ModernarnModerna, Inc. announced that it has submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a 25 µg two-dose series of Spikevax, the Company's vaccine against COVID-19, in children six months to under six years of age.
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Similar requests are underway with international regulatory authorities and are based on a 25 μg two-dose primary series of mRNA-1273.
Positive interim results from the Phase 2/3 KidCOVE study showed a robust neutralizing antibody response in the six months to under six years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile.
The antibody titers in the pre-specified six months to 23 months and two years to under six years age sub-groups met the statistical criteria for similarity to the adults in the COVE Study, which satisfied the primary objective of the study.
The previously announced results included a supportive preliminary efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19.
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 six 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. In addition, the tolerability profile was generally consistent with that observed in children aged six to under 12, in adolescents aged 12 to 17, and in adults.
The KidCOVE study is an ongoing randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of Spikevax given to healthy children 28 days apart. The study population is divided into three age groups (6 to <12 years, 2 to <6 years, and six months to <2 years).
The 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 (HHS).
The ClinicalTrials.gov identifier is NCT04796896.
On February 24, 2022, the EMA's CHMP adopted a positive opinion recommending marketing authorization for Spikevax to include children six years of age and older. Moderna is currently studying booster doses for all pediatric cohorts.
SPIKEVAX (elasomeran mRNA vaccine) has been granted Conditional Marketing Authorization by the European Commission, based upon the recommendation of the European Medicines Agency, and is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals six years of age and older.
A booster dose may be given at least three months after the second dose for people aged 18 years and older. ■