Moderna seeks FDA authorization for its COVID-19 vaccine for children under 6

A pop-up vaccine clinic will be held at the Cristo Rey Church in East Austin on July 24, 2021.

Michael Minasi/KUT

Moderna is hoping to get the green light to give a low-dose vaccine to children ages 6 months to 6 years of age.

In the coming weeks, the pharmaceutical company will submit a request to the Food and Drug Administration for authorization for a two-dose, 25 microgram-each shot. The company said 25% of the first two doses were received by adults.

The need for a vaccine against COVID-19 in infants and young children is why Moderna is working with the FDA and regulators around the world.

In tests, the doses were given to 2,500 children ages 6 months to under 2 and to 4,200 children ages 2 to under 6.

The company said that the doses showed a robust neutralizing antibody response similar to adults, with a favorable safety profile.

In children from 2 to under 6, the efficacy was 37.5%. There were no severe cases of COVID-19.

The study leaves many questions unanswered, such as how long the children were observed after being vaccine free, and whether efficacy could decline over time, according to Dr. Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University.

It is unclear whether protection against severe disease, which is most important, may be greater than protection against milder infections, as has been seen in adults.

The COVID-19 vaccine is available for five year olds. Pfizer has a vaccine for children from 5 to 11 years old, but research shows the effectiveness drops after seven weeks.

Moderna said that the majority of adverse events were mild or moderate.

14.6% of children from 2 to under 6 had the same side effect as the children from 6 months to under 2 years old. The results are in line with other commonly used and recommended vaccines.

There were no reports of myocarditis, or heart inflammation, as a side effect.

The director of the Yale Institute for Global Health said that the protection against severe disease should be higher and that a booster shot should be considered. Moderna is currently testing a booster dose for children from 6 months to 11 years of age, and is planning to submit its vaccine for emergency authorization use for children ages 6 to 11.

Rob Stein said that the FDA usually convenes outside advisers to review data and make a recommendation about whether to authorize a vaccine. The Centers for Disease Control and Prevention can weigh in very quickly.