Food and Drug Administration (FDA) officials have approved Pfizer’s COVID-19 vaccine for children ages 5 to 11.
The Vaccines and Related Biological Products Advisory Committee convened Tuesday morning to hear presentations for several hours before it held the vote. The FDA will consider the recommendation before deciding whether to grant emergency authorization for smaller doses vaccine for children in the younger age range.Last week, the pharma company said that the doses were better than 90% effective in children 5-11.To date, fewer than 100 children between 5 and 11 have died from COVID-19 and 8,300 have been hospitalized, said Dr. Peter Marks, who heads the FDA vaccines division, according to The New York Times.
The next phase in this approval process comes next week. The Centers for Disease Control and Prevention (CDC) will then decide whether to recommend the shots and which youngsters should get them.
While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness — including over 8,300 hospitalizations reported, about a third requiring intensive care, and nearly 100 deaths.The dose for young children is just one-third of the Pfizer shot already recommended for everyone 12 and older. Moderna also is studying its vaccine for young children.
One big concern related to the vaccine in children are reports of myocarditis (inflammation of heart tissue) in young men. The panelist indicated the smaller dose would mean such an occurrence would be unlikely.
“We’ve identified a lower dose which we expect is going to decrease the frequency of the rare side effect of myocarditos,” said Dr. Arnold Monto, chairman of the committee an a professor of epidemiology at the University of Michigan.”I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine. “I think that would be an error at this time.”But Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said that was unlikely.Just to reassure the committee, because we are taking an emergency use authorization rather than an approval, in general, although it’s possible that mandates could be put in place, I suppose, in general people have not done mandates with emergency use authorizations and there are certain governors who have already announced that they would not do a mandate until there was an approval as opposed to an emergency use authorization,” Marks said after the vote.
It must be noted that studies in the already-vaccinated show the Pfizer vaccine efficacy decline substantially over time.
A study published on Monday in The Lancet medical journal found that the efficacy of the Pfizer-BioNTech COVID-19 vaccine fell below 50 percent after about six months after the second dose.The Pfizer-funded study found that Pfizer’s vaccine was 88 percent effective in the first month after full vaccination but dropped to 47 percent effectiveness at about six months. The vaccine was also found to be highly effective against the delta variant, which was found to be over 90 percent effective in the first months before dropping to 53 percent effectiveness after four months.
I suspect the same would be true for the kids’ shots as well.
I sure hope, for the sake of the children, the vaccine is as safe as our “experts” are claiming.
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