Moderna Inc. said it expects to report Covid-19 vaccine trial data in children 2-5 years of age in March. The vaccine maker plans to proceed with regulatory filings for children in this age group if the data is supportive and subject to regulatory consultation.
In a statement, the company noted that the U.S. Food and Drug Administration or FDA requested additional participants at a given dose level in pediatric cohorts after the VRBPAC review of requirements for pediatric EUA on June 10, 2021, and Moderna complied at that time.
Outside the United States, Moderna’s vaccine, based on the messenger RNA or mRNA platform, has received regulatory authorizations in Europe, UK, Australia, and Canada for adolescents 12-17 years of age. The company has also submitted applications for children 6-11 years of age.
Moderna said in early December it 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 its ongoing clinical trials.
The company is also evaluating a booster dose in adolescents 12-17 years of age. It is in the process of implementing those various protocol amendments.
Moderna’s Spikevax vaccine is currently authorized by FDA for emergency use as a two-dose primary series, as well as a single booster dose for adults 18 years and older. The vaccine is yet to get full FDA approval. The FDA is reviewing the Biologics License Application for Spikevax and a decision is expected in April 2022.
Moderna CEO Stephane Bancel recently said a fourth COVID-19 vaccine shot might be required for better protection particularly against the rapidly spreading Omicron variant.
The company had earlier said it was working on a vaccine candidate tailored to the Omicron variant of the coronavirus.
The U.S. Centers for Disease Control and Prevention or CDC recently recommended that people take the mRNA COVID-19 vaccines made by Pfizer and Moderna instead of Johnson & Johnson’s single-shot COVID-19 vaccine due to a rare blood clotting disorder.
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