I wish this were a joke, but it isn’t.
Moderna plans to ask the Food and Drug Administration to authorize its mRNA jabs for infants as young as six months.
The company this morning released partial results from a clinical trial of its shots in 6,700 children up to six years old. The trial showed the mRNA jabs had little benefit in reducing Covid infections and caused fevers in many children, including fevers of more than 104 degrees in a handful.
Moderna claimed in a press release it believes the shots might reduce the risk of severe Covid in young children. But the trial showed nothing of the sort. No children in it had severe Covid, so the company could not evaluate whether the shots actually will have meaningful benefit against serious illness.
The shots reduced the risk of Covid from the Omicron variant in children by only about 40 percent, below the 50 percent level that regulators had generally called the minimum level for approval in 2020.
Recall that the major adult trials from Moderna and Pfizer showed a 95 percent reduction in infections against the original coronavirus variant - a finding that FAR overstated their real-world effectiveness after a few months. A similar decline from the 40 percent trial figure Moderna reported would suggest the potential for negative real-world efficacy - or increased infection risk after vaccination - in months.
The company did not report any details on side effects except for the fever data. About 15 percent of kids had fevers over 100.4 degrees, and 1 in 500 had fevers over 104 degrees, which can require hospitalization. The company did not report whether any children needed to be hospitalized as a result of fevers or other side effects.
Given the weakness of these results and the fact Covid poses almost no risk to kids who are not profoundly ill or morbidly obese, it is not entirely clear why Moderna would try to convince regulators to move ahead. Parents have already been very reluctant to have kids aged five to 12 take Pfizer’s mRNA jab, and surveys suggest even more resistance for younger kids.
But Moderna made clear it does plan to go ahead.
Perhaps Moderna believes regulators will not feel they can say no this late in the game.
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