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COVID-19 Resource Center

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Moderna announces positive top line data from phase 2/3 study of COVID-19 vaccine in children 6 to 11 years of age. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-top-line-data-phase-23-study-covid-19. Published Oct. 25, 2021. Accessed Oct. 25, 2021.

Disclosures: Bancel is employed by Moderna.
October 25, 2021
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Moderna says vaccine generates ‘robust’ response in kids aged 6-11 years

Source:

Moderna announces positive top line data from phase 2/3 study of COVID-19 vaccine in children 6 to 11 years of age. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-top-line-data-phase-23-study-covid-19. Published Oct. 25, 2021. Accessed Oct. 25, 2021.

Disclosures: Bancel is employed by Moderna.
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Moderna on Monday announced positive topline data from a study of its COVID-19 vaccine in children aged 6 to 11 years, saying it generated a “robust neutralizing antibody response” and had a “favorable safety profile.”

In a press release, the company said it would submit the data to the FDA and other global regulators “in the near term” but did not specify when.

Source: Adobe Stock.
Moderna announced positive topline data for its COVID-19 vaccine in children aged 6 to 11 years. Source: Adobe Stock

The announcement came 1 day before the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to review Pfizer and BioNTech’s request to authorize their vaccine for emergency use in children aged 5 to 11 years, which would make it the first COVID-19 vaccine authorized for children aged younger than 12 years. Pfizer submitted its topline data for that age group on Sept. 28, around a week after announcing it in a press release.

The White House has already announced plans for a nationwide campaign to roll out and promote that vaccine in the young age group, pending its authorization.

The newly reported Moderna data are from the company’s phase 2/3 randomized, observer-blind, placebo-controlled KidCOVE study, which is assessing the vaccine candidate, mRNA-1273, in three age groups: 6 months to less than 2 years old, 2 to less than 6 years old, 6 to 11 years old.

The data released Monday are from a cohort of 4,753 children in the older age group. Children received two 50 µg doses of the vaccine — half the adult dosage, and the same size as Moderna’s booster shot —28 days a part.

According to Moderna, “the SARS-Cov-2-neutralizing antibody geometric mean ratio comparing the response in children to the response in young adults from the phase 3 COVE study was 1.5 (95% Cl, 1.3-1.8), with a seroresponse rate of 99.3%, representing a difference of 0.6% (95% CI, –2.8 to 2.8%) to the phase 3 benchmark,” demonstrating a strong immune response.

The vaccine was “generally well tolerated” by the pediatric participants, with the most common adverse effects being fatigue, headache, fever and injection site pain.

“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,” Moderna CEO Stéphane Bancel, MSc, MBA, said in the release. “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 vaccine has not yet received full approval from the FDA and continues to be administered to adults aged 18 years or older under an emergency use authorization (EUA). Moderna submitted an EUA request for children aged 12 to 17 years in June, but the FDA has still not ruled on it.