Below is an overview of some of the factors to consider in this decision regarding the most recent age groups not yet covered by previous US regulatory licenses for COVID-19 vaccines.
How many doses are needed?
Moderna has applied to the U.S. Food and Drug Administration (FDA) to approve a two-dose regimen of its vaccine, called Spikevax, for children ages 6 months to 6 years old. Pfizer has not yet completed enforcement of its FDA clearance, but its clinical trial has tested a three-dose treatment of the vaccine for children 6 months to 5 years old.
Moderna plans to use the 25 mcg dose in this age group, less than the 100 mcg used for the first two doses in adults and 50 mcg used as a booster dose for non-compromised adults. In its clinical trial, Moderna took the two doses 28 days apart.
The Pfizer and BioNTech vaccine, called Comirnaty, has been tested with the 3 microgram formula in children under 5 years old, unlike the 10 microgram version used in children 5 to 11 years old, and the 30 microgram dose is used in people 12 years old. of age and older. In their clinical trial, children received the first two doses about three weeks later, with the third dose given at least three months after the second.
The lower-dose versions should reduce the side effects associated with the vaccines.
How effective are vaccines?
For the Moderna vaccine, in a clinical trial of nearly 6,700 children, the efficacy in preventing accidental infections in children aged 6 months to 2 years was 43.7%, while the efficacy was 37.5% for children aged 2 to 6 years.
There were not enough incidents of COVID-19 among children in the Pfizer-BioNTech trial to produce a definitive effective number. A preliminary analysis based on 10 asymptomatic cases of COVID-19 identified when the omicron coronavirus variant was prevalent, suggested a vaccine efficacy of 80.3% in children under five. Pfizer and BioNTech plan to update these numbers after at least 21 children in the trial developed symptoms of COVID-19.
Are vaccinations for children?
Safety data from 1,678 children in the Pfizer trial showed that side effects were generally comparable to those observed in adults. Pfizer said it chose the low-dose 3 mcg version because of its safety properties. Although it did not disclose specific safety data, it said that a vaccine with this strength was generally as safe as the placebo used in the study.
Moderna’s data showed that any side effects were mostly mild to moderate, with a temperature similar to that experienced after vaccination with other pediatric vaccines. A fever above 104 degrees Fahrenheit was observed in 0.2% of children aged 2 to 6 years and those aged 2 months to 2 years.
Moderna said no reports of myocarditis or pericarditis, two types of heart inflammation that have been linked to mRNA vaccines in rare cases in young adults, have been reported in its trial.
The US Centers for Disease Control and Prevention said, based on Pfizer vaccine data, that rates of carditis were significantly lower in boys ages 5 to 11 than in teens and young adults.
Why vaccinate young children?
If vaccines gain regulatory approval in these age groups, parents will have to decide whether their children will be vaccinated. One question they might ask is whether it was worth it, given that many young children were injured during the Omicron wave. According to experts, the natural immunity weakens over time. The data showed that in older children and adults, those who became infected and got a booster dose had the most protection against COVID-19, according to Dr. Matthew Harris, a pediatric emergency physician at Northwell Health New York.
Vaccines also protect against hospitalization and death, Harris said, describing these important reasons why parents should consider vaccinating their children.
The FDA has set June 15 as the review date for the authorization of Moderna and Pfizer/BioNTech vaccines for these age groups.