Moderna files for authorization of its COVID-19 Vaccine in young children six months to under six years of age

Excerpt

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that it has submitted an emergency use authorization (EUA) request to the US Food and Drug Administration for its COVID-19 vaccine (mRNA-1273) in children aged 6 months to under 2 years and 2 years to under 6 years, as well as similar requests to international regulatory authorities.

Article Summary

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that it has submitted an emergency use authorization (EUA) request to the US Food and Drug Administration for its COVID-19 vaccine (mRNA-1273) in children aged 6 months to under 2 years and 2 years to under 6 years, as well as similar requests to international regulatory authorities. The requests are based on a 25 μg two-dose primary series of mRNA-1273.

On March 23, 2022, positive interim findings from the Phase 2/3 KidCOVE study were announced, showing a significant neutralising antibody response in the 6 month to under 6 year old age group after a two-dose primary series with mRNA-1273, as well as a favourable safety profile. The antibody titers in the pre-specified 6 to 23 month and 2 to under 6 year age sub-groups met the statistical requirements for similarity to adults in the COVE study, achieving the study’s principal goal. A favourable preliminary efficacy analysis on cases largely collected during the Omicron wave, including home testing for COVID-19, was previously announced.

When the analysis is limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR vaccine efficacy remained significant at 51% (95% 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.

The EUA submission for children aged 6 months to under 6 years will be finished soon. Booster doses are also being investigated by Moderna for all paediatric groups.

The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.

BARDA, part of ASPR within the U.S. HHS is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract.

Source : Moderna

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