This story appeared in The Hill. Read more here.
Throughout the COVID-19 pandemic, pediatricians have stressed the need to follow the science. That same phrase is repeated often when it comes to COVID-19 vaccine safety and effectiveness for young children. And while this has caused angst for parents of young children at times, the need for data and to ensure safety has been paramount when it comes to vaccinating young children.
However, this week has brought a bit of light and hope to parents of children less than 5 years of age and their pediatricians, who have been holding their breath waiting for what seems like a blue moon occurrence. The turning point comes as Moderna announced that it has applied for FDA authorization of its two dose COVID-19 vaccine for children ages 6 months through 6 years of age after showing that it is safe and has met the established criteria for success, meaning it may be available for children this spring.
First and foremost, Moderna reported that the vaccine is safe in children in this younger age range. In nearly 7,000 children who were enrolled in the trials there were no identified cases of myocarditis, or the rare type of heart inflammation that was seen in mostly male adolescents and young adults who received the mRNA vaccines. As a reminder, the number of those cases remain exceedingly small, mild and self-limited and less than myocarditis rates from COVID-19 infection. The rate of mild and moderate fevers seen after vaccination was similar to that seen for other childhood vaccines and only 14 children, or 0.2 percent, experienced fever higher than 104 degrees.
Additionally, safety data from the Centers for Disease Control and Prevention (CDC) on approximately 8 million doses of the Pfizer vaccine administered in children ages 5 to 11 years of age has shown excellent safety profile in children. The safety data for the Pfizer vaccine in children ages 6 months to 5 years of age is reported to be similarly safe and it was the question of effectiveness, not safety, as to why approval has been delayed for vaccination using this vaccine in this age group. Moderna has found a safe dose in children using a quarter of the adult dose in two shots.
Second, children can and do get COVID-19 and can and do become severely affected by it in some cases.
As of March 23, the CDC reports that 1,092 children have died from COVID-19. The American Academy of Pediatrics reports that nearly 12.8 million children have been diagnosed with COVID-19 over the course of the pandemic. Recent studies have shown that for children as young as 2 to 11 years of age, up to almost 13 percent may experience continued or recurring symptoms, known as long COVID, up to five weeks or more after infection.
While it is true that the rates of severe illness in children may pale in comparison to rates in adults, we must remember that children are generally healthy, have low rates of mortality, and compare COVID-19 to other childhood illnesses. COVID-19 remains in the top 10 causes of death for children in the U.S. since its onset. Hospitalizations increased sharply for young children during the omicron wave. The bottom line is that if childhood hospitalizations and deaths can be prevented by safe and effective vaccine, then we should make every effort to do so.
Third, while the data around the efficacy or effectiveness of the Moderna vaccine in young children is a little more complicated, the studies show that it met the pre-trial efficacy criteria. In plain language, that means this vaccine is likely to keep young children from serious illness or death. This is no small thing in the face of the highly transmissible omicron variant, which proved to be unlike almost anything we have seen previously. The vaccine showed about a 40 percent effectiveness, similar to adult rates during the omicron wave, and booster shots for young children are still being studied and may offer additional protection. Moderna will work to submit their data and ask for formal emergency authorization from the Food and Drug Administration (FDA) as soon as possible.
So while this data has not yet been peer reviewed, it will undergo the rigorous approval process that all COVID-19 vaccines have been subjected to, first requiring FDA approval and then a CDC recommendation. It is disheartening that some people discount the benefit of COVID-19 vaccination because it cannot fully prevent 100 percent of the disease burden. If only it were that easy to create a vaccination to fully protect us against a rapidly changing virus — but it just is not. We should not overstate the purpose of this vaccination but rather acknowledge that it gives us an advantage over this virus.
Vaccinating all children is an important step in continuing to return to our new normal way of life in the United States. We still have a long way to go to vaccinate millions of adults and children over 5 years of age, but this approval opens vaccination to an additional nineteen million children. This would provide protection for almost all children, but especially those with compromised immune systems, those at high risk for severe illness, those living with similar adult populations, and children with special health care needs.
We must continue comprehensive efforts to vaccinate children against COVID-19 while also recognizing the need to increase vaccination rates for all childhood vaccines, as we have seen drastic declines in vaccinations rates due to the pandemic and delayed care. We encourage parents to visit their pediatrician, talk to them about vaccination and to make sure their children are up to date on their immunizations.
We have come so far, and we cannot leave out our littlest and most vulnerable children as we emerge from the night, celebrate the blue moon this opportunity brings, and bask in the bright sunlight of a hopeful, reemergent spring season- fully vaccinated.