Many parents are said to be relieved that they can now take their toddler or 6-month-old infant for their COVID shots. The federal advisory committee considering the shots voted 22 to zero to recommend Emergency Use Authorization (EUA) for both Pfizer and Moderna injections for children at least 6 months old, and FDA and CDC approved them with lightning speed. Thus, the shots that the federal government already bought and paid for won’t have to be wasted.
The shots only have an EUA, not FDA approval, and you will need to sign a consent form. Some data you might like to consider: As of May, there had been 60,442 adverse events involving liver damage reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS), including 204 in children under age 12. Some involved death or need for a liver transplant.
Evidently, children under age 12 were being given unauthorized shots.
Observers of the hearings pointed out:
· The trials in young children enrolled 4,500 subjects, but 3,000 (67%) dropped out.
· No actual health benefits were shown, so they used “immunobridging”—comparing antibody response to that of older subjects in a previous trial. A number of experts said that antibody response did not correlate well with immunity, especially against the new variants.
· Committee members received risk: benefit documents (190 single-spaced pages) at most two days before the meeting, so they did not have adequate time to study them.
· By fall of 2021, 26 high-quality studies from outside the U.S. showed a two- to seven-fold increased risk of myocarditis (inflammation of the heart) from mRNA shots.
While the shots are “free,” children and their parents will pay the costs of any adverse reactions.
Parents need to do due diligence. In particular, they need to be alert to mild symptoms that could warn of myocarditis. Doctors need to have a “high index of suspicion” for checking blood troponin levels and other indicators of heart damage to allow early diagnosis and treatment.
Jane Orient, M.D., Executive Director, Association of American Physicians and Surgeons, jane@aapsonline.org