CAMBRIDGE, MA - Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, 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 -microg two-dose series of Spikevax, the Company's vaccine against COVID-19, in children six months to under six years of age. Similar requests are underway with international regulatory authorities and are based on a 25 ?g two-dose primary series of mRNA-1273.

'We are proud to announce this filing for the use of our COVID-19 vaccine in children six months to under six years of age in the European Union, said Stephane Bancel, Chief Executive Officer of Moderna. 'We believe our vaccine will be able to safely protect this important age group against SARS-CoV-2, which is vital in our continued fight against COVID-19 and will be particularly welcomed by the parents and caregivers of these children.'

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

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