Two weeks ago, a colleague of mine who is a pediatrician had her 2-year-old son vaccinated against COVID. The boy did well with the first dose of the Moderna vaccine, with no reactions or side effects. “The only sign he got vaccinated was the bandage on his thigh,” the mum said. The parents and their older children were already fully immunized, so the mother described feeling comfortable now that all family members finally have some degree of protection, especially as summer vacation approaches. , air travel and visits to 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 U.S. children under age 5 who were not previously eligible for vaccination. It is certainly a welcome development as we battle a further rise in pandemic variants. Let’s look at the data behind it and what permission means for parents like us.
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What vaccines are allowed?
Previously, the Pfizer-BioNTech (Comirnaty) mRNA vaccine was approved for ages 16 and older and received EUA for ages 5-15. The new EUA covers children from 6 months to 4 years old. People over the age of 12 receive two 30 mcg injections given three weeks apart, followed by a booster five months later. Children 5 to 11 years old receive 10 mcg on the same schedule. Children under 5 receive one-tenth the adult dose, 3 mcg, in a primary series of three injections without a booster.
The mRNA vaccine Moderna (Spikevax) has only been officially approved for adults. The new EUA covers all pediatric populations from 6 months to 17 years of age. People over the age of 12 receive two 100 mcg doses four weeks apart, followed by a 50 mcg booster five months later. Children ages 6 to 11 receive two 50 mcg doses and children under 6 receive two 25 mcg doses, with no boosters.
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What is the supporting data?
In a clinical trial involving 4,500 children under the age of 5, the Pfizer pediatric vaccine generated antibody titers similar to those seen in adults after vaccination. Three doses worked better than two. The vaccine was 80% effective in preventing symptomatic COVID infection compared to placebo. Similarly, the Moderna pediatric vaccine solicited an adequate immune response in a trial involving 6,700 children under the age of 6. Its effectiveness against symptomatic COVID was 37% in children 2 to 5 years old and 51% in children 6 to 23 months old. There were not enough cases in either trial to discern protection against serious illness, hospitalization or death. The trials were also too short to monitor “long COVID”. Rates of side effects were similar between the vaccine and placebo groups and most reactions were mild, such as pain at the injection site or low fever.
How have young children been affected by COVID-19?
About 2.5 million children under the age of 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. Rates of infection, hospitalization and death from COVID are several times higher than those from other childhood vaccine-preventable diseases such as rubella, chicken pox and rotavirus. In addition, COVID is disrupting school and family life and affecting children’s mental health.
In conclusion, data from pediatric trials are not as strong as those for adults and adolescents where vaccine efficacy is greater than 90%. This reflects the known decrease in potency of existing vaccines against omicron-derived variants and the low prevalence of severe disease in children. Nonetheless, the benefits and safety were compelling enough for the FDA to grant the EUA and for the CDC and American Academy of Pediatrics to recommend the vaccines for young children. Investigations of boosters in this population are ongoing, as well as the development of vaccines targeting specific variants. However, it will be a long time before a potentially more effective new 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 give our little ones.
Qing Yang and Kevin Parker are married and live in Springfield. Dr. Yang received his medical degree from Yale University School of Medicine and completed his residency training at Massachusetts General Hospital. She is an anesthetist at HSHS Medical Group. Parker has helped formulate and administer public policy for various city and state governments across the country. He previously served as Group Information Director for Education at the Illinois Department of Innovation and Technology. This column is not intended to replace professional medical advice, diagnosis or treatment. The opinions are those of the authors and do not represent the views of their employers.