Moderna revealed Monday that its COVID-19 vaccine elicited a significant immunological response in children and was well-tolerated.

(Photo : Artur Widak/NurPhoto via Getty Images)
Moderna COVID-19 vaccine to submit data to US FDA to vaccinate children ages 12 to 15.

Moderna's COVID-19 Vaccine Proves Higher Antibody Levels

In a recently published article in MSN News, Moderna discovered that children aged 6 to 11 years old who received two 50 microgram doses of the vaccine had 1.5 times greater antibody levels than immunized young adults in their trial.

The dose for the youngsters is half of the 100 micrograms used for the first two adult injections, but the booster shot is the same quantity approved. According to the pharmaceutical company, these youngsters had a "strong neutralizing antibody response" and a "favorable safety profile" with the vaccination, which is comparable with teenage and adult responses.

Meanwhile, the majority of adverse events were mild or severe, with tiredness, headache, fever, and injection site discomfort being the most common symptoms, according to a published report in Euro News. Additionally, more than 4,700 children between the ages of 6 and 11 were enrolled in the study, which will be followed for a year following the second injection.

Read Also: Moderna Claims Its Vaccine Shows a Robust Neutralizing Antibody Response for Children Between the Ages 6 and 11

Moderna Plans To Submit Data To the US FDA

Moderna said that it intends to submit data to the Food and Drug Administration (FDA) and other agencies "in the near future," including in Europe. The data demonstrating efficacy and safety have "encouraged" Moderna CEO Stéphane Bancel.

The CEO said, "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," according to a recently published article in The Hill.

However, Moderna provided an executive summary of the findings, which have yet to be published in a peer-reviewed publication. The news comes only one day before an FDA advisory group will meet to evaluate data on Pfizer-COVID-19 BioNTech's vaccination for children aged 6 to 11.

Children Aged 12 to 15 Years Old Can Get Vaccinated

In May, the FDA approved the Pfizer-BioNTech vaccine for children aged 12 to 15. Moderna said it is continuing to accept children aged 6 months to 5 years old for further studies, with roughly 5,700 youngsters registered in the United States and Canada.

In June, the vaccine producer asked that the FDA provide emergency use authorization for the vaccine to be given to 12-to-17-year-olds, but the FDA has yet to act on that request. Moderna's statistics showed that the COVID-19 vaccination was 100 percent effective against illnesses in that age range, prompting the submission.

Moreover, in a published article in Healthcare Finance, Pfizer's COVID-19 vaccine for children aged 12 to 15 has been granted Emergency Use Authorization by the Food and Drug Administration, making it the first COVID-19 dose accessible for this age range.

The FDA's Emergency Use Authorization for the vaccination in people aged 16 and above, which was approved in December 2020, has now been extended. Adolescents still need two doses of the Pfizer vaccine, three weeks apart. The approval, according to Acting FDA Commissioner Dr. Janet Woodcock, is a "major milestone in the battle against the COVID-19 pandemic."

Related Article: Kids Could Get Pfizer COVID-19 Vaccine by October But Their Dosage Will Be Different From Adults; Here's Why