• CDC
  • Heart Failure
  • Cardiovascular Clinical Consult
  • Adult Immunization
  • Hepatic Disease
  • Rare Disorders
  • Pediatric Immunization
  • Implementing The Topcon Ocular Telehealth Platform
  • Weight Management
  • Screening
  • Monkeypox
  • Guidelines
  • Men's Health
  • Psychiatry
  • Allergy
  • Nutrition
  • Women's Health
  • Cardiology
  • Substance Use
  • Pediatrics
  • Kidney Disease
  • Genetics
  • Complimentary & Alternative Medicine
  • Dermatology
  • Endocrinology
  • Oral Medicine
  • Otorhinolaryngologic Diseases
  • Pain
  • Gastrointestinal Disorders
  • Geriatrics
  • Infection
  • Musculoskeletal Disorders
  • Obesity
  • Rheumatology
  • Technology
  • Cancer
  • Nephrology
  • Anemia
  • Neurology
  • Pulmonology

Moderna Announces Filing for Emergency Use Authorization for its COVID-19 Vaccine in Children Under Age 6 Years

Article
©photogranary/AdobeStock

©photogranary/AdobeStock

Moderna announced on Thursday that it had submitted to the US Food and Drug Administration (FDA) a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children aged 6 months to under 2 years and 2 years to under 6 years of age, making it the first manufacturer to do so.

Similar requests are underway with international regulatory authorities, the biotechnology company said in a press release. The requests are based on a 25 µg 2-dose primary series of mRNA-1273.

On March 23, 2022, Moderna announced that interim results from the phase 2/3 KidCOVE study showed a “robust” neutralizing antibody response in participants aged 6 months to <6 years after a 2-dose primary series of mRNA-1273, as well as a favorable safety profile. The antibody titers in the prespecified 6-month to 23-month and 2-years to <6-years age subgroups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study.

These previous interim findings included a supportive preliminary efficacy analysis on COVID-19 cases that were mostly collected during the Omicron wave, including home testing. When the analysis was limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR, vaccine efficacy remained significant at 51% (95% confidence interval [CI]: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 to <6 years.

“These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273,” noted the company in the press release.

Moderna said the EUA submission for children aged 6 months to <6 years will be completed by next week. The company is also currently studying booster doses for all pediatric cohorts.

At this time, mRNA-1273 is only indicated for persons aged ≥18 years.


Recent Videos
"Vaccination is More of a Marathon than a Sprint"
Vaccines are for Kids, Booster Fatigue, and Other Obstacles to Adult Immunization
Document COVID Sequelae and Primary Care: An Interview with Samoon Ahmad, MD
© 2024 MJH Life Sciences

All rights reserved.