FDA approves Moderna’s mRNA COVID-19 shot for at-risk children
The Food and Drug Administration (FDA) has fully approved Moderna’s mRNA COVID-19 shot for at-risk children as young as six months, the drugmaker announced on Thursday.
Spikevax was previously made available to the public under an emergency use authorization. It now has the FDA’s full approval for kids said to at risk of severe disease or death from COVID-19. In June, the FDA ordered Moderna and Pfizer to update their respective COVID-19 vaccine packaging with warnings about myocarditis and pericarditis, two of the most common side effects of the shots. Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the heart lining. Both can be fatal if they go undetected and untreated.
The FDA stopped recommending the COVID-19 shots for the general population in May, instead narrowing the target groups to seniors over 65 and younger Americans with at least one health condition that may increase their risk of severe illness or death. The FDA is also reportedly urging pharmaceutical companies to conduct large, lengthy randomized controlled trials before marketing injections to healthy people—something that was not done with the mRNA shots.
In a recent interview with Tucker Carlson, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. said he is “not satisfied” with the safety of mRNA technology and that the HHS has “a lot of skepticism about mRNA vaccines.”
“The safety studies simply have not been done,” said Kennedy. “But there is enough anecdotal reports of people getting profound injuries that may or may not be associated with it, and we’re going to answer those questions.”
MAHA fury
The FDA’s approval has stung Kennedy’s Make America Healthy Again (MAHA) base, with some slamming the move as a betrayal.
“In a stunning betrayal of both common sense and their duty to protect from unsafe and ineffective pharma interventions the FDA has approved the new Moderna mRNA COVID injection for children despite it being well documented that kids risk from COVID is nearly zero,” said Tom Renz, a renowned lawyer within MAHA circles. “This is NOT science - it is corruption.”
“Moderna's mRNA COVID shot — linked to heart damage, brain damage, cancer, and death — just got FULL FDA APPROVAL for ‘at-risk’ children as young as 6 months,” Nicolas Hulscher, an epidemiologist with the McCollough Foundation, wrote on X. “This is gravely worrisome. Our regulatory agencies are still completely compromised.”
The Independent Medical Alliance (IMA), a group of medical professionals formerly known as the FLCCC, expressed “deep concern” over the news.
“Children face an extremely low risk of severe COVID-19 outcomes, yet the mRNA vaccine carries documented life-altering risks, such as myocarditis and pericarditis, particularly in young males,” said IMA President and Chief Medical Officer Dr. Joseph Varon in a statement. “Our extensive clinical experience and review of data, including large-scale studies revealing elevated risks particularly among young men, lead us to question the necessity of this approval for such a young population.”
“The fact is, we’re seeing continued heart inflammation issues, as well as unexplained re-emergences of cancers and other life-altering complications,” Varon continued. “This move puts America’s children at high risk and is a giant step backward for science-based healthcare.”
