Last week, the FDA granted approval for use of both the Pfizer and Moderna vaccines in children as young as 6 months old through the Emergency Use Authorization process. Previously, the vaccines were approved for use down to age 5 for Pfizer and age 6 for Moderna. There are approximately 23 million children in the US who are in the age group of 6 months to 6 years. This approval is based on clinical trials done by both pharmaceutical companies that look at potential side effects and the effectiveness of the vaccine. Both studies were part of ongoing research that has already led to the approval of those vaccines in older children.
The Pfizer study involved 4,500 children up to age 12, of whom 1,678 were under age 5. The Moderna study involved 11,700 children in the same age range with 6,700 being under the age of 6. Both studies showed benefit in preventing symptomatic illness from COVID in fully vaccinated children. The Pfizer vaccine, which involves a total of three shots, was 80% effective in preventing illness, while the Moderna vaccine, which uses only two shots, was about 50% effective. This is for any illness from COVID. We should keep in mind that it is unusual for a small child to become seriously ill with COVID.
Neither vaccine was associated with any serious side effects. The majority of children had no discernable side effects. For those who did, the side effects were what we would expect, namely fever, irritableness, and achiness. One potential, serious side effect that both studies looked for but did not find was myocarditis/pericarditis. It is an inflammation involving the heart muscle or the membrane the encloses the heart. This was of importance because a few cases of this have been reported in young men in their early 20’s following the Moderna vaccine. It is considered a serious but rare complication that typically resolves without problems. There were no cases of myocarditis or pericarditis identified in either the Pfizer or Moderna clinical trials in children.
This week, the CDC followed up the FDA approval with a statement recommending that all children in this age group receive one or the other of the two vaccines. The Pfizer is given as two doses given three weeks apart followed by a third dose two months later. The Moderna is given as just two doses spaced 28 days apart. While some parents are eager to have their children fully vaccinated, others are hesitant or oppose vaccination outright. Only 29% of kids aged 5 to 12 are fully vaccinated despite approval from the FDA since November. It will be interesting to see if the rate of vaccinations for toddlers is any different. The vaccines are expected to become available in another two weeks or so.
A valid question remains: how crucial is it for children in this lowest age group to get vaccinated against COVID? We know that the vast majority of serious illness and death from COVID has been in adults over the age of 65 with very few serious illnesses and death in young children. The current US COVID deaths for children less than age 4 totals 476 since the start of the pandemic. Compare this to the over 1 million deaths in US adults. While any death of a child is tragic and should be prevented, this age group is at significantly less risk even without a COVID vaccination. Also, to further put this in perspective, during that same two-year period of the pandemic there were a total of 54,579 deaths from all causes in children aged 4 or less. During that time, the five leading causes of death in these young children were, in descending order, accidental injuries, birth defects, drowning, cancer, and homicide. At the other end of the age spectrum, during the past two years COVID ranks 3rd behind heart disease and cancer as the leading cause of death in the US for people ages 65 to 84.
Dr. Chris Robshaw, our local pediatrician who practices at Mendocino Coast Clinics in Ft. Bragg had this to say, “Little kids rarely get really sick with COVID. The reason we are recommending vaccination of little kids is so that they don’t act as vectors to spread it to others. Preschools and daycares can be ways that COVID is brought into the home and given to grandparents who then could get really sick.”
As with so many decisions we must make in life, it comes down to how averse we are individually to risk and what our perceptions of those risks are. These risks are then weighed against the benefits, real or perceived.
For a look at the history of vaccination starting back to China in the 1500’s, check out the two-part Miler Report series “To Vaccinate or Not to Vaccinate?” for March 29th, 2021, and April 5th, 2021. The November 23rd, 2021, Miller Report may also be of interest as it looked at safety and benefit of the vaccines in the related age group of 5 to 11. You can access these online at www.WMillerMD.com, where you can also find all of my previous articles.
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