammation Side Effect

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After four Nordic countries recommended against using Moderna for young children, the FDA is pausing approval of Moderna’s Covid-19 injection for adolescents until it investigates cases of myocarditis, described as an “inflammation of the heart muscle.” The Wall Street Journal reported that the European Medicines Agency safety database recorded three times as many reports of myocarditis among Moderna vaccine recipients than Pfizer-BioNTech recipients. In the US, Moderna’s shot is still pending FDA approval, and the Pfizer-BioNTech jab remains the only injection with to be approved for 12 to 17-year-olds, despite the jab prompting several cases of the exact same heart condition.

The FDA is pausing approval of Moderna’s Covid-19 vaccine until it investigates cases of myocarditis, the Wall Street Journal reports.

According to an anonymous source, the federal regulatory agency is investigating whether the mRNA jab could lead to higher incidences of the supposedly rare side effect, described as an “inflammation of the heart muscle” by the Mayo Clinic, after several Nordic countries recommended against Moderna’s use in young children.

From the WSJ:

The Food and Drug Administration is delaying a decision on authorizing Moderna Inc.’s MRNA -2.31% Covid-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition, according to people familiar with the matter.

After four Nordic countries strengthened their stances against giving Moderna vaccines to younger adults last week, the FDA has been taking another look at the risk of the condition, known as myocarditis, among younger men who took Moderna’s vaccine, especially compared with those who received the vaccine from Pfizer Inc. PFE -0.43% and BioNTech SE, BNTX -1.06% the people said.

So far, the regulators haven’t determined whether there is an elevated risk, the people said. The delay could be several weeks, but the timing is unclear, one of the people said.

Myocarditis cases are reportedly contributing to vaccine-hesitant skepticism over the vaccine.

The Journal notes regulators are being extra cautious after several European countries halted the AstraZeneca vaccine rollout over heart complication issues, with Johnson & Johnson’s Covid vaccine showing similar issues in the US.

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Ragnar D.
Ragnar D.
1 month ago

I predict that the FDA will “investigate” the Moderna poison COVID death shots for the kiddos for a week or two and then say, “Good news, Everybody! We have determined that the Moderna shot is extremely safe for your child.” They might recommend giving a lower dose or spreading them out over a longer time period. But if you’re a Moderna shareholder, don’t worry too much about The Wall Street Journal’s hard hitting news coverage; Moderna and WSJ are owned by the same globalist firms.