Two weeks ago, a colleague of mine who’s a pediatric doctor, got her 2-year-old son vaccinated for COVID. The boy did well with the first dose of the Moderna vaccine, with no reactions or side effects. “The only sign that he got a shot was the Band-Aid on his thigh,” said the mom. Both parents and their older children were already fully vaccinated, so the mom described feeling at ease now that everyone in the family finally has some degree of protection, especially as they head into summer vacations, air travel and visits with grandparents.
On June 17, the FDA granted emergency use authorization (EUA) to Pfizer-BioNTech and Moderna vaccines for the prevention of COVID in children as young as 6 months of age. This long-awaited decision expands access to the 19 million American children younger than 5 who were not previously eligible for vaccination. It’s certainly a welcome development as we battle yet another rise of variants in the pandemic. Let’s look at the data behind and what the authorization means for parents like us.
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Which vaccines are authorized?
Previously, the Pfizer-BioNTech mRNA vaccine (Comirnaty) has been approved for ages 16+ and received EUA for ages 5-15. The new EUA covers ages 6 months to 4 years. Those older than 12 receive two shots of 30 mcg administered three weeks apart, followed by a booster five months later. Children 5-11 receive 10 mcg on the same schedule. Those younger than 5 receive one-tenth of the adult dose, 3 mcg, in a three-shot primary series without a booster.
The Moderna mRNA vaccine (Spikevax) has been officially approved only in adults. The new EUA covers all pediatric populations from 6 months to 17 years. Those older than 12 receive two doses of 100 mcg four weeks apart, followed by a 50 mcg booster five months later. Children ages 6-11 receive two 50 mcg doses, and those under 6 receive two 25 mcg doses, without a booster.
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What is the supporting data?
In a clinical trial involving 4,500 children younger than 5, the Pfizer pediatric vaccine generated similar antibody titers as seen in adults after vaccination. Three doses worked better than two. The vaccine was 80% effective at preventing symptomatic COVID infection when compared to placebo. Similarly, the Moderna pediatric vaccine solicited adequate immune response in a trial involving 6,700 children under age 6. Its efficacy against symptomatic COVID was 37% in children ages 2–5, and 51% in children 6-23 months. There were not enough cases in either trial to discern protection against severe illness, hospitalization or death. The trials were also too short to monitor for “long COVID”. The rates of adverse reactions were similar between the vaccine and placebo groups and most of the reactions were mild such as soreness at injection site or low fever.
How have young children been affected by COVID-19?
About 2.5 million children younger than 5 have been infected with COVID since the start of the pandemic, resulting in 4,000 hospitalizations, 2,000 cases of multisystem inflammatory syndrome, and more than 400 deaths. COVID is now the fifth-leading cause of death in this age group. The rates of infection, hospitalization, and deaths from COVID is severalfold that of other vaccine-preventable childhood diseases such as rubella, chickenpox, and rotavirus. Moreover, COVID has been disruptive to school and family life and deleterious to children’s mental health.
In conclusion, the data from the pediatric trials are not as robust as those for adults and adolescents where the vaccine efficacy is above 90%. It reflects the known decreased potency of the existing vaccines against omicron-derived variants and the low prevalence of severe illness in children. Nevertheless, the benefits and safety were convincing enough for the FDA to grant EUA and for the CDC and the American Academy of Pediatrics to recommend the vaccines for young children. Investigations on boosters in this population is underway, as well as development of vaccines targeting specific variants. However, it’ll be a long time before any new and potentially more effective vaccine is tested and approved for children. In the meantime, something is probably better than nothing and vaccination still offers the best protection we can provide for our little ones.
Qing Yang and Kevin Parker are a married couple and live in Springfield. Dr. Yang received her medical degree from Yale University School of Medicine and completed residency training at Massachusetts General Hospital. She is an anesthesiologist at HSHS Medical Group. Parker has helped formulate and administer public policy at various city and state governments around the country. He is formerly the group chief information officer for education with the Illinois Department of Innovation and Technology. This column is not intended to substitute for professional medical advice, diagnosis or treatment. The opinions are those of the writers and do not represent the views of their employers.
