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Is the Pfizer Vaccine Safe and Effective for Kids Under 12?
By Bill Hoagland
Children under the age of 12 years are now getting vaccinated for COVID 19. The safety and efficacy of these vaccines for kids is a troubling issue for any parent but it is an issue that unfortunately is not going to go away anytime soon. I was surprised to learn recently that as of September 30, one-fourth of all new COVID infections from July through September involved children younger than 18; in addition, the number of children requiring hospitalization in order to treat COVID infections was at an all-time high in September. So what do we really know about the safety and efficacy of the Pfizer vaccine with regard to children under the age of 12 years?
First, we know that on October 29, the FDA approved the emergency use of the Pfizer vaccine for children between the ages of five and 11. And on November 9, Pfizer released its official report regarding the safety, immunogenicity and efficacy of this vaccine for children between the ages of five and 11 years of age; surprisingly, this report also included partial results of testings on children ranging in age from six months to five years. The Pfizer report was published in the New England Journal of Medicine on November 9. I will summarize that report here but the full report can be obtained at www.nejm.org or if you can’t get it from that website, let me know and I can email a copy.
This trial was conducted from July to September 2021 and involved the administration of a two dose regime, given 21 days apart. There were 2,268 children involved in this Phase III trial and of those children, 1,517 children were given the two dose shots and 751 were given the placebo. They were then tested seven days after the second shot and again one month after the second shot. The children selected were of a variety of racial and ethnic backgrounds and included participants from the US, Spain, Finland and Poland.
Based on the test results, the Pfizer vaccine was determined to be safe and effective by the FDA for children between the ages of five and 11 years of age. After administration of the two shot dose, three children who received the vaccine still contracted COVID and 16 children who received the placebo contracted COVID. We are told that this correlates to a 90.7% efficacy rate. (No, I did not do the math.) More importantly, there were no serious adverse side effects reported, such as myocarditis or anaphylaxis. The side effects that did occur involved primarily injection site soreness, fatigue and headaches, all of which were described as transitory and “mild to moderate”.
The participants in this trial will continue to be followed medically for the next two years. With respect to those children between the ages of six months and five years who were vaccinated, the report indicated that it is too soon to properly evaluate the vaccine for children so young, which means that will have to await further study. (I am frankly surprised that children as young as six months are being vaccinated in a test study at this point, but the hard realism is that we may soon need an effective vaccine for infants too.)
Overall, the Pfizer three-phase testing is encouraging and suggests that the Pfizer vaccine is safe and effective for young children. Among other medical personnel, Dr. Lee Beers, President of the American academy of Pediatrics, strongly recommends that children be vaccinated as soon as possible.
The problems with the Pfizer study are that it does not include many participants between the ages of five and 11, and the follow-up with the participants, performed only one month after the second dose, may not have been long enough to be reliable as to the issue of efficacy. However, when combined with the earlier study done by Pfizer on children between 12 and 18, the combined results were deemed by the FDA to be sufficiently large enough and long enough to justify the emergency authorization for children between five and 11. So with that in mind, I looked at the YouTube podcast run by Christy Risinger, MD., to see what she is saying about the Pfizer vaccine for kids under 12. I don’t always agree with her opinions, but Dr. Risinger seems to be a reasonable person and more importantly, she is an internist with two children of her own under the age of 11. Despite generally being a “pro-vaccine” doctor, she indicated that she is probably going to await further follow-up on the participants in the Pfizer three-phase testing before vaccinating her own children. She concluded by saying that in any event, everyone with young children should consult with and follow the advice of their own pediatrician; that is because some children, due to obesity or other pre-existing conditions, have a greater susceptibility for a COVID infection than others and one rule doesn’t medically suit every child.
These are unnerving times when we have to consider what to do about young children and this horrible disease, especially if we ever reach the point when COVID vaccinations become mandatory for children before they can attend school.
• Bill Hoagland has practiced law in Alton for more than 50 years, but he has spent more than 70 years hunting, fishing and generally being in the great outdoors. His wife, Annie, shares his love of the outdoor life. Much of their spare time is spent on their farm in Calhoun County. Bill can be reached at email@example.com.