Drugmaker Moderna announced Monday that its COVID-19 vaccine is safe and generates a strong immune response in children ages 6-11.

What You Need To Know

  • Moderna announced Monday that its COVID-19 vaccine is safe and generates a strong immune response in children ages 6-11

  • The drugmaker tested a 50 microgram dose of the vaccine, which the FDA authorized last week as a booster, in a study of more than 4,700 children; two doses were given 28 days apart

  • One month after inoculation, children in the trial saw an antibody response 1.5 times higher than that of young adults

  • The results come one day before a panel of advisers to the FDA is scheduled to discuss authorizing the Pfizer-BioNTech COVID-19 vaccine for kids 5-11

Moderna tested a 50 microgram dose of the vaccine, which the FDA authorized last week as a booster, in a study of more than 4,700 children. The two doses were given 28 days apart.

One month after inoculation, children in the trial saw an antibody response 1.5 times higher than that of young adults in a similar trial.

The vaccine was "generally well tolerated," according to Moderna, with results similar to those experienced in adolescents and adults. The majority of side effects were "mild or moderate in severity," the most common of which being fever, fatigue, headache and injection site pain.

The company plans to submit its data, which has not yet been peer reviewed, to regulators worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Stéphane Bancel, Chief Executive Officer of Moderna said in a statement. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”

The results come one day before a panel of advisers to the FDA is scheduled to discuss authorizing the Pfizer-BioNTech COVID-19 vaccine for kids 5-11.

Pfizer announced last week that its vaccine is safe and is 91% effective at preventing symptomatic COVID-19 in children ages 5 to 11.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s roughly 28 million 5- to 11-year-olds. If the vaccine is authorized, millions of doses will be promptly shipped around the country, along with kid-size needles.

The shots could begin early next month, with some children fully vaccinated by Christmas, if regulators give their go-ahead.

Moderna's two-dose vaccine is currently authorized for individuals 18 and older. Pfizer's vaccine is fully approved for people 16 and older, and authorized for children 12-15. Johnson & Johnson's single-dose vaccine is also authorized for those 18 and older.

More than 105 million Americans have been fully vaccinated with Pfizer-BioNTech's vaccine, with over 69 million Americans fully protected with Moderna and more than 15 million with Johnson & Johnson, according to data from the Centers for Disease Control and Prevention (CDC).

This is a developing story. Check back later for further udpates.