Moderna asked the Food and Drug Administration (FDA) today to approve low-dose COVID-19 vaccine shots for children under five. They request emergency use authorization.
There are approximately 18 million children under five in the United States.
In a study of 6,700 children between the ages of six months and five-years with two low-dose Moderna shots, the vaccine was about 51% effective at preventing COVID-19 cases in toddlers and babies, and only about 37% effective in the two to five-year-old group. The Omicron variant is attributed to the low efficacy, and similar findings of the variant evading immunity from vaccines has been reported in adults. The study reported no serious side effects. Pain at the injection site and fever were most the most noted reactions.
In the study, the children received two 25 microgram doses, four weeks apart, which is 25% of the dosage given adults.
Right now in the US, the Moderna COVID-19 vaccine is allowed only for adults. Moderna has applied for distribution to older children, but the FDA has not approved the request yet.
The FDA approved the Pfizer vaccine for children five and older.
COVID-19 isn’t considered to be as dangerous in young people as it is in adults, but some children do have severe illness, and some have died. Since the start of the pandemic, according to the CDC, about 475 children under five have died from COVID-19. Hospitalizations of children have increased since the Omicron variant hit the US.
In spite of the risks from COVID-19, some parents have hesitated to vaccinate their young children. Less than 33% of kids between the ages of five and 11 have had two shots. Only 58% of youngsters 12-17 have had two doses.
However, many anxious families who send their children to school want to vaccinate their children, as highly contagious variants continue to spread and evolve.
Dr. Paul Burton, Chief Medical Officer at Moderna, said, “There is an important unmet medical need here with these youngest kids,” and that two low doses will safely protect them. “I think it is likely that over time they will need additional doses. But we’re working on that.”
Dr. Burton said millions of older children were given Moderna shots outside the US, and the safety data should be reassuring to parents.
Dr. Peter Marks of the FDA’s Center for Biologics Evaluation and Research, said the agency will “move quickly without sacrificing our standards.” The FDA also said that Moderna has to submit more data from its studies before the FDA schedules public debate to discuss the science. It is expected Moderna will do so soon, after which the FDA is expected to make its final decision in June of this year.
After the FDA approves vaccinations, it is up to the CDC to recommend to the public who should receive them.
It remains to the discretion of parents whether they will have their young children vaccinated for COVID-19. Opinion in the US is very divided.