Massachusetts-based Moderna Inc. issued a statement on January 12, 2022, clarifying its efforts to obtain U.S. FDA authorization to immunize two-to-five-year-old children with the SpikeVax vaccine.
Moderna stated ‘We expect to report data in children 2-5 years of age in March 2022.’
‘If the data is supportive and subject to regulatory consultation, Moderna may proceed with regulatory filings for children 2-5 years of age thereafter.’
The FDA requested additional participants at a given dose level in pediatric cohorts after reviewing requirements for a pediatric authorization on June 10, 2021, and Moderna complied at that time.
In early December 2021, Moderna also decided to evaluate the potential of lower doses to meet regulatory guidance for immunogenicity in children 6-11 years of age and in adolescents 12-17 years of age in our ongoing clinical trials.
The Company is also evaluating a booster dose in adolescents 12-17 years of age. The Company is in the process of implementing those various protocol amendments.
Outside the United States, Moderna has received regulatory authorizations in Europe, the U.K., Australia, and Canada for adolescents 12-17 years of age and has submitted applications for 6-11 years of age.
The SpikeVax COVID-19 Vaccine is a Messenger RNA (mRNA) vaccine targeted against the SARS-CoV-2 betacoronavirus.
SpikeVax’s active ingredient is CX-024414 (single-stranded, 5’-capped mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the S protein of SARS-CoV-2.
Moderna designs its mRNA vaccines using the virus’s sequence, not the coronavirus itself.
As of January 13, 2022, the U.S. NIH’s OpenData Portal reported in vitro Therapeutic Activity against the Omicron virus variant. But, given the breaking nature of Omicron, the data should be interpreted with caution.