Moderna announced last week that it is applying to the FDA to receive emergency use authorization (EUA) for its COVID vaccine in children ages 6 months through 5 years. In the US, this age group comprises approximately 23 million children. Pfizer has also announced that it plans to request EUA for its vaccine in this age group within the next several weeks. Currently, Moderna is approved for children age 6 and up, while Pfizer is approved for ages 5 and up. The FDA has responded that it will likely wait until Pfizer makes its application so that it can consider them side by side. This will likely mean a decision in June with availability of the vaccine a few months after that.
The Moderna application is based on its research study that has involved 6,700 children. The results for a two-dose regimen shows an effectiveness in preventing COVID illness to be between 37% to 51%. This is not as impressive as the results are for adults. It is suggested that perhaps the initial series should be three doses spread out over time instead of two.
The political landscape is especially heating up over the topic since it involves little children. Criticisms are firing from both sides, some people claiming that the process is moving too slow while others claiming it is moving too fast. Many parents are concerned that the rolling back of mask mandates and social distancing requirements, especially in schools, is putting their unvaccinated youngsters at higher risk. However, even though COVID vaccination is available for older children, the CDC data shows that currently only 30% of US children ages 5 to 11 are fully vaccinated.
The question remains as to how crucial is it for children in this lowest age group to get vaccinated? The vast proportion of serious illness and death has been in adults over the age of 65 with relatively few serious illnesses and death in young children. For example, the current US COVID deaths for children less than age 4 is 476 and for children ages 5 to 11 is 357. Compare this to the 995,000 deaths in US adults and it is easy to see that, while any death of a child is tragic and should be prevented whenever possible, this age group is at significantly less risk even without a COVID vaccination.
Perhaps because of the emotionally sensitive nature of a discussion that involves small children, social media has been stirred up with many unfounded claims that the vaccines cause infertility or delayed puberty. The American Academy of Pediatricians has put out a statement on its website rebutting these claims, stating, “Unfounded claims linking COVID-19 vaccines to infertility have been scientifically disproven. There is no evidence that the vaccine can lead to loss of fertility. While fertility was not specifically studied in the clinical trials of the vaccine, no loss of fertility has been reported among trial participants or among the millions who have received the vaccines since their authorization, and no signs of infertility appeared in animal studies. Similarly, there is no evidence that the COVID-19 vaccine affects puberty.”
Both vaccines use mRNA to induce an immune response, and thus antibody production, by coaxing the person’s cells to produce the viral proteins that would be targeted if a real infection occurred. This process of mRNA directed protein production is exactly the same as what would happen if the virus entered the body and took over a person’s cells and did the same thing. Neither of these processes alter the genetic code of the person or their cells which is maintained as DNA, not RNA.
For a look at the history behind concerns around vaccination safety in general and for more in-depth discussion of how the mRNA technology of vaccines works, I recommend that you read the two-part Miler Report series “To Vaccinate or Not to Vaccinate?” that came out on March 29th and April 5th of 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 year olds. You can access these online at www.WMillerMD.com, where you can also find all of my previous articles.