Moderna said Monday that the low dose COVID-19 vaccine is safe and appears to work between ages 6 and 11, as the manufacturer joins rival Pfizer in a push to expand vaccinations for children.
Pfizer vaccine doses for children are close to widespread use. They are being evaluated by the FDA for young people of roughly the same age group, 5 to 11 years old, and may be available by early November. The company’s vaccine is already approved for anyone over 12 years old.
Moderna has yet to receive approval to offer its vaccine to teens, but is pending, exploring lower doses for young children.
The researchers tested two vaccinations for children 6 to 11 years old, at monthly intervals, each containing half the adult dose. Preliminary results show that vaccinated children develop antiviral antibodies similar to those produced in young people after full-strength injections, Moderna said.
The study involved 4,753 children aged 6 to 11 years who received the vaccine or pacifiers. Moderna said that, like adults, the vaccinated young people had temporary side effects, including fatigue, headache, fever, and pain at the injection site.
The study was too small to reveal any extremely rare side effects, such as inflammation of the heart, which sometimes occurs after vaccinations with Moderna or Pfizer, mostly among young men.
Moderna did not provide any further details and did not submit its data to a scientific journal, but said it plans to share interim results with the FDA and international regulatory bodies soon. Research is still ongoing and the company cannot calculate the vaccine’s effectiveness in actually preventing infections in children unless there are enough COVID-19 cases to compare rates between vaccinated and unvaccinated participants.
The FDA has yet to rule on the company’s announcement to expand vaccinations for children between the ages of 12 and 17, although some countries have allowed Moderna to vaccinate teens.
But the US is expected to start vaccinating children under 12 sometime next month if the FDA approves low doses of Pfizer vaccine for children ages 5-11. Pfizer reported last week that its pediatric doses were nearly 91% effective in preventing symptomatic COVID-19 in this age group, even though the extra-contagious delta variant is widespread.
FDA advisers will weigh Pfizer’s evidence in a public meeting on Tuesday. If the agency allows Pfizer’s vaccines for children, the Centers for Disease Control and Prevention must recommend who they should be given next week.