November 2, 2021

FDA authorizes Pfizer-BioNTech vaccine for children 5 to 11

With the authorization of the Pfizer vaccine for children 5 to 11, parents/guardians must now consider whether to vaccinate their children and allow for unknown vaccine risk (if any) or not vaccinate and worry about the long-term side effects of COVID should their children contract it. Holly Fernandez Lynch spoke to The Washington Post last week.

From The Washington Post

The Food and Drug Administration’s emergency action cleared the first pediatric coronavirus vaccine in the United States — a two-shot regimen administered three weeks apart. The dose, 10 micrograms, is one-third of that used for adolescents and adults. In a clinical trial of 5- to 11-year-olds, the vaccine was almost 91 percent effective at preventing covid-19, the disease caused by the virus. The vaccine’s safety was studied in about 3,100 children who received the shot and had no serious side effects, the agency said.

The debate over the shot points up the complexities of making decisions involving vaccines, which are nearly always intended for healthy people. Covid poses special challenges because “while children are at lower risk of bad outcomes, they are not at no risk,” said Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania.

About 1.9 million children 5 to 11 years old have been infected, and at least 146 have died, according to federal health officials. Those infected are vulnerable to “long-haul covid,” with lingering symptoms including fatigue, brain fog and respiratory problems, and a serious but rare condition called MIS-C, or multisystem inflammatory syndrome, which can cause inflammation of the heart, lungs, kidneys, brain and other organs.

In addition, Lynch said, there are other types of side effects that go beyond the strictly physical: “When children have exposures, they have to stay home from school and parents have to miss work.”

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